CVS and Walgreens Under Fire for Slow Pace of Vaccination in Nursing Homes

The effort to vaccinate some of the country’s most vulnerable residents against covid-19 has been slowed by a federal program that sends retail pharmacists into nursing homes — accompanied by layers of bureaucracy and logistical snafus.

As of Thursday, more than 4.7 million doses of the Pfizer-BioNTech and Moderna covid vaccines had been allocated to the federal pharmacy partnership, which has deputized pharmacy teams from Walgreens and CVS to vaccinate nursing home residents and workers. Since the program started in some states on Dec. 21, however, they have administered about one-quarter of the doses, according to the Centers for Disease Control and Prevention.

Across the country, some nursing home directors and health care officials say the partnership is actually hampering the vaccination process by imposing paperwork and cumbersome corporate policies on facilities that are thinly staffed and reeling from the devastating effects of the coronavirus. They argue that nursing homes are unique medical facilities that would be better served by medical workers who already understand how they operate.

Mississippi’s state health officer, Dr. Thomas Dobbs, said the partnership “has been a fiasco.”

The state has committed 90,000 vaccine doses to the effort, but the pharmacies had administered only 5% of those shots as of Thursday, Dobbs said. Pharmacy officials told him they’re having trouble finding enough people to staff the program.

Dobbs pointed to neighboring Alabama and Louisiana, which he says are vaccinating long-term care residents at four times the rate of Mississippi.

“We’re getting a lot of angry people because it’s going so slowly, and we’re unhappy too,” he said.

Many of the nursing homes that have successfully vaccinated willing residents and staff members are doing so without federal help.

For instance, Los Angeles Jewish Home, with roughly 1,650 staff members and 1,100 residents on four campuses, started vaccinating Dec. 30. By Jan. 11, the home’s medical staff had administered its 1,640th dose. Even the facility’s chief medical director, Noah Marco, helped vaccinate.

The home is in Los Angeles County, which declined to participate in the CVS/Walgreens program. Instead, it has tasked nursing homes with administering vaccines themselves, and is using only Moderna’s easier-to-handle product, which doesn’t need to be stored at ultracold temperatures, like the Pfizer vaccine. (Both vaccines require two doses to offer full protection, spaced 21 to 28 days apart.)

By contrast, Mariner Health Central, which operates 20 nursing homes in California, is relying on the federal partnership for its homes outside of L.A. County. One of them won’t be getting its first doses until next week.

“It’s been so much worse than anybody expected,” said the chain’s chief medical officer, Dr. Karl Steinberg. “That light at the end of the tunnel is dim.”

Nursing homes have experienced some of the worst outbreaks of the pandemic. Though they house less than 1% of the nation’s population, nursing homes have accounted for 37% of deaths, according to the COVID Tracking Project.

Facilities participating in the federal partnership typically schedule three vaccine clinics over the course of nine to 12 weeks. Ideally, those who are eligible and want a vaccine will get the first dose at the first clinic and the second dose three to four weeks later. The third clinic is considered a makeup day for anyone who missed the others. Before administering the vaccines, the pharmacies require the nursing homes to obtain consent from residents and staffers.

Despite the complaints of a slow rollout, CVS and Walgreens said they’re on track to finish giving the first doses by Jan. 25, as promised.

“Everything has gone as planned, save for a few instances where we’ve been challenged or had difficulties making contact with long-term care facilities to schedule clinics,” said Joe Goode, a spokesperson for CVS Health.

Dr. Marcus Plescia, chief medical officer at the Association of State and Territorial Health Officials, acknowledged some delays through the partnership, but said that’s to be expected because this kind of effort has never before been attempted.

“There’s a feeling they’ll get up to speed with it and it will be helpful, as health departments are pretty overstretched,” Plescia said.

But any delay puts lives at risk, said Dr. Michael Wasserman, the immediate past president of the California Association of Long Term Care Medicine.

“I’m about to go nuclear on this,” he said. “There should never be an excuse about people not getting vaccinated. There’s no excuse for delays.”

Bringing in Vaccinators

Nursing homes are equipped with resources that could have helped the vaccination effort — but often aren’t being used.

Most already work with specialized pharmacists who understand the needs of nursing homes and administer medications and yearly vaccinations. These pharmacists know the patients and their medical histories, and are familiar with the apparatus of nursing homes, said Linda Taetz, chief compliance officer for Mariner Health Central.

“It’s not that they aren’t capable,” Taetz said of the retail pharmacists. “They just aren’t embedded in our buildings.”

If a facility participates in the federal program, it can’t use these or any other pharmacists or staffers to vaccinate, said Nicole Howell, executive director for Ombudsman Services of Contra Costa, Solano and Alameda counties.

But many nursing homes would like the flexibility to do so because they believe it would speed the process, help build trust and get more people to say yes to the vaccine, she said.

Howell pointed to West Virginia, which relied primarily on local, independent pharmacies instead of the federal program to vaccinate its nursing home residents.

The state opted against the partnership largely because CVS/Walgreens would have taken weeks to begin shots and Republican Gov. Jim Justice wanted them to start immediately, said Marty Wright, CEO of the West Virginia Health Care Association, which represents the state’s long-term care facilities.

The bulk of the work is being done by more than 60 pharmacies, giving the state greater control over how the doses were distributed, Wright said. The pharmacies were joined by Walgreens in the second week, he said, though not as part of the federal partnership.

“We had more interest from local pharmacies than facilities we could partner them up with,” Wright said. Preliminary estimates show that more than 80% of residents and 60% of staffers in more than 200 homes got a first dose by the end of December, he said.

Goode from CVS said his company’s participation in the program is being led by its long-term care division, which has deep experience with nursing homes. He noted that tens of thousands of nursing homes — about 85% nationally, according to the CDC — have found that reassuring enough to participate.

“That underscores the trust the long-term care community has in CVS and Walgreens,” he said.

Vaccine recipients don’t pay anything out-of-pocket for the shots. The costs of purchasing and administering them are covered by the federal government and health insurance, which means CVS and Walgreens stand to make a lot of money: Medicare is reimbursing $16.94 for the first shot and $28.39 for the second.

Bureaucratic Delays

Technically, federal law doesn’t require nursing homes to obtain written consent for vaccinations.

But CVS and Walgreens require them to get verbal or written consent from residents or family members, which must be documented on forms supplied by the pharmacies.

Goode said consent hasn’t been an impediment so far, but many people on the ground disagree. The requirements have slowed the process as nursing homes collect paper forms and Medicare numbers from residents, said Tracy Greene Mintz, a social worker who owns Senior Care Training, which trains and deploys social workers in more than 100 facilities around California.

In some cases, social workers have mailed paper consent forms to families and waited to get them back, she said.

“The facilities are busy trying to keep residents alive,” Greene Mintz said. “If you want to get paid from Medicare, do your own paperwork,” she suggested to CVS and Walgreens.

Scheduling has also been a challenge for some nursing homes, partly because people who are actively sick with covid shouldn’t be vaccinated, the CDC advises.

“If something comes up — say, an entire building becomes covid-positive — you don’t want the pharmacists coming because nobody is going to get the vaccine,” said Taetz of Mariner Health.

Both pharmacy companies say they work with facilities to reschedule when necessary. That happened at Windsor Chico Creek Care and Rehabilitation in Chico, California, where a clinic was pushed back a day because the facility was awaiting covid test results for residents. Melissa Cabrera, who manages the facility’s infection control, described the process as streamlined and professional.

In Illinois, about 12,000 of the state’s roughly 55,000 nursing home residents had received their first dose by Sunday, mostly through the CVS/Walgreens partnership, said Matt Hartman, executive director of the Illinois Health Care Association.

While Hartman hopes the pharmacies will finish administering the first round by the end of the month, he noted that there’s a lot of “headache” around scheduling the clinics, especially when homes have outbreaks.

“Are we happy that we haven’t gotten through round one and West Virginia is done?” he asked. “Absolutely not.”

KHN correspondent Rachana Pradhan contributed to this report.

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Journalists Examine How Covid Polarizes Communities

California Healthline senior correspondent Anna Maria Barry-Jester discussed public health backlash on WABE’s “Did You Wash Your Hands?” on Jan. 5.

KHN Colorado correspondent Rae Ellen Bichell dissected how covid-19 exacerbates tensions between counties in Colorado on NPR’s “Weekend Edition” on Jan. 9.

KHN chief Washington correspondent Julie Rovner talked about mental health care and the pandemic on WAMU/NPR’s “1A” on Jan. 11.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Geography Is Destiny: Dentists’ Access to Covid Shots Depends on Where They Live

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Dr. Monte Junker, an Oregon dentist, is waiting for his turn to get vaccinated for covid even though he considers himself a front-line health worker.

“If they offered it to me today, I would be there,” he said.

In December, just before the first vaccines were cleared for emergency use, the Centers for Disease Control and Prevention immunization advisory board recommended that health care workers — as well as nursing home residents and staff members — be the first to be inoculated because of their high risks of infection.

But Oregon is one of a handful of states, including Colorado, North Carolina and Texas, that have put dentists lower in priority order than other health professionals who treat patients — even though they have their hands in people’s mouths and are exposed to aerosols that spray germs in their faces during procedures.

As a result, dentists in those states must wait while many of their peers got their shots in December.

Dr. Tam Le, president of the Connecticut State Dental Association, was vaccinated in December along with employees at his practice in Cheshire. He said he lobbied the state to include dentists with other front-line hospital and health workers.

“In Connecticut, we are doing really well,” he said, noting that the state set up an online registration system for eligible health workers and then contacted them about when and where they could get the vaccine. Le said he and his staff went to a nearby community health center for their shots.

Dentists gained goodwill from state officials last spring by donating gloves and masks to hospitals, Le said. They also offered to help administer the shots since they have experience with that.

States are increasingly diverging from CDC guidance in their vaccination plans, according to an analysis by KFF. “Timelines vary significantly across states, regardless of priority group, resulting in a vaccine rollout labyrinth across the country,” the report said. (KHN is an editorially independent program of KFF.)

The American Dental Association said it’s aware that the lack of a national immunization strategy has meant that dentists and their staffs are not being treated equally across the country.

The CDC advisory board included dentists when it recommended that front-line health workers get priority.

“Each state government’s approach to vaccination will be different based on populations and need, but all dental team members should be prioritized in the first-tier distribution as the vaccines roll out by the different state and county public health departments,” said Daniel Klemmedson, the ADA president. An oral surgeon in Arizona, he has been vaccinated.

In Florida, dentists and their staffs are included among front-line workers eligible for vaccines in the first wave, but a lack of supply has hindered some from getting their shots, according to Drew Eason, CEO of the Florida Dental Association. Some county health departments have also incorrectly turned dentists away, he added.

Dr. Cindy Roark, a Boca Raton dentist and chief clinical officer of Sage Dental, which has 15 offices in Florida and Georgia, said she has no idea when she’ll get vaccinated. She said Georgia dentists in her company have been vaccinated, while those in Florida must wait. The only exceptions appear to be the relatively few dentists affiliated with hospitals. “We are equally vulnerable,” she said.

Still, Roark said she is not upset. “I know I can protect myself,” she said, adding that her office staffers wear N95 masks, face shields and gloves to protect themselves and patients. “Most dentists feel completely safe running their practice and preventing transmission.”

Junker, regional dental director at Advantage Dental in The Dalles, Oregon, said he understands that intensive care staff members, emergency department workers and the elderly in nursing homes need the vaccine first.

“But we are definitely up there for the copious quantities of aerosol in our faces each day,” he said. “The atmosphere is highly concentrated” with virus.

He’s upset at the poor planning and coordination between states and the federal government to make dentists a priority.

In cases where hospital staffers are declining the vaccine because they don’t trust it, Junker said, hospitals should offer shots to dentists and others who are eager for them.

“I don’t think it’s fair for them to sit on the vaccine for a month or two. It needs to get used, and if the hospital workers later decide to get vaccinated, they can get back in line,” he said.

Dr. Stan Hardesty, a Raleigh, North Carolina, dentist and president of the state dental society, said it’s disappointing to see dentists in other states get the vaccine while he and his colleagues have been told to wait.

“We have been advocating on behalf of our members to have dentists and our team members included in phase 1a as recommended by the CDC,” he said. “Unfortunately, the decision-makers [in the state government] have decided to utilize a different prioritization in their vaccine implementation.”

North Carolina dentists will be in “phase 1b,” which includes adults 75 and older, essential workers such as police officers and firefighters.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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5 Reasons to Wear a Mask Even After You’re Vaccinated

As an emergency physician, Dr. Eugenia South was in the first group of people to receive a covid vaccine. She received her second dose last week  — even before President-elect Joe Biden.

Yet South said she’s in no rush to throw away her face mask.

“I honestly don’t think I’ll ever go without a mask at work again,” said South, faculty director of the Urban Health Lab at the University of Pennsylvania in Philadelphia. “I don’t think I’ll ever feel safe doing that.”

And although covid vaccines are highly effective, South plans to continue wearing her mask outside the hospital as well.

Health experts say there are good reasons to follow her example.

“Masks and social distancing will need to continue into the foreseeable future — until we have some level of herd immunity,” said Dr. Preeti Malani, chief health officer at the University of Michigan. “Masks and distancing are here to stay.”

Malani and other health experts explained five reasons Americans should hold on to their masks:

1. No vaccine is 100% effective.

Large clinical trials found that two doses of the Moderna and Pfizer-BioNTech vaccines prevented 95% of illnesses caused by the coronavirus. While those results are impressive, 1 in 20 people are left unprotected, said Dr. Tom Frieden, a former director of the Centers for Disease Control and Prevention.

Malani notes that vaccines were tested in controlled clinical trials at top medical centers, under optimal conditions.

In the real world, vaccines are usually slightly less effective. Scientists use specific terms to describe the phenomenon. They refer to the protection offered by vaccines in clinical trials as “efficacy,” while the actual immunity seen in a vaccinated population is “effectiveness.”

The effectiveness of covid vaccines could be affected by the way they’re handled, Malani said. The genetic material used in mRNA vaccines — made with messenger RNA from the coronavirus — is so fragile that it has to be carefully stored and transported.

Any variation from the CDC’s strict guidance could influence how well vaccines work, Malani said.

2. Vaccines don’t provide immediate protection.

No vaccine is effective right away, Malani said. It takes about two weeks for the immune system to make the antibodies that block viral infections.

Covid vaccines will take a little longer than other inoculations, such as the flu shot, because both the Moderna and Pfizer products require two doses. The Pfizer shots are given three weeks apart; the  Moderna shots, four weeks apart.

In other words, full protection won’t arrive until five or six weeks after the first shot. So, a person vaccinated on New Year’s Day won’t be fully protected until Valentine’s Day.

3. Covid vaccines may not prevent you from spreading the virus.

Vaccines can provide two levels of protection. The measles vaccine prevents viruses from causing infection, so vaccinated people don’t spread the infection or develop symptoms.

Most other vaccines — including flu shots — prevent people from becoming sick but not from becoming infected or passing the virus to others, said Dr. Paul Offit, who advises the National Institutes of Health and Food and Drug Administration on covid vaccines.

While covid vaccines clearly prevent illness, researchers need more time to figure out whether they prevent transmission, too, said Phoenix-based epidemiologist Saskia Popescu, an assistant professor in the biodefense program at George Mason University’s Schar School of Policy and Government.

“We don’t yet know if the vaccine protects against infection, or only against illness,” said Frieden, now CEO of Resolve to Save Lives, a global public health initiative. “In other words, a vaccinated person might still be able to spread the virus, even if they don’t feel sick.”

Until researchers can answer that question, Frieden said, wearing masks is the safest way for vaccinated people to protect those around them.

4. Masks protect people with compromised immune systems.

People with cancer are at particular risk from covid. Studies show they’re more likely  than others to become infected and die from the virus, but may not be protected by vaccines, said Dr. Gary Lyman, a professor at Fred Hutchinson Cancer Research Center.

Cancer patients are vulnerable in multiple ways. People with lung cancer are less able to fight off pneumonia, while those undergoing chemotherapy or radiation treatment have weakened immune systems. Leukemia and lymphoma attack immune cells directly, which makes it harder for patients to fight off the virus.

Doctors don’t know much about how people with cancer will respond to vaccines, because they were excluded from randomized trials, Lyman said. Only a handful of study participants were diagnosed with cancer after enrolling. Among those people, covid vaccines protected only 76%.

Although the vaccines appear safe, “prior studies with other vaccines raise concerns that immunosuppressed patients, including cancer patients, may not mount as great an immune response as healthy patients,” Lyman said. “For now, we should assume that patients with cancer may not experience the 95% efficacy.”

Some people aren’t able to be vaccinated.

While most people with allergies can receive covid vaccines safely, the CDC advises those who have had severe allergic reactions to vaccine ingredients, including polyethylene glycol, to avoid vaccination. The agency also warns people who have had dangerous allergic reactions to a first vaccine dose to skip the second.

Lyman encourages people to continue wearing masks to protect those with cancer and others who won’t be fully protected.

5. Masks protect against any strain of the coronavirus, in spite of genetic mutations.

Global health leaders are extremely concerned about new genetic variants of the coronavirus, which appear to be at least 50% more contagious than the original.

So far, studies suggest vaccines will still work against these new strains.

One thing is clear: Public health measures — such as avoiding crowds, physical distancing and masks — reduce the risk of contracting all strains of the coronavirus, as well as other respiratory diseases, Frieden said. For example, the number of flu cases worldwide has been dramatically lower since countries began asking citizens to stay home and wear masks.

“Masks will remain effective,” Malani said. “But careful and consistent use will be essential.”

The best hope for ending the pandemic isn’t to choose between masks, physical distancing and vaccines, Offit said, but to combine them. “The three approaches work best as a team,” he said.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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KHN’s ‘What the Health?’: On Capitol Hill, Actions Have Consequences

Can’t see the audio player? Click here to listen on SoundCloud.

The reverberations from the Jan. 6 storming of the U.S. Capitol by supporters of President Donald Trump continue. A broad array of business groups, including many from the health industry, are halting contributions to Republicans in the House and Senate who voted against certifying the victory of President-elect Joe Biden. Meanwhile, Republicans in the House who have refused to wear masks or insisted on carrying weapons are being subjected to greater enforcement, including significant fines.

Away from the Capitol, the Trump administration has granted a first-in-the-nation waiver to Tennessee to turn its Medicaid program into a block grant, which would give the state potentially less federal money but more flexibility to structure the federal-state health program for those with low incomes. And in its waning days, the administration is moving to make its last-minute policies harder for Biden to undo.

This week’s panelists are Julie Rovner of KHN, Joanne Kenen of Politico, Margot Sanger-Katz of The New York Times and Kimberly Leonard of Business Insider.

Among the takeaways from this week’s podcast:

  • The decision by industry groups to cut their political contributions to some Republican lawmakers could reshape businesses’ relationships on Capitol Hill. But it’s still not clear if this announcement will affect the vast sums of political contributions that come through PACs and other unnamed sources, as well as individual contributions from corporate officials.
  • The slow start of the covid vaccination campaign points to the tension between the need to steer the vaccine to people at high risk of contracting the disease and the concerns about wasting the precious medicine. Because the vaccines that have been approved for emergency use have a relatively short shelf life, some doses may go to waste if they are reserved for specific populations.
  • The response to the vaccine among health care workers varies widely. In some areas, staffers are eager to get the shots, while in other places, some workers have been hesitant and the shots are going unused. And the federal government has not provided a strong public messaging campaign about the vaccines.
  • The Trump administration’s announcement last week that it would move to convert Tennessee’s Medicaid program to a block grant program is raising concerns among advocates for the poor, who fear that the flexibility the state is gaining could lead to enrollees getting less care, especially since the state will get a hefty portion of any savings it finds in running the program.
  • It may not be easy for the Biden administration to change this decision. Federal officials in recent weeks have been sending states, including Tennessee, letters to sign that could protect the Medicaid waivers they have received from the Trump administration and could serve as a legal guarantee that would require a long, difficult process to unwind.
  • Mental health care may be a casualty of the coronavirus pandemic. As states look to balance their budgets after a year in which revenues were slashed, they may turn to cutting mental health care services provided through Medicaid and other programs.

Also this week, Rovner interviews KHN’s Victoria Knight, who wrote the latest KHN-NPR “Bill of the Month” feature — about an unusually large bill for in-network care. If you have an outrageous medical bill you’d like to share with us, you can do that here.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week that they think you should read too:

Julie Rovner: The Washington Post’s “Young ER doctors Risk Their Lives on the Pandemic’s Front Line. But They Struggle to Find Jobs,” by Ben Guarino

Margot Sanger-Katz: The New York Times’ “Why You’re Probably Not So Great at Risk Assessment,” by AC Shilton

Joanne Kenen: The Atlantic’s “Why Aren’t We Wearing Better Masks?” by Zeynep Tufekci and Jeremy Howard

Kimberly Leonard: Business Insider’s “I Was Offered a Covid Vaccine Even Though I’m Young and Healthy. Here’s How I Did It,” by Kimberly Leonard

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcherGoogle PlaySpotify, or Pocket Casts.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Most Hispanic Adults Lean Towards Getting a COVID-19 Vaccine, But Many Younger Adults are Hesitant

A new analysis of KFF COVID-19 Vaccine Monitor survey data finds that most Hispanic adults across the country want to get a COVID-19 vaccine at some point though younger adults are more hesitant, in part because of lower confidence that it is safe and effective. Overall a quarter (26%) of Hispanic adults say they willMore

Delicate Covid Vaccines Slow Rollout — Leading to Shots Given Out of Turn or, Worse, Wasted

For Heather Suri, a registered nurse in Virginia, the race to vaccinate Americans against covid has thrown up some unprecedented obstacles.

The vaccines themselves are delicate and require a fair bit of focus over time. Consider Moderna’s instructions for preparing its doses: Select the number of shots that will be given. Thaw the vials for 2.5 hours in a refrigerator set between 36 and 46 degrees. Then rest them at room temperature for 15 minutes. Do not refreeze. Swirl gently between each withdrawal. Do not shake. Inspect each vial for particulate matter or discoloration. Store any unused vaccine in refrigeration.

And then there’s this: Once open, a vial is good for only six hours. As vaccines go, that’s not very long. Some flu vaccine keeps almost a month.

“This is very different, administering this vaccine. The process, it takes a whole lot longer than any mass vaccination event that I’ve been involved with,” said Suri, a member of the Loudoun Medical Reserve Corps who joined her first clinic Dec. 28, to vaccinate first responders.

Of the first two covid vaccines on the market, Moderna’s is considered more user-friendly. Pfizer-BioNTech’s shot must be stored in specialized freezers at 94 degrees below zero. Once out of deep freeze, it lasts just five days, compared with 30 days for Moderna’s.

One thing the shots have in common: They last a paltry six hours once the first dose is removed from a vial. That short shelf life raises the stakes for the largest vaccination effort in U.S. history by forcing clinicians to anticipate the exact number of doses they’ll need each day. If they don’t get it right, precious stores of vaccine may go to waste.

During one recent clinic over several hours, Suri estimated she gave “maybe 25” shots, many fewer than the number of flu shots she’s given during similar clinics over the years.

With covid, she said, “the vaccine itself slows things down.”

The slow rollout has frustrated people who at Thanksgiving imagined millions of vaccines in arms by Christmas. Promises that 20 million would be vaccinated by New Year’s fell well short: Just 2.8 million had the first of two required shots by the end of December, according to data from the Centers for Disease Control and Prevention.

Public health officials say many factors are at play, including a shortage of workers trained to administer shots, covid protocols that require physical distancing at clinics and vaccine allocation numbers from the federal government that fluctuate by the week.

And then there are the logistics of the first covid vaccines, which are complex and make hyper-vigilant practitioners wary of opening too many vials over the course of each day, for fear that anything unused will have to be tossed. Vaccine providers also report wasted or spoiled doses to public health authorities.

“If you get to the end of your clinic and every nurse has half a vial left, what are you going to do with that vaccine?” Suri said. “The clock is ticking. You don’t want to waste those doses.”

That impulse has led some health personnel to make dramatic decisions at the end of a day: calling non-front-line health workers or offering shots to whoever is at hand in, say, a grocery store, instead of scrambling to find the health workers and residents of nursing homes in the government’s first tier for injections.

“We jumped and ran and got the vaccine,” said Dr. Mark Hathaway, an OB-GYN in the District of Columbia who received the first dose of a Moderna vaccine on Dec. 26 along with his wife, a registered nurse specializing in nutrition. Both clinicians received vaccines faster than anticipated at a Unity Health Care clinic when there were extra doses because fewer front-line health care workers than expected showed up.

“Health care workers have been priority 1a, so our first attempt has always been our staff,” said Dr. Jessica Boyd, Unity Health Care’s chief medical officer. Since then, the community health center network has broadened its criteria for extra doses to include staff members or high-risk patients visiting a clinic, she said.

Health officials encourage using the doses to get as many Americans vaccinated as quickly as possible. Public health experts say the need to vaccinate people is especially urgent as a new and more contagious variant of the virus first detected in the United Kingdom is showing up in multiple states. Some states, including New York and California, have loosened their guidelines on who can get vaccinated after an outcry over health care providers throwing away doses that didn’t meet officials’ strict criteria.

The tiers “are simply recommendations, and they should never stand in the way of getting shots in arms instead of keeping vaccine in the freezer or wasting vaccine in the vial,” Health and Human Services Secretary Alex Azar said Jan. 6, referring to CDC guidelines saying health care workers and residents and staff of long-term care facilities should be first in line, then people at least 75 years old. The Trump administration this week also said it would make more shots available by releasing second doses and urged states to broaden rules to allow anyone 65 or older and any resident with a serious medical condition to get a shot.

Pfizer-BioNTech’s ultra-cold storage requirements have made it less ideal for local public health departments and rural areas.

Both of the available vaccines arrive in multidose vials — Pfizer-BioNTech’s contains about five doses, Moderna’s 10. Neither contains preservatives and they are viable for only six months frozen. By contrast, during the H1N1 pandemic roughly a decade ago, the swine flu vaccines lasted 18 weeks to 18 months, Sen. Chuck Grassley (R-Iowa) wrote in a May 2010 letter to then-HHS Secretary Kathleen Sebelius.

“We can’t get the vaccine out fast enough; we have people dying. But, at the same time, we have to get it right,” said Claire Hannan, executive director of the Association of Immunization Managers.

The added risk of losing doses due to quick expiration is another thing “causing angst,” Hannan said. “You can’t just draw it up and let it sit. It can’t just sit out like that.”

The Trump administration fell significantly short of its promise that 20 million Americans would be vaccinated by the end of December, partly the result of a disjointed and underfunded public health system that has received limited guidance from federal officials. As of Jan. 11, 25.5 million vaccine doses had been distributed nationwide but only 9 million administered, according to the CDC.

Federal officials have released sparse data about who is getting vaccinated, but state information has shown significant variation in vaccination rates depending on the facility. New York Gov. Andrew Cuomo on Jan. 4 said New York City’s public hospital system had used only 31% of its allocated vaccines, while private health systems NewYork-Presbyterian and Northwell Health had used 99% and 62%, respectively.

“When you target a priority group, it’s inefficient. When you open it up to a larger group, it’s efficient … but you’re not going to have enough supply,” Hannan said. “You still have the challenge of getting those health care workers vaccinated and no matter any way you slice it, you still have limited supply. You can’t please everyone.”

While Pfizer’s vaccine has largely been earmarked for large institutions like hospitals and nursing homes, Moderna’s has been more widely distributed to smaller sites like public health departments and clinics run by volunteers. State and local officials have begun or will soon vaccinate other priority populations, including police officers, teachers and other K-12 school employees, and seniors overall.

Unlike the covid vaccines, many flu vaccines come in prefilled syringes — each syringe’s cap is removed only when a shot is given, which speeds the process and eases some concerns about storage. However, relying on prefilled syringes during a pandemic has its own complications, according to Michael Watson, former president of Valera, a Moderna subsidiary: They take up more fridge space. They’re more expensive. And they can’t be used for frozen products, he said.

“For all these reasons, a vial was the best and only option,” he said.

In Ohio, Eric Zgodzinski, health commissioner for Toledo-Lucas County, said two-thirds of first responders the county surveyed said they would get the vaccine. Still, he said, his department has encountered situations in which a covid vaccine dose is left over in an open vial and officials have turned to a waiting list to find someone who can arrive within minutes to get a jab.

His department also has an internal running list of potential vaccine takers, including health department staffers, people in congregate care settings or those who had scheduled vaccination appointments for later on.

“We’re not going to open up a vial for one individual and figure out nine other people right away,” said Zgodzinski, whose department planned to distribute 2,200 doses of the Moderna vaccine the week of Jan. 4.

“If I have one dose left, who can I give it to?” he added. “A shot in the arm for anybody is better than it being wasted.”

San Francisco editor Arthur Allen and senior correspondent JoNel Aleccia contributed to this report.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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California Counties ‘Flying the Plane as We Build It’ in a Plodding Vaccine Rollout

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In these first lumbering weeks of the largest vaccination campaign in U.S. history, Dr. Julie Vaishampayan has had a battlefront view of a daunting logistical operation.

Vaishampayan is the health officer in Stanislaus County, an almond-growing mecca in California’s Central Valley that has recorded about 40,000 cases of covid-19 and lost 700 people to the illness. Her charge is to see that potentially lifesaving covid shots make it into the arms of 550,000 residents.

And like her dozens of counterparts across the state, she is improvising as she goes.

From week to week, Vaishampayan has no idea how many new doses of covid vaccines will be delivered until just days before they arrive, complicating advance planning for mass inoculation clinics. The inoculation clinics themselves can be a bureaucratic slog, as county staffers verify the identities and occupations of people coming in for shots to ensure strict compliance with the state’s multitiered hierarchy of eligibility. In these early days, the county also has provided vaccines to some area hospitals so they can inoculate health care workers, but the state system for tracking whether and how those doses are administered has proven clumsy.

With relatively little help from the federal government, each state has built its own vaccination rollout plan. In California, where public health is largely a county-level operation, the same departments managing testing and contact tracing for an out-of-control epidemic are leading the effort. That puts an already beleaguered workforce at the helm of yet another time-consuming undertaking. A lack of resources and limited planning by the federal and state governments have made it that much harder to get operations up and running.

“We are flying the plane as we are building it,” said Jason Hoppin, a spokesperson for Santa Cruz County. ”All of these logistical pieces are just a huge puzzle to work out.”

It’s a massive enterprise. Counties must figure out who falls where in the state’s multitiered system for eligibility, locate vaccination sites, hire vaccinators, notify workforce groups when they are eligible, schedule appointments, verify identities, then track distribution and immunizations administered.

Some of that burden has been eased by a federal program that is contracting with major pharmacies Walgreens and CVS to vaccinate people living in nursing homes and long-term care facilities, as well as a California mechanism that allows some large multicounty health care providers to order vaccines directly. As of this week, some smaller clinics and doctors’ offices also can get vaccine directly from the state.

But much of the job falls on health departments, the only entities required by law to protect the health of every Californian. And they are doing it amid pressures from the state to prevent people from skipping the line and a public eager to know why the rollout isn’t happening faster.

As of Monday, only a third of the nearly 2.5 million doses allocated to California counties and health systems had been administered, according to the most recent state data available. Gov. Gavin Newsom has acknowledged the rollout has “gone too slowly.” Health directors counter it’s the best that could be expected given the short planning timeline, limited vaccine available and other strictures.

“I would not call this rollout slow,” said Kat DeBurgh, executive director of the Health Officers Association of California. “This isn’t the same as a flu vaccine clinic where all you have to do is roll up your sleeve and someone gives you a shot.”

It has been one month since the first vaccines arrived in California, and just over five weeks since the state first outlined priority groups for vaccinations, then passed the ball to counties to devise ways to execute the plan.

Like most states, California opened its rollout with strict rules about the order of distribution. The first phase prioritized nursing home residents and hospital staffs before expanding to other broad categories of health care workers. In the weeks after the vaccines first arrived, state officials made clear that providers could be penalized if they gave vaccinations to people not in those initial priority groups.

Multiple counties said there had been little in the way of line-skipping, but stray reports in the media or complaints sent directly to community officials need to be chased down, wasting precious public health resources. The same goes for reports of vaccine doses being thrown away. One of the vaccines in circulation, once removed from ultra-cold storage, must be used within five days or discarded.

State officials have since loosened their rules, telling counties and providers to do their best to adhere to the tiers, but not to waste doses. On Jan. 7, California officials told counties they could vaccinate anyone in “phase 1a,” expanding beyond the first priority group of nursing homes and hospitals to nearly everyone in a health-related job. Once that wide-ranging category is finished, counties were supposed to move to “phase 1b,” which unfolds with its own set of tiers, starting with people 75 and older, educators, child care workers, providers of emergency services, and food and agricultural workers before expanding to all people 65 and older.

Mariposa and San Francisco both said they would be vaccinating people in the first 1b categories this week. That means residents will start seeing inequities among counties, said DeBurgh, noting that some counties had not yet received enough vaccine doses to cover health care workers while others are nearly finished. Stanislaus County, for example, had received approximately 16,000 first doses as of Jan. 9, but estimates it has between 35,000 and 40,000 health care workers phase 1a.

And the orders are changing yet again, forcing counties to pivot. On Tuesday, U.S. Health and Human Services Secretary Alex Azar said the Trump administration would begin releasing more of its vaccine supply, holding onto fewer vials for second doses; and he encouraged states to open up vaccinations to everyone age 65 and older. In response, California officials said Wednesday that once counties are done with phase 1a, people 65 and older are in the next group eligible for vaccines.

Some local health directors expressed dismay at the prospect, saying they welcome the influx of vaccines but need to prioritize people 75 and older who represent the bulk of hospitalizations. They also noted that states already offering broader access have had their own challenges, including flooded health department phone lines, crashed websites and fragile seniors camping out overnight in hopes of securing their place in line.

While sensible in theory, California’s phased approach to the rollout has proved cumbersome when it comes to verifying that people showing up for shots fall under the umbrella groups deemed eligible. In Stanislaus, for example, 6,600 people qualify as in-home support workers. Someone from another county department has to sit with health department staffers to verify their eligibility, since the health department doesn’t have access to official data on who is a qualified member of the group.

Complicating matters, about half the county’s in-home workers are caring for a family member, and many are bringing that person with them to get vaccinated. The county is required to turn those family members away if they don’t meet the eligibility criteria, Vaishampayan said.

A range of other hiccups hampered the rollout. Across the state, uptake of vaccination slowed to a crawl from Christmas to New Year’s. Health workers, particularly those who do not work in hospitals, were on vacation and enjoying a few days off with family after a tough year, several county officials said. Many chose not to get vaccinated during that time.

Others are choosing not to get vaccinated at all. Across the state, health care workers are declining vaccinations in large numbers. The health officer for Riverside County has said 50% of hospital workers there have declined the vaccine.

And in Los Angeles and Sonoma, officials described software challenges that prevented them from quickly enrolling doctors’ offices to receive vaccines and perform injections.

Still, statewide, officials said they were confident that the pace would pick up in the coming days, as more doses arrive, data snags get sorted out and more vaccination sites come on board. Los Angeles County announced this week it would convert Dodger Stadium and a Veterans Affairs site from mass testing sites into mass vaccination clinics. Similar plans are underway at Petco Park in San Diego and the Disneyland Resort in Orange County. Officials hope Dodger Stadium alone can handle up to 12,000 people a day.

The move solves one problem, but potentially exacerbates another: The two Los Angeles sites have been testing 87,000 people a week, according to Dr. Christina Ghaly, Los Angeles County Department of Health Services director. That will put new constraints on testing, even as covid cases in the nation’s most populous county continue to rise and hospitals are beyond capacity.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Vaccination Disarray Leaves Seniors Confused About When They Can Get a Shot

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For weeks, doctors’ phones have been ringing off the hook with anxious older patients on the other end of the line.

“When can I get a covid-19 vaccine?” these patients want to know. “And where?”

Frustration and confusion are rampant as states and counties begin to offer vaccines to all seniors after giving them first to front-line health care workers and nursing home residents — the groups initially given priority by state and federal authorities.

My 91-year-old mother-in-law, who lives in upstate New York, was one of those callers. She said her doctor’s office told her it could be several months before she can get her first shot.

That was before New York’s Gov. Andrew Cuomo announced on Friday that the state would begin offering vaccines to residents age 75 and older starting Monday. On Tuesday, the state changed vaccine policies again, this time making residents 65 and older eligible.

In this chaotic environment, with covid cases and deaths skyrocketing and distribution systems in a state of disarray, it’s difficult to get up-to-date, reliable information. Many older adults don’t know where to turn for help.

Since the holidays, I’ve heard from dozens of people frustrated by poorly informed staffers at physicians’ offices, difficult-to-navigate state and county websites, and burdensome or malfunctioning sign-up arrangements. Below are some questions they posed, with answers drawn from interviews with experts and other sources, that may prove helpful.

Keep in mind that states, counties and cities have varying policies, and this is a rapidly shifting landscape with many uncertainties. Foremost among them are questions regarding vaccine supply: how many doses will become available to states and when and how those will be allocated.

Q: How can I make an appointment to get a vaccine? — James Vanderhye, 77, Denver

Vanderhye is a throat cancer survivor who suffers from sarcoidosis of the lungs and heart — an inflammatory disease.

Colorado Gov. Jared Polis announced on Dec. 30 that residents 70 and older could start getting covid vaccines, but Vanderhye wasn’t sure whether he needed to sign up somewhere or whether he’d be contacted by his physicians — a common source of confusion.

UCHealth, the system where Vanderhye’s doctors practice, has created a registry of patients 70 and older and is randomly selecting them for appointments, Dr. Jean Kutner, its chief medical officer told me. It’s reaching out to patients through its electronic patient portal and is planning to notify those who don’t respond by phone down the line. Then, it’s up to patients to finalize arrangements.

Nearly 200,000 people 70 and older are patients at UCHealth’s hospitals and clinics in Colorado, Wyoming and Nebraska.

TIPS: Although some health systems such as UCHealth are contacting patients, don’t assume that will happen. In most cases, it appears, you will need to take the initiative.

Check with the physician’s office, hospital or medical clinic where you usually receive care. Many institutions (though not all) are posting information about covid vaccines on their websites. Some have set up phone lines.

Some health systems are willing to vaccinate anyone who signs up, not just their patients. Kaiser Permanente, which operates in California, Colorado, Georgia, Hawaii, Oregon, Washington, Washington, D.C., and parts of Virginia and Maryland, is among them, according to Dr. Craig Robbins, co-leader of its national covid vaccination program. (Within the next few weeks, it will post an online registration tool on plan websites.) Check with major hospitals or health systems in your area to see what they’re doing. (KHN is not affiliated with Kaiser Permanente.)

Most places are asking people to sign up online for appointments; some sites require multiple steps and their systems may seem hard to use. If you don’t have a computer or you aren’t comfortable using one, ask a younger family member, friend or neighbor for help. Similarly, ask for help if you aren’t fluent in English.

If you can’t figure out how to sign up online, call your local county health department, Area Agency on Aging or county department on aging and ask for assistance. Every state has a covid-19 hotline; see if the hotline can direct you to a call center that’s taking appointments. Be prepared for long waits; phone lines are jammed.

Q: My mother has stage 3 renal failure, high blood pressure and dementia. She’s unable to take care of herself or be left alone. When can I get her vaccinated with the COVID shot? — Wendy, 61, Chandler, Arizona

Wendy had checked Maricopa County’s website days before we talked on Jan. 5 and couldn’t figure out when her 84-year-old mother might get a vaccine appointment. The week before, her 90-year-old father died, alone, of renal failure complicated by pneumonia in a nursing home.

Three days after our conversation, Maricopa County announced that people 75 and older could start making appointments to be vaccinated on a “first-come, first-served” basis on Monday, Jan. 11. (The state’s appointment site is https://podvaccine.azdhs.gov/; callers should try 844-542-8201 or 211, according to information provided by the county.)

In Arizona, “it’s up to each county to come up and execute a plan for vaccine distribution,” said Dana Kennedy, state director of AARP Arizona.

Demand is high and vaccine supplies are limited, other places have found. For example, on Jan. 7, a 1,200-slot vaccine clinic in Oklahoma City for adults 65 and older filled up within four minutes, according to Molly Fleming, a public information officer at the Oklahoma City-County Health Department.

“Once we get more vaccine supplies coming more frequently, we will do more clinics,” Fleming said. “The challenge we have right now is, we need the vaccine and we don’t know when it’s coming in.”

TIPS: Consult AARP’s state-by-state covid vaccine guides, focused on older adults and updated daily. (To access, go to https://www.aarp.org/coronavirus/. In the right-hand column, click on “the vaccine in your state.”) More than 20 states are listed there now, but guides for all states should be available by the end of January.

Meanwhile, check local media and your county’s and state’s health department websites regularly for fresh information about covid vaccine distribution plans.

On Monday, for example, Washington, D.C., unveiled a new vaccination registration site for residents 65 and older and health care workers. The week before, Illinois announced it would extend vaccines to residents 65 and older when it moved into the next phase of its vaccination plan, and the city of Chicago followed suit. The timetable for those transitions remains unclear.

Be prepared to be patient as problems with distribution surface. States and counties around the country are learning from problems that have arisen in places such as Florida — crashed phone lines, long lines of older adults waiting outdoors, massive confusion. It may take some time, but vaccine rollouts should become smoother as more sites come online and supplies become more readily available.

Q: When can a 72-year-old male with chronic lymphocytic leukemia expect to be vaccinated at Kaiser Permanente in Southern California? — Barry

California last week announced that counties that have made significant progress and have adequate supplies can move toward offering vaccines to residents 75 and older.

How soon this will happen isn’t clear yet; it will vary by location. But even then, Barry wouldn’t qualify immediately since he’s only 72 and it could take several months for vaccines to become available to people in his age group (65 to 74), said Robbins, who’s helping lead Kaiser Permanente’s vaccination program.

Barry is at especially high risk of doing poorly if he develops covid because of the type of cancer he has — leukemia. But, for the most part, medical conditions are not being taken into account in the initial stages of vaccine distribution around the country.

An exception is the Mayo Clinic. It’s identifying patients at highest risk of getting severe infections, being hospitalized and dying from covid at the Mayo Clinic Health System, a network of physician practices, clinics and hospitals in Iowa, Minnesota and Wisconsin. When states allow older adults outside of long-term care institutions to start getting vaccines, it will offer them first to patients at highest risk, said Dr. Abinash Virk, co-chair for Mayo Clinic’s vaccine rollout.

TIPS: Even if vaccines aren’t available right away, production is increasing, new products are in the pipeline, and new ways of distributing vaccines — notably mass distribution sites — are being planned. If you have to wait several weeks or months, don’t give up. Persistence is worth the effort, given the vaccine’s benefits.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Feeling Left Out: Private Practice Doctors, Patients Wonder When It’s Their Turn for Vaccine

Dr. Andrew Carroll — a family doctor in Chandler, Arizona — wants to help his patients get immunized against covid, so he paid more than $4,000 to buy an ultra-low-temperature freezer from eBay needed to store the Pfizer vaccine.

But he’s not sure he’ll get a chance to use it, given health officials have so far not said when private doctor’s offices will get vaccine.

“I’m really angry,” said Carroll.

Not only are doctors having trouble getting vaccine for patients, but many of the community-based physicians and medical staff that aren’t employed by hospitals or health systems also report mixed results in getting inoculated. Some have had their shots, yet others are still waiting, even though health workers providing direct care to patients are in the Centers for Disease Control and Prevention’s top-priority group.

Many of these doctors say they don’t know when — or if — they will get doses for their patients, which will soon become a bigger issue as states attempt to vaccinate more people.

“The reason that’s important is patients trust their doctors when it comes to the vaccine,” said Carroll, who has complained on social media that his county hasn’t yet released plans on how primary care doctors will be brought into the loop.

Collectively, physicians in the county could vaccinate thousands of patients a day, he said, and might draw some who would otherwise be hesitant if they had to go to a large hospital, a fairground or another central site.

His concern comes as, nationally, the rollout of the vaccine is off to a slower start than expected, lagging far behind the initial goal of giving 20 million doses before the new year.

But Dr. Jen Brull, a family practice doctor in Plainville, Kansas, said her rural area has made good progress on the first phase of vaccinations, crediting close working relationships formed well before the pandemic.

This fall, before any doses became available, the local hospital, the health department and physician offices coordinated a sign-up list for medical workers who wanted the vaccine. So, when their county, with a population of 5,000, got its first 70 doses, they were ready to go. Another 80 doses came a week later.

“We’ll be able to vaccinate almost all the health care-associated folks who wanted it in the county” Brull said recently

Gaps in the Rollout

But that’s not the case everywhere.

Dr. Jason Goldman, a family doctor in Coral Gables, Florida, said he was able to get vaccinated at a local hospital that received the bulk of vaccines in his county and oversaw distribution.

In the weeks since, however, he said several of his front-line staff members still “don’t have access to the vaccine.”

Additionally, “a tremendous number” of patients are calling his office because Florida has relaxed distribution guidelines to include anyone over age 65, Goldman said, asking when they can get the vaccine. He’s applied to officials about distributing the vaccines through his practice but has heard nothing back.

Patients “are frustrated that they do not have clear answers and that I am not being given clear answers to provide them,” he said. “We have no choice but to direct them to the health department and some of the hospital systems.”

Another troubling point for Goldman, who served as a liaison between the American Academy of Family Physicians and the expert panel drawing up the CDC distribution guidelines, is the tremendous variation in how those recommendations are being implemented in the states.

The CDC recommends several phases, with front-line health care workers and nursing home residents and staff in the initial group. Then, in the second part of that phase, come people over 75 and non-health care front-line workers, which could include first responders, teachers and other designated essential workers.

States have the flexibility to design their own rollout schedule and priority groups. Florida, for example, is offering doses to anyone 65 and up. In some counties, older folks were told vaccines were available on a first-come, first-served basis, a move that has resulted in long lines.

“To say right now, 65-plus, when you haven’t even appropriately vaccinated all the health care workers, is negating the phasing,” said Goldman. “There needs to be a national standard. We have those guidelines. We need to come up with some oversight.”

On Thursday, the American Hospital Association echoed that concern in a letter to Health and Human Services Secretary Alex Azar. Hospitals — along with health departments and large pharmacy chains — are doing the bulk of the vaccinations.

Calling for additional coordination by federal officials, the letter outlined what it would take to reach the goal of vaccinating 75% of Americans by the end of May: 1.8 million vaccinations every day. Noting there are 64 different rollout plans from states, cities and other jurisdictions, the letter asked whether HHS has “assessed whether these plans, taken as a whole, are capable of achieving this level of vaccination?”

Making It Work

Lack of direct national support or strategy means each county is essentially on its own, with success or failure affected by available resources and the experience of local officials. Most state and local health departments are underfunded and are under intense pressure because of the surging pandemic.

Still, the success of vaccination efforts depends on planning, preparation and clear communication.

In Lorain County, Ohio, population 310,000, local officials started practicing in October, said Mark Adams, deputy health commissioner. They set up mass vaccination clinics for influenza to study what would be needed for a covid vaccination effort. How many staff? What would the traffic flow be like? Could patients be kept 6 feet apart?

“That gave us an idea of what is good, what is bad and what needs to change,” said Adams, who has had previous experience coordinating mass vaccination efforts at a county level.

So, when the county got its first shipment of 500 doses Dec. 21, Adams had his plan ready. He called the fire chiefs to invite all emergency medical technicians and affiliated personnel to an ad hoc vaccination center set up at a large entertainment venue staffed by his health department. Upon arrival, people were greeted at the door and directed to spaced-apart “lanes” where they would get their shots, then to a monitoring area where they could wait for 15 minutes to make sure they didn’t have a reaction.

Right after Christmas, another 400 doses arrived — and the makeshift clinic opened again. This time, doses went to community-based physicians, dentists and other hands-on medical practitioners, 600 of whom had previously signed up. (Hospital workers and nursing home staff and residents are getting their vaccinations through their own institutions.)

As they move into the next phase — recipients include residents over 80, people with developmental disorders and school staff — the challenges will grow, he said. The county plans a multipronged approach to notify people when it’s their turn, including use of a website, the local media, churches, other organizations and word-of-mouth.

Adams shares the concerns of medical providers nationwide: He gets only two days’ notice of how many doses he’s going to receive and, at the current pace of 400 or 500 doses a week, it’s going to take a while before most residents in the county have a chance to get a shot, including the estimated 33,000 people 65 and older.

With 10 nurses, his clinic can inject about 1,200 people a day. But many other health professionals have volunteered to administer the shots if he gets more doses.

“If I were to run three clinics, five days a week, I could do 15,000 vaccinations a week,” Adams said. “With all the volunteers, I could do almost six clinics, or 30,000 a week.”

Still, for those in the last public group, those age 18 and up without underlying medical conditions, “it could be summer,” Adams said.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Hospitals’ Rocky Rollout of Covid Vaccine Sparks Questions of Fairness

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Last week, after finishing inoculations of some front-line hospital staff, Jupiter Medical Center was left with 40 doses of precious covid vaccine. So, officials offered shots to the South Florida hospital’s board of directors and their spouses over age 65.

But that decision sparked outrage among workers left unvaccinated, including those at one of the hospital’s urgent care clinics, or who believe the hospital was currying favor with wealthy insiders before getting all its staffers protected, according to a hospital employee who spoke on the condition of not being named.

The move also prompted dozens of calls from donors looking to get vaccinated.

The hospital received 1,000 doses of the Moderna vaccine two days before Christmas, fewer than half of what it requested from the state to cover its workforce. Officials prioritized delivering the vaccine to front-line medical workers who requested it, performing inoculations on Christmas Eve or the holiday weekends.

Patti Patrick, a hospital vice president, said the hospital acted appropriately in its offerings of the vaccine, which has a short shelf life once vials are opened. Neither she nor other administrators who don’t work directly with patients were included in this first round of shots.

“This was a simple way to move 40 doses very quickly” before it spoiled, she said.

She added that all front-line staff from the health system, including the clinics, were given the opportunity to get the shots.

Jupiter is not the only hospital in the nation facing questions about its handling of the vaccines. The initial rollout — aimed at health care workers and nursing home residents — has been uneven at best because of a lack of a federal strategy on how it should work, with states, hospitals, nursing homes and pharmacies often making decisions on their own about who gets vaccinated and when.

In some hospitals, administrators and other personnel who have no contact with patients or face no risk at work from the virus are getting shots, while patients — and even front-line staff — who are at heightened risk for covid complications are being passed by. Some administrators who have been working remotely throughout the pandemic have been vaccinated, especially at hospitals that decided to allocate doses by age group rather than exposure risk.

Although states and federal health groups laid out broad guidelines on how to prioritize who gets the vaccine, in practice what’s mattered most was who controlled the vaccine and where the vaccine distribution was handled.

Stanford Health Care in California was forced to rework its priority list after protests from front-line doctors in training who said they had been unfairly overlooked while the vaccine was given to faculty who don’t regularly see patients. (Age was the important factor in the university’s algorithm.)

Members of Congress have called for an investigation following media reports that MorseLife Health System, a nonprofit that operates a nursing home and assisted living facility in West Palm Beach, Florida, vaccinated donors and members of a country club who donated thousands of dollars to the health company.

At least three other South Florida hospital systems — Jackson Health, Mount Sinai Medical Center and Baptist Health — have offered vaccines to donors in advance of the general public, while administering the shots to front-line employees, The Miami Herald reported.

Like Jupiter Medical, the hospitals insist that those offered shots were 65 and older, as prioritized by state officials.

Staffing Problems at Hospitals

An advisory board to the Centers for Disease Control and Prevention designated hospitals and nursing homes to get covid vaccines first because their workers and residents were considered at highest risk, and most states have followed that recommendation. But in many cases, the health institutions have found demand from staffers, some of whom are leery of the voluntary shot, is less than anticipated.

In addition, the arrival of promised shipments has been unpredictable. While the federal government approved the first covid vaccine on Dec. 14, some hospitals did not receive allotments until after Christmas.

That was the case at Hendry Regional Medical Center in Clewiston, Florida, which got 300 doses from the state. The hospital vaccinated 30 of its 285 employees between Dec. 28 and Jan. 5, said R.D. Williams, its chief executive officer. Some employees preferred to wait until after New Year’s weekend out of concern about side effects, he said.

The vaccine has been reported to commonly cause pain at the injection site and sometimes produce fever, lethargy or headache. The reactions generally last no more than a few days.

“I’m happy with how it’s going so far,” Williams said. “I know many of our employees want to be vaccinated, but I don’t see it as a panacea that they have to have it today,” he said, noting that staffers already have masks and gloves to protect themselves from the virus.

The hospital is also trying to coordinate vaccination schedules so 10 people at a time get the shot to ensure none of the medication is wasted after the multidose vials are thawed. Once vaccine is thawed, it must be used within hours to retain its effectiveness.

As of Jan. 6, Howard University Hospital in Washington, D.C., had vaccinated slightly more than 900 health workers since its first doses arrived Dec. 14. It has received 3,000 doses.

Success has been limited by reluctance among workers to get a vaccine and a lack of personnel trained to administer it, CEO Anita Jenkins said.

“We still have a hospital to run and have patients in the hospital with heart attacks and other conditions, and we don’t have additional staff to run the vaccine clinics,” she said.

While some hospitals offer the vaccine only to front-line workers who interact with patients, Howard makes it available to everyone, including public relations staff, cafeteria workers and administrators. Jenkins defended the move because, she said, it’s the best way to protect the entire hospital.

She noted such employees as information technology personnel who don’t see patients may be around doctors and nurses who do. “Working in a hospital, almost everyone runs into patients just walking down the hallway,” she said.

At Eisenhower Health, a nonprofit hospital based in Rancho Mirage, California, 2,300 of the 5,000 employees have been vaccinated.

“Our greatest challenge has been managing the current patient surge and staffing demands in our acute and critical care areas while also trying to ensure we have adequate staffing resources to operate the vaccine clinics,” said spokesperson Lee Rice.

A Non-System of Inequitable Distribution

Arthur Caplan, a bioethicist at NYU Langone Medical Center in New York City, said hospitals should not be inoculating board members ahead of hospital workers unless those people have a crucial role in running the hospital.

“That seems, to me, jostling to the head of the line and trying to reward those who may be potential donors,” he said. But he acknowledged that the hospitals’ vaccination systems are not always rational or equitable.

Covid vaccines need to get out as quickly as possible, he added, but hospitals can give them only to people they are connected with.

Caplan noted he was vaccinated at an NYU outpatient site last week, even though his primary care doctor hadn’t yet gotten the vaccine because his clinic had not received any doses.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Are You Old Enough to Get Vaccinated? In Tennessee, They’re Using the Honor System

In December, all states began vaccinating only health care workers and residents and staffers of nursing homes in the “phase 1A” priority group. But, since the new year began, some states have also started giving shots to — or booking appointments for — other categories of seniors and essential workers.

As states widen eligibility requirements for who can get a covid-19 vaccine, health officials are often taking people’s word that they qualify, thereby prioritizing efficiency over strict adherence to distribution plans.


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“We are doing everything possible to vaccinate only those ‘in phase,’ but we won’t turn away someone who has scheduled their vaccine appointment and tells us that they are in phase if they do not have proof or ID,” said Bill Christian, spokesperson for the Tennessee Department of Health.

Among the states pivoting to vaccinating all seniors, timelines and strategies vary. Tennessee started offering shots to people 75 and older on Jan. 1. So, Frank Bargatze of Murfreesboro, Tennessee, snagged an appointment online for his father — and then went ahead and put his own name in, though he’s only 63.

“He’s 88,” Bargatze said, pointing to his father in the passenger seat after they both received their initial shots at a drive-thru vaccination site in Murfreesboro, a large city outside Nashville. “I jumped on his bandwagon,” he added with a laugh. “I’m going to blame it on him.”

Bargatze does work a few days a week with people in recovery from addiction, he added, so in a way, he might qualify as a health care worker.

Some departments are trying more than others, but overwhelmed public health departments don’t have time to do much vetting.

Dr. Lorraine MacDonald is the medical examiner in Rutherford County, Tennessee, where she’s been staffing the vaccination site. If people seeking the vaccine make it through the sign-up process online, MacDonald said, and show up for their appointment, health officials are not going to ask any more questions — as long as they’re on the list from the online sign-up.

“That’s a difficult one,” MacDonald acknowledged, when asked about people just under the age cutoff joining with older family members and putting themselves down for a dose, too. “It’s pretty much the honor system.”

People getting vaccinated in several Tennessee counties told a reporter they did not have to show ID or proof of qualifying employment when they arrived at a vaccination site. Tennessee’s health departments are generally erring on the side of simply giving the shot, even if the person is not a local resident or is not in the country legally.

The loose enforcement of the distribution phases extends to other parts of the country, including Los Angeles. In response, New York’s governor is considering making line-skipping a punishable offense.

Still, many people who don’t qualify on paper believe they might need the vaccine as much as those who do qualify in the initial phases.

Gayle Boyd of Murfreesboro is 74, meaning she didn’t quite make the cutoff in Tennessee, which is 75. But she’s also in remission from lung cancer, and so eager to get the vaccine and start getting back to a more normal life, that she joined her slightly older husband at the Murfreesboro vaccination site this week.

“Nobody’s really challenged me on it,” she said, noting she made sure to tell vaccination staffers about her medical issues. “Everybody’s been exceptionally nice.”

Technically, in the state’s current vaccine plan, having a respiratory risk factor like lung cancer doesn’t leapfrog anyone who doesn’t otherwise qualify. But in some neighboring states such as Georgia, where the minimum age limit is 65, Boyd would qualify.

Even for those who sympathize with such situations, anecdotes about line-skipping enrage many trying to wait their turn.

“We try to be responsible,” said 57-year-old Gina Kay Reid of Eagleville, Tennessee.

Reid was also at the Murfreesboro vaccination site, sitting in the back seat as she accompanied her older husband and her mother. She said she didn’t think about trying to join them in getting their first doses of vaccine. “If you take one and don’t necessarily need it, you’re knocking out somebody else that is in that higher-risk group.”

But there is a way for younger, healthier people to get the vaccine sooner than later — and not take a dose away from anyone more deserving.

A growing number of jurisdictions are realizing they have leftover doses at the end of every day. And the shots can’t be stored overnight once they’re thawed. So some pharmacists, such as some in Washington, D.C., are offering them to anyone nearby.

Jackson, Tennesse, has established a “rapid response” list for anyone willing to make it down to the health department within 30 minutes. Dr. Lisa Piercey, the state’s health commissioner, said her own aunt and uncle received a call at 8 p.m. and rushed to the county vaccination site to get their doses.

Piercey called it a “best practice” that she hopes other jurisdictions will adopt, offering a way for people eager for the vaccine to get it, while also helping states avoid wasting precious doses.

This story is part of a partnership that include WPLN, NPR and Kaiser Health News.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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The Challenge of Vaccine Hesitancy In Rural America

In his latest Axios column, Drew Altman looks at the challenge of vaccine hesitancy in rural America and its implications. One of them: a highly tailored outreach campaign is needed. “Addressing this hesitancy will require convincing rural Americans about the seriousness of the pandemic, and then that the vaccine is a way to protect them, their families and their way of life,” he said.

California Budget Reflects ‘Pandemic-Induced Reality,’ Governor Says

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SACRAMENTO, Calif. — The coronavirus pandemic doomed Gov. Gavin Newsom’s ambitious plans last year to combat homelessness, expand behavioral health services and create a state agency to control soaring health care costs.

But even as the pandemic continues to rage, California’s Democratic governor said Friday he plans to push forward with those goals in the coming year, due to a rosier budget forecast buoyed by higher tax revenue from wealthy Californians who have fared relatively well during the crisis.

Newsom’s $227.2 billion budget blueprint also prioritizes billions to safely reopen K-12 schools shuttered by the pandemic, $600 payments for nearly 4 million low-income Californians — in addition to federal stimulus payments — and coronavirus relief grants and tax credits for hard-hit small businesses.

However, his 2021-22 fiscal year spending plan does not include additional public health money for local health departments steering California’s pandemic response, which have been chronically underfunded. He vowed to support cities and counties by boosting state testing and contact tracing capacity, speeding vaccination efforts and funding state-run surge hospitals that take overflow patients.

Newsom said Friday his budget reflects a “pandemic-induced reality” with investments aimed at spurring California’s economic recovery by helping businesses and people living in poverty. Wealth and income disparities, he added, “must be addressed.”

But Democrats in control of the state legislature, county leaders and social justice groups say that will be difficult to achieve because Newsom’s spending plan does not sufficiently fund health and social safety-net programs.

And without additional public health money, local leaders worry California will not be able to adequately control the spread of the virus.

“County public health is drowning,” said Graham Knaus, executive director of the California State Association of Counties. “We are triaging right now between testing, contact tracing and vaccination, and it’s impacting the response to the pandemic.”

Newsom’s budget proposal is the first step in a months-long negotiation process with the Democratic-controlled legislature, which has until June 15 to adopt the state budget that takes effect July 1. Lawmakers have become increasingly frustrated with the governor’s response to the pandemic, including his unilateral spending decisions in response to the emergency. Newsom is also facing a burgeoning recall effort, backed by heavyweight Republicans such as former San Diego Mayor Kevin Faulconer, who is considering challenging Newsom in the 2022 California gubernatorial election.

Newsom said he expects to make some tough calls on spending even though the state anticipates a $15 billion budget surplus for the coming fiscal year, largely because a state fiscal analysis projected deficits in subsequent years.

“While we are enjoying the fruits of a lot of one-time energy and surplus, it’s not permanent and we have to be mindful of over-committing,” Newsom said, explaining why he didn’t include funding to expand Medicaid to more unauthorized immigrants.

Some lawmakers say they will nonetheless press Newsom to use higher-than-expected revenues — and perhaps seek new taxes — to expand health coverage to more Californians.

The following health care proposals factor heavily into Newsom’s 2021-22 budget proposal.

Covid Relief

Newsom committed $4.4 billion in his budget to vaccine distribution, increased testing, contact tracing and other short-term pandemic expenses. Because that spending is related to the public health emergency, the state expects at least 75% to be reimbursed by the federal government and insurance payments.

He also proposed $52 million to fund costs at state-run surge hospitals, including support staff. And he is asking lawmakers to sign off on a covid relief package that would provide funding before the start of the fiscal year in July. It would include $2 billion to help school districts reopen classrooms to in-person instruction beginning in February by paying for protective equipment, ventilation systems and adequate testing. It would also commit billions to economic recovery, such as stimulus payments for individuals, and grants and tax credits for struggling small businesses.

Newsom also wants to increase the budget for the Department of Industrial Relations by $23 million to fund up to 113 additional workplace inspectors at the California Division of Occupational Safety and Health to police health order violations at businesses and enforce workplace safety laws.

Transforming Medi-Cal

Spending for Medi-Cal, the state’s Medicaid program for low-income residents, is expected to grow in the coming year because of the economic impact of the pandemic — as is its enrollment. The program has roughly 13 million enrollees, or about one-third of the state population.

In the coming year, Newsom will also press forward with a major overhaul of Medi-Cal, through a project called CalAIM, to provide new benefits emphasizing mental health care and substance use treatment, and pay for some nontraditional costs such as housing assistance. The hope is the program would divert homeless and other vulnerable people away from expensive emergency room care and keep them out of jail.

State Medi-Cal officials estimate the program would cost $1.1 billion for the first year. The state is working with the federal Centers for Medicare & Medicaid Services to obtain approval for the program.

Newsom also wants to expand Medi-Cal benefits to cover over-the-counter cold medicine and blood glucose monitors for people with diabetes. His budget includes $95 million for a major expansion of telehealth services that would permanently provide higher payments for virtual doctor visits.

Controlling Health Care Costs

Newsom is proposing a new state agency, the Office of Health Care Affordability, which he said would help control health care costs. He budgeted $63 million over the next three years for the office, which would set health care cost targets for the health care industry — along with financial penalties for failing to meet future targets.

Powerful health industry groups said they are still assessing whether they will support the proposal. But some expressed concern last year when Newsom floated the idea. Doctors and hospitals routinely fight proposals in Sacramento that might limit their revenue.

Newsom acknowledged Friday the task would be “tough.”

Battling Homelessness and Food Insecurity

Newsom is proposing a one-time infusion of $1.75 billion to battle homelessness.

Of that, Newsom said, $750 million would help counties purchase hotels and transform them into permanent housing for chronically homeless people. Another $750 million would allow counties to purchase facilities to treat people with mental illness or substance use disorders. And $250 million would help counties purchase and renovate homes for low-income older people.

Newsom’s budget also includes $30 million to help overwhelmed food banks and emergency food assistance programs.

Lawmakers said they plan to negotiate for even more funding for homelessness and safety-net programs.

“We absolutely need to significantly increase our investment to address homelessness because the need is so intense,” said Assembly member David Chiu (D-San Francisco). “And I don’t think there’s a single legislator who isn’t incredibly concerned about the food insecurity we’re seeing: lines around the block for food banks in what should be the wealthiest state in the country.”

Expanding Health Coverage

Newsom did not include money in his proposed budget to expand Medi-Cal to unauthorized immigrants age 65 and older. He had previously promised to fund the proposal, estimated to cost $350 million per year once fully implemented, but he said Friday the state cannot afford to commit to ongoing costs with a projected budget deficit starting in fiscal year 2022-23. California already offers full Medicaid benefits for income-eligible unauthorized immigrants up to age 26.

Some lawmakers and health care advocates countered that providing health insurance for undocumented immigrants would save lives and reduce costs, especially during the pandemic, and vowed to continue to fight for the expansion.

“To say we are disappointed is describing it very lightly,” said Orville Thomas, a lobbyist with the California Immigrant Policy Center. “These are Californians dying and getting sick at disproportionate rates during covid.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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New Analysis Takes In-Depth Look at How States are Prioritizing Who Gets a COVID-19 Vaccine

A new KFF analysis examines the different approaches states are taking to manage the limited initial supply of COVID-19 vaccines and balance the desire to vaccinate those at greatest risk first with the need to ensure a fast and effective statewide vaccination effort. Based on a review of state vaccination plans, the analysis finds thatMore

Is Your Covid Vaccine Venue Prepared to Handle Rare, Life-Threatening Reactions?

As the rollout of covid-19 vaccines picks up across the U.S., moving from hospital distribution to pharmacies, pop-up sites and drive-thru clinics, health experts say it’s vital that these expanded venues be prepared to handle rare but potentially life-threatening allergic reactions.

“You want to be able to treat anaphylaxis,” said Dr. Mitchell Grayson, an allergist-immunologist with Nationwide Children’s Hospital in Columbus, Ohio. “I hope they’re in a place where an ambulance can arrive within five to 10 minutes.”

Of the more than 6 million people in the U.S. who have received shots of the two new covid vaccines, at least 29 have suffered anaphylaxis, a severe and dangerous reaction that can constrict airways and send the body into shock, according to the Centers for Disease Control and Prevention.

Such incidents have been rare — about 5.5 cases for every million doses of vaccine administered in the U.S. between mid-December and early January — and the patients recovered. For most people, the risk of getting the coronavirus is far higher than the risk of a vaccine reaction and is not a reason to avoid the shots, Grayson said.

Still, the rate of anaphylaxis so far is about five times higher for the covid vaccines than for flu shots, and some of those stricken had no history of allergic reactions. In this early phase of the vaccine rollout, all the patients were treated in hospitals and health centers that could offer immediate access to full-service emergency care.

As states look to scale up distribution, the shots will be administered by a varied assortment of professionals at venues including drugstores, dental offices and temporary sites attended by National Guard troops, among others. Health officials say every site involved in the wider community rollout must be able to recognize problems and have the training and equipment to respond swiftly if something goes wrong.

“We are really pushing to make sure that anybody administering vaccines needs not just to have the EpiPen available but, frankly, to know how to use it,” said Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, in a call with reporters. She was referring to a common epinephrine injector that many people with severe allergies carry with them. Those health care workers must also know the warning signs of the need for advanced care, she added.

Anaphylaxis typically occurs within minutes and can cause hives, nausea, vomiting, dizziness or fainting, and life-threatening problems such as low blood pressure and constricted airways. Initial treatment is an injection of epinephrine, or adrenalin, to reduce the body’s allergic response. However, severely affected patients can require intensive treatments including oxygen, IV antihistamines and steroids such as cortisone to save their lives. Community sites are unlikely to have these treatments on hand and would need quick access to emergency responders.

Anybody administering vaccines needs not just to have the EpiPen available, but, frankly, to know how to use it.

Dr. Nancy Messonnier, CDC

Scientists are still investigating what’s triggering the severe reactions to the Pfizer-BioNTech and Moderna mRNA vaccines. They suspect the culprit may be polyethylene glycol, or PEG, a component present in both vaccines that has been associated with allergic reactions.

Even as they call for education and support for providers, experts are urging the more than 50 million Americans with allergies — whether to foods, insect venom, medications or other vaccines — to be proactive about finding a venue that’s properly prepared. Before scheduling a vaccine, contact the site and ask pointed questions about its emergency precautions, said Dr. Kimberly Blumenthal, quality and safety officer for allergy at Massachusetts General Hospital.

“Ask the question: Do they have an anaphylaxis kit? Can they take vital signs?” she said. People who routinely carry EpiPens should remember to bring them when they are vaccinated, she added.

A CDC website details a list of equipment and medications that sites should have on hand and urges that all patients be observed for 15 minutes after vaccination or 30 minutes if they’re at higher risk for reactions. The list recommends — but does not require — that sites stock the more intensive treatments, such as IV fluids. People who experience severe reactions shouldn’t get the recommended second dose of the vaccine, the agency said.

“Appropriate medical treatment for severe allergic reactions must be immediately available in the event that an acute anaphylactic reaction occurs following administration of an mRNA COVID-19 vaccine,” the site says.

Still, that’s a tall order, given the scope of the vaccination effort. The federal government is sending vaccines to more than 40,000 pharmacy locations involving 19 chains, including CVS, Walgreens, Costco and Rite Aid. At the same time, dozens of pop-up inoculation sites are ramping up in New York City, and drive-thru clinics have been set up in Ohio, Florida and other states.

Drive-thru sites, in particular, worry allergists like Blumenthal, who said it’s crucial to recognize symptoms of anaphylaxis quickly. “If you’re in a car, are you going to have your windows open? Where are the medicines? Are you in a parking lot?” she said. “It just sounds logistically more challenging.”

Ask the question: Do they have an anaphylaxis kit? Can they take vital signs?

Dr. Kimberly Blumenthal, Massachusetts General Hospital

In Columbus, more than 2,400 people had been vaccinated by Jan. 6 at a drive-thru clinic set up at the Ohio Expo Center. No allergic reactions have been reported, according to Kelli Newman, a spokesperson for Columbus Public Health. But if they occur, she said, health officials are prepared.

“We have a partnership with our EMS and they are observing those being vaccinated for 15 minutes to make sure there are no adverse reactions,” Newman said in an email. “They have two EMS trucks available with emergency equipment and epinephrine, if needed.”

Similarly, representatives for CVS Health and Walgreens said they have the staff and supplies to handle “rare but severe” reactions.

“We have emergency management protocols in place that are required for all vaccine providers, which, following a clinical assessment, may include administering epinephrine, calling 911 and administering CPR, if needed,” Rebekah Pajak, a spokesperson for Walgreens, said in an email.

If the vaccine sites have appropriately trained staffers, plus adequate supplies and equipment, the vast majority of people should opt for the shot, especially as the pandemic continues to surge, said Dr. David Lang, immediate past president of the American Academy of Allergy, Asthma & Immunology and chairman of the department of immunology at the Cleveland Clinic.

“The overwhelming likelihood is that you won’t have anaphylaxis and the overwhelming benefit far exceeds the risk for harm,” Lang said.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Mientras los vulnerables esperan, cónyuges de polٌíticos reciben la vacuna contra covid

Los suministros de vacunas contra covid-19 son escasos, por eso un panel asesor federal recomienda primero administrarlas a los trabajadores de salud, que mantienen en funcionamiento el sistema médico del país, y a los adultos mayores en hogares, que tienen más probabilidades de morir a causa del coronavirus.

En ninguna parte de la lista de personas prioritarias están los cónyuges de los funcionarios públicos.

Sin embargo, las primeras damas de Kentucky y West Virginia; Karen Pence, la esposa del vicepresidente Mike Pence; Jill Biden, la esposa del presidente electo Joe Biden; y Doug Emhoff, el esposo de la vicepresidenta electa Kamala Harris, estuvieron entre los primeros estadounidenses en recibir las vacunas que podrían salvar vidas.

Kentucky también vacunó a seis ex gobernadores y cuatro ex primeras damas, incluidos los padres de Andy Beshear, el actual gobernador demócrata.

Las primeras vacunas a los cónyuges provocaron indignación en las redes sociales, y varios usuarios de Twitter dijeron que no deberían poder “saltar la fila” antes que los médicos, enfermeras y personas mayores.

En la mayoría de los 29 estados que respondieron a las consultas de KHN (que llamó a las 50 oficinas de gobierno estatales), los principales funcionarios electos dijeron que ellos, y sus cónyuges, serán vacunados, pero han optado por esperar su turno detrás de electores más vulnerables.

Algunos miembros del Congreso de ambos partidos dijeron lo mismo cuando rechazaron las primeras dosis ofrecidas, en nombre de mantener al gobierno en funcionamiento.

Los gobernadores que recibieron las vacunas junto con sus cónyuges, y la oficina del vicepresidente, dijeron que querían dar el ejemplo a los residentes, generar confianza, salvar las divisiones ideológicas y demostrar que la vacuna es segura y eficaz.

Pero algunos cuestionan esta razón.

“Se parece más a hacer trampa. Los políticos pueden conseguir que los hospitales los vacunen bajo esta ilusión de generar confianza. Pero es una fachada”, dijo Arthur Caplan, profesor de bioética y director fundador de la división de ética médica de la Escuela de Medicina Grossman de la Universidad de Nueva York. “La gente podría decir: ‘Típica gente rica. No se puede confiar en ellos’. Esto socava la meta original”.

Caplan agregó que, de todos modos, el público no confía demasiado en los políticos, por lo que la vacunación de celebridades, líderes religiosos o figuras deportivas probablemente ayudaría más a aumentar la confianza en la vacuna.

Elvis Presley recibió la famosa vacuna contra la polio en 1956 para ganar la confianza de los escépticos; las acciones de las esposas de los gobernadores de ese período se recuerdan menos.

El doctor José Romero, presidente del Comité Asesor de Prácticas de Inmunización de los Centros para el Control y Prevención de Enfermedades (CDC), dijo en un correo electrónico a KHN que si bien su grupo proporciona un esquema para distribuir dosis limitadas de vacunas, “las jurisdicciones tienen la flexibilidad de hacer lo que sea apropiado para su población”.

Los funcionarios de Kentucky y Texas señalaron que el doctor Robert Redfield, director de los CDC, alentó a los gobernadores a vacunarse públicamente.

Nadie mencionó razones médicas para que sus cónyuges se vacunaran; los hospitales generalmente no están vacunando a los cónyuges de los profesionales médicos que han recibido la vacuna.

La oficina del gobernador de West Virginia, el republicano Jim Justice, publicó fotografías de él, su esposa, Cathy Justice, y otros funcionarios recibiendo las dosis. También posteó su propia vacunación en YouTube.

La oficina de Beshear en Kentucky también publicó fotos del gobernador recibiendo la vacuna en diciembre, el mismo día que su esposa, Britainy Beshear, y otros funcionarios estatales.

“Es cierto que hay dudas sobre las vacunas”, dijo Beshear en una reunión informativa sobre el coronavirus, el día en el que los ex gobernadores de Kentucky y sus cónyuges fueron vacunados. Aludió a un programa futuro que involucra a líderes religiosos y a otras personas influyentes.

Su padre, el ex gobernador demócrata Steve Beshear, publicó fotos de su vacunación en su página de Facebook, diciendo que él y su esposa, Jane Beshear, junto con otros ex gobernadores de Kentucky de ambos partidos y sus cónyuges, intervinieron en parte para alentar a los residentes a vacunarse.

Kentucky se encuentra actualmente en la primera etapa de distribución de vacunas, dirigida a trabajadores de salud y a residentes de centros de vida asistida. Se habían distribuido menos de 15,000 de las 58,500 dosis para estas residencias cuando los ex gobernadores y sus cónyuges fueron vacunados.

Tres Watson, ex director de comunicaciones del Partido Republicano de Kentucky, que fundó una firma de consultoría política, se mostró escéptico sobre las intenciones detrás del evento. Dijo que parecía ser un esfuerzo de relaciones públicas creado para que el gobernador pudiera vacunar a sus padres.

“Entiendo la continuidad del gobierno, pero las primeras damas no tienen parte en la continuidad del gobierno”, dijo. “Tienes que ajustarte a las prioridades. Una vez que empiezas a hacer excepciones, es cuando tienes problemas”.

Los funcionarios que representan al equipo de transición de Biden-Harris y otros tres estados donde se vacunaron los gobernadores (West Virginia y Texas liderados por republicanos, y Kansas liderado por un demócrata) no respondieron a KHN. El gobernador republicano de Alabama, Kay Ivey, recibió la vacuna y está divorciado.

Políticos de otros estados han hecho lo opuesto.

En Arkansas, el gobernador republicano Asa Hutchinson se centra en garantizar que los grupos de alta prioridad, como los trabajadores de salud, y el personal y residentes de centros de vida asistida, se vacunen, dijo la vocera LaConda Watson. “Él y su esposa recibirán la vacuna cuando sea su turno”, informó.

En Missouri, Kelli Jones, directora de comunicaciones del gobernador republicano Mike Parson, dijo en un correo electrónico que él y la primera dama tienen la intención de vacunarse. Al igual que los gobernadores de Colorado, Nevada y otros lugares, ambos se han recuperado de covid-19, dijo Jones, y “esperarán hasta que su grupo de edad sea elegible” según el plan estatal. Los médicos recomiendan las vacunas incluso para personas que ya han tenido covid.

Cissy Sanders, de 52 años, directora de eventos que vive en Austin, Texas, dijo que entiende por qué los legisladores deberían vacunarse. Su propio gobernador, el republicano Greg Abbott, se vacunó por televisión en vivo para infundir confianza, dijo su secretaria de prensa, Renae Eze, quien no quiso comentar si la esposa de Abbott se había vacunado.

Pero Sanders dijo que los cónyuges de los políticos no deben vacunarse antes que los residentes de un asilo, como su propia madre de 71 años. La madre de Sanders recibió la vacuna a fines de diciembre pero dijo que todavía hay demasiados residentes de hogares esperando en todo el país.

“¿Por qué un grupo que no es de alto riesgo, es decir, estos cónyuges, va a vacunarse antes que el grupo de mayor riesgo? ¿Quién toma estas decisiones?, se preguntó. “Los cónyuges de los políticos no han estado en la zona cero del virus. Los residentes de hogares sí”.

La corresponsal de Montana, Katheryn Houghton, la corresponsal de California Healthline, Angela Hart y los corresponsales Markian Hawlyruk y JoNel Aleccia colaboraron con esta historia.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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KHN on the Air This Week

KHN Editor-in-Chief Elisabeth Rosenthal discussed issues with the U.S. rollout of the covid-19 vaccines with NPR’s “Weekend Edition” and MSNBC’s “The Week With Joshua Johnson” on Jan. 3.

KHN chief Washington correspondent Julie Rovner discussed covid’s impact on current politics with WAMU’s “1A” on Dec. 31.

KHN Midwest correspondent Lauren Weber discussed covid in a 2020 news roundup on WAMU’s “1A” on Dec. 31.

KHN senior correspondent Phil Galewitz discussed deep cleaning the White House before the Bidens arrive with Newsy on Dec. 23.

KHN Midwest correspondent Cara Anthony discussed what it’s like to be a reporter during a pandemic with St. Louis Public Radio’s “We Live Here.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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As the Vulnerable Wait, Some Political Leaders’ Spouses Get Covid Vaccines

With supplies of covid-19 vaccines scarce, a federal advisory panel recommends first putting shots into the arms of health care workers, who keep the nation’s medical system running, and long-term care residents most likely to die from the coronavirus.

Nowhere on the list of prioritized recipients are public officials’ spouses.

Yet the first ladies of Kentucky and West Virginia; Republican Vice President Mike Pence’s wife, Karen Pence; Democratic President-elect Joe Biden’s wife, Jill Biden; and Vice President-elect Kamala Harris’ husband, Doug Emhoff, were among the first Americans to get the potentially lifesaving shots.

Kentucky also vaccinated six former governors and four former first ladies, including current Democratic Gov. Andy Beshear’s parents.

The early vaccinations of political spouses spurred outrage on social media, with several Twitter users saying they should not be able to “jump the line” ahead of doctors, nurses and older people.

In most of the 29 states that responded to KHN inquiries of all 50 governors’ offices, top elected officials said they — and their spouses — will be vaccinated but have chosen to wait their turn behind more vulnerable constituents. Some Congress members from both parties said much the same when they refused early doses offered in the name of keeping the government running. Those weren’t offered to their spouses.

Governors who got the shots along with their spouses, and the vice president’s office, said they wanted to set an example for residents, build trust, bridge ideological divides and show that the vaccine is safe and effective.

But that’s a rationale some critics don’t buy.

“It looks more like cutting in line than it does securing trust. The politicians can get the hospitals to give it to them under this illusion of building trust. But it’s a façade,” said Arthur Caplan, a bioethics professor and founding head of the medical ethics division at New York University Grossman School of Medicine. “People might say: ‘Yup, typical rich people. They can’t be trusted.’ This undermines what they set out to do.”

Besides, Caplan said, the public doesn’t trust politicians all that much anyway, so inoculating celebrities, religious leaders or sports figures would likely do more to boost confidence in the vaccine. Rock ’n’ roll king Elvis Presley famously got the polio vaccine in 1956 to help win over those who were skeptical; the actions of governors’ wives from that period are less remembered.

Dr. José Romero, chairperson of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, said in an email to KHN that while his group provides an outline for distributing limited vaccine doses, “jurisdictions have the flexibility to do what’s appropriate for their population.” Kentucky and Texas officials pointed out that CDC Director Dr. Robert Redfield encouraged governors to publicly get the vaccine.

No one mentioned medical reasons for their spouses to get vaccines; hospitals are generally not vaccinating the spouses of medical professionals who have gotten the shot. (It’s unclear whether vaccinated people can still spread the virus, so it’s possible that a vaccinated person could pass the virus to their spouse or have to quarantine if an unvaccinated spouse were to get covid.)

The office of West Virginia’s governor, Republican Jim Justice, released pictures of him, his wife, Cathy Justice, and other officials receiving shots. He also showed his own vaccination on YouTube.

Beshear’s office in Kentucky also released photos of him getting the vaccine in December on the same day as his wife, Britainy Beshear, and other state officials.

“There is no question that there is vaccine hesitancy out there,” Beshear said at a coronavirus briefing on Monday, the day former Kentucky governors and their spouses were vaccinated. He alluded to a future program involving faith leaders and others. “Validators are incredibly important to building that confidence.”

His father, Democratic former Gov. Steve Beshear, posted photos of his vaccination on his Facebook page, saying that he and his wife, Jane Beshear, along with other former Kentucky governors of both parties and their spouses, stepped up partly to show residents the vaccine is safe and encourage them to get it when it’s available to them.

Kentucky is currently in the first stage of vaccine distribution, which targets health care workers and residents of long-term care and assisted living facilities. Fewer than 15,000 of the 58,500 doses received for long-term care had been given out when the former governors and their spouses were vaccinated.

Tres Watson, a former communications director for the Republican Party of Kentucky who founded a political consulting firm, was skeptical about the intentions behind the event. He said it seemed to be a public relations effort created so the governor could vaccinate his parents.

“I understand the continuity of government, but first ladies have no part in the continuity of government,” he said. “You need to stick with the priorities. Once you start making exceptions, that’s when you run into problems.”

Officials representing the Biden-Harris transition team and three other states where governors got vaccinated — Republican-led West Virginia and Texas, and Democratic-led Kansas — either didn’t respond to KHN or didn’t answer questions about spouses. Alabama’s Republican governor, Kay Ivey, got the vaccine and is divorced.

Politicians in other states have taken the opposite tack.

In Arkansas, Republican Gov. Asa Hutchinson is focused on ensuring high-priority groups such as health care workers, long-term care staffers and residents are vaccinated, said spokesperson LaConda Watson. “He and his wife will receive the vaccination when it’s their turn,” she said.

In Missouri, Kelli Jones, communications director for Republican Gov. Mike Parson, said in an email that he and the first lady fully intend to get the vaccine. Like governors from Colorado, Nevada and elsewhere, they’ve both recovered from covid-19, Jones said, and will “wait until their age group is eligible” under the state plan. Doctors recommend vaccinations even for people who have already had covid.

Cissy Sanders, 52, an events manager who lives in Austin, Texas, said she understands why lawmakers would need to get the vaccine. Her own governor, Republican Greg Abbott, received it on live television to instill confidence, said his press secretary, Renae Eze, who wouldn’t address whether Abbott’s wife was vaccinated.

But Sanders said politicians’ spouses should not be vaccinated before nursing home residents like her 71-year-old mom. Sanders’ mother received the vaccine in late December — after some public officials’ spouses — but she said far too many nursing home residents across America are still waiting.

“Why is a non-high-risk group — i.e., these spouses — going before the most high-risk group? Who makes these decisions? Who thinks this is a good, responsible, safe decision to make?” she said. “Political spouses have not been at ground zero for the virus. Nursing home residents have been.”

KHN Montana correspondent Katheryn Houghton, California Healthline correspondent Angela Hart and KHN senior correspondents Markian Hawryluk and JoNel Aleccia contributed to this report.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Merck KGaA Acquires AmpTec to Strengthen its mRNA Capabilities for Vaccines, Treatments and Diagnostics

Shots:

  • The acquisition will integrate AmpTec’s PCR-based mRNA technology with Merck’s expertise in lipids manufacturing, providing combine offering across mRNA value chain
  • The deal will expand Merck’s capabilities to develop & manufacture mRNA for use in vaccines, treatments, and diagnostics applicable in COVID-19 and many other diseases. Additionally, AmpTech’s diagnostic business focusing on customized long RNAs and DNAs for IVDs, complements existing Merck’s portfolio
  • The addition of AmpTech’s PCR-based technology to Merck allow the companies to offer innovative technologies, products, and services, advancing life-enhancing therapies

Click here ­to­ read full press release/ article | Ref: Merck KGaA | Image: Glassdoor

The post Merck KGaA Acquires AmpTec to Strengthen its mRNA Capabilities for Vaccines, Treatments and Diagnostics first appeared on PharmaShots.

January 14 Web Event: A Shot in the Arm For Long-Term Care Facilities? Early Lessons from the COVID-19 Vaccine Rollout to High Priority Populations

With the pandemic taking a heavy toll among older Americans, the Centers for Disease Control and Prevention and most states have placed a high priority on vaccinating residents and staff of long-term care facilities. People in nursing homes and other long-term care settings account for 8 percent of cases but 40 percent of deaths fromMore

Eureka! Two Vaccines Work — But What About the Also-Rans in the Pharma Arms Race?


This story also ran on Daily Beast. It can be republished for free.

As I prepared to get my shot in mid-December as part of a covid vaccine trial run by Janssen Pharmaceuticals, I considered the escape routes. Bailing out of the trial was a very real consideration since two other vaccines, made by Moderna and Pfizer-BioNTech, had been deemed safe and effective for emergency approval.

Leaving the trial would be a perfectly sane decision for me or anyone who had volunteered for an ongoing covid experiment. Why risk getting covid-19 if I was given a placebo, a shot with no vaccine in it? The way tests are designed, I might not be told whether I received the vaccine until the clinical trial is over, months from now.

Dropping the placebo arm could also be ethically sound from the company’s point of view. Researchers frequently halt trials when they have a product that works — or manifestly doesn’t. And the two approved vaccines are 95% effective.

That very real choice for thousands of people offering to join or remain in the ongoing vaccine tests creates a conundrum for science and for society. If trials can’t go forward, that could very well have an impact on the world’s supply of covid vaccines and eventually on vaccine prices, especially if booster shots are needed in years to come. In markets where there are only two competing drugs, prices can shoot sky-high. If there are four or five on the market, competition usually kicks in to control costs.

In short, the welcome arrival of two covid vaccines deemed safe has uncovered a series of ethical and logistical challenges. And it has governments, companies and scientists scrambling for solutions.

“The world’s vaccine experts are saying the longer we can carry out a placebo-controlled trial the better,” Matthew Hepburn, who runs the vaccine development arm of Operation Warp Speed, the multibillion-dollar federal program to fight covid-19, told me. “But as a volunteer in the Janssen trial, you can always drop out.”

As for the best way to resolve broader problems, “it’s a debate in real time,” he said.

Generally, there are two aspects to the debate. First, what should be done with placebo recipients of the Moderna and Pfizer trials now that it’s clear both shots prevent the disease and appear safe? Second, how can the scores of companies in the United States and overseas that are still testing covid vaccines adapt when there are apparently reliable products already on the market?

The FDA’s advisory committee debated the first question during two meetings in December. They heard Stanford University statistician Steven Goodman argue in favor of a “double-blind crossover” modification of the Pfizer and Moderna trials. Everyone who got placebo shots in the trials would now get two doses of the real vaccine, and vice versa. That way everyone would be protected but still “blind” as to when they were properly vaccinated.

Such a rejigger of the current trial would provide more data on the vaccine’s safety and durability of protection, although the longer-term comparison of vaccine versus placebo would be lost. It’s a marvelous idea in principle, the panelists agreed, but pretty hard to carry out. Neither Moderna nor Pfizer has agreed to it.

Pfizer wants to “unblind” placebo recipients of its vaccine — to reveal they got the saline solution and give them the real thing — once their risk group gets its turn in line for the vaccine. It has already started vaccinating health care workers who got the placebo.

Moderna, which has thousands of soon-to-expire leftover doses from its trial, said it intends to unblind its trial and vaccinate all the placebo recipients. In doing so, it would be recognizing the altruistic service the test subjects made to science and society by joining the trial.

Another proposal would split the placebo recipients in the trial into two groups. In one group, everyone would get a single dose of the vaccine. In the other, each would get two doses. This would be a way of testing evidence that emerged during the Pfizer and Moderna trials that a single dose might provide sufficient protection. If that were true, vaccination of the country could happen nearly twice as fast, because there would be twice as many doses of vaccine to go around.

No one knows to what extent the Food and Drug Administration could force the hands of the two companies, which still expect to get full licensure for their vaccines this year. Moderna is considered more amenable to the suggestion since, unlike Pfizer, it got nearly $1 billion in federal funding to develop its vaccine.

Other vaccine developers — including Operation Warp Speed participants Janssen (owned by Johnson & Johnson), AstraZeneca, Novavax, Sanofi and Merck & Co. — are closely watching to see which path is taken.

They are in a race against time — a race that may not end well for those running late in getting their vaccine out. And halting those efforts could hurt billions of people elsewhere in the world whose lives and livelihoods will depend on the arrival of plentiful, cheap vaccines.

One problem is finding willing test subjects. As increasing numbers of Americans are vaccinated, and the virus recedes from our shores, “the fewer the number of people eligible to participate in trials,” said Susan Ellenberg, professor of biostatistics at the University of Pennsylvania.

For now, AstraZeneca and Janssen appear well situated. Both have closed enrollment in their U.S. trials and are likely to file within a few months for emergency use authorizations, like those that have allowed Moderna and Pfizer to start vaccinating the public.

Novavax officials last week started their late-stage trial in the U.S. and predict they can get full enrollment before the majority of the U.S. population is vaccinated.

Sanofi and Merck, whose timetables are more drawn out, are more likely to conduct most of their trials overseas.

In theory, drug companies could overcome these hurdles by testing multiple vaccines against one another and against approved vaccines. Dr. Steven Joffe, a University of Pennsylvania bioethicist, proposed in a recent JAMA article that Operation Warp Speed pay for such a trial.

Scientists and policymakers batted around the idea of a single U.S. trial, with multiple vaccine candidates competing against one another and a single placebo arm, during initial discussions last spring about the creation of Operation Warp Speed.

The idea went nowhere in the United States. It was taken up by World Health Organization officials and major biomedical research groups, which have tried to create such a vaccine trial in the rest of the world — with little success thus far.

So, for now, future vaccine trials are somewhat up in the air.

“There’s this tension created by getting the first vaccines out there so quickly,” said David Wendler, a senior researcher in bioethics at the National Institutes of Health’s Clinical Center. “For public health it’s good, but it has the potential to undermine our ability to keep going on the research side and really knock out the virus.”

Companies, governments and outside funders need to quickly develop consensus on appropriate trial designs and regulatory processes for additional covid vaccines, added Mark Feinberg, president and CEO of the International AIDS Vaccine Initiative.

As for me, I decided I would stay in the Janssen trial. However, the day before I was scheduled to get my injection — real or fake — the research organization running the inoculations called to say I failed to make the cut: J&J had stopped its trial enrollment.

So, I’ll buy some new masks and get in line for my vaccine with everyone else.

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Analysis: Some Said the Vaccine Rollout Would Be a ‘Nightmare.’ They Were Right.


This story also ran on The New York Times. It can be republished for free.

WASHINGTON — Even before there was a vaccine, some seasoned doctors and public health experts warned, Cassandra-like, that its distribution would be “a logistical nightmare.

After Week 1 of the rollout, “nightmare” sounds like an apt description.

Dozens of states say they didn’t receive nearly the number of promised doses. Pfizer says millions of doses sat in its storerooms, because no one from President Donald Trump’s Operation Warp Speed task force told them where to ship them. A number of states have few sites that can handle the ultra-cold storage required for the Pfizer product, so, for example, front-line workers in Georgia have had to travel 40 minutes to get a shot. At some hospitals, residents treating COVID patients protested that they had not received the vaccine while administrators did, even though they work from home and don’t treat patients.

The potential for more chaos is high. Dr. Vivek Murthy, named as the next surgeon general under President-elect Joe Biden, said this week that the Trump administration’s prediction — that the general population would get the vaccine in April — was realistic only if everything went smoothly. He instead predicted wide distribution by summer or fall.

The Trump administration had expressed confidence that the rollout would be smooth, because it was being overseen by a four-star general, Gustave Perna, an expert in logistics. But it turns out that getting fuel, tanks and tents into war-torn mountainous Afghanistan is in many ways simpler than passing out a vaccine in our privatized, profit-focused and highly fragmented medical system. Gen. Perna apologized this week, saying he wanted to “take personal responsibility.” It’s really mostly not his fault.

Throughout the COVID pandemic, the U.S. health care system has shown that it is not built for a coordinated pandemic response (among many other things). States took wildly different COVID prevention measures; individual hospitals varied in their ability to face this kind of national disaster; and there were huge regional disparities in test availability — with a slow ramp-up in availability due, at least in some part, because no payment or billing mechanism was established.

Why should vaccine distribution be any different?

In World War II, toymakers were conscripted to make needed military hardware airplane parts, and commercial shipyards to make military transport vessels. The Trump administration has been averse to invoking the Defense Production Act, which could help speed and coordinate the process of vaccine manufacture and distribution. On Tuesday, it indicated it might do so, but only to help Pfizer obtain raw materials that are in short supply, so that the drugmaker could produce — and sell — more vaccines in the United States.

Instead of a central health-directed strategy, we have multiple companies competing to capture their financial piece of the pandemic health care pie, each with its patent-protected product as well as its own supply chain and shipping methods.

Add to this bedlam the current decision-tree governing distribution: The Centers for Disease Control and Prevention has made official recommendations about who should get the vaccine first — but throughout the pandemic, many states have felt free to ignore the agency’s suggestions.

Instead, Operation Warp Speed allocated initial doses to the states, depending on population. From there, an inscrutable mix of state officials, public health agencies and lobbyists seem to be determining where the vaccine should go. In some states, counties requested an allotment from the state, and then they tried to accommodate requests from hospitals, which made their individual algorithms for how to dole out the precious cargo. Once it became clear there wasn’t enough vaccine to go around, each entity made its own adjustments.

Some doses are being shipped by FedEx or UPS. But Pfizer — which did not fully participate in Operation Warp Speed — is shipping much of the vaccine itself. In nursing homes, some vaccines will be delivered and administered by employees of CVS and Walgreens, though issues of staffing and consent remain there.

The Moderna vaccine, rolling out this week, will be packaged by the “pharmaceutical services provider” Catalent in Bloomington, Indiana, and then sent to McKesson, a large pharmaceutical logistics and distribution outfit. It has offices in places like Memphis, Tennessee, and Louisville, which are near air hubs for FedEx and UPS, which will ship them out.

Is your head spinning yet?

Looking forward, basic questions remain for 2021: How will essential workers at some risk (transit workers, teachers, grocery store employees) know when it’s their turn? (And it will matter which city you work in.) What about people with chronic illness — and then everyone else? And who administers the vaccine — doctors or the local drugstore?

In Belgium, where many hospitals and doctors are private but work within a significant central organization, residents will get an invitation letter “when it’s their turn.” In Britain, the National Joint Committee on Vaccination has settled on a priority list for vaccinations — those over 80, those who live or work in nursing homes, and health care workers at high risk. The National Health Service will let everyone else “know when it’s your turn to get the vaccine ” from the government-run health system.

In the United States, I dread a mad scramble — as in, “Did you hear the CVS on P Street got a shipment?” But this time, it’s not toilet paper.

Combine this vision of disorder with the nation’s high death toll, and it’s not surprising that there is intense jockeying and lobbying — by schools, unions, even people with different types of preexisting diseases — over who should get the vaccine first, second and third. It’s hard to “wait your turn” in a country where there are 200,000 new cases and as many as 2,000 new daily COVID deaths — a tragic per capita order of magnitude higher than in many other developed countries.

So kudos and thanks to the science and the scientists who made the vaccine in record time. I’ll eagerly hold out my arm — so I can see the family and friends and colleagues I’ve missed all these months. If only I can figure out when I’m eligible, and where to go to get it.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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As the Terror of COVID Struck, Health Care Workers Struggled to Survive. Thousands Lost the Fight.


This story also ran on The Guardian. It can be republished for free.

Workers at Garfield Medical Center in suburban Los Angeles were on edge as the pandemic ramped up in March and April. Staffers in a 30-patient unit were rationing a single tub of sanitizing wipes all day. A May memo from the CEO said N95 masks could be cleaned up to 20 times before replacement.

Patients showed up COVID-negative but some still developed symptoms a few days later. Contact tracing took the form of texts and whispers about exposures.

By summer, frustration gave way to fear. At least 60 staff members at the 210-bed community hospital caught COVID-19, according to records obtained by KHN and interviews with eight staff members and others familiar with hospital operations.

The first to die was Dawei Liang, 60, a quiet radiology technician who never said no when a colleague needed help. A cardiology technician became infected and changed his final wishes — agreeing to intubation — hoping for more years to dote on his grandchildren.

Few felt safe.

Ten months into the pandemic, it has become far clearer why tens of thousands of health care workers have been infected by the virus and why so many have died: dire PPE shortages. Limited COVID tests. Sparse tracking of viral spread. Layers of flawed policies handed down by health care executives and politicians, and lax enforcement by government regulators.

All of those breakdowns, across cities and states, have contributed to the deaths of more than 2,900 health care workers, a nine-month investigation by over 70 reporters at KHN and The Guardian has found. This number is far higher than that reported by the U.S. government, which does not have a comprehensive national count of health care workers who’ve died of COVID-19.

The fatalities have skewed young, with the majority of victims under age 60 in the cases for which there is age data. People of color have been disproportionately affected, accounting for about 65% of deaths in cases in which there is race and ethnicity data. After conducting interviews with relatives and friends of around 300 victims, KHN and The Guardian learned that one-third of the fatalities involved concerns over inadequate personal protective equipment.

Many of the deaths occurred in New York and New Jersey, and significant numbers also died in Southern and Western states as the pandemic wore on.

Workers at well-funded academic medical centers — hubs of policymaking clout and prestigious research — were largely spared. Those who died tended to work in less prestigious community hospitals like Garfield, nursing homes and other health centers in roles in which access to critical information was low and patient contact was high.

Garfield Medical Center and its parent company, AHMC Healthcare, did not respond to multiple calls or emails regarding workers’ concerns and circumstances leading to the worker deaths.

So as 2020 draws to a close, we ask: Did so many of the nation’s health care workers have to die?

New York’s Warning for the Nation

The seeds of the crisis can be found in New York and the surrounding cities and suburbs. It was the region where the profound risks facing medical staff became clear. And it was here where the most died.

As the pandemic began its U.S. surge, city paramedics were out in force, their sirens cutting through eerily empty streets as they rushed patients to hospitals. Carlos Lizcano, a blunt Queens native who had been with the New York City Fire Department (FDNY) for two decades, was one of them.

He was answering four to five cardiac arrest calls every shift. Normally he would have fielded that many in a month. He remembered being stretched so thin he had to enlist a dying man’s son to help with CPR. On another call, he did chest compressions on a 33-year-old woman as her two small children stood in the doorway of a small apartment.

“I just have this memory of those kids looking at us like, ‘What’s going on?’”

After the young woman died, Lizcano went outside and punched the ambulance in frustration and grief.

The personal risks paramedics faced were also grave.

More than 40% of emergency medical service workers in the FDNY went on leave for confirmed or suspected coronavirus during the first three months of the pandemic, according to a study by the department’s chief medical officer and others.

In fact, health care workers were three times more likely than the general public to get COVID-19, other researchers found. And the risks were not equally spread among medical professions. Initially, CDC guidelines were written to afford the highest protection to workers in a hospital’s COVID-19 unit.

Yet months later, it was clear that the doctors initially thought to be at most risk — anesthesiologists and those working in the intensive care unit — were among the least likely to die. This could be due to better personal protective equipment or patients being less infectious by the time they reach the ICU.

Instead, scientists discovered that “front door” health workers like paramedics and those in acute-care “receiving” roles — such as in the emergency room — were twice as likely as other health care workers to be hospitalized with COVID-19.

For FDNY’s first responders, part of the problem was having to ration and reuse masks. Workers were blind to an invisible threat that would be recognized months later: The virus spread rapidly from pre-symptomatic people and among those with no symptoms at all.

In mid-March, Lizcano was one of thousands of FDNY first responders infected with COVID-19.

At least four of them died, city records show. They were among the 679 health care workers who have died in New York and New Jersey to date, most at the height of the terrible first wave of the virus.

“Initially, we didn’t think it was this bad,” Lizcano said, recalling the confusion and chaos of the early pandemic. “This city wasn’t prepared.”

Neither was the rest of the country.

An Elusive Enemy

The virus continued to spread like a ghost through the nation and proved deadly to workers who were among the first to encounter sick patients in their hospital or nursing home. One government agency had a unique vantage point into the problem but did little to use its power to cite employers — or speak out about the hazards.

Health employers had a mandate to report worker deaths and hospitalizations to the Occupational Safety and Health Administration.

When they did so, the report went to an agency headed by Eugene Scalia, son of conservative Supreme Court Justice Antonin Scalia who died in 2016. The younger Scalia had spent part of his career as a corporate lawyer fighting the very agency he was charged with leading.

Its inspectors have documented instances in which some of the most vulnerable workers — those with low information and high patient contact — faced incredible hazards, but OSHA’s staff did little to hold employers to account.

Beaumont, Texas, a town near the Louisiana border, was largely untouched by the pandemic in early April.

That’s when a 56-year-old physical therapy assistant at Christus Health’s St. Elizabeth Hospital named Danny Marks called in sick with a fever and body aches, federal OSHA records show.

He told a human resources employee that he’d been in the room of a patient who was receiving a breathing treatment — the type known as the most hazardous to health workers. The CDC advises that N95 respirators be used by all in the room for the so-called aerosol-generating procedures. (A facility spokesperson said the patient was not known or suspected to have COVID at the time Marks entered the room.)

Marks went home to self-isolate. By April 17, he was dead.

The patient whose room Marks entered later tested positive for COVID-19. And an OSHA investigation into Marks’ death found there was no sign on the door to warn him that a potentially infected patient was inside, nor was there a cart outside the room where he could grab protective gear.

The facility did not have a universal masking policy in effect when Marks went in the room, and it was more than likely that he was not wearing any respiratory protection, according to a copy of the report obtained through a public records request. Twenty-one more employees contracted COVID by the time he died.

“He was a beloved gentleman and friend and he is missed very much,” Katy Kiser, Christus’ public relations director, told KHN.

OSHA did not issue a citation to the facility, instead recommending safety changes.

The agency logged nearly 8,700 complaints from health care workers in 2020. Yet Harvard researchers found that some of those desperate pleas for help, often decrying shortages of PPE, did little to forestall harm. In fact, they concluded that surges in those complaints preceded increases in deaths among working-age adults 16 days later.

One report author, Peg Seminario, blasted OSHA for failing to use its power to get employers’ attention about the danger facing health workers. She said issuing big fines in high-profile cases can have a broad impact — except OSHA has not done so.

“There’s no accountability for failing to protect workers from exposure to this deadly virus,” said Seminario, a former union health and safety official.

More ‘Lost on the Frontline’ Stories

Desperate for Safety Gear

There was little outward sign this summer that Garfield Medical Center was struggling to contain COVID-19. While Medicare has forced nursing homes to report staff infections and deaths, no such requirement applies to hospitals.

Yet as the focus of the pandemic moved from the East Coast in the spring to Southern and Western states, health care worker deaths climbed. And behind the scenes at Garfield, workers were dealing with a lack of equipment meant to keep them safe.

Complaints to state worker-safety officials filed in March and April said Garfield Medical Center workers were asked to reuse the same N95 respirator for a week. Another complaint said workers ran out of medical gowns and were directed to use less-protective gowns typically provided to patients.

Staffers were shaken by the death of Dawei Liang. And only after his death and a rash of infections did Garfield provide N95 masks to more workers and put up plastic tarps to block a COVID unit from an adjacent ward. Yet this may have been too late.

The coronavirus can easily spread to every corner of a hospital. Researchers in South Africa traced a single ER patient to 119 cases in a hospital — 80 among staff members. Those included 62 nurses from neurology, surgical and general medical units that typically would not have housed COVID patients.

By late July, Garfield cardiac and respiratory technician Thong Nguyen, 73, learned he was COVID-positive days after he collapsed at work. Nguyen loved his job and was typically not one to complain, said his youngest daughter, Dinh Kozuki. A 34-year veteran at the hospital, he was known for conducting medical tests in multiple languages. His colleagues teased him, saying he was never going to retire.

Kozuki said her father spoke up in March about the rationing of protective gear, but his concerns were not allayed.

The PPE problems at Garfield were a symptom of a broader problem. As the virus spread around the nation, chronic shortages of protective gear left many workers in community-based settings fatally exposed. Nearly 1 in 3 family members or friends of around 300 health care workers interviewed by KHN or The Guardian expressed concerns about a fallen workers’ PPE.

Health care workers’ labor unions asked for the more-protective N95 respirators when the pandemic began. But Centers for Disease Control and Prevention guidelines said the unfitted surgical masks worn by workers who feed, bathe and lift COVID patients were adequate amid supply shortages.

Mary Turner, an ICU nurse and president of the Minnesota Nurses Association, said she protested alongside nurses all summer demanding better protective gear, which she said was often kept from workers because of supply-chain shortages and the lack of political will to address them.

“It shouldn’t have to be that way,” Turner said. “We shouldn’t have to beg on the streets for protection during a pandemic.”

At Garfield, it was even hard to get tested. Critical care technician Tony Ramirez said he started feeling ill on July 12. He had an idea of how he might have been exposed: He’d cleaned up urine and feces of a patient suspected of having COVID-19 and worked alongside two staffers who also turned out to be COVID-positive. At the time, he’d been wearing a surgical mask and was worried it didn’t protect him.

Yet he was denied a free test at the hospital, and went on his own time to Dodger Stadium to get one. His positive result came back a few days later.

As Ramirez rested at home, he texted Alex Palomo, 44, a Garfield medical secretary who was also at home with COVID-19, to see how he was doing. Palomo was the kind of man who came to many family parties but would often slip away unseen. A cousin finally asked him about it: Palomo said he just hated to say goodbye.

Palomo would wear only a surgical mask when he would go into the rooms of patients with flashing call lights, chat with them and maybe bring them a refill of water, Ramirez said.

Ramirez said Palomo had no access to patient charts, so he would not have known which patients had COVID-19: “In essence, he was helping blindly.”

Palomo never answered the text. He died of COVID-19 on Aug. 14.

And Thong Nguyen had fared no better. His daughter, a hospital pharmacist in Fresno, had pressed him to go on a ventilator after seeing other patients survive with the treatment. It might mean he could retire and watch his grandkids grow up. But it made no difference.

“He definitely should not have passed [away],” Kozuki said.

Nursing Homes Devastated

During the summer, as nursing homes recovered from their spring surge, Heather Pagano got a new assignment. The Doctors Without Borders adviser on humanitarianism had been working in cholera clinics in Nigeria. In May, she arrived in southeastern Michigan to train nursing home staffers on optimal infection-control techniques.

Federal officials required worker death reports from nursing homes, which by December tallied more than 1,100 fatalities. Researchers in Minnesota found particular hazards for these health workers, concluding they were the ones most at risk of getting COVID-19.

Pagano learned that staffers were repurposing trash bin liners and going to the local Sherwin-Williams store for painting coveralls to backfill shortages of medical gowns. The least-trained clinical workers — nursing assistants — were doing the most hazardous jobs, turning and cleaning patients, and brushing their teeth.

She said nursing home leaders were shuffling reams of federal, state and local guidelines yet had little understanding of how to stop the virus from spreading.

“No one sent trainers to show people what to do, practically speaking,” she said.

As the pandemic wore on, nursing homes reported staff shortages getting worse by the week: Few wanted to put their lives on the line for $13 an hour, the wage for nursing assistants in many parts of the U.S.

The organization GetusPPE, formed by doctors to address shortages, saw almost all requests for help were coming from nursing homes, doctors’ offices and other non-hospital facilities. Only 12% of the requests could be fulfilled, its October report said.

And a pandemic-weary and science-wary public has fueled the virus’s spread. In fact, whether or not a nursing home was properly staffed played only a small role in determining its susceptibility to a lethal outbreak, University of Chicago public health professor Tamara Konetzka found. The crucial factor was whether there was widespread viral transmission in the surrounding community.

“In the end, the story has pretty much stayed the same,” Konetzka said. “Nursing homes in virus hot spots are at high risk and there’s very little they can do to keep the virus out.”

The Vaccine Arrives

From March through November, 40 complaints were filed about the Garfield Medical Center with the California Department of Public Health, nearly three times the statewide average for the time. State officials substantiated 11 complaints and said they are part of an ongoing inspection.

For Thanksgiving, AHMC Healthcare Chairman Jonathan Wu sent hospital staffers a letter thanking “frontline healthcare workers who continue to serve, selflessly exposing themselves to the virus so that others may cope, recover and survive.”

The letter made no mention of the workers who had died. “A lot of people were upset by that,” said critical care technician Melissa Ennis. “I was upset.”

By December, all workers were required to wear an N95 respirator in every corner of the hospital, she said. Ennis said she felt unnerved taking it off. She took breaks to eat and drink in her car.

Garfield said on its website that it is screening patients for the virus and will “implement infection prevention and control practices to protect our patients, visitors, and staff.”

On Dec. 9, Ennis received notice that the vaccine was on its way to Garfield. Nationwide, the vaccine brought health workers relief from months of tension. Nurses and doctors posted photos of themselves weeping and holding their small children.

At the same time, it proved too late for some. A new surge of deaths drove the toll among health workers to more than 2,900.

And before Ennis could get the shot, she learned she would have to wait at least a few more days, until she could get a COVID test.

She found out she’d been exposed to the virus by a colleague.

Shoshana Dubnow and Anna Sirianni contributed to this report.Video by Hannah NormanWeb production by Lydia Zuraw

This story is part of “Lost on the Frontline,” an ongoing project from The Guardian and Kaiser Health News that aims to document the lives of health care workers in the U.S. who die from COVID-19, and to investigate why so many are victims of the disease. If you have a colleague or loved one we should include, please share their story.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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COVID Vaccines Appear Safe and Effective, but Key Questions Remain

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The recent rollout of two newly authorized COVID-19 vaccines is a bright ray of hope at the pandemic’s darkest hour.

We now have a path that can lead us to happier times — even as we watch and suffer from the horrible onslaught of new infections, hospitalizations and deaths that mark the end of this regrettable year.

Health care workers and nursing home residents have already begun to get shots in the first phase of the rollout. Vaccinations should start to be available to the general public sometime in the first few months of next year.

The two vaccines — one developed by Pfizer and BioNTech, the other by Moderna — use the same novel genetic approach. Their development in under a year, shattering all records, is a marvel of science. It’s also a cause for concern for millions of Americans who fear the uncertainty of an unknown technology.

The clinical trial data for the Pfizer and Moderna vaccines show that when both shots of the dual-injection immunization are taken, three weeks to a month apart, they are about 95% effective — at least at preventing severe COVID illness.

However, “a vaccine that remains in the vial is 0% effective no matter what the data show,” says Dr. Walter Orenstein, a professor of infectious diseases at the Emory University School of Medicine in Atlanta and associate director of the Emory Vaccine Center.

Hence, the imperative of persuading millions of people, across racial, cultural, religious, political and generational lines, to get immunized when a vaccine becomes available to them. A survey published this month showed 45% of respondents are taking a wait-and-see approach to vaccination.

Because the vaccines were developed under duress as the coronavirus exacted its deadly toll, the premium was on speed — “warp speed.” So although the number of people in the trials is as large as or larger than in previous vaccine trials, some key questions won’t be answered until millions more are vaccinated.

For example, we don’t know to what extent the vaccines will keep us from transmitting or contracting the virus — though the protection from potentially fatal illness they are likely to confer is in itself something of a miracle.

We don’t know whether irreversible side effects might emerge, or who is at higher risk from them. And we don’t know whether we’ll need to get vaccinated every year, every three years, or never again.

These unknowns add to the challenges faced by the federal government, local health authorities, medical professionals and private sector entities as they seek to persuade people across the broadest possible swath of the population to get a vaccine.

Skepticism resides in many quarters, including among African Americans, many of whom have a long-standing mistrust of the medical world; the vocal “anti-vaxxers”; and people of all stripes with perfectly understandable doubts. Not to mention communities with language barriers and immigrants without documents — more than 2 million strong in California — who may fear coming forward.

Here are answers to some questions you might be asking yourself about the new vaccines:

Q: How can I be sure they’re safe?

There’s no ironclad guarantee. But the federal Food and Drug Administration, in authorizing the Moderna and Pfizer vaccines, determined that their benefits outweighed their risks.

The side effects observed in trial participants were common to other vaccines: pain at the injection site, fatigue, headache, muscle pain and chills. “Those are minor side effects, and the benefit is not dying from this disease,” says Dr. George Rutherford, a professor of epidemiology at the University of California-San Francisco.

Saturday, the Centers for Disease Control and Prevention reported six cases of anaphylactic allergic reaction in the first 272,000 people who got the Pfizer vaccine outside the clinical trials. This has led the CDC to recommend that people receiving the vaccine be observed for up to 30 minutes afterward.

It’s possible other unexpected adverse effects could pop up down the road. “The chances are low, but they are not zero,” says Orenstein. There’s not enough data yet to know if the vaccines pose an elevated risk to pregnant or lactating women, for example, or to immunocompromised people, such as those with HIV. And we know very little about the effects in children, who were not in the initial trials and for whom the vaccines are not authorized.

Q: Why should my family and I take it?

First of all, because you will protect yourselves from the possibility of severe illness or even death. Also, by getting vaccinated you will be doing your part to achieve a vaccination rate high enough to end the pandemic. Nobody knows exactly what percentage of the population needs to get inoculated for that to happen, but infectious disease experts put the number somewhere between 60% and 70% — perhaps even a little higher. Think of it as a civic duty to get your shots.

Q: So, when can I get mine?

It depends on your health status, age and work. In the first phase, already underway, health care workers and nursing home residents are getting vaccinated. The 40 million Moderna and Pfizer doses expected to be available by year’s end should immunize most of them.

Next in line are people 75 and older and essential workers in various public-facing jobs. They will be followed by people ages 65-74 and those under 65 with certain medical conditions that put them at high risk. Enough vaccine could be available for the rest of the population by late spring, but summer or even fall is more likely. Already, some distribution bottlenecks have developed.

On the bright side, two other vaccines — one from Johnson & Johnson, the other from AstraZeneca and Oxford University — could win FDA authorization early next year, significantly increasing the supply.

Q: Once I’m vaccinated, can I finally stop wearing a mask and physical distancing?

No. Especially not early on, before a lot of people have been vaccinated. One reason for that is self-protection. The Moderna and Pfizer vaccines are 95% effective, but that means you still have a 5% chance of falling ill if you are exposed to someone who hasn’t been vaccinated — or who has been but is still transmitting the virus.

Another reason is to protect others, since you could be the one shedding virus despite the vaccination.

Q: I’ve already had COVID-19, so I don’t need the vaccine, right?

We don’t know for sure how long exposure to the virus protects you from reinfection. Protection probably lasts at least a few months, but public health experts say it’s a good idea to get vaccinated when your turn comes up — especially if it’s been many months since you tested positive.

There’s been some talk among health officials of pushing those who’ve been infected in the last 90 days or so toward the back of the line, to ensure adequate supply for those who might be at higher risk.

Q: How long before our lives get back to normal?

“If everything goes well, next Thanksgiving might be near normal, and we might be getting close to that by the summer,” says Dr. William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine in Nashville, Tennessee. ”But there would have to be substantial acceptance of the vaccine and data showing the virus moving in a downward direction.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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At Risk of Extinction, Black-Footed Ferrets Get Experimental COVID Vaccine

In late summer, as researchers accelerated the first clinical trials of COVID-19 vaccines for humans, a group of scientists in Colorado worked to inoculate a far more fragile species.

About 120 black-footed ferrets, among the most endangered mammals in North America, were injected with an experimental COVID vaccine aimed at protecting the small, weasel-like creatures rescued from the brink of extinction four decades ago.

The effort came months before U.S. Department of Agriculture officials began accepting applications from veterinary drugmakers for a commercial vaccine for minks, a close cousin of the ferrets. Farmed minks, raised for their valuable fur, have died by the tens of thousands in the U.S. and been culled by the millions in Europe after catching the COVID virus from infected humans.

Vaccinating such vulnerable species against the disease is important not only for the animals’ sake, experts say, but potentially for the protection of people. Some of the most pernicious human diseases have originated in animals, including the new coronavirus, which is believed to have spread from bats to an intermediary species before jumping to humans and sparking the pandemic.

The worry when it comes to animals like farmed minks, which are kept in crowded pens, is that the virus, contracted from humans, can mutate as it spreads rapidly in the susceptible animals, posing a new threat if it spills back to people. Danish health officials in November reported detecting more than 200 COVID cases in humans that had variants associated with farmed minks, including a dozen with a mutation scientists feared could undermine the effectiveness of vaccines. However, officials now say that variant appears to be extinct.

In the U.S., scientists have not found similar COVID mutations in the domestic farmed mink populations, though they recently noted with concern the discovery of the first case of the virus in a wild mink in Utah.

“For highly contagious respiratory viruses, it’s really important to be mindful of the animal reservoir,” said Dr. Corey Casper, a vaccinologist and chief executive of the Infectious Disease Research Institute in Seattle. “If the virus returns to the animal host and mutates, or changes, in such a way that it could be reintroduced to humans, then the humans would no longer have that immunity. That makes me very concerned.”

For the newly vaccinated ferrets, the main risk is to the animals themselves. They’re part of a captive population at the National Black-footed Ferret Conservation Center outside Fort Collins, Colorado, where there have been no cases of COVID-19 to date. But the slender, furry creatures — known for their distinctive black eye mask, legs and feet — are feared to be highly vulnerable to the ravages of the disease, said Tonie Rocke, a research scientist at the National Wildlife Health Center who is testing the ferret vaccine. They’re all genetically similar, having come from a narrow breeding pool, which weakens their immune systems. And they likely share many of the features that have made the disease so deadly to minks.

“We don’t have direct evidence that black-footed ferrets are susceptible to COVID-19, but given their close relationship to minks, we wouldn’t want to find out,” Rocke said.

Rocke began working on the experimental vaccine in the spring, as she and Pete Gober, black-footed ferret recovery coordinator for the U.S. Fish and Wildlife Service, watched reports about the new coronavirus with growing alarm. An exotic disease is “the biggest nemesis for ferret recovery,” said Gober, who has worked with black-footed ferrets for 30 years. “It can knock you right back down to zero.”

The ferrets are a native species that once roamed vast areas of the American West. Their ranks declined precipitously over many decades as populations of prairie dogs, the ferrets’ primary source of food and shelter, were decimated by farming, grazing and other human activity.

In 1979, black-footed ferrets were declared extinct — until a small population was discovered on a ranch in Wyoming. Most of those rare animals were then lost to disease, including sylvatic plague, the animal version of the Black Death that has plagued humans. The species survived only because biologists rescued 18 ferrets to form the basis of a captive breeding program, Gober said.

With the threat of new disease looming, Gober doubled-down on the strict infection prevention precautions at the center, which houses more than half of the 300 black-footed ferrets in captivity. An additional 400 have been reintroduced to the wild. Then he called Rocke, who previously created a vaccine shown to protect ferrets from sylvatic plague. It uses a purified protein from Yersinia pestis, the bacterium that causes the disease.

Would the same technique work against the virus that causes COVID-19? Under the research authority granted by the Fish and Wildlife Service, the scientists were free to try.

“We can do these sorts of things experimentally in animals that we can’t do in humans,” Rocke noted.

Rocke acquired purified protein of a key component of the SARS-CoV-2 virus, the spike protein, from a commercial producer. She mixed the liquid protein with an adjuvant, a substance that enhances immune response, and injected it under the animals’ skin.

The first doses were given in late spring to 18 black-footed ferrets, all male, all about a year old, followed by a booster dose a few weeks later. Within weeks of getting the second shots, tests of the animals’ blood showed antibodies to the virus, a good — and expected — sign.

By early fall, 120 of the 180 ferrets housed at the center were inoculated, with the rest remaining unvaccinated in case something went wrong with the animals, which generally live four to six years in captivity. So far, the vaccine appears safe, but there’s no data yet to show whether it protects the animals from disease. “I can tell you, we have no idea if it will work,” said Rocke, who plans to conduct efficacy tests this winter.

But Rocke’s effort makes sense, said Casper, who has created several vaccines for humans. Rocke’s approach — introducing an inactivated virus in an animal to stimulate an immune response — is the basis for many common vaccines, such as those that prevent polio and influenza.

Vaccines containing inactivated virus to prevent COVID-19 have been tested in certain animals — and in human vaccines, including CoronaVac, created by the Chinese firm Sinovac Life Sciences. But the effort in Colorado may be among the first aimed at preventing COVID-19 in a specific animal population, Rocke said.

Gober said he is optimistic that the ferrets are protected, but it will take a well-designed study to settle the question. Until then, he’ll work to keep the fragile ferrets free of COVID-19. “The price of peace is eternal vigilance, they say. We can’t let our guard down.”

The tougher task is doing the same for people, Gober observed.

“We’re just holding our breath, hoping we can get all the humans vaccinated in the country. That will give us all a sigh of relief.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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2020 in review: COVID-19 and patient centric clinical trials

The trials and tribulations of 2020 have brought the vital role of research, pharma, and biotech into sharp focus. But how has the push to develop treatments and vaccines for SARS-CoV-2 affected the industry’s commitment to patient centricity?

This time last year, researchers and industry players were working hard to embed patient centricity and engagement into their everyday work.

Then COVID-19 hit, and organisations big and small were forced to pivot operations to tackle the real and present danger of the pandemic. Since then, we have seen some mind-boggling scientific achievements, with innovations in vaccine development being just such one example.

But how has this global push for SARS-CoV-2 vaccines and treatments affected the research community’s commitment to patient centricity? We take a look back over the last 12 months to find out.

Green shoots of engagement

At the start of the year, the industry was busy incorporating the patient voice into trials in a bid to overcome the recruitment and retention problem – the figures showed that fewer than 5% of all those eligible to take part in research signed up, and the global average dropout rate was around 30%.

“The pandemic also accelerated the adoption of many patient centric study practices. Remote monitoring, for example, went from a nice to have to a necessity overnight.”

While the research community was aware of the benefits of patient centric trials, however, they were still unclear on how to put that into practice, said patient engagement agency, Couch, back in February.

Said the team: “In the Annual Patient Centricity Benchmark Survey, when asked about training or preparing people to behave in patient-focused ways, over half of employees from biopharmaceutical and medical device companies said: ‘We are actively looking at how to teach this to our people’.

“Only 22% selected: ‘We know exactly what and how to teach this to our people’.”

That said, the community was going in the right direction. In March, we reported on how researchers were increasingly using methods such as patient-reported outcomes, remote reporting, and lay summaries to boost engagement.

Widespread interest

But then the pandemic piqued people’s interest in medical research at previously unimaginable scale.

The RECOVERY Trial, a multi-arm RCT studying the efficacy of several repurposed treatments in COVID-19, recruited a staggering 2,000-plus people across 16 NHS sites in little more than three weeks. At the same time, thousands more signed up to report their health status to the King’s College London COVID Symptom tracker app every day.

Speaking to pharmaphorum in May, Dr Sheuli Porkess, Executive Director of Research, Medical and Innovation at the Association of the British Pharmaceutical Industry (ABPI) said, if harnessed correctly, such changes could benefit research efforts for years to come.

“The studies are being covered on the news and that’s great for letting people know how they can get involved in research right now. What’s more, that ongoing exposure to discussions around trials and what people do when they are in a trial will, in the future, help people to say ‘yes, I want to be involved’.  I think we really need to look into what it was that enabled people to sign up so quickly.”

The pandemic also accelerated the adoption of many patient centric study practices. Remote monitoring, for example, went from a nice to have to a necessity overnight. In doing so, it proved it could provide robust data at the same time as reducing participant burden.

Casualty of speed?

But while the pandemic certainly created a collaborative discovery atmosphere, it also introduced an element of intense urgency – and this has, arguably, had a detrimental effect on engagement in research.

In November, pharmaphorum reported from the Pioneering Partnerships conference, organised by the ABPI, the National Institute for Health Research (NIHR), and the Association of Medical Research Charities (AMRC). We asked if rapid progress and patient engagement were mutually exclusive.

NIHR director, Jeremy Taylor, said: “One of the consequences of the system commissioning lots of urgent COVID-19 research was that, to a certain extent, patient and public involvement got bypassed. For various reasons it was too difficult or too time consuming to do when everybody was in a frightful rush.

“Patient and public involvement turned out to be less embedded than we thought, so I think COVID has been a bit of a shock to the system. It’s made us think that maybe we have been a little too complacent.”

Lessons to learn

The last 12 months have been something of a whirlwind for everyone, but the healthcare and research community have been in the eye of the storm.

In 2021, the research community can build on the widescale adoption of remote monitoring and huge increases in study recruitment rates, but it must also put what it has learned about “doing” engagement at speed and at scale into practice.

  • Want to read more about how COVID-19 has impacted in patient centricity? Check out the latest edition of pharmaphorum’s Deep Dive magazine, which is dedicated to the topic.

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Inside the First Chaotic Days of the Effort to Vaccinate America

One tray of COVID-19 vaccine from pharmaceutical giant Pfizer contains 975 doses — way too many for a rural hospital in Arkansas.

But with the logistical gymnastics required to safely get the Pfizer vaccine to rural health care workers, splitting the trays into smaller shipments has its own dangers. Once out of the freezer that keeps it at 94 degrees below zero, the vaccine lasts only five days and must be refrigerated in transit.

In Arkansas — where over 40% of its counties are rural and COVID infections are climbing — solving this distribution puzzle is urgently critical, said Dr. Jennifer Dillaha, the state’s epidemiologist.

“If their providers come down with COVID-19,” Dillaha said, “there’s no one there to take care of the patients.”

Such quandaries resonate with officials in Georgia, Kentucky, Utah, Indiana, Wisconsin and Colorado. The first push of the nation’s mass COVID vaccination effort has been chaotic, marked by a lack of guidance and miscommunication from the federal level.

With Washington punting most vaccination decisions, each state and county is left to weigh where to send vaccines first and which of two vaccines authorized by the Food and Drug Administration for emergency use makes the most sense for each nursing home, hospital, local health department and even school. And after warning for months that they lacked the resources to distribute vaccines, state officials are only now set to receive a major bump in funding — $8.75 billion in Congress’ latest relief bill, which lawmakers are likely to pass this week.

The feat facing public health officials has “absolutely no comparison” in recent history, said Claire Hannan, executive director of the Association of Immunization Managers.

Officials who thought the H1N1 swine flu shot in 2009 was a logistical nightmare say it now looks simple in comparison. “It was a flu vaccine. It was one dose. It came at refrigerator-stable temperatures,” Hannan said. “It was nothing like this.”

Within just a few days, the logistical barriers of the vaccine made by Pfizer and BioNTech were laid bare. Many officials now hang their hopes on Moderna, whose vaccine comes in containers of 100 doses, doesn’t require deep freezing and is good for 30 days from the time it’s shipped.

The federal government had divvied up nearly 8 million doses of Pfizer and Moderna’s vaccines to distribute this week, on top of roughly 3 million Pfizer shots that were sent last week, said Army Gen. Gustave Perna, chief operating officer of the Trump administration’s Operation Warp Speed effort.

Perna said he took “personal responsibility” for overstating how many Pfizer doses states would receive.

Federal delays have led to confusion, Dillaha said: “Sometimes we don’t have information from CDC or Operation Warp Speed until right before a decision needs to be made.”

Officials in other states painted a mixed picture of the rollout.

Georgia’s Coastal Health District, which oversees public health for eight counties and has offices in Savannah and Brunswick, spent more than $27,000 on two ultra-cold freezers for the Pfizer vaccine, which it’s treating “like gold,” said Dr. Lawton Davis, its health director. Health care workers are being asked to travel, some up to 40 minutes, to get their vaccinations, because shipping them would risk wasting doses, he said. Vaccination uptake has been lower than Davis would like to see. “It’s sort of a jigsaw puzzle and balancing act,” he said. “We’re kind of learning as we go.”

In Utah, sites to vaccinate teachers and first responders starting in January had no capability to store the Pfizer vaccine, although officials are trying to secure some ultra-cold storage, a state department of health spokesperson said. Very few of Kentucky’s local health offices could store the Pfizer shots, because of refrigeration requirements and the size of shipments, said Sara Jo Best, public health director of the Lincoln Trail District. Indiana’s state health department had to identify alternative cold storage options for 17 hospitals following changes in guidance for the vaccine thermal shippers.

And in New Hampshire, where the National Guard will help administer vaccines, officials last week were still finalizing details for 13 community-based sites where first responders and health care workers are due to get vaccinated later this month. Jake Leon, a state Health and Human Services spokesperson, said that while the sites will be able to administer both companies’ vaccines, most likely they’ll get Moderna’s because of its easier transport. Even as the earliest vaccines are injected, much remains up in the air.

“It’s day to day and even then hour by hour or minute by minute — what we know and how we plan for it,” Leon said Friday. “We’re building the plane while flying it.”

In all, the Trump administration has bought 900 million COVID vaccine doses from six companies, but most of the vaccines are still in clinical studies. Even the front-runners whose shots have received FDA emergency authorization— Pfizer and BioNTech on Dec. 11, Moderna on Dec. 18 — will require months to manufacture at that scale. The Trump administration plans to distribute 20 million vaccine doses to states by early January, Perna said Saturday.

By spring, officials hope to stage broader vaccine deployment beyond top-priority populations of health care workers, nursing home residents and staff, as well as first responders.

During the effort to vaccinate Americans against H1N1, Dillaha said, health departments set up mass vaccination clinics in their counties and delivered doses to schools. But hospitals are taking charge of parts of the initial COVID immunization campaign, both because health care workers are at highest risk of illness or death from COVID-19, and to pick up the slack from health departments overwhelmed by case investigations and contact tracing from an unending stream of new infections.

Best said her workforce is struggling to keep up with COVID infections alone, much less flu season and upcoming COVID vaccinations. Public health department personnel in Kentucky shrank by 49% from 2009 to 2019, according to state data she supplied. Across the country, 38,000 state and local health positions have disappeared since the 2008 recession. Per capita spending for local health departments has dropped by 18% since 2010.

Nationally, Pfizer and Moderna have signed contracts with the federal government to each provide 100 million vaccine doses by the end of March; Moderna is set to deliver a second tranche of 100 million doses by June. States were playing it safe last week, directing Pfizer vials mainly to facilities with ultra-cold freezers, Hannan said.

“A lot of that vaccine is destined for institutional facilities,” Sean Dickson, director of health policy for West Health Policy Center, said of the Pfizer shots. The center, with the University of Pittsburgh School of Pharmacy, found that 35% of counties have two or fewer facilities to administer COVID vaccines.

The analysis found tremendous variation in how far people would need to drive for the vaccine. Residents of North Dakota, South Dakota, Montana, Wyoming, Nebraska and Kansas face the longest drives, with more than 10% living more than 10 miles from the closest facility that could administer a shot.

Counties with long driving distances between sites and a low number of sites overall “are going to be the hardest ones to reach,” said Inmaculada Hernandez, an assistant professor at the University of Pittsburgh School of Pharmacy and lead author of the analysis.

Certain vaccines could be better suited for such places, including Johnson & Johnson’s potential offering, which is a single shot, and health departments could distribute in rural areas through mobile units, she said. The company is expected to apply for FDA emergency authorization in February, Operation Warp Speed chief scientific adviser Moncef Slaoui said this month.

Until then, Pfizer and Moderna are the companies supplying doses for the country, and they’re not considered equal even though each is more than 90% effective at reducing disease.

In Wisconsin, the Moderna vaccine “gives us many more options” and “allows for us to get doses to those smaller clinics, more-rural clinics, in a way that reduces the number of logistics” needed for ultra-cold storage, Dr. Stephanie Schauer, the state’s immunization program manager, told reporters Wednesday.

Alan Morgan, head of the National Rural Health Association, echoed that the Moderna vaccine is being looked to as a “rural solution.” But he said states including Kansas have shown that a Pfizer rural rollout can be done.

“It’s where these states put a priority — either they prioritize rural or they don’t,” he said. “It’s a cautionary tale of what we may see this spring, of rural populations perhaps being second-tier when it comes to vaccination.”

Virginia, too, has a plan for getting the Pfizer vaccine to far-flung places. It’s shipping the vaccines to 18 health facilities with ultra-cold freezers across the state. The hubs are distributed widely enough so vaccinators can bring shots from there to health workers even in thinly populated areas before they spoil, said Brookie Crawford, spokesperson for the Virginia Department of Health’s central region.

Washington, on the other hand, allows hospitals without ultra-cold freezers to temporarily store Pfizer vaccines in the thermal boxes they arrive in, said Franji Mayes, spokesperson for the state’s health department. That means a box needs to be used quickly, before doses expire. “We are also working on a policy that will allow hospitals who don’t expect to vaccinate 975 people to transfer extra vaccine to other enrolled facilities,” she said. “This will reduce wasted vaccine.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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With Few Takers for COVID Vaccine, DC Hospital CEO Takes ‘One for the Team’


This story also ran on Daily Beast. It can be republished for free.

Administrators at Howard University Hospital in Washington, D.C., were thrilled to be among the city’s first hospitals to get a COVID-19 vaccine, but they knew it could be a tough sell to get staffers to take the shot.

They were right.

The hospital, located on the campus of one the nation’s oldest historically Black colleges, received 725 doses of the vaccine made by Pfizer and BioNTech on Dec. 14 and expects 1,000 more vaccine doses this week to immunize its workers.

Yet, as of Friday afternoon, about 600 employees had signed up for the shots, touted as about 95% effective in preventing the deadly disease. Howard has about 1,900 employees, not counting hundreds of independent contractors it also hoped to vaccinate.

“There is a high level of mistrust and I get it,” said Anita Jenkins, the hospital’s chief executive officer who received the shot Tuesday in hopes of inspiring her staff to follow her lead. “People are genuinely afraid of the vaccine.”

Studies showed few serious side effects in more than 40,000 people before the vaccine was authorized for emergency use in the U.S. A few people worldwide have had allergic reactions in the past week.

In late November, a hospital survey of 350 workers found 70% either did not want to take a COVID vaccine or did not want it as soon as it became available.

So, officials are not dismayed at the turnout so far, saying it shows their educational campaign is beginning to work.

“This is a significant win,” said Jenkins, who added she was happy to “take one for the team” when she and other health care personnel got the first shots. About 380 Howard employees or affiliated staff had been vaccinated by Friday afternoon.

Although hesitancy toward the vaccine is a challenge nationally, it’s a significant problem among Black adults because of their generations-long distrust of the medical community and racial inequities in health care.

When Jenkins posted a picture of herself getting vaccinated on her Facebook page, she received many thumbs up but also pointed criticism. “One called me a sellout and asked why I would do that to my people,” she said.

Before being vaccinated, Jenkins said, she read about the clinical trials and was glad to learn the first vaccines in development were unlike some that use weakened or inactivated viruses to stimulate the body’s immune defense. The COVID vaccine by Pfizer and BioNTech does not contain the actual virus.

And one factor driving her to take the shot was that some employees said they would be more willing to do it if she did.

The hesitancy among her staff members has its roots in the Tuskegee syphilis experiment, said Jenkins, who started at Howard in February.

The 40-year study, which was run by the U.S. Public Health Service until 1972, followed 600 Black men infected with syphilis in rural Alabama over the course of their lives. The researchers refused to tell patients their diagnosis or treat them for the debilitating disease. Many men died of the disease and several wives contracted it.

Jenkins said she was not surprised that many Howard employees — including doctors — are questioning whether to take a vaccine, even though Black patients are twice as likely to die of COVID-19.

While African Americans make up 45% of the population in the District of Columbia, they account for 74% of the 734 COVID deaths. Nationally, Blacks are nearly four times more likely to be hospitalized due to COVID compared with whites and nearly three times more likely to die.

Howard, which has treated hundreds of COVID patients, was one of six hospitals in the city to get the first batch of nearly 7,000 doses of the Pfizer vaccine Monday. About one-third of those doses were administered by Friday morning, said Justin Palmer, a vice president of the District of Columbia Hospital Association.

Federal officials Friday authorized a second vaccine, made by Moderna, for emergency use. That vaccine is expected to be distributed starting this week.

The political bickering over the COVID response has also hurt efforts to instill confidence in the vaccine, Jenkins said.

Other than a sore arm, Jenkins said, she’s had no side effects from the vaccine, which can also commonly cause fatigue and headache. “Today I am walking the halls,” she explained, “and I got the shot two days ago.”

Part of the challenge for Jenkins and other hospital officials will be persuading employees not just to take a vaccine now but to return for the booster shot three weeks later. One dose offers only partial protection.

Jenkins said the hospital plans to make reminder calls to get people to follow up. She said efforts to increase participation at the hospital will also continue.

“It was important for me to be a standard-bearer to show the team I am in there with them,” she said.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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FDA gives nod to Moderna vaccine for Covid-19

The company’s vaccine is the second approved for emergency use by the FDA. It is expected to pose fewer logistical challenges than the first, which was developed by Pfizer and BioNTech.

Gaps in Cost Sharing Protections for COVID-19 Testing and Treatment Could Spark Public Concerns About COVID-19 Vaccine Costs

In the issue brief, KFF experts highlight the laws and regulations that are in place to ensure access to free COVID-19 vaccines for individuals regardless of their insurance status and explain how vaccine administration costs will be covered in private insurance, Medicare and Medicaid, and for the uninsured.

KHN on the Air This Week

KHN Midwest correspondent Lauren Weber discussed how the COVID-19 backlash undermines public health on Newsy on Thursday.

California Healthline editor Arthur Allen discussed COVID vaccines with KIQI 1010AM’s “Hecho en California” on Thursday. (The interview, conducted in Spanish, begins around the 2:50 mark.)

California Healthline correspondent Angela Hart co-moderated a panel on the future of the Affordable Care Act in California at the Sacramento Press Club on Tuesday.

KHN senior correspondent Phil Galewitz discussed COVID vaccine distribution on Newsy on Tuesday.

KHN Editor-in-Chief Elisabeth Rosenthal discussed COVID prevention PSAs and why they should be scarier on WNYC’s “The Takeaway” on Tuesday. She also discussed COVID and President-elect Joe Biden’s health care team on WBUR’s “On Point” on Dec. 11.

KHN Midwest correspondent/editor Laura Ungar discussed COVID primary care closures on Minnesota Public Radio on Dec. 11.

KHN chief Washington correspondent Julie Rovner discussed the surge in COVID cases and efforts for a relief bill in Congress with WAMU’s “1A” on Dec. 11.

KHN senior Colorado correspondent Markian Hawryluk discussed contact tracing in a Latino immigrant community with KUNC’s “Colorado Edition” on Dec. 10.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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KHN’s ‘What the Health?’: All I Want for Christmas Is a COVID Relief Bill

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Congress appears to be inching ever closer to agreement on a long-delayed COVID-19 relief bill, which would extend unemployment insurance and other emergency programs set to expire in the next several days. That bill, however, apparently will not include the top-priority items for both political parties: business liability protections supported by Republicans and aid to states and localities sought by Democrats.

The bill is likely to be part of a giant spending bill to keep the federal government funded for the rest of the fiscal year. And it might include a last-minute surprise: legislation to put an end to “surprise” medical bills sent to patients who inadvertently obtain care outside their insurance network.

This week’s panelists are Julie Rovner of Kaiser Health News, Alice Miranda Ollstein of Politico, Rebecca Adams of CQ Roll Call and Mary Agnes Carey of KHN.

Among the takeaways from this week’s podcast:

  • Congress has essentially agreed on a federal spending bill for the rest of the fiscal year — which began in October. But it will likely wait as lawmakers continue squabbling over the COVID relief package, with negotiations now centering on small details.
  • Republicans for months have been hesitant to move forward on a bill that would provide more relief for consumers affected by the pandemic because party leaders did not like Democrats’ insistence that it include more state and local aid. But that provision has been jettisoned, so Republicans are less opposed to the measure. Plus, they see a political downside to holding up the bill: Their two Georgia candidates for Senate — facing Democratic opponents in a special runoff election — are being hammered on the issue.
  • The compromise on surprise medical bills came after supporters secured agreement among Democrats who had favored varying remedies and all the committees in the House and Senate on the bill, a consensus that was forged with major concessions by progressives.
  • But doctors’ groups and other industry critics are still attacking the surprise billing proposal — even though many observers see the bill as tilted in their favor over insurers — so its passage is not guaranteed. Supporters are banking on the looming end of the congressional session to move the measure over the finish line.
  • Vice President Mike Pence announced he will get vaccinated against COVID-19 in public this week in hopes of convincing anyone skeptical about the shots that they are safe. President-elect Joe Biden is planning to do the same soon. But this is a difficult stance for politicians. They don’t want to look as if they are pushing themselves ahead in line, but they also want to normalize the use of the vaccine.
  • About 200 state and local public health leaders have quit or been fired because of public opposition to measures to curb the coronavirus. Although President Donald Trump has reined in his criticism of some of these officials and their efforts, the opposition is still strong. Those critics may be buttressed by fears that new restrictions imposed to control the surging virus will hurt the economy.

Also this week, Rovner interviews Elizabeth Mitchell, president and CEO of the Pacific Business Group on Health, about the future of employer-provided health insurance.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read too:

Julie Rovner: The Texas Monthly’s “Texas Wedding Photographers Have Seen Some $#!+,” by Emily McCullar

Alice Miranda Ollstein: The New York Times’ “‘Like a Hand Grasping’: Trump Appointees Describe the Crushing of the C.D.C.,” by Noah Weiland

Mary Agnes Carey: NPR’s “How Do We Grieve 300,000 Lives Lost?” by Will Stone

Rebecca Adams: Bloomberg News’ “White House Official Recovers From Severe Covid-19, Friend Says,” by Jennifer Jacobs

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcherGoogle PlaySpotify, or Pocket Casts.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Voces confiables ayudan a inmigrantes a superar el temor a la vacuna contra COVID

MINNEAPOLIS.- Gloria Torres-Herbeck se aplica la vacuna contra la gripe cada temporada. Pero la maestra de 53 años de Rochester, Minnesota, aún no está convencida de querer estar primera en la fila para una contra COVID-19.

“No soy muy mayor, pero no soy tan fuerte como otras personas”, dijo. “Por eso, necesito ser realista sobre mi situación. ¿Quiero participar en algo que podría ponerme en riesgo? ”

La Administración de Drogas y Alimentos (FDA) ya otorgó la autorización de uso de emergencia para una vacuna y está considerando la aprobación de una segunda.

Mientras tanto, funcionarios de salud pública de todo el país se preparan para lo que podría ser tan desafiante como la distribución de la vacuna: persuadir a comunidades que han sido duramente afectadas por el virus, familias de bajos ingresos, personas de raza negra y latinos (de cualquier raza) de que se vacunen.

Sin embargo, funcionarios creen que algunas zonas tienen ventaja. Rochester, en Minnesota, sede de la Clínica Mayo, es uno de ellas. La Rochester Healthy Community Partnership ha estado trabajando para reducir las disparidades de salud en las comunidades de inmigrantes del área, residentes somalíes, hispanos, camboyanos, sursudaneses y etíopes, durante 15 años.

La asociación está compuesta por investigadores y proveedores de salud de Mayo, funcionarios de salud pública del condado y voluntarios comunitarios como Torres-Herbeck, quien emigró desde México hace 27 años.

“Cuando la pandemia impactó en marzo, nos dimos cuenta que con estas alianzas de larga data estábamos en una posición única por la confianza construida a lo largo de los años entre los expertos de Mayo y sus socios comunitarios”, dijo el doctor Mark Wieland, quien apoya al grupo y estudia el impacto de estas asociaciones.

Aunque hasta ahora solo se ha recopilado evidencia preliminar, hay indicios de que desde que comenzaron estos esfuerzos, Rochester ha aumentado las pruebas para COVID-19, ha mejorado el rastreo de contactos y ha impulsado comportamientos preventivos como el uso de máscaras y el distanciamiento físico en estas comunidades vulnerables, agregó Wieland.

El grupo espera que esos primeros éxitos sean un buen augurio para la aceptación de la vacuna.

Aprendiendo del sarampión

La asociación de Rochester apuesta por un enfoque de sentido común que se centra en valores compartidos, transparencia y comunicación clara.

Es una estrategia que ha tenido éxito en el pasado.

Cuando una epidemia de sarampión golpeó a la población somalí en Minneapolis-St. Paul, en 2017, la Clínica Mayo se acercó a los líderes comunitarios de los 25,000 inmigrantes somalíes que viven en el área de Rochester.

Muchos tenían miedo de vacunarse por la falsa presunción de que la vacuna podría causar autismo, y las tasas de vacunación eran bajas en la comunidad. Médicos realizaron reuniones públicas en mezquitas y centros comunitarios, respondiendo preguntas sobre la seguridad de las vacunas y asegurando a los residentes que no había evidencia científica de un vínculo con el autismo.

Actores somalíes crearon videos de YouTube para ayudar a abordar preocupaciones comunes. Al final, no se registraron casos de sarampión en el condado de Olmsted, hogar de Rochester.

Hace aproximadamente un año, y a pedido de un rabino, el doctor Robert Jacobson, director médico del Programa de Ciencias de la Salud de la Población en la Clínica Mayo, visitó una comunidad judía ortodoxa en Nueva York en la que el rechazo a la vacuna estaba generando otro brote de sarampión. Ayudó a líderes de la atención médica a disipar preocupaciones.

“Los judíos ortodoxos de esa comunidad rechazaban esa vacuna por la misma razón por la que la recomendamos”, dijo Jacobson. “Estaban tratando de proteger a sus hijos”.

Los esfuerzos de líderes judíos, expertos en salud pública como Jacobson y legisladores que endurecieron las leyes sobre exenciones de vacunas, ayudaron a sofocar el brote.

Desde marzo, la asociación de Rochester ha transmitido mensajes similares sobre COVID-19. El miedo o los malentendidos fueron un problema al comienzo de la pandemia. Los miembros de las comunidades de inmigrantes colgaban cuando los llamaban del departamento de salud.

Entonces, la asociación desarrolló mensajes en varios idiomas para explicar la importancia de esas llamadas telefónicas. Resolvieron problemas de comunicación. Por ejemplo, en somalí se usa la misma palabra para “resfriado” y “gripe”.

Ahora, menos gente cuelga.

Los miembros de esta alianza “son expertos en las sutilezas de sus comunidades”, observó Wieland.

Cuando el grupo se enteró de que muchos inmigrantes se sentían intimidados por las pruebas de COVID-19 y no estaban seguros de la logística, recomendó simplificar el proceso: ahora, videos con líderes comunitarios en las redes sociales dirigen a las personas a los sitios de prueba. Una vez allí, cualquiera que no hable inglés puede realizar la prueba sin necesidad de identificación ni tarjeta de seguro médico.

Faltaba el “por qué”

Solo el 40% de los adultos mayores de raza negra y el 51% de los hispanos mayores dijeron que probablemente se vacunarían contra COVID-19, en comparación con el 63% de los blancos no hispanos mayores, reveló una encuesta de la Universidad de Michigan.

Sus preocupaciones reflejan las de Torres-Herbeck: qué tan bien funciona la vacuna o qué tan segura es.

Una encuesta aún más reciente de personas de todas las edades para COVID Collaborative, un grupo de defensa de salud, mostró que la confianza en la seguridad de las vacunas es tan baja como el 14% para los afroamericanos y el 34% para los latinos.

Los adultos mayores dijeron que les gustaría recibir recomendaciones de personas en las que confían, según la encuesta de Michigan. Y los afroamericanos tienen el doble de probabilidades de confiar en voceros de su propia raza, reveló la otra encuesta.

La ventaja de grupos como la asociación de Rochester es que sus miembros son mensajeros de confianza.

Torres-Herbeck contó que había estado hablando con un jardinero que no usaba máscara. Ella le explicó que COVID-19 es un virus y cómo se propaga. El jardinero se sorprendió y se puso un cubrebocas.

A menudo, los funcionarios de salud pública ofrecen instrucciones sobre cómo actuar y qué hacer, como usar una máscara y lavarse las manos, pero no explican por qué, dijo Torres-Herbeck.

Sin embargo, no se trata solo de difundir hechos. Centrarse en los valores compartidos es clave para generar confianza. Cuando Adeline Abbenyi, gerente del programa de Mayo Clinic para el Centro de Investigación sobre Equidad Saludable y Participación Comunitaria, dijo que su madre, que nunca había temido a las vacunas, dudaba en recibir una vacuna COVID-19, Jacobson entendió.

“Muchos de nosotros sentimos lo mismo”, dijo Jacobson en una reunión por Zoom. “Participo del optimismo de que tendremos una vacuna que sea segura y efectiva, pero no la usaré hasta que vea esa evidencia”.

Es normal que la gente dude, no son anti-vacunas. Los médicos y enfermeras que están recibiendo las primeras dosis probablemente ayudarán a muchas personas a superar esa vacilación, agregó.

De hecho, Torres-Herbeck dijo que lo que la persuadiría a ella de vacunarse es ver a Jacobson recibir la vacuna.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Trusted Messengers May Help Disenfranchised Communities Overcome Vaccine Hesitancy

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MINNEAPOLIS — Gloria Torres-Herbeck gets the flu vaccine every year, but the 53-year-old teacher in Rochester, Minnesota, isn’t yet convinced she wants to be first in line for a potential COVID-19 vaccine.

“I’m not super old, but I’m not as strong as other people,” she said. “So, I need to be realistic on my own situation. Do I want to participate in something that might be a big risk for me?”

This month, the Food and Drug Administration gave emergency use authorization for one vaccine and is weighing approval of another. So, public health officials around the country are gearing up for what might be as challenging as figuring out how to store a vaccine at 70 degrees below zero Celsius. They need to persuade people who are part of communities that have been hit hard by the virus — those in low-income families and some minority populations, especially Black and Latino residents — to take a vaccine developed in less than a year and approved under emergency use authorization.

Yet there are a few places where officials think they have a head start. Rochester, Minnesota, home of the Mayo Clinic, is one of them. The Rochester Healthy Community Partnership has been working to reduce health disparities in the area’s immigrant communities, including Somali, Hispanic, Cambodian, South Sudanese and Ethiopian residents, for 15 years.

The partnership is composed of Mayo health providers and researchers, county public health officials and community volunteers like Torres-Herbeck, who immigrated to the U.S. 27 years ago from Mexico. One of the first of its kind, other similar efforts have sprung up around the country, but no one officially tracks such partnerships.

“What we realized when the pandemic hit in spades in March was that with long-established partnerships we were uniquely positioned to leverage” trust built up over the years between Mayo experts and their community partners, said Dr. Mark Wieland, who helps direct the group and studies the impact of such partnerships. “We realized we were obligated to jump in with two feet.”

Although only preliminary evidence has been gathered so far, there are indications that since the efforts began, Rochester has increased COVID-19 testing, improved contact tracing and boosted preventive behaviors such as mask-wearing, hand-washing and physical distancing in these vulnerable communities, he said. The group is hoping those early successes portend well for vaccine acceptance.

Learning From a Measles Outbreak

The Rochester partnership is banking on a commonsense approach that focuses on shared values, transparency and clear communication.

It’s a strategy that has succeeded in the past.

When a measles epidemic hit the large Somali population in Minneapolis-St. Paul in 2017, the Mayo Clinic reached out to community leaders among the 25,000 Somali immigrants in the Rochester area. Many had been frightened of the measles vaccine by baseless claims that it could cause autism, and vaccination rates were low in the community. Medical experts held town hall meetings in mosques and community centers, answering questions about vaccine safety and reassuring people that there was no scientific evidence of a link to autism. Somali actors created YouTube videos to help address common concerns. In the end, there were no recorded cases of measles in Olmsted County, home to Rochester.

About a year ago, Dr. Robert Jacobson, medical director for the Population Health Science Program at Mayo Clinic, at the request of a rabbi visited an Orthodox Jewish community in New York in which vaccine refusal was fueling another measles outbreak. He helped health care leaders there allay concerns.

“The Orthodox Jews in that community were refusing that vaccine for the same reason we were recommending it,” Jacobson said. “They were trying to protect their children.”

Efforts by Jewish leaders, public health experts such as Jacobson and lawmakers who tightened up laws on vaccine exemptions helped quell the outbreak.

Since March, the Rochester partnership has broadcast similar messages about COVID-19 to diverse audiences. Fear or misunderstanding was an issue at the beginning of the pandemic. Health leaders found that members of the immigrant communities were hanging up when the public health department called. So, the partnership developed messaging in several languages to explain the importance of the phone calls. They worked around problems, including that other languages don’t always have terms that mesh with English words for illnesses. For example, the word for “cold” and “flu” is the same in Somali.

Now fewer people hang up.

At the same time, these public health teams report back to the medical experts on what the community needs. “They’re the experts on the subtleties of their communities,” Wieland said.

So when the group learned that many immigrants were intimidated by COVID-19 testing and unsure of the logistics, the group recommended simplifying the process: Now, videos featuring community leaders on social media direct people to testing sites. Once there, anyone who doesn’t speak English automatically gets tested — no identification or insurance card necessary.

“We think that’s part of the reason that, as a county, we have overtested minority populations in relation to white populations,” Wieland said.

The ‘Why’ Was Missing

Only 40% of older Black adults and 51% of older Hispanics said they are somewhat or very likely to get the COVID-19 vaccination — compared with 63% of older white people, a University of Michigan poll shows. Their concerns mirror Torres-Herbeck’s: how well will the vaccine work or how safe it will be.

An even more recent survey of people of all ages for the COVID Collaborative, an advocacy group of national and state health and economic leaders, the NAACP and other groups shows trust in vaccine safety is as low as 14% in Black Americans and 34% in Latinos.

Older adults said they would like recommendations from doctors, health officials, or family and friends — people they trust, according to the Michigan poll. And Black Americans are twice as likely to trust Black messengers versus white messengers, the other survey showed.

“Even if people don’t trust doctors in general, they trust their own doctor,” said Dr. Preeti Malani, one of the authors of the Michigan survey and chief health officer of the university.

The advantage of groups like the Rochester partnership is that its members are also trusted messengers.

Several weeks ago, Torres-Herbeck said, she talked to a landscaper who didn’t wear a mask while working with his business partner. She told him that COVID-19 is a virus and explained how it spreads. He was surprised, and Torres-Herbeck understood. “When I came here 27 years ago, we were not as educated on that,” she said. “When I grew up, it was believed that if you walk barefoot you will catch a cold.”

Often, she said, public health officials provide directions on how to act and what to do, such as use a mask and clean your hands, but don’t explain why.

“That ‘why’ was missing for him,” she said.

Now when she talks to him, he puts a mask on.

In mid-November, Jacobson visited with members of the Rochester partnership via Zoom, part of the group’s initial effort to disseminate vaccine information.

Approving a vaccine under emergency use authorization is no less stringent than the normal procedure, he explained. The process has been dramatically sped up and condensed, he said, by the amount of money poured in and newer technology — and by increased FDA resources.

It’s not all about disseminating facts, however. Focusing on shared values is key to building trust. So when Adeline Abbenyi, the Mayo Clinic program manager for the Center for Healthy Equity and Community Engagement Research, said her mother, who had never feared vaccines, was hesitant to get a COVID-19 vaccine, Jacobson understood.

“A lot of us are feeling the same way,” Jacobson said in that Zoom meeting. “I go into this optimistic that we will have a vaccine that’s safe and effective, but I won’t use it until I see that evidence” of safety and efficacy the FDA is reviewing.

It’s normal for people to hesitate, he said, but that is far different from — and more widespread than — the anti-vaccine movement. Doctors and nurses getting the first doses will likely help many people overcome that hesitancy, he said.

Indeed, one thing that would persuade Torres-Herbeck to be inoculated? Seeing Jacobson get the vaccine, she said.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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With Vaccine Delivery Imminent, Nursing Homes Must Make a Strong Pitch to Residents

Imagine this: Your elderly mother, who has dementia, is in a nursing home and COVID-19 vaccines are due to arrive in a week or two.

You think she should be vaccinated, having heard the vaccine is effective in generating an immune response in older adults. Your brother disagrees. He worries that development of the vaccine was rushed and doesn’t want your mother to be among the first people to get it.

These kinds of conflicts are likely to arise as COVID vaccines are rolled out to long-term care facilities across the country.

“This is a highly politicized environment, not only with respect to vaccines but also over the existence of the virus itself,” said Michael Dark, a staff attorney with California Advocates for Nursing Home Reform. “It’s not hard to imagine disputes arising within families.”

About 3 million people — most of them elderly — live in nursing homes, assisted living centers and group homes, where more than 105,000 residents have died of COVID-19. They should be among the first Americans to receive vaccines, along with health care workers, according to recommendations from the Centers for Disease Control and Prevention and various state plans.

But long-term care residents’ participation in the fastest and most extensive vaccination effort in U.S. history is clouded by a significant complication: More than half have cognitive impairment or dementia.

This raises a number of questions. Will all older adults in long-term care understand the details of the vaccines and be able to consent to getting them? If individual consent isn’t possible, how will families and surrogate decision-makers get the information they need on a timely basis?

And what if surrogates don’t agree with the decision an elderly person has made and try to intervene?

“Imagine that the patient, who has some degree of cognitive impairment, says ‘yes’ to the vaccine but the surrogate says ‘no’ and tells the nursing home, ‘How dare you try to do this?” said Alta Charo, a professor of law and bioethics at the University of Wisconsin-Madison Law School.

Addressing these issues will occur against a backdrop of urgency. Deaths in long-term care facilities are rising dramatically, with new estimates suggesting that 19 residents die of COVID-19 every hour. With viral outbreaks increasing, already-overwhelmed staffers may not have much time to sit down with residents to answer questions or have conversations with families over the phone.

Meanwhile, CVS and Walgreens, the companies operating vaccine programs at most long-term care facilities, have aggressive timetables. Both companies have said the large-scale rollout of the Pfizer-BioNTech vaccine — the first one that the Food and Drug Administration has authorized — will begin on Dec. 21.But facilities in some states may get supplies earlier. Altogether, there are more than 15,000 nursing homes and nearly 29,000 assisted living residences in the U.S.

At a meeting of the federal Advisory Committee on Immunization Practices early this month, Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, acknowledged the agency was “very concerned” that information about vaccines be adequately explained to long-term care residents. “It’s very important for the frail elderly not only to ensure that they are understanding the vaccine that they’re getting but also that their family members do,” she said.

Each vaccine manufacturer will be required to prepare a fact sheet describing what’s known about benefits and risks associated with a vaccine, what’s not known, and making it clear that a vaccine has received “emergency use authorization” from the FDA — a conditional endorsement that falls short of full approval. A second vaccine, from Moderna, is poised to receive this kind of authorization after an FDA meeting on Thursday.

Something that will need to be made clear to residents: while vaccines have been tested on people age 65 and older, those tests did not include individuals living in long-term care, according to Dr. Sara Oliver, a CDC expert.

Some operators have crafted communication plans around the vaccines and already begun intensive outreach. Others may not be well prepared.

Juniper Communities operates 22 senior housing communities (a standalone nursing home, multiple memory care and assisted living facilities, and two continuing care retirement communities) in Colorado, New Jersey and Pennsylvania. This week, it is planning an hour-long town hall videoconferencing session for residents and families about coronavirus vaccines. Last week, it held a similar event for staffers.

Juniper has contracted with CVS, which is requiring that every resident and staff member fill out consent forms in triplicate before being inoculated. When written consent can’t be obtained directly, verbal consent, confirmed independently, may substitute. Walgreens has similar requirements.

For residents with memory impairment, two Juniper nurses will reach out by phone to whomever has decision-making authority. “One will ask questions and obtain verbal consent; the other will serve as a witness,” said Lynne Katzmann, Juniper’s founder and chief executive officer. Separately, emails, blog posts and prerecorded voice messages about the vaccines have gone out to Juniper residents and staffers, starting at the end of November.

A key message is “we’ve done this before, not at this scale, mind you, and not at this level of import, but we do flu vaccinations annually,” said Katzmann, who plans to be the first Juniper employee to get the Pfizer vaccine when it comes to New Jersey.

At Genesis Healthcare, crucial messages are “these vaccines have been studied thoroughly, tens of thousands of people have received them already, they’re very, very effective, and no steps have been skipped in the scientific process,” said Dr. Richard Feifer, executive vice president and chief medical officer. Genesis, the nation’s largest long-term care company, operates more than 380 nursing homes and assisted living residences in 26 states, with about 45,000 employees and more than 30,000 residents.

Medical directors at each Genesis facility have been scheduling video conferences with families, residents and staffers during the past few weeks to address concerns. They’ve also distributed a letter and a question-and-answer document prepared by the Society for Post-Acute and Long-Term Care Medicine, in addition to getting information out through closed-circuit TV channels and social media.

In partnership with Brown University researchers, the company will monitor daily the side effects that its long-term care residents experience after getting coronavirus vaccines. Most reactions are expected to be mild or moderate and resolve within a few days. They include fatigue, pain at the injection site, headaches, body aches, fever and, rarely, allergic responses.

Administering the vaccine will occur over three visits for all long-term care facilities. At the first, all Genesis residents and staffers will get inoculations. At the second, three to four weeks later, those same people will get a second dose, and new staffers and residents will get a first dose. At the third, those who still qualify for a second vaccine dose will get one.

What will happen if lots of people experience uncomfortable side effects and employees don’t come in for a couple of days while recovering? “It’s a very difficult problem and we’re making contingency plans to address it,” Feifer said.

And what about continuing care retirement communities — also known as “life plan communities” — where residents in skilled nursing, assisted living and independent living can reside in close proximity?

That’s the case at Bayview in Seattle, which houses 210 residents in a 10-story building. For the moment, independent living residents aren’t on the priority list but “I know there will be a contingent of residents and staff who won’t want to be vaccinated and we’ll see if we can use those vaccines for our independent living people instead,” said Joel Smith, Bayview’s health services administrator.

Logistical challenges are sure to arise, but many operators have an acute sense of mission. “It is critical that we lead the way out of this crisis,” Feifer of Genesis said. “Nursing homes need to go first and be the first ones to address vaccine hesitancy head-on and be successful at generating a high level of acceptance. There is no alternative, no Plan B right now. We have to be successful.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Readers and Tweeters Defend Front-Line Nurses and Blind Us With Science

Letters to the Editor is a periodic feature. We welcome all comments and will publish a selection. We edit for length and clarity and require full names.

The demand for skilled nurses during the pandemic is through the roof! Travel nurses command a hefty salary and they are worth every penny… #COVID19 #pandemic #RN https://t.co/gYQpkHqaoX

— Talmage Egan, MD (@UofU_Anes_Chair) November 26, 2020

— Dr. Talmage Egan, Salt Lake City

Nurses Deserve to Be Paid Handsomely

I read your article “Need a COVID-19 Nurse? That’ll Be $8,000 a Week” (Nov. 24) in the Springfield Journal-Register. It was an interesting article as I have a daughter who is a nurse. Nurses have been underpaid and unappreciated for years. It made me angry that the article characterized the wages some hospitals are willing to pay for nurses as exorbitant. Hogwash if you think someone should risk their life every hour of the day to care for COVID patients without proper compensation. How many doctors make over a million a year? You don’t cite that as unusual. I feel that nurses should go for the gold as they have been taken advantage of for years and, too bad, but good for them. Choose your words more carefully in the future. Nurses ROCK!!!!

— Mike Booher, Lincoln, Illinois

Hospitals go out of their way to avoid competing for nursing labor by raising wages. Now hospital executives and public health advocates act like it’s a travesty that COVID nurses are finally getting paid market rates to take on risky jobs. https://t.co/6z0idToVn6

— Devon M. Herrick (@DevonHerrick) November 24, 2020

— Devon M. Herrick, Dallas

Missing in the Mix of Vaccine Coverage

I must note two important omissions in the article “Time to Discuss Potentially Unpleasant Side Effects of COVID Shots? Scientists Say Yes” (Nov. 12). First, although these were interim trial results, the placebo arm should also have been reported out. What was the placebo infection rate? Reporting 90% effectiveness is irrelevant without reporting the placebo rate simultaneously. And one needs to align the infection rate in trial subjects with the incidence of disease in the U.S. population. They should be similar, but if not, any discrepancy must be explained (such as, no elderly people or children participating in the trial). Secondly, and perhaps more important: What other mitigating measures were volunteers in this trial required/advised to take? For example, physical distancing, masks, etc. I could find no mention of this, positively or negatively, when reading the protocol on clinicaltrials.gov. Any vaccine alone could not provide 94.5% efficacy. To determine the relative contributions of other measures, you’d need, say, a four-arm study — placebo with mask, placebo without mask, vaccine with mask, vaccine without mask. Statistically and clinically, one must account for other variables that may confound an apparent result.

This is a crucial point as the lay public is thinking that, by getting the vaccine, masks might no longer be necessary and they’ll have a 95% chance of not being infected. This is rubbish. The media and the public “experts” need to address this as they are setting themselves up for an immense PR failure and still greater skepticism. People may need to wear masks for many more months, maybe years, even with an effective vaccine.

— Stephen Zaruby, Truckee, California

I’m already confused 😕 https://t.co/UlJPh2EEvK

— hameen tariq (@hameentariq) November 23, 2020

— Hameen Tariq, Wilmington, Delaware

Exploring Cancer Drug’s Effects on COVID

Your story “Clots, Strokes and Rashes: Is COVID a Disease of the Blood Vessels?” (Nov. 13) was reprinted in my local newspaper. My brother, James L. Kinsella Ph.D., led the original work at the National Institutes of Health researching how the chemotherapy drug Taxol could reduce inflammation in coronary articles following the placement of coronary stents. This led to the very effective use of drug-eluting coronary stents. My unprofessional musing causes me to wonder if this anti-inflammatory response to Taxol might have some application as an early therapeutic intervention to reduce the inflammatory response of COVID-19 being studied by Dr. William Li. I can’t ask my brother; he passed away.

— Rick Kinsella, Oneida, New York

He wouldn’t be dead without covid. We’ve learned that things that aren’t life threatening are made life threatening by this disease. It attacks your blood vessels so it can exacerbate anything anywhere in your body that uses blood vessels. Stay safe indeed https://t.co/BFsqrKSFmH

— James McPicnic (@WhiteRatbit) December 3, 2020

— James “J.P.” McPicnic, Los Angeles

Women’s Health Should Not Be Up for Debate

Birth control medication is so much more than a pawn in politics (“Coming Abortion Fight Could Threaten Birth Control, Too,” Nov. 5). It changes the lives of so many women for the better. Birth control access has been proven to lead to higher rates of education for women, lower levels of child poverty, lower Medicaid costs for women’s health and higher productivity of society as a whole. It also treats a large number of medical conditions associated with women’s health. It effectively treats severe menstrual migraines, hormonal acne, endometriosis, severe menstrual pain, uterine abnormalities, anemia and heavy menstrual bleeding, among other health conditions. This medication is involved in treating so many women’s health concerns, improves infant and child health outcomes, and reduces child poverty, and yet almost 20 million women in the U.S. currently have no access to birth control medication. American politicians need to consider, if nothing else, the spillover costs to society when birth control access is reduced.

Women’s reproductive health should not be up for debate and yet it is at the center of so many political agendas. As a 24-year-old woman pursuing dual master’s degrees in public health and physician assistant studies, my focus should be on learning to become an exceptional health care provider, not whether my health will be up for debate in court. If politicians truly have the best interests of Americans at heart, they should be looking to expand birth control access, not restrict it.  Evidence needs to be incorporated into political agendas, and the evidence shows that when women succeed, society succeeds. Women’s education, health and reproductive rights should be at the forefront of every discussion on what constitutes a thriving population — the evidence has proven that women’s autonomy holds the answer and access to birth control is a vital piece of that.

— Gabby Henshue, Madison, Wisconsin

Scary times for women’s bodies.

“States could effectively ban contraception by arguing that some contraceptives act as abortifacients.” Threat is real. I’ve worked in states where this argument has been made.https://t.co/LmdWFRUNOZ

— Elizabeth M. Baskett (@EMBaskett) November 11, 2020

— Elizabeth M. Baskett, Denver

Injustice in High Gear

I was appalled at the charges on the medical bill from the Carson City emergency department for that child who fell off his bike (“Bill of the Month: After Kid’s Minor Bike Accident, Major Bill Sets Legal Wheels in Motion,” Nov. 25) — $18,000 for an exam and stitches? What would it take to sort out such problems in our health system? Lower prices from providers could only result in lower insurance premiums.

— Karen Johnson, San Rafael, California

Attempted subrogation, man, I tell yah https://t.co/spxcMlSiCk

— Annie M. Davidson (@attyannie) November 25, 2020

— Annie M. Davidson, St. Paul, Minnesota

KHN Morning Briefing: A Wealth of Information in One Spot!

I just wanted to say it is awesome to have portions of articles from many major news outlets because never does one tell the whole story. Case in point: I was trying to research what exactly President Donald Trump had done that “allowed doctors to discriminate against LGBT people,” and it was very helpful having a wide array of media sources on a single page to help get the bigger picture and try and weed through the bias of all of them (“Trump Administration’s Expanded Conscience Rule Will Allow Medical Professionals To Refuse To Provide Health Care Services,” May 3). Just sending my compliments. Keep up the great work.

— Nolan Steeley, Greensburg, Pennsylvania

💥Racism in #healthcare undermines #quality of care and patient safety. There’s hard work to be done to weed it out of all parts of society, especially clinical care. https://t.co/TbK0yIuraB

— Natalie S. Burke (@natalie4health) November 28, 2020

— Natalie S. Burke, Washington, D.C.

Education and Coverage Gaps Lead to Avoidable Amputations 

Coming to terms with systemic racism in health care is long overdue (“What Doctors Aren’t Always Taught: How to Spot Racism in Health Care,” Nov. 17). The way medicine is taught and the payment policies that shape the system have created persistent disparities in patient outcomes across racial and ethnic groups.

As a result, Black Americans are 80% more likely than whites to be diagnosed with diabetes and are twice as likely to die from the disease. Furthermore, Black American patients are up to four times more likely to experience an amputation than their white counterparts due to advanced peripheral artery disease (PAD), a common complication for people with diabetes and other chronic conditions. Similarly, Latinos are up to 75% more likely to experience an amputation than whites, while Native Americans are twice as likely to lose a limb.

As many as 85% of the nation’s 200,000 non-traumatic amputations could be prevented with access to screening and early detection. By screening for PAD through non-invasive arterial testing, the likelihood of an individual needing a PAD-related amputation can be reduced by up to 90%. Unfortunately, too few Americans — particularly racial and ethnic minorities — are even offered routine screening for PAD due to a widespread lack of understanding about the disease, as well as structural coverage barriers to simple, painless tests. As a result, many do not even know they have the disease until it is too late to save their limbs.

Communities of color deserve better. Members of the Congressional PAD Caucus — led by Rep. Donald Payne Jr. (D-N.J.) — recently introduced the Amputation Reduction and Compassion (ARC) Act to establish an education program about the disease — particularly for high-risk populations — and update reimbursement policy to disallow payment for non-emergent amputations unless arterial testing has been done in the three months before amputation. These simple solutions have the power to prevent thousands of avoidable amputations, and begin to correct health disparities in minority communities.

While we still have a long way to go as our country continues to grapple with systemic racism in health care, the ARC Act represents an important step toward ending disparities in PAD care.

— Dr. Foluso Fakorede, CEO of Cardiovascular Solutions of Central Mississippi, Cleveland, Mississippi

Racism in Health Care? Another example of injecting Politics. Inarguably, racism exists everywhere, but to make this a big issue is a disservice. Diff DX requires inclusion of Race/Ethnicity, to wit: Sickle Cell in Blacks,Alpha & Beta Thalassemia in Asians https://t.co/xyP54dPjH8

— Alexander R. Lim, MD (@AlexanderLim13) November 25, 2020

— Dr. Alexander R. Lim, Corpus Christi, Texas

‘Obamacare’ Unfairly Politicizes Health Law

I found this article interesting (“Biden Plan to Lower Medicare Eligibility Age to 60 Faces Hostility From Hospitals,” Nov. 11) but was surprised that the Affordable Care Act was referred to as “Obamacare.” Please don’t politicize the ACA — we really need it to continue allowing people to access health care. Many people do not have health care through their workplace and are unable to afford private insurance premiums. I was once one of those people before I was hired at our local library. It was really tough. Thank you for your reporting.

— Pamela Elicker, Port Townsend, Washington

Putting People First on the Podcast

When you were talking about drug policy and the ballot in a recent podcast (“KHN’s ‘What the Health?’: Change Is in the Air,” Nov. 6), you used terms that are considered incorrect or stigmatizing. For example, saying “opioid epidemic” when it’s really a crisis and referring to substance use as “abuse.” The Associated Press and NPR, among others, have pledged to use people-first language, as also supported by the American Psychological Association.

— Deirdre Dingman, Philadelphia

The Backbone of the Insurance Industry

It’s disingenuous to assert that people “can’t always rely on insurance brokers to give them accurate information or steer them to comprehensive coverage” based on the unfortunate experience of one consumer with a short-term health plan, as Michelle Andrews did in the article “Think Your Health Care Is Covered? Beware of the ‘Junk’ Insurance Plan” (Dec. 4).

Agents and brokers are crucial to our nation’s efforts to get people covered. This year, they assisted almost half of all healthcare.gov enrollees — and brought 1.12 million new enrollees into the marketplace. It’s no wonder that a new report from the Centers for Medicare & Medicaid Services has called agents and brokers “instrumental in driving greater participation in the individual health insurance market.”

Further, agents and brokers have long maintained that short-term plans are not appropriate substitutes for comprehensive exchange coverage. We at the National Association of Health Underwriters stated as much in official comments filed with the Trump administration before it finalized a rule extending the duration of short-term plans to 12 months.

— Janet Trautwein, CEO of the National Association of Health Underwriters, Washington, D.C.

 


Not Tickling My Funny Bone

You ought to find some cartoonists who are not so flagrantly left-leaning — continuing to provide left-sided commentary is not right. It’s like all of the news stations pushing for socialism.

— Harry Gousha, Upland, California

Editor’s note: It is the tradition and mission among editorial cartoonists to satirize those in power. As with the nation’s leadership, the targets of political cartoons toggle from right to left. Balance is not these artists’ goal, but over time their commentary balances out. Stick with us, and we hope to amuse you in the future.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Lie of the Year: The Downplay and Denial of the Coronavirus


This story was produced in partnership with PolitiFact. It can be republished for free.

A Florida taxi driver and his wife had seen enough conspiracy theories online to believe the virus was overblown, maybe even a hoax. So no masks for them. Then they got sick. She died. A college lecturer had trouble refilling her lupus drug after the president promoted it as a treatment for the new disease. A hospital nurse broke down when an ICU patient insisted his illness was nothing worse than the flu, oblivious to the silence in beds next door.   

Lies infected America in 2020. The very worst were not just damaging, but deadly. 

President Donald Trump fueled confusion and conspiracies from the earliest days of the coronavirus pandemic. He embraced theories that COVID-19 accounted for only a small fraction of the thousands upon thousands of deaths. He undermined public health guidance for wearing masks and cast Dr. Anthony Fauci as an unreliable flip-flopper

But the infodemic was not the work of a single person. 

Anonymous bad actors offered up junk science. Online skeptics made bogus accusations that hospitals padded their coronavirus case numbers to generate bonus payments. Influential TV and radio opinion hosts told millions of viewers that physical distancing was a joke and that states had all of the personal protective equipment they needed (when they didn’t).

It was a symphony of counter-narrative, and Trump was the conductor, if not the composer. The message: The threat to your health was overhyped to hurt the political fortunes of the president. 

Every year, PolitiFact editors review the year’s most inaccurate statements to elevate one as the Lie of the Year. The “award” goes to a statement, or a collection of claims, that prove to be of substantive consequence in undermining reality. 

It has become harder and harder to choose when cynical pundits and politicians don’t pay much of a price for saying things that aren’t true. For the past month, unproven claims of massive election fraud have tested democratic institutions and certainly qualify as historic and dangerously baldfaced. Fortunately, the constitutional foundations that undergird American democracy are holding. 

Meanwhile, the coronavirus has killed more than 300,000 in the United States, a crisis exacerbated by the reckless spread of falsehoods.

PolitiFact’s 2020 Lie of the Year: claims that deny, downplay or disinform about COVID-19. 

‘I Wanted to Always Play It Down’

On Feb. 7, Trump leveled with book author Bob Woodward about the dangers of the new virus that was spreading across the world, originating in central China. He told the legendary reporter that the virus was airborne, tricky and “more deadly than even your strenuous flus.”

Trump told the public something else. On Feb. 26, the president appeared with his coronavirus task force in the crowded White House briefing room. A reporter asked if he was telling healthy Americans not to change their behavior.

“Wash your hands, stay clean. You don’t have to necessarily grab every handrail unless you have to,” he said, the room chuckling. “I mean, view this the same as the flu.”

Three weeks later, March 19, he acknowledged to Woodward: “To be honest with you, I wanted to always play it down. I still like playing it down. Because I don’t want to create a panic.”

His acolytes in politics and the media were on the same page. Rush Limbaugh told his audience of about 15 million on Feb. 24 that the coronavirus was being weaponized against Trump when it was just “the common cold, folks.” That’s wrong — even in the early weeks, it was clear the virus had a higher fatality rate than the common cold, with worse potential side effects, too.

As the virus was spreading, so was the message to downplay it. 

“There are lots of sources of misinformation, and there are lots of elected officials besides Trump that have not taken the virus seriously or promoted misinformation,” said Brendan Nyhan, a government professor at Dartmouth College. “It’s not solely a Trump story — and it’s important to not take everyone else’s role out of the narrative.” 

Hijacking the Numbers 

In August, there was a growing movement on Twitter to question the disproportionately high U.S. COVID-19 death toll.  

The skeptics cited Centers for Disease Control and Prevention data to claim that only 6% of COVID-19 deaths could actually be attributed to the virus. On Aug. 24, BlazeTV host Steve Deace amplified it on Facebook.

“Here’s the percentage of people who died OF or FROM Covid with no underlying comorbidity,” he said to his 120,000 followers. “According to CDC, that is just 6% of the deaths WITH Covid so far.”

That misrepresented the reality of coronavirus deaths. The CDC had always said people with underlying health problems — comorbidities — were most vulnerable if they caught COVID-19. The report was noting that 6% died even without being at obvious risk. 

But for those skeptical of COVID-19, the narrative confirmed their beliefs. Facebook users copied and pasted language from influencers like Amiri King, who had 2.2 million Facebook followers before he was banned. The Gateway Pundit called it a “SHOCK REPORT.”

“I saw a statistic come out the other day, talking about only 6% of the people actually died from COVID, which is very interesting — that they died from other reasons,” Trump told Fox News host Laura Ingraham on Sept. 1.

Fauci, director of the National Institute of Allergy and Infectious Diseases, addressed the claim on “Good Morning America” the same day. 

“The point that the CDC was trying to make was that a certain percentage of them had nothing else but just COVID,” he said. “That does not mean that someone who has hypertension or diabetes who dies of COVID didn’t die of COVID-19 — they did.”

Trump retweeted the message from an account that sported the slogans and symbols of QAnon, a conspiracy movement that claims Democrats and Hollywood elites are members of an underground pedophilia ring. 

False information moved between social media, Trump and TV, creating its own feedback loop.

“It’s an echo effect of sorts, where Donald Trump is certainly looking for information that resonates with his audiences and that supports his political objectives. And his audiences are looking to be amplified, so they’re incentivized to get him their information,” said Kate Starbird, an associate professor and misinformation expert at the University of Washington.

Weakening the Armor: Misleading on Masks

At the start of the pandemic, the CDC told healthy people not to wear masks, saying they were needed for health care providers on the front lines. But on April 3 the agency changed its guidelines, saying every American should wear non-medical cloth masks in public.

Trump announced the CDC’s guidance, then gutted it.

“So it’s voluntary. You don’t have to do it. They suggested for a period of time, but this is voluntary,” Trump said at a press briefing. “I don’t think I’m going to be doing it.”

Rather than an advance in best practices on coronavirus prevention, face masks turned into a dividing line between Trump’s political calculations and his decision-making as president. Americans didn’t see Trump wearing a mask until a July visit to Walter Reed National Military Medical Center.

Meanwhile, disinformers flooded the internet with wild claims: Masks reduced oxygen. Masks trapped fungus. Masks trapped coronavirus. Masks just didn’t work.

In September, the CDC reported a correlation between people who went to bars and restaurants, where masks can’t consistently be worn, and positive COVID-19 test results. Bloggers and skeptical news outlets countered with a misleading report about masks.

On Oct. 13, the story landed on Fox News’ flagship show, “Tucker Carlson Tonight.” During the show, Carlson claimed “almost everyone — 85% — who got the coronavirus in July was wearing a mask.”

“So clearly [wearing a mask] doesn’t work the way they tell us it works,” Carlson said.

That’s wrong, and it misrepresented a small sample of people who tested positive. Public health officials and infectious disease experts have been consistent since April in saying that face masks are among the best ways to prevent the spread of COVID-19.

But two days later, Trump repeated the 85% stat during a rally and at a town hall with NBC’s Savannah Guthrie. 

“I tell people, wear masks,” he said at the town hall. “But just the other day, they came out with a statement that 85% of the people that wear masks catch it.”

The Assault on Hospitals 

On March 24, registered nurse Melissa Steiner worked her first shift in the new COVID-19 ICU of her southeastern Michigan hospital. After her 13-hour workday caring for two critically ill patients on ventilators, she posted a tearful video.

“Honestly, guys, it felt like I was working in a war zone,” Steiner said. “[I was] completely isolated from my team members, limited resources, limited supplies, limited responses from physicians because they’re just as overwhelmed.” 

“I’m already breaking, so for f—’s sake, people, please take this seriously. This is so bad.”

Steiner’s post was one of many emotional pleas offered by overwhelmed hospital workers last spring urging people to take the threat seriously. The denialists mounted a counteroffensive.

On March 28, Todd Starnes, a conservative radio host and commentator, tweeted a video from outside Brooklyn Hospital Center. There were few people or cars in sight.

“This is the ‘war zone’ outside the hospital in my Brooklyn neighborhood,” Starnes said sarcastically. The video racked up more than 1.5 million views.

Starnes’ video was one of the first examples of #FilmYourHospital, a conspiratorial social media trend that pushed back on the idea that hospitals had been strained by a rapid influx of coronavirus patients. 

Several internet personalities asked people to go out and shoot their own videos. The result: a series of user-generated clips taken outside hospitals, where the response to the pandemic was not easily seen. Over the course of a week, #FilmYourHospital videos were uploaded to YouTube and posted tens of thousands of times on Twitter and Facebook.

Nearly two weeks and more than 10,000 deaths later, Fox News featured a guest who opened a new misinformation assault on hospitals.

Dr. Scott Jensen, a Minnesota physician and Republican state senator, told Ingraham that, because hospitals were receiving more money for COVID-19 patients on Medicare — a result of a coronavirus stimulus bill — they were overcounting COVID-19 cases. He had no proof of fraud, but the cynical story took off

Trump used the false report on the campaign trail to continue to minimize the death toll. 

“Our doctors get more money if somebody dies from COVID,” Trump told supporters at a rally in Waterford, Michigan, on Oct. 30. “You know that, right? I mean, our doctors are very smart people. So what they do is they say, ‘I’m sorry, but, you know, everybody dies of COVID.’”  

The Real Fake News: The Plandemic

The most viral disinformation of the pandemic was styled to look as if it had the blessing of people Americans trust: scientists and doctors.

In a 26-minute video called “Plandemic: The Hidden Agenda Behind COVID-19,” a former scientist at the National Cancer Institute claimed the virus was manipulated in a lab, hydroxychloroquine is effective against coronaviruses, and face masks make people sick. 

Judy Mikovits’ conspiracies received more than 8 million views, partly credited to the online outrage machine — anti-vaccine activists, anti-lockdown groups and QAnon supporters — that push disinformation into the mainstream. The video was circulated in a coordinated effort to promote Mikovits’ book release.

Around the same time, a similar effort propelled another video of fact-averse doctors to millions of people in only a few hours. 

On July 27, Breitbart published a clip of a press conference hosted by a group called America’s Frontline Doctors in front of the U.S. Supreme Court. Looking authoritative in white lab coats, these doctors discouraged mask-wearing and falsely said there was already a cure in hydroxychloroquine, a drug used to treat rheumatoid arthritis and lupus.

Trump, who had been talking up the drug since March and claimed to be taking it himself as a preventive measure in May, retweeted clips of the event before Twitter removed them as misinformation about COVID-19. He defended the “very respected doctors” in a July 28 press conference

When Olga Lucia Torres, a lecturer at Columbia University, heard Trump touting the drug in March, she knew it didn’t bode well for her own prescription. Sure enough, the misinformation led to a run on hydroxychloroquine, creating a shortage for Americans like her who needed the drug for chronic conditions. 

A lupus patient, she went to her local pharmacy to request a 90-day supply of the medication. But she was told they were granting only partial refills. It took her three weeks to get her medication through the mail. 

“What about all the people who were silenced and just lost access to their staple medication because people ran to their doctors and begged to take it?” Torres said.

No Sickbed Conversion

On Sept. 26, Trump hosted a Rose Garden ceremony to announce his nominee to replace the late Ruth Bader Ginsburg on the U.S. Supreme Court. More than 150 people attended the event introducing Amy Coney Barrett. Few wore masks, and the chairs weren’t spaced out.

In the weeks afterward, more than two dozen people close to Trump and the White House became infected with COVID-19. Early on Oct. 2, Trump announced his positive test.

Those hoping the experience and Trump’s successful treatment at Walter Reed might inform his view of the coronavirus were disappointed. Trump snapped back into minimizing the threat during his first moments back at the White House. He yanked off his mask and recorded a video.

“Don’t let it dominate you. Don’t be afraid of it,” he said, describing experimental and mostly out-of-reach therapies he received. “You’re going to beat it.” 

In Trump’s telling, his hospitalization was not the product of poor judgment about large gatherings like the Rose Garden event, but the consequence of leading with bravery. Plus, now, he claimed, he had immunity to the virus.

On the morning after he returned from Walter Reed, Trump tweeted a seasonal flu death count of 100,000 lives and added that COVID-19 was “far less lethal” for most populations. More false claims at odds with data — the U.S. average for flu deaths over the past decade is 36,000, and experts said COVID-19 is more deadly for each age group over 30.

When Trump left the hospital, the U.S. death toll from COVID-19 was more than 200,000. Today it is more than 300,000. Meanwhile, this month the president has gone ahead with a series of indoor holiday parties. 

The Vaccine War 

The vaccine disinformation campaign started in the spring but is still underway.

In April, blogs and social media users falsely claimed Democrats and powerful figures like Bill Gates wanted to use microchips to track which Americans had been vaccinated for the coronavirus. Now, false claims are taking aim at vaccines developed by Pfizer and BioNTech and other companies.

  • A blogger claimed Pfizer’s head of research said the coronavirus vaccine could cause female infertility. That’s false.
  • An alternative health website wrote that the vaccine could cause an array of life-threatening side effects, and that the FDA knew about it. The list included all possible — not confirmed— side effects.
  • Social media users speculated that the federal government would force Americans to receive the vaccine. Neither Trump nor President-elect Joe Biden has advocated for that, and the federal government doesn’t have the power to mandate vaccines, anyway.

As is often the case with disinformation, the strategy is to deliver it with a charade of certainty. 

“People are anxious and scared right now,” said Dr. Seema Yasmin, director of research and education programs at the Stanford Health Communication Initiative. “They’re looking for a whole picture.” 

Most polls have shown far from universal acceptance of vaccines, with only 50% to 70% of respondents willing to take the vaccine. Black and Hispanic Americans are even less likely to take it so far.

Meanwhile, the future course of the coronavirus in the U.S. depends on whether Americans take public health guidance to heart. The Institute for Health Metrics and Evaluation projected that, without mask mandates or a rapid vaccine rollout, the death toll could rise to more than 500,000 by April 2021.

“How can we come to terms with all that when people are living in separate informational realities?” Starbird said.

PolitiFact staff researcher Caryn Baird contributed to this report.

Note: Readers can find the detailed source list for this story, as well as PolitiFact’s related coverage, or vote in the Lie of the Year Readers’ Choice Poll at PolitiFact.com.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Pediatricians Want Kids to Be Part of COVID Vaccine Trials

If clinical trials for COVID-19 vaccines aren’t expanded soon to include children, it’s unlikely that even kids in their teens will be vaccinated in time for the next school year.

The hurdle is that COVID vaccine makers are only in the early stages of testing their products on children. The Pfizer vaccine authorized for use by the Food and Drug Administration on Friday was greenlighted only for people ages 16 and up. Moderna just started trials for 12- to 17-year-olds for its vaccine, likely to be authorized later this month.

It will take months to approve use of the vaccines for middle- and high school-aged kids, and months more to test them in younger children. But some pediatricians say that concerns about the safety of the front-runner vaccines make the wait worthwhile.

Although most pediatricians believe the eventual vaccination of children will be crucial to subduing the COVID virus, they’re split on how fast to move toward that, says Dr. James Campbell, professor of pediatrics at the University of Maryland School of Medicine’s Center for Vaccine Development and Global Health. Campbell and colleagues say it’s a matter of urgency to get the vaccines tested in kids, while others want to hold off on those trials until millions of adults have been safely vaccinated.

Much of the debate centers on two issues: the degree of harm COVID-19 causes children, and the extent to which children are spreading the virus to their friends, teachers, parents and grandparents.

COVID-19’s impact on children represents a tiny fraction of the suffering and death experienced by vulnerable adults. Yet it would qualify as a pretty serious childhood disease, having caused 154 deaths and more than 7,500 hospitalizations as of Dec. 3 among people 19 and younger in the United States. Those numbers rank it as worse than a typical year of influenza, and worse than diseases like mumps or hepatitis B in children before the vaccination era.

Studies thus far show that 1%-2% of children infected with the virus end up requiring intensive care, Dr. Stanley Plotkin, professor emeritus of pediatrics at the University of Pennsylvania, told a federal panel. That’s in line with the percentage who become gravely ill as result of infections like Haemophilus influenza type B, or Hib, for which doctors have vaccinated children since the 1980s, he pointed out.

Campbell, who with colleagues has developed a plan for how to run pediatric COVID vaccine trials, points out that “in a universe where COVID mainly affected children the way it’s affecting them now, and we had potential vaccines, people would be clamoring for them.”

The evidence that teens can transmit the disease is pretty clear, and transmission has been documented in children as young as 8. Fear of spread by children has been enough to close schools, and led the American Academy of Pediatrics to demand that children be quickly included in vaccine testing.

“The longer we take to start kids in trials, the longer it will take them to get vaccinated and to break the chains of transmission,” said Dr. Yvonne Maldonado, a professor of pediatrics at Stanford University who chairs the AAP’s infectious disease committee. “If you want kids to go back to school and not have the teachers union terrified, you have to make sure they aren’t a risk.”

Other pediatricians worry that early pediatric trials could backfire. Dr. Cody Meissner, chief of pediatric infectious diseases at Tufts Medical Center and a member of the FDA’s advisory committee on vaccines, is worried that whatever causes Multisystem Inflammatory Syndrome in Children, a rare but frightening COVID-related disorder, might also be triggered, however rarely, by vaccination.

Meissner abstained from the committee’s vote Thursday that supported, by a 17-4 vote, an emergency authorization of the Pfizer vaccine for people 16 and older.

“I have trouble justifying it for children so unlikely to get the disease,” he said during debate on the measure.

But panel member Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children’s Hospital, said the 16-and-up authorization would speed the vaccine’s testing in and approval for younger children. That is vital for the world’s protection from COVID-19, he said, since in the United States and most places “most vaccines are delivered early in life.”

While vaccines given to tens of thousands of people so far appear to be safe, the lack of understanding of the inflammatory syndrome means that children in any trials should be followed closely, said Dr. Emily Erbelding, director of the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases.

Under a 2003 law, vaccine companies are required eventually to test all their products on children. By late last month, Pfizer had vaccinated approximately 100 children 12-15 years of age, said spokesperson Jerica Pitts.

Moderna has started enrolling 3,000 children 12 and over in another clinical trial, and other companies have similar plans. Assuming the trials show the vaccines are safe and provide a good immune response, future tests could include progressively younger children, moving to, say, 6- to 12-year-olds next, then 2- to 6-year-olds. Eventually, trials could include younger toddlers and infants.

Similar stepdown approaches were taken to test vaccines against human papillomavirus (HPV), influenza and other diseases in the past, Erbelding noted. Such trials are easiest to conduct when researchers know that a measurable immune response, like antibody levels in the blood, translates to effective protection against disease. Armed with such knowledge, they can see whether children were protected without them having to be exposed to the virus. Federal scientists hope to get that data from the Moderna and Pfizer adult vaccine trials, she said.

Vaccine trials geared to tweens or younger children may involve testing half-doses, which, if protective, would require less vaccine and might cause fewer incidents of sore arms and fevers that afflicted many who’ve received the Pfizer and Moderna vaccines, Campbell said.

But unless additional studies begin quickly, the window for having an FDA-authorized vaccine available before the next school yearwill be closed even for our oldest children,” said Dr. Evan Anderson, a pediatrics professor at Emory University. “Our younger children are almost certainly going into next school year without a vaccine option available for them.”

In the meantime, teachers are likely to be high on the priority list for vaccination. Protecting school staff could allow more schools to reopen even if most children can’t be vaccinated, Erbelding said.

Eventually, if the SARS-CoV-2 virus remains in circulation, governments may want to mandate childhood vaccination against the virus to protect them as they grow up and protect society as a whole, Plotkin said.

In the 1960s, Plotkin invented the rubella vaccine that has been given to hundreds of millions of children since. Like COVID-19, rubella, or German measles, is not usually a serious illness for children. But congenital rubella syndrome afflicted babies in the womb with blindness, deafness, developmental delays and autism. Immunizing toddlers, which, in turn, protects their pregnant mothers, has indirectly prevented hundreds of thousands of such cases.

“We don’t want to use children to protect everyone in the community,” said Campbell. “But when you can protect both children and their community, that’s important.”

And while a coronavirus infection may not be bad for most children, missed school, absent friends and distanced families have caused them immense suffering, he said.

“It’s a huge burden on a child to have their entire world flipped around,” Campbell said. “If vaccinating could help to flip it back, we should begin testing to see if that’s possible.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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KFF Launches New COVID-19 Vaccine Monitor to Track the Public’s Confidence in the Vaccine and Experiences for the Duration of the Pandemic

Republicans and Black Americans are More Likely to Be Hesitant but Even Among These Groups Reasons Vary KFF has launched a new COVID-19 Vaccine Monitor to dive deeply into the public’s views about the vaccine and experiences getting it for as long as the pandemic lasts. First results released today show that Americans’ enthusiasm forMore

KFF COVID-19 Vaccine Monitor: December 2020

This initial survey for the KFF COVID-19 Vaccine Monitor tracks the public’s attitudes and experiences with COVID-19 vaccinations, with a focus on sub-groups of Americans. It explores confidence in vaccines, assesses trust in messengers, and highlights key challenges for vaccination efforts.

Desafío en hospitales: a qué trabajadores de salud vacunar primero contra COVID

Si existe una cita con el destino, está escrita en el calendario del doctor Taison Bell.

Al mediodía del martes 15 de diciembre, Bell, especialista en cuidados intensivos del Sistema de Salud de la Universidad de Virginia será uno de los primeros en arremangarse para recibir la vacuna que lo protegerá del coronavirus.

Bell, de 37 años, se inscribió la semana pasada a través del correo electrónico del hospital para recibir la vacuna. “La historia de esta crisis es que cada semana se siente como un año. Esta es realmente la primera vez que hay una esperanza genuina de que podemos revertir esta situación”.

Por ahora, esa esperanza se limita a unos pocos elegidos. Bell atiende a algunos de los pacientes con COVID-19 más enfermos en el hospital UVA Health en Charlottesville, Virginia.

Bell es uno de los 12,000 trabajadores del hospital “que trabajan directo con estos pacientes”, que podrían ser elegibles para unas 3,000 primeras dosis de vacunas, dijo el doctor Costi Sifri, director de epidemiología del hospital.

“Estamos tratando de encontrar las categorías de mayor riesgo, aquellas que realmente pasan una cantidad significativa de tiempo cuidando a los pacientes”, dijo Sifri. “No se tiene en cuenta a todo el mundo”.

Incluso cuando la Administración de Alimentos y Medicamentos (FDA) participaba en intensas deliberaciones antes de la autorización del viernes de la vacuna contra COVID de Pfizer y BioNTech, y días antes de que se liberaran las 6.4 millones de dosis iniciales, los hospitales de todo el país ya estaban planeando cómo distribuir la primeras, y escasas, dosis.

Un comité asesor de los Centros para el Control y Prevención de Enfermedades (CDC) recomendó que la máxima prioridad sea para los hogares de adultos mayores de atención a largo plazo y para los trabajadores de atención médica de primera línea.

Pero se sabía que la primera tanda de vacunas no iba a cubrir toda la necesidad y que se iba a tener que hacer un proceso más selectivo, incluso entre los trabajadores críticos del hospital.

En general, se aconseja a los hospitales que cubran a los miembros de su fuerza laboral con mayor riesgo, pero las instituciones deben decidir exactamente quiénes serán, dijo Colin Milligan, vocero de la Asociación Estadounidense de Hospitales, en un correo electrónico.

“Está claro que los hospitales no recibirán lo suficiente en las primeras semanas para vacunar a todos los miembros de su personal, por lo que hubo que tomar decisiones”, escribió Milligan.

En Intermountain Healthcare, en Salt Lake City, Utah, las primeras inyecciones serán para los miembros del personal “con el mayor riesgo de contacto con pacientes COVID positivos o sus desechos”, dijo la doctora Kristin Dascomb, directora médica de prevención de infecciones y salud del personal. Dentro de ese grupo, los gerentes determinarán qué cuidadores son los primeros en la fila.

En la UW Medicine, en Seattle, Washington, que incluye el Harborview Medical Center, un plan temprano requería que el personal de alto riesgo fuera seleccionado al azar para recibir las primeras dosis, dijo la doctora Shireesha Dhanireddy, directora médica de la clínica de enfermedades infecciosas.

Pero el sistema hospitalario de la Universidad de Washington espera recibir dosis suficientes para vacunar a todas las personas en ese nivel de alto riesgo dentro de dos semanas, por lo que la selección aleatoria no ha sido necesaria por ahora.

“Permitimos que las mismas personas programen la cita”, dijo Dhanireddy, y alentamos al personal a vacunarse cerca del final de sus semanas laborales en caso de que tengan reacciones a la nueva vacuna.

Los resultados de los ensayos han demostrado que las inyecciones con frecuencia producen efectos secundarios que, aunque no debilitantes, podrían causar síntomas como fiebre, dolores musculares o fatiga que podrían mantener a alguien en casa por uno o dos días.

“Queremos asegurarnos de que no todo el mundo reciba la vacuna el mismo día para que, si hay algunos efectos secundarios, no acabemos quedando cortos de personal”, dijo Sifri, de UVA Health, y señaló que las directrices exigen que no más del 25% de cualquier unidad se vacune a la vez.

En UVA Health, una vez que se distribuyan las 3,000 dosis iniciales, el hospital planea confiar en lo que Sifri describió como “un código de honor muy estricto” para permitir que los miembros del personal decidan qué lugar ocupar en la fila. Se les ha pedido que consideren factores profesionales, como el tipo de trabajo que realizan, así como riesgos personales: la edad o afecciones subyacentes como la diabetes.

“Vamos a pedirles a los miembros del equipo, utilizando el código de honor, que determinen cuál es su riesgo de COVID y si necesitan tener una cita temprana para la vacuna o una fecha posterior”, explicó.

Se elaboró este plan después que el personal de atención médica rechazara rotundamente otras opciones. Por ejemplo, pocos favorecieron una propuesta para asignar dosis a través de una lotería, como el caótico sistema basado en la fecha de cumpleaños de la película “Contagion”, sobre una horrible pandemia.

Funcionarios del hospital también enfatizaron que están tratando de diseñar planes de distribución que garanticen que las vacunas se asignen de manera equitativa entre los trabajadores de salud, incluidos los grupos sociales, raciales y étnicos que han sido perjudicados de manera desproporcionada por COVID-19. Eso requiere pensar más allá de los médicos y enfermeras de primera línea.

Por ejemplo, en UVA Health, uno de los primeros grupos invitados a vacunarse será el de 17 trabajadores cuya tarea es limpiar cuartos en la unidad de patógenos especiales donde se tratan los casos graves de COVID.

“Reconocemos que todo el mundo está en riesgo de contraer COVID, todo el mundo merece una vacuna”, dijo Sifri.

En muchos casos, quedará claro quién debe ir primero. Por ejemplo, aunque Dhanireddy es doctora especialista en enfermedades infecciosas que consulta sobre casos de COVID, está feliz de esperar. “No me pondría en el primer grupo en absoluto”, dijo. “Creo que tenemos que proteger a nuestro personal que realmente está ahí con ellos la mayor parte del día, y esa no soy yo”.

Para algunos trabajadores de salud, no ser el primero en la fila para la vacunación está bien. Debido a que la vacuna inicialmente fue autorizada solo para uso de emergencia, los hospitales no requerirán que los empleados sean vacunados como parte de esta primera ronda. Entre el 70% y el 75% del personal de atención médica de UVA Health e Intermountain Health aceptaría una vacuna COVID, mostraron encuestas internas. El resto no está seguro o no está dispuesto.

“Hay algunos que aceptarán de inmediato y otros querrán observar y esperar”, dijo Dascomb.

Aún así, autoridades del hospital dicen que confían en que aquellos que quieran la vacuna no tengan que esperar mucho. Dosis suficientes para aproximadamente 21 millones del personal de atención médica deberían estar disponibles a principios de enero, según funcionarios de los CDC.

Bell, el médico de cuidados intensivos, dijo que está agradecido de estar entre los primeros en recibir la vacuna, especialmente después que sus padres, que viven en Boston, contrajeran COVID-19. Publicó sobre su próxima cita en Twitter y dijo que otros trabajadores de salud que se encuentran entre los primeros en la fila deberían hacer público el proceso.

“Serviremos como ejemplo de que esta es una vacuna segura y eficaz”, dijo. “La estamos dejando entrar en nuestros cuerpos. Deberías dejar que entre en el tuyo también”.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Agrícolas, bomberos y azafatas buscan estar entre los primeros en recibir la vacuna

Se espera que los trabajadores de salud de primera línea, así como los residentes y el personal de los hogares de adultos mayores, reciban las dosis iniciales de la vacuna contra COVID. La cuestión más espinosa es averiguar quiénes serán los siguientes.

La respuesta probablemente dependerá de en dónde vivas.

Aunque una influyente junta asesora federal hará sus recomendaciones a finales de este mes, los departamentos de salud estatales y los gobernadores decidirán sobre quién tendrá acceso a un número limitado de vacunas este invierno.

Como resultado, las últimas semanas han sido tensas, ya que fabricantes, empleados en tiendas, cajeros de bancos, dentistas y compañías que proveen servicios de transporte se agolpan literalmente para estar lo más arriba posible en la lista.

El Comité Asesor sobre Prácticas de Inmunización (ACIP) de los Centros para el Control y Prevención de Enfermedades (CDC) votó 13 a 1, este mes, para dar prioridad de vacunación a los trabajadores de salud y a los residentes de centros de atención de largo plazo una vez que la Administración de Alimentos y Medicamentos (FDA) aprobara una o más vacunas COVID-19 para uso de emergencia.

Se espera que el comité asesor proporcione más detalles de su lista de receptores prioritarios antes de finales de año.

Es probable que sus próximas recomendaciones se centren en dar prioridad a las personas que hacen que la sociedad funcione, como los trabajadores de la alimentación y la agricultura, la seguridad pública y la educación. Las personas mayores y las que padecen enfermedades crónicas también se consideran prioritarias.

Pero debido a que los primeros suministros de vacunas son limitados, habrá que tomar decisiones difíciles. Por ejemplo: ¿Es más importante dar prioridad a los maestros que entran en contacto con muchas personas cada día, o a los trabajadores agrícolas que no pueden trabajar a distancia para proporcionar alimentos al país?

“Tenemos que ser conscientes de las cuestiones de equidad, de la comorbilidad y de la probabilidad de muerte o supervivencia, incluso entre estos trabajadores esenciales”, dijo Mitch Steiger, activista legislativo de la Federación del Trabajo de California. Surgirán “muchas conversaciones realmente duras y muchos principios que compiten entre sí”.

Al principio, los estados no conseguirán suficientes dosis de vacunas para cubrir incluso sus grupos de mayor riesgo.

En California, un estado de 40 millones de residentes, los envíos iniciales de alrededor de 1 millón de dosis se quedarán muy cortos para cubrir a quienes están en primera línea. Más de 2 millones de personas entran en la categoría de fase 1 de distribución de la vacuna, que cubre sólo a aquellos que corren el riesgo de enfermarse en un centro de atención médica o de cuidado de largo plazo.

Incluso dentro de esa categoría de trabajadores de salud, ha comenzado toda una carrera para situarse primeros en la lista, con farmacéuticos y dentistas abogando por ser prioridad.

La doctora Laurie Forlano, comisionada adjunta para la salud de la población en el Departamento de Salud de Virginia, dijo que el estado ha escuchado los intereses de muchos a través de cartas, llamadas telefónicas y reuniones virtuales antes de decidir cuáles “trabajadores críticos” seguirán al grupo inicial para ser vacunados. “Es complejo”, aseguró. “Pero no es nuevo para la salud pública tener que tomar este tipo decisiones”.

Los estados ya han señalado diferentes prioridades.

Ron DeSantis, gobernador de Florida, dijo que después de que se inoculen a los adultos mayores en hogares y los trabajadores sanitarios de primera línea, el estado intentará vacunar a las personas de 65 años o más y a los residentes con enfermedades importantes.

El gobernador de Kentucky, Andy Beshear, dijo que los maestros de escuelas primarias deberían ser los siguientes en la lista luego de los trabajadores de salud y adultos mayores en centros, junto a los miembros de la seguridad pública y los adultos con enfermedades significativas.

Pennsylvania incluirá a los “trabajadores esenciales” y a las personas con condiciones de alto riesgo en la parte superior de su lista de prioridades, junto con los trabajadores de salud, los residentes y el personal de las residencias de adultos mayores y los equipos de intervención inmediata, según Rachel Kostelac, vocera del departamento de salud estatal.

A nivel nacional, organizaciones de derechos de los pacientes señalan que las personas con algunas condiciones preexistentes corren un mayor riesgo de muerte si se infectan con el coronavirus. La Asociación Americana de Diabetes publicó un artículo de opinión en defensa de sus pacientes; la Asociación Nacional de Administradores Renales escribió a los reguladores federales diciendo que se debería dar prioridad a los enfermos del riñón.

El doctor Marcus Plescia, director médico de la Asociación de Funcionarios de Salud Estatales y Territoriales, dijo que espera que los estados sigan, en gran medida, la lista de prioridades del comité. Pero no está claro cuántos detalles proporcionará el comité de los CDC en su próxima ronda de recomendaciones, como por ejemplo qué “individuos de alto riesgo” y trabajadores críticos incluir.

Dejar algo de flexibilidad a los estados es bueno, indicó Plescia, porque pueden diferir en las formas de vacunar de manera eficiente. Por ejemplo, algunos estados pueden albergar grandes fábricas donde las personas están en mayor riesgo y podrían vacunarse en el lugar de trabajo.

Ahí es también donde el lobby o cabildeo entra en juego.

“La prioridad 1a para nosotros es conseguir que nuestros empleados entren en ese grupo de ‘prioridad 1b’”, comentó Bryan Zumwalt, vicepresidente ejecutivo de asuntos públicos de la Asociación de Marcas de Consumo, que representa a las empresas que fabrican miles de productos para el hogar, desde papel higiénico hasta gaseosas. De sus 2,3 millones de miembros, 1,7 millones se consideran trabajadores esenciales, añadió.

“Los trabajadores de nuestras empresas fabrican productos para que la vida siga”, explicó Zumwalt. La asociación ha enviado cartas a los departamentos de salud estatales, pero Zumwalt aclara que el proceso sería más fácil si hubiera un orden nacional uniforme para la vacuna, en lugar de dejar que los estados tengan la última palabra.

Estas compañías están lidiando con tasas de ausentismo laboral de un 10%, apuntó, lo que podría causar retrasos en la producción de alimentos y otros productos clave.

“Cuando un trabajador da positivo, entre cinco y diez trabajadores adicionales deben ser retirados de las líneas de producción”, señaló Zumwalt.

En Idaho, una junta asesora de COVID-19 decidió este mes que, después de los trabajadores de la salud y los residentes y el personal de las residencias de mayores, debían recibir las vacunas el personal de intervención inmediata, como policía y bomberos, así como los maestros y el personal no docente de las escuelas, seguidos por el personal de las instituciones correccionales, los trabajadores de la industria alimentaria, los trabajadores de los supermercados y la Guardia Nacional estatal.

La doctora Elizabeth Wakeman, catedrática de filosofía en el College of Idaho y miembro de la junta directiva, les había dicho a sus colegas que tenía más sentido vacunar para reducir la transmisión del virus en lugar de clasificar a los grupos según su valor para la sociedad.

Eso pondría a los trabajadores de la industria alimentaria por delante de los empleados de supermercados, porque hay más espacio para mantener la distancia y mejor ventilación en un mercado, opinó.

También hay presión para proteger de inmediato a los trabajadores de la alimentación y la agricultura. Diana Tellefson Torres, directora ejecutiva de la Fundación de Trabajadores Agrícolas Unidos, dijo que estos trabajadores son esenciales y están en riesgo inminente. Pueden trabajar al aire libre donde el riesgo de transmisión es menor, pero a menudo viven y viajan al trabajo con muchas personas que no viven con ellos, explicó.

La mayoría de los trabajadores agrícolas son inmigrantes indocumentados que carecen de seguro médico y “puede que ni siquiera sepan que padecen condiciones de salud subyacentes”, señaló Tellefson Torres, que forma parte del Comité Asesor de Vacunas de la Comunidad de California. “Hay mucha vulnerabilidad”.

Ya casi es temporada de cosechar los cítricos de invierno en California, y hay que recoger la lechuga en Arizona.

“Es importante que a la comunidad de personas que proporcionan alimentos a este país, los alimentos que llegan a nuestras mesas, también se les tenga en cuenta como una prioridad”, concluyó Tellefson Torres.

En la semana de apertura de la sesión legislativa de California, uno de los primeros proyectos de ley que se presentó argumentó que la mano de obra de suministro de alimentos debe ser la primera en la lista para las vacunas y las pruebas rápidas.

La Asociación Internacional de Bomberos, un sindicato que representa a 322,000 bomberos y personal médico de emergencia, presiona para incluir a sus miembros entre los primeros en tener acceso a la vacuna, argumentando que los bomberos proporcionan servicios médicos de emergencia que los llevan a los hogares de las personas y a otros espacios cerrados.

Los empleados de las aerolíneas también quieren ser vacunados rápidamente.

Y los farmacéuticos también han alzado su voz. Aunque el ACIP incluyó a los farmacéuticos en su categoría de trabajadores de la salud de Fase 1a, cada estado interpreta las recomendaciones de manera diferente en función de su suministro de vacunas, señaló Mitchel Rothholz, de la Asociación Americana de Farmacéuticos, que le reclama a los estados situar a sus miembros en la parte superior de la lista.

“Es una carrera por quién recibe la vacuna primero”, dijo. “Todo el mundo desea que haya suficiente suministro para todos desde el principio, pero esa no es la situación”.

Esta historia fue producida por KHN, que publica California Healthline, un servicio editorialmente independiente de la California Health Care Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Hospitals Scramble to Prioritize Which Workers Are First for COVID Shots


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If there’s such a thing as a date with destiny, it’s marked on Dr. Taison Bell’s calendar.

At noon Tuesday, Bell, a critical care physician, is scheduled to be one of the first health care workers at the University of Virginia Health System to roll up his sleeve for a shot to ward off the coronavirus.

“This is a long time coming,” said Bell, 37, who signed up via hospital email last week. “The story of this crisis is that each week feels like a year. This is really the first time that there’s genuine hope that we can turn the corner on this.”

For now, that hope is limited to a chosen few. Bell provides direct care to some of the sickest COVID-19 patients at the UVA Health hospital in Charlottesville, Virginia. But he is among some 12,000 “patient-facing” workers at his hospital who could be eligible for about 3,000 early doses of vaccine, said Dr. Costi Sifri, director of hospital epidemiology.

“We’re trying to come up with the highest-risk categories, those who really spend a significant amount of time taking care of patients,” Sifri said. “It doesn’t account for everybody.”

Even as the federal Food and Drug Administration engaged in intense deliberations ahead of Friday’s authorization of the Pfizer and BioNTech COVID vaccine, and days before the initial 6.4 million doses were to be released, hospitals across the country have been grappling with how to distribute the first scarce shots.

An advisory committee of the Centers for Disease Control and Prevention has recommended that top priority go to long-term care facilities and front-line health care workers, but the early allocation was always expected to fall far short of the need and require selective screening even among critical hospital workers.

Hospitals in general are advised to target the members of their workforce at highest risk, but the institutions are left on their own to decide exactly who that will be, Colin Milligan, a spokesperson for the American Hospital Association, said in an email.

“It is clear that the hospitals will not receive enough in the first weeks to vaccinate everyone on their staff, so decisions had to be made,” Milligan wrote.

At Intermountain Healthcare in Salt Lake City, the first shots will go to staff members “with the highest risk of contact with COVID-positive patients or their waste,” said Dr. Kristin Dascomb, medical director of infection prevention and employee health. Within that group, managers will determine which caregivers are first in line.

At UW Medicine in Seattle, which includes Harborview Medical Center, one early plan called for high-risk staff to be selected randomly to receive first doses, said Dr. Shireesha Dhanireddy, medical director of the infectious disease clinic. But the University of Washington hospital system expects to receive enough doses to vaccinate everyone in that high-risk tier within two weeks, so randomization isn’t necessary — for now.

“We are allowing people to schedule themselves,” Dhanireddy said, and encouraging staffers to be vaccinated near the end of their workweeks in case they have reactions to the new vaccine.

Trial results have shown the shots frequently produce side effects that, while not debilitating, could cause symptoms such as fever, muscle aches or fatigue that might keep someone home for a day or two.

“We want to make sure that not everybody has the vaccine on the same day so that if there are some side effects, we don’t end up being short-staffed,” said Sifri, of UVA Health, noting that guidelines call for no more than 25% of any unit to be vaccinated at once.

At UVA Health, once the initial 3,000 doses are distributed, the hospital plans to rely on what Sifri described as “a very strong honor code” to allow staff members to decide where they should be in line. They’ve been asked to consider professional factors, like the type of work they do, as well as personal risks, such as age or underlying conditions like diabetes.

“We’re going to ask team members, using the honor code, to determine what their risk is for COVID and to determine whether they need to have an early vaccine sign-up time or a later vaccine sign-up time,” he said.

That plan was chosen after health care staff members soundly rejected other options. For instance, few favored a proposal to allocate dosages via a lottery, like the chaotic birthday-based system depicted in the 2011 pandemic horror film “Contagion.” “That was the biggest loser,” he said.

Hospital officials also stressed they are trying to devise distribution plans that ensure vaccines are allocated equitably among health care workers, including the social, racial and ethnic groups that have been disproportionately harmed by COVID-19 infections. That requires thinking beyond front-line doctors and nurses.

At UVA Health, for example, one of the first groups invited to get shots will be 17 workers whose job is to clean rooms in the special pathogens unit where severe COVID cases are treated.

“We acknowledge that everybody is at risk for COVID, everybody is deserving of a vaccine,” Sifri said.

In many cases, it will be clear who should go first. For instance, although Dhanireddy is an infectious disease doctor who consults on COVID cases, she is happy to wait to be vaccinated. “I wouldn’t put myself in the first group at all,” she said. “I think that we need to protect our staff that are really right there with them most of the day — and that’s not me.”

But hospitals must remain vigilant about relying on workers to prioritize their own access, Dhanireddy cautioned. “Sometimes, self-selection works more for self-advocacy,” she said. “It’s great that some individuals say they would defer to others, but sometimes that’s not actually the case.”

For some health care workers, not being first in line for vaccination is fine. Because the vaccine initially has been authorized only for emergency use, hospitals won’t require employees to be inoculated as part of this first round. Between 70% and 75% of health care staff at UVA Health and Intermountain Health would accept a COVID vaccine, internal surveys showed. The rest are unsure — or unwilling.

“There are some that will be immediate acceptors and some who will want to watch and wait,” Dascomb said.

Still, hospital officials say they’re confident that those who want the vaccine won’t have to wait long. Enough doses for roughly 21 million health care personnel should be available by early January, according to CDC officials.

Bell, the critical care doctor, said he’s grateful to be among the first to receive the vaccine, especially after his parents, who live in Boston, both contracted COVID-19. He has posted about his upcoming appointment on Twitter and said he and other health care workers who are among the first in line should be public about the process.

“We’ll serve as an example that this is a safe and effective vaccine,” he said. “We’re letting it go into our bodies. You should let it go into yours, too.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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KHN on the Air This Week

KHN senior correspondent JoNel Aleccia discussed the demand for COVID-19 vaccines with Newsy’s “Morning Rush” on Thursday.

KHN Editor-in-Chief Elisabeth Rosenthal discussed COVID vaccine distribution and its potential hiccups with RNN TV’s “Richard French Live” on Tuesday. The exchange starts at about the three-minute mark.

California Gov. Gavin Newsom called out the health care reporting chops of California Healthline correspondent Angela Hart during a press conference on Monday.

KHN Colorado correspondent Rae Ellen Bichell discussed the shortage of nurses that has turned hospital staffing into a sort of national bidding war with KUNC’s “Colorado Edition” on Dec. 3.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Supply Is Limited and Distribution Uncertain as COVID Vaccine Rolls Out

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High stakes and big challenges await as the U.S. prepares to roll out vaccines against COVID-19, with front-line health care workers and vulnerable nursing home residents recommended as the top priority.

Doses could be on their way very soon. An independent advisory committee to the Food and Drug Administration on Thursday gave a green light to the first vaccine candidate, made by Pfizer in conjunction with the German company BioNTech — a recommendation expected to be approved by the agency within days. The committee is scheduled to consider a second candidate, made by Moderna, Dec. 17.

On tap is an initial stockpile of vaccines made during the approval process, with federal officials hoping to distribute at least 20 million doses by year’s end.

While that will go a long way toward reaching the top-priority groups — the nation’s 21 million health care workers and 3 million long-term care residents — there won’t be enough to inoculate everyone on Day One, or even the first week.

In Ohio, for example, the governor expects an initial delivery of 98,000 doses, with the state allocating 88,000 of those to long-term care facilities, said Pete Van Runkle, executive director of the Ohio Health Care Association, which represents long-term care facilities.

“It’s more than a drop in the bucket, but it’s not all that’s needed,” said Van Runkle, who estimated there are between 150,000 and 175,000 residents and staff members in long-term care centers in the state.

Consequently, the doses will be distributed in waves, with the centers and hospitals not chosen for the first wave getting them in the coming weeks, he said.

Facilities will have to divvy up the supplies to best address the needs of patients and employees.

For hospitals, first up are likely to be “workers with the greatest exposure” to the virus, said Anna Legreid Dopp, a senior director at the American Society of Health-System Pharmacists, a trade group representing more than 55,000 pharmacists who work for hospitals and health systems.

Then who? Perhaps those with personal medical conditions putting them at higher risk. And there may be other considerations specific to individual hospitals. What if, for example, only two people are trained to run a specialized treatment system in the ICU needed to care for patients seriously ill with COVID-19?

“Are they at the top of the list?” asked Dopp.

Nursing homes have a slightly different calculation because they have fewer employees than hospitals, said Van Runkle.

“It’s more a question of choosing which facilities” will get the initial doses, he said. “Once those are chosen, they’ll vaccinate everyone there [who consents], not pick and choose among people.”

Even so, there may be some selectivity because most nursing home employees are women and many are of child-bearing age. Because the vaccines have not yet been tested on pregnant women, those who are pregnant or breastfeeding may not be eligible in the initial rollout.

Which long-term care facilities get the vaccine first may come down to where they are located in relation to two large pharmacy chains: CVS and Walgreens.

In October, the federal government signed an agreement with CVS and Walgreens to store and administer the vaccines. Most long-term care facilities opted to join the partnership.

Under the agreement, the pharmacist teams will make at least three trips to each nursing home over a couple of months to administer the vaccines, which must be given in two doses, set several weeks apart.

One big hurdle in distributing the two vaccines seeking FDA approval is keeping them cold. The Pfizer vaccine is stored at around 94 degrees below zero, while the Moderna option is kept at minus 4 degrees. CVS expects to keep the vaccine at 1,100 locations around the country that have the required refrigeration technology, said Mike DeAngelis, senior director of corporate communications at CVS Health. From those hubs, teams of pharmacists and pharmacy technicians will take thawed doses of the vaccines to the long-term care facilities and administer them to staff and residents. About 30,000 homes have signed on with CVS for the clinics.

Walgreens expects to administer the vaccinations in more than 23,000 long-term care locations, according to a written statement.

While there’s no charge to the nursing homes or residents, Medicare will pay an administrative fee to CVS and Walgreens of $16.94 for the first shot and $28.39 for the second.

Yet there’s a flip side to the supply equation: What if no one wants to go first?

“That’s what keeps me up at night,” said Dr. Michael Wasserman, the immediate past president of the California Association of Long Term Care Medicine, a group of physicians, nurses, social workers and others who provide care to seniors.

That’s key because a good portion of America must be vaccinated to get to the much-sought-after “herd immunity,” in which most people are protected and the virus finds it difficult to spread.

“What if government and pharmacies do a great job in getting vaccine to the front door, then no one takes it?” Wasserman worries.

Nursing home residents are particularly vulnerable to COVID-19 and account for 40% of all reported deaths.

With COVID-positive test results on the rise in almost every state, vaccinating nursing home workers is crucial to protecting not only themselves, but also their patients.

That reality meets a reluctance among many front-line nursing home workers to take the vaccine, said Lori Porter, co-founder and CEO of the National Association of Health Care Assistants, which represents certified nursing assistants who work in long-term care.

Their distrust stems from many things, she said, including politicization around the vaccines, fueled by misinformation on social media.

Educational campaigns and personal endorsements from trusted organizations could help counter the falsehoods, she said. A nationwide event planned for next week by her organization will allow certified nursing assistants to ask questions directly of physician experts and hear from a panel of their peers.

“I’m asked 100 times a day if I’m going to be taking it,” said Porter, who definitely will, hoping to do so in a live webcast, to further convince her members it’s safe.

Despite the need to vaccinate staff to protect residents, Wasserman, a former regulator and nursing home executive, does not think mandates are appropriate for workers, many of whom are low-paid and people of color. “As a society, are we prepared to force this group of folks to get a brand-new vaccine?” he asked.

A better approach, he said, is the type of educational programs that Porter mentioned, so that workers can weigh the evidence and decide whether they want to get vaccinated.

Although employers may have the authority to mandate vaccination, many experts don’t think that policy will be widespread in the nursing home industry, given a shortage of workers and a fear of losing staffers who choose not to comply.

“I can tell you our members are not going to do that,” said Van Runkle, with the Ohio trade group. “If they were to try a mandate, some number of workers would say, ‘Sorry, this is the last straw. I’m leaving.’”

Instead of a mandate, Porter said, a few nursing homes are offering prizes or financial incentives — with at least one talking about offering a drawing for a new car among those who participate. Others, however, may take the opposite approach: ending supplemental hazard pay for workers who refuse.

As for residents, there is no debate. They will not get the vaccine unless they agree, often in writing, said Van Runkle.

For those with dementia or other health problems that prevent making such a decision, family members or others with legal authority must sign, which could slow down the vaccination process considerably.

“During a pandemic, it may be difficult to get hold of them or get their handwritten signature on a document,” said Van Runkle. “We’ve got to sort all this out in the next couple of weeks.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Farmworkers, Firefighters and Flight Attendants Jockey for Vaccine Priority

With front-line health workers and nursing home residents and staff expected to get the initial doses of COVID vaccines, the thornier question is figuring out who goes next.

The answer will likely depend on where you live.

While an influential federal advisory board is expected to make its recommendations later this month, state health departments and governors will make the call on who gets access to a limited number of vaccines this winter.

As a result, it’s been a free-for-all in recent weeks as manufacturers, grocers, bank tellers, dentists and drive-share companies all jostle to get a spot near the front of the line.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted 13 to 1 this month to give first vaccination priority to health care workers and residents of long-term care facilities once the Food and Drug Administration approves one or more COVID-19 vaccines for emergency use. The advisory committee is expected to provide further details of its list of prioritized recipients before year’s end.

Its next recommendations are likely to focus on prioritizing people who keep society functioning, like workers in food and agriculture, public safety and education. Older people and those with chronic diseases are also considered high on the list.

But because early supplies of vaccine are limited, tough choices lie ahead, such as: Is it more important to prioritize teachers who come into contact with many people each day, or farmworkers, who can’t work remotely and provide the country’s food?

“We have to be mindful of equity issues, comorbidities and the likelihood of death versus survival, even within these essential workers,” said Mitch Steiger, a legislative advocate for the California Labor Federation. There will be “a lot of really tough conversations and a lot of different competing principles.”

Initially, states won’t get enough vaccine doses to cover even their top-ranked groups.

In California, a state of 40 million residents, the initial shipments of around 1 million doses won’t come close to covering everyone at the front of the line. More than 2 million people fall into the Phase 1a category of vaccine distribution, which covers only those at risk of getting sick at a health care or long-term care setting.

Even within that health worker category, there’s jockeying to get to the front of the line, with pharmacists and dentists arguing for priority.

Dr. Laurie Forlano, deputy commissioner for population health at the Virginia Department of Health, said the state has been hearing from numerous parties via letters, phone calls and virtual meetings as it decides which “critical workers” will follow the initial bunch in getting vaccinated. “It is complex,” she said of the undertaking. “But it is not new for public health to make these decisions.”

States have already signaled different priorities.

Florida Gov. Ron DeSantis said that after nursing home residents and front line health workers are inoculated, the state will try to vaccinate people 65 and over and residents with significant illnesses.

Kentucky Gov. Andy Beshear said grade school teachers should be next in line after health care workers and nursing home residents, along with first responders and adults with significant illnesses.

Pennsylvania will include “critical workers” and people with high-risk conditions at the top of its priority list, along with health workers, nursing home residents and staff and first responders, according to state health department spokesperson Rachel Kostelac.

Nationally, disease advocacy groups point out that people with some preexisting conditions are at a greater risk of death if they become infected with the coronavirus. The American Diabetes Association published an opinion piece advocating for its patients; the National Renal Administrators Association wrote to federal regulators saying kidney patients should be prioritized.

Dr. Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials, said he expects states to largely follow the committee’s priority list. But it’s unclear how much detail the CDC committee will provide in its next round of recommendations — such as which “high-risk individuals” and critical workers to include.

Leaving some flexibility for states is good, Plescia said, because they may differ on ways to vaccinate people efficiently. For example, some states may be home to large factories where people are at higher risk and could get vaccinated on-site.

That’s also where lobbying comes into play.

“Priority 1a for us is getting our employees into that ‘priority 1b’ priority group,” said Bryan Zumwalt, executive vice president of public affairs for the Consumer Brands Association, which represents companies that make thousands of household products, from toilet paper to soda. Of the membership’s 2.3 million employees, 1.7 million are considered essential, he said.

“Workers at our companies are making life-sustaining products,” Zumwalt said. The association is reaching out with letters to state health departments, but Zumwalt said the process would be easier if there were a uniform national priority order for the vaccine, instead of letting states have final say.

These companies are dealing with absenteeism rates averaging 10%, he said, which could cause delays in producing food and other key products.

“When one worker tests positive, an additional five to 10 workers have to be taken off the production lines,” he said.

In Idaho, a COVID-19 advisory board decided this month that after health workers and nursing home residents and staff, first responders such as police and firefighters, and grade school teachers and staff should get the shots, followed by correctional facility staff, then food-processing workers, grocery workers and the Idaho National Guard.

Dr. Elizabeth Wakeman, an associate professor of philosophy at the College of Idaho, and a member of the board, had told her colleagues that it made more sense to vaccinate with the aim of slowing virus transmission rather than ranking groups on their value to society.

That would put food-processing workers ahead of grocery clerks, because there’s more room to maintain distance and better ventilation in a grocery store, Wakeman said.

There’s also pressure to quickly protect food service and farmworkers. Diana Tellefson Torres, executive director of the United Farm Workers Foundation, said farmworkers are both essential and deeply at risk. They may work outdoors where transmission risk is lower, but they often live and ride to work with many people outside their immediate families, she said.

Most farmworkers are undocumented immigrants who lack health insurance and “might not even know they have underlying health conditions,” said Tellefson Torres, who sits on California’s Community Vaccine Advisory Committee. “There’s a lot of vulnerability.”

It’s almost time for the winter citrus crops to be harvested in California, and the lettuce needs to be picked in Arizona.

“It’s important to ensure that the community of individuals who provide food for this country, the food at each one of our tables, is also taken into consideration as a top priority,” said Tellefson Torres.

In the opening week of California’s legislative session, one of the first pieces of legislation to be introduced argued that the food-supply workforce should be first in line for vaccines and rapid tests.

The International Association of Fire Fighters, a union representing 322,000 firefighters and emergency medical personnel, is pushing to include its members as among the first to get access to the vaccine, arguing that firefighters provide emergency medical services that bring them into people’s homes and other closed spaces.

Airline employees also want to be quickly vaccinated.

Pharmacists, too, have also been making their case. While the ACIP included pharmacists in its Phase 1a health worker category, each state interprets the recommendations differently based on its vaccine supply, noted Mitchel Rothholz, chief of governance and state affiliates for the American Pharmacists Association, which is urging states to keep its members atop the list. “It’s a race for who gets the vaccine first,” he said. “Everybody wishes there was enough supply for everyone right out of the gate, but that’s not the situation.”



This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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KHN’s ‘What the Health?’: Vaccines Coming Soon but COVID Relief Bill Still Stalled

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The first vaccine to protect against COVID-19 could be approved in the U.S. within days, but legislation to help fund its distribution remains mired in Congress.

And President-elect Joe Biden has tapped California Attorney General Xavier Becerra as his secretary of Health and Human Services. The choice of Becerra, who served 12 terms in the House of Representatives, is being criticized by Republicans for his support of single-payer health care.

This week’s panelists are Julie Rovner of Kaiser Health News, Joanne Kenen of Politico, Kimberly Leonard of Business Insider and Mary Ellen McIntire of CQ Roll Call.

Among the takeaways from this week’s podcast:

  • Despite indications that both Republican and Democratic lawmakers are eager to push out a new COVID relief bill, they are having trouble finding common ground on the issue of liability protections for employers whose workers or customers may get sick. And the party leaders, notably Senate Majority Leader Mitch McConnell, have not tipped their hands on whether they will go along with the effort.
  • Complicating the COVID relief bill talks is Congress’ inability thus far to come to terms on a spending bill for the government for the fiscal year that began Oct. 1.
  • Some of the delay in getting deals on spending and COVID relief is linked to the uncertainty over which party will control the Senate after the January special elections in Georgia, which will determine two Senate seats. Although many observers expect the Republicans to win at least one, if not both, of those races, McConnell can’t be sure. He likely aims to use what political muscle he has now with the majority and an ally in the White House to get deals favorable to his causes.
  • Despite the grumbling by some Republican senators over Becerra’s nomination, it is still too early to suggest that he won’t win approval. The outcome may also depend on whether McConnell remains majority leader and whether Republicans determine that this is a nomination they want to take a stand on — or whether they save the gunpowder for another nominee.
  • Dr. Vivek Murthy, chosen by Biden to be the next surgeon general, is likely to have a broader portfolio than that office typically has because of his strong relationship with Biden.
  • An advisory committee for the Food and Drug Administration is meeting to consider an application for Pfizer’s COVID vaccine. If the request is approved, consumers should still anticipate there could be glitches in distribution and some unforeseen issues with the vaccine, such as the side effects noted in Britain this week in people with strong allergies. Nevertheless, this vaccine and others can be expected to make significant progress in the battle against the coronavirus. 
  • The clinical trials for the COVID vaccine have shown it reduces the severity of the disease, but it’s not clear whether the vaccine will stop disease transmission.

Also this week, Rovner interviews Michael Mackert, director of the Center for Health Communication at the University of Texas-Austin and a professor both at the Dell Medical School and the Stan Richards School of Advertising and Public Relations.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read, too:

Julie Rovner: Politico’s “How Biden Aims to Covid-Proof His Administration,” by Alice Miranda Ollstein and Daniel Lippman

Kimberly Leonard: Business Insider’s “Here’s How the GSA Plans to Disinfect the White House Between Trump’s Departure and Biden’s Arrival,” by Robin Bravender and Kimberly Leonard

Mary Ellen McIntire: The Atlantic’s “The Danger of Assuming That Family Time Is Dispensable,” by Julia Marcus

Joanne Kenen: The New Yorker’s “How Will We Tell the Story of the Coronavirus?” by Andrew Dickson

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcherGoogle PlaySpotify, or Pocket Casts.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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New National and State Estimates for Recommended COVID-19 Vaccination Priority Population

This month the Centers for Disease Control and Prevention (CDC) adopted a recommendation that health care workers and long-term care residents should be the first to receive the COVID-19 vaccine once it is authorized or approved by the FDA. A new KFF analysis estimates there are 15.5 million people working in health care settings whoMore

What Seniors Can Expect When COVID Vaccines Begin to Roll Out

Vaccines that protect against COVID-19 are on the way. What should older adults expect?

The first candidates, from Pfizer and Moderna, could arrive before Christmas, according to Alex Azar, who heads the Department of Health and Human Services.

Both vaccines are notably effective in preventing illness due to the coronavirus, according to information released by the companies, although much of the data from clinical trials is still to come. Both have been tested in adults age 65 and older, who mounted a strong immune response.

Seniors in nursing homes and assisted living centers will be among the first Americans vaccinated, following recommendations last week by a federal advisory panel. Older adults living at home will need to wait a while longer.

Many uncertainties remain. Among them: What side effects can older adults anticipate and how often will these occur? Will the vaccines offer meaningful protection to seniors who are frail or have multiple chronic illnesses?

Here’s a look at what’s known, what’s not and what lies ahead.

Decision-making timetable. Pfizer’s vaccine will be evaluated by a 15-member Food and Drug Administration advisory panel on Thursday. Moderna’s vaccine is expected to go before the panel Dec. 17.

At least two days before each meeting, an analysis by FDA staff will be made public. This will be the first opportunity to see extensive data about the vaccines’ performance in large phase 3 clinical trials, including more details about their impact on older adults.

So far, summary results disclosed in news releases indicate that Pfizer’s vaccine, produced in partnership with BioNTech, has an overall efficacy rate of 95% and efficacy of 94% in people 65 and older. Moderna’s overall efficacy is 94%, with 87% efficacy in preventing moderate disease in older adults, according to Moncef Slaoui, chief science adviser to Operation Warp Speed, the government’s COVID-19 vaccine development program.

If the advisory panel gives a green light, the FDA will decide within days or weeks whether to authorize the Pfizer and Moderna vaccines for emergency use. Distribution of the vaccine has already begun, and health care providers are expected to begin administering it immediately after the FDA acts.

Allocation framework. At a Dec. 1 meeting of the Advisory Commission on Immunization Practices (ACIP), which guides the Centers for Disease Control and Prevention on vaccines, experts recommended that people living in long-term care (primarily nursing homes and assisted living facilities) and health care workers be the first groups to get COVID-19 vaccines.

This recognizes the extraordinary burden of COVID-19 in long-term care facilities. Although their residents represent fewer than 1% of the U.S. population, they account for 40% of COVID deaths — more than 100,000 deaths to date.

The commission’s decision comes despite a lack of evidence that Pfizer’s and Moderna’s vaccines are effective and safe for frail, vulnerable seniors in long-term care. Vaccines were not tested in this population. Federal officials insist side effects will be carefully monitored.

Next in line likely would be essential workers who cannot work from home, such as police, firefighters, teachers and people employed in food processing and transportation, according to commission deliberations Nov. 23 that have not come to a formal vote.

Then would be adults with high-risk medical conditions such as diabetes, cancer, kidney disease, obesity, heart disease and autoimmune diseases and all adults age 65 and older.

Although states typically follow ACIP guidelines, some states may choose, for instance, to vaccinate high-risk older adults before some categories of essential workers.

Left off the list are family caregivers, who provide essential support to vulnerable older adults living in the community — an unpaid workforce of tens of millions of people. “If someone is providing day-to-day care, it makes sense they should have access to the vaccine, too, to keep everyone safe,” said Beth Kallmyer, vice president of care and support for the Alzheimer’s Association.

Further prioritization. The priority groups constitute nearly half of the U.S. population — 21 million health care workers, 3 million long-term care residents, 66 million essential workers, more than 100 million adults with high-risk conditions and 53 million adults age 65 and older.

With initial supplies of vaccines limited, setting priorities will be inevitable. Practically, this means that hospitals and physicians may try to identify older adults who are at the highest risk of becoming seriously ill from COVID-19 and offer them vaccines before other seniors.

A study of more than 500,000 Medicare beneficiaries age 65 and older provides new evidence that could influence these assessments. It found the conditions that most increase older adults’ chances of dying from COVID-19 are sickle cell disease, chronic kidney disease, leukemias and lymphomas, heart failure, diabetes, cerebral palsy, obesity, lung cancer and heart attacks, in that order.

“Out of all Medicare beneficiaries, we identified just under 2,500 who had no medical problems and died of COVID-19,” said Dr. Martin Makary, co-author of the study and a professor of health policy and management at Johns Hopkins Bloomberg School of Public Health in Baltimore. “We knew risk was skewed toward comorbidity [multiple underlying medical conditions], but we didn’t realize it skewed this much.”

Supplies available. Both the Pfizer and Moderna vaccines require two doses, administered three to four weeks apart. The companies have said about 40 million doses of their vaccines should be available this year, enough to fully vaccinate about 20 million people.

After that, 50 million doses might become available in January, followed by 60 million doses in both February and March, according to Dr. Larry Corey, a virologist who heads the COVID-19 Prevention Trials Network.

That translates into enough vaccine for another 85 million people and should be sufficient to vaccinate older adults in addition to medical personnel on the front lines and many other at-risk individuals, Corey suggested at a recent panel on COVID-19 sponsored by the National Academy of Medicine and American Public Health Association.

He acknowledged these were estimates, based on information he has been given. Pfizer and Moderna have not yet specified how much vaccine will be delivered and when. Nor is it clear when other vaccines under investigation will become available — 13 are in phase 3 clinical trials — or what their monthly production capacity might be.

Distribution issues. As Pfizer’s and Moderna’s vaccines are rolled out, a very vulnerable group may have difficulty getting them: 2 million seniors who are homebound and another 5.3 million with physical impairments who have problems getting around.

The reason: handling and cold storage requirements.

Pfizer’s vaccine needs to be stored at minus 70 degrees Celsius, calling for special equipment not available in small hospitals, clinics or doctors’ offices. Moderna’s vaccine needs long-term storage at minus 20 degrees Celsius.

Landmark Health provides in-home medical care to more than 120,000 frail, chronically ill homebound seniors in 15 states. “We don’t have the capabilities to store and distribute these vaccines to our population,” said Dr. Michael Le, the company’s co-founder and chief medical officer.

Instead, he said, Landmark is working to arrange transportation for its patients to centers where COVID-19 vaccines will be administered and educating them about the benefits of the vaccines. “Given the trust, the bond we have with our patients, we can play a big role as advocates,” Le said.

Addressing mistrust. Advocates have a big job ahead of them. According to a recent poll from the University of Michigan, only 58% of older adults (ages 50 to 80) said they were very or somewhat likely to get a COVID-19 vaccine. A significant number of older adults, 46%, thought they’d get the vaccine eventually but wanted others to go first. Only 20% wanted to get it as soon as possible.

Most important in making decisions is knowing how well the vaccine works, according to 80% of the 1,556 older adults surveyed. Just over half (52%) said a recommendation from their doctor would be influential.

Dr. Sharon Inouye, a geriatrician at Hebrew Senior Life in Boston and a professor of medicine at Harvard Medical School, is among the physicians impatiently awaiting the publication of data from Pfizer’s and Moderna’s phase 3 clinical trials.

Among the things she wants to know: How many older adults with chronic health conditions participated? How many participants were 75 and older? Did side effects differ for older adults?

“What I worry about most is the side effects,” she said. “We may not be able to know about serious but rare side effects until millions of people take them.”

But that’s a gamble she’s willing to take. Not only will Inouye get a vaccine, she just told her 91-year-old mother, who lives in assisted living, to say “yes” when one is offered.

“My whole family lives in fear that something will happen to her every day,” Inouye said. “Even though there’s a lot we still don’t know about these vaccines, it’s compelling that we protect people from this overwhelming illness.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Leaders in the Life Sciences Speak about the Pandemic

We are in a global pandemic that is exposing major issues in the commercial environment in which healthcare companies operate, with changes that are completely altering the landscape for the long term. Our 3rd Annual Leaders in Life Sciences Roundtable consisted of eight industry leaders with diverse perspectives and experiences discussing these changes, their impacts, and best practices learned […]

The post Leaders in the Life Sciences Speak about the Pandemic appeared first on PharmaVOICE.

December 11 Web Briefing: Racism and Discrimination in Health Care – Experiences Today and Actions to Address Going Forward

Approaching the end of 2020, two of the most pressing concerns facing the country are the long-standing issue of racial discrimination and the ongoing coronavirus pandemic. The issues have merged with the pandemic taking a disproportionate health and economic toll on people of color. As vaccines become available, prioritizing racial equity will become increasingly importantMore

Demand for COVID Vaccines Expected to Get Heated — And Fast

Americans have made no secret of their skepticism of COVID-19 vaccines this year, with fears of political interference and a “warp speed” timeline blunting confidence in the shots. As recently as September, nearly half of U.S. adults said they didn’t intend to be inoculated.

But with two promising vaccines primed for release, likely within weeks, experts in ethics and immunization behavior say they expect attitudes to shift quickly from widespread hesitancy to urgent, even heated demand.

“People talk about the anti-vaccine people being able to kind of squelch uptake. I don’t see that happening,” Dr. Paul Offit, a vaccinologist with Children’s Hospital of Philadelphia, told viewers of a recent JAMA Network webinar. “This, to me, is more like the Beanie Baby phenomenon. The attractiveness of a limited edition.”

Reports that vaccines produced by drugmakers Pfizer and BioNTech and Moderna appear to be safe and effective, along with the deliberate emphasis on science-based guidance from the incoming Biden administration, are likely to reverse uncertainty in a big way, said Arthur Caplan, director of the division of medical ethics at New York University School of Medicine.

“I think that’s going to flip the trust issue,” he said.

The shift is already apparent. A new poll by the Pew Research Center found that by the end of November 60% of Americans said they would get a vaccine for the coronavirus. This month, even as a federal advisory group met to hash out guidelines for vaccine distribution, a long list of advocacy groups — from those representing home-based health workers and community health centers to patients with kidney disease — were lobbying state and federal officials in hopes their constituents would be prioritized for the first scarce doses.

“As we get closer to the vaccine being a reality, there’s a lot of jockeying, to be sure,” said Katie Smith Sloan, chief executive of LeadingAge, a nonprofit organization pushing for staff and patients at long-term care centers to be included in the highest-priority category.

Certainly, some consumers remain wary, said Rupali Limaye, a social and behavioral health scientist at the Johns Hopkins Bloomberg School of Public Health. Fears that drugmakers and regulators might cut corners to speed a vaccine linger, even as details of the trials become public and the review process is made more transparent. Some health care workers, who are at the front of the line for the shots, are not eager to go first.

“There will be people who will say, ‘I will wait a little bit more for safety data,” Limaye said.

But those doubts likely will recede once the vaccines are approved for use and begin to circulate broadly, said Offit, who sits on the FDA advisory panel set to review the requests for emergency authorization Pfizer and Moderna have submitted.

He predicted demand for the COVID vaccines could rival the clamor that occurred in 2004, when production problems caused a severe shortage of flu shots just as influenza season began. That led to long lines, rationed doses and ethical debates over distribution.

“That was a highly desired vaccine,” Offit said. “I think in many ways that might happen here.”

Initially, vaccine supplies will be tight, with federal officials planning to ship 6.4 million doses within 24 hours of FDA authorization and up to 40 million doses by the end of the year. The CDC panel recommended that the first shots go to the 21 million health care workers in the U.S. and 3 million nursing home staff and residents, before being rolled out to other groups based on a hierarchy of risk factors.

Even before any vaccine is available, some people are trying to boost their chances of access, said Dr. Allison Kempe, a professor of pediatrics at the University of Colorado School of Medicine and expert in vaccine dissemination. “People have called me and said, ‘How can I get the vaccine?’” she said. “I think that not everyone will be happy to wait, that’s for sure. I don’t think there will be rioting in the streets, but there may be pressure brought to bear.”

That likely will include emotional debates over how, when and to whom next doses should be distributed, said Caplan. Under the CDC recommendations, vulnerable groups next in line include 87 million workers whose jobs are deemed “essential” — a broad and ill-defined category — as well as 53 million adults age 65 and older.

“We’re going to have some fights about high-risk groups,” said Caplan of NYU.

The conversations will be complicated. Should prisoners, who have little control over their COVID exposure, get vaccine priority? How about professional sports teams, whose performance could bolster society’s overall morale? And what about residents of facilities providing care for people with intellectual and developmental disabilities, who are three times more likely to die from COVID-19 than the general population?

Control over vaccination allocation rests with the states, so that’s where the biggest conflicts will occur, Caplan said. “It’s a short fight, I hope, in the sense in which it gets done in a few months, but I think it will be pretty vocal.”

Once vaccine supplies become more plentiful, perhaps by May or June, another consideration is sure to boost demand: requirements for proof of COVID vaccination for work and travel.

“It’s inevitable that you’re going to see immunity passports or that you’re required to show a certificate on the train, airplane, bus or subway,” Caplan predicted. “Probably also to enter certain hospitals, probably to enter certain restaurants and government facilities.”

But with a grueling winter surge ahead, and new predictions that COVID-19 will fell as many as 450,000 Americans by February, the tragic reality of the disease will no doubt fuel ample demand for vaccination.

“People now know someone who has gotten COVID, who has been hospitalized or has unfortunately died,” Limaye said.

“We’re all seeing this now,” said Kempe. “Even deniers are beginning to see what this illness can do.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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KHN on the Air This Week

KHN correspondent Aneri Pattani discussed how Black faith communities provide support in the face of racial unrest and COVID-19 with Newsy on Thursday.

KHN chief Washington correspondent Julie Rovner discussed President-elect Joe Biden’s plans for health policy and pandemic response with WBUR’s “Here & Now” on Monday. She also discussed the rollout of COVID vaccines with WDET’s “Detroit Today” on Tuesday.

KHN Colorado correspondent Rae Ellen Bichell discussed COVID-19 contact tracing apps with KUNC’s “Colorado Edition” on Nov. 25.

KHN reporter Victoria Knight discussed COVID risks and holiday travel with Newsy on Nov. 24.

KHN senior Colorado correspondent Markian Hawryluk discussed face masks with Colorado Public Radio’s “Colorado Matters” on Nov. 24.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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KHN’s ‘What the Health?’: Who Will Run the Biden Health Effort?

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The quadrennial guessing game about who will get what health job in a new presidential administration has taken on a new urgency in 2020 as the COVID-19 pandemic continues to rage.

Meanwhile, as two promising vaccine candidates inch closer to approval, the federal government is gearing up for the immense effort of delivering two shots to as many Americans as they can.

This week’s panelists are Julie Rovner of Kaiser Health News, Margot Sanger-Katz of The New York Times, Alice Miranda Ollstein of Politico and Paige Winfield Cunningham of The Washington Post.

Among the takeaways from this week’s podcast:

  • After naming his national security and economic teams, President-elect Joe Biden is expected to focus next on his health care officials. Those names likely will be unveiled by next week. But even without a full list of appointees, it’s clear Biden will have strong health experience in the White House with his choice of Ron Klain as chief of staff and Neera Tanden to head the Office of Management and Budget. Klain was the Ebola response coordinator for President Barack Obama, and Tanden worked on the Affordable Care Act negotiations.
  • The departure of Dr. Scott Atlas from the list of President Donald Trump’s key advisers does not mean his influence is over. His advocacy for policies that opened the economy — even if they caused wider spread of the coronavirus — and an acceptance of attempting to achieve herd immunity by letting the virus spread have gained traction in some states and among conservatives.
  • Democratic House and Senate leaders endorsed efforts by a bipartisan group of lawmakers for a $900 billion COVID relief bill. But Senate Majority Leader Mitch McConnell has not yet said he will sign on to the effort, nor has Trump.
  • Public health officials are concerned that many people will be hesitant to get a coronavirus vaccine, if one is approved by the Food and Drug Administration, because the effort has been so politicized. Trump’s hard press to get the vaccine out before the election alarmed some consumers, who fear that the usual careful procedures were rushed. But if approved, a vaccine would be highly touted by health officials and celebrities.
  • What’s not known about the rollout of the vaccine is whether private companies and schools will make inoculation mandatory for workers and children.
  • Among the news items that may have been overlooked during Thanksgiving celebrations, Canada announced it would bar the exports of drugs to the U.S. if it would cause shortages there. Trump and some states, including Florida, have been pushing for importation programs to help lower drug costs in the U.S.
  • Also last week, the 5th Circuit Court of Appeals agreed that Texas could remove Planned Parenthood from its list of Medicaid providers and said that patients in the federal-state health program do not have a right to challenge state decisions on which providers are accepted into the program. The decision is likely headed to the Supreme Court.

Also this week, Rovner interviews KHN’s Julie Appleby, who wrote the latest KHN-NPR “Bill of the Month” feature — about a boy, a bicycle accident and a really big bill. If you have an outrageous medical bill you’d like to share with us, you can do that here.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read too:

Julie Rovner: ProPublica’s “States With Few Coronavirus Restrictions Are Spreading the Virus Beyond Their Borders,” by David Armstrong

Margot Sanger-Katz: Science Magazine’s “Public Needs to Prep for Vaccine Side Effects,” by Meredith Wadman

Paige Winfield Cunningham: Politico’s “Biden’s Chief of Staff Has Battled Pandemics Before. Here’s How He Plans to Beat This One,” by Alice Miranda Ollstein

Alice Miranda Ollstein: The New York Times’ “Prisons Are Covid-19 Hotbeds. When Should Inmates Get the Vaccine?” by Roni Caryn Rabin

To hear all our podcasts, click here.

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Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Come for Your Eye Exam, Leave With a Band-Aid on Your Arm

With multiple COVID-19 vaccines rapidly heading toward approval, optometrists and dentists are pushing for the authority to immunize patients during routine eye exams and dental cleanings.

Across the country, these medical professionals say their help will be needed to distribute the vaccines to millions of Americans — and they already have the know-how.

“When you look at what dentists do, and how many injections they give day in and day out, I think they’re more than qualified,” said Jim Wood, a California state assembly member and dentist. “It’s kind of a no-brainer.”

In California, the professional organizations representing dentists and optometrists are in talks with state officials to expand their job descriptions to include administering vaccines. Oregon has already begun training and certifying dentists to give vaccines. And at least half the states have considered allowing dentists to administer COVID vaccines once they’re available, according to the American Association of Dental Boards.

That list is likely to grow, because the U.S. Centers for Medicare & Medicaid Services recommended in October that states consider expanding their list of vaccine providers.

The dentists and optometrists seeking permission to vaccinate patients against COVID-19 and other diseases argue that their help will take some of the pressure off hospitals and doctors’ offices. It could also bring some extra money into their practices.

“Everyone in our specialized health care system should also play a preventive role,” said Dr. William Sage, a professor of law and medicine at the University of Texas-Austin. “Pandemic or not, being alert to preventive health in any setting is a good thing.”

In November, Pfizer, Moderna and AstraZeneca announced that their COVID vaccine candidates delivered promising results in clinical trials, and that millions of doses could be ready before the end of the year. Pfizer’s has to be stored at ultracold temperatures, while Moderna’s and AstraZeneca’s can be kept at standard refrigerator temperatures.

This wouldn’t be the first time health professionals other than doctors administered vaccines during a pandemic. Nursing students, EMTs and midwives in a handful of states were granted temporary and limited authority to administer flu vaccines during the H1N1 swine flu pandemic of 2009-10. Dentists in Massachusetts, Illinois, New York and Minnesota also were temporarily deputized as vaccinators.

Since then, Minnesota and Illinois have adopted laws to allow dentists to give flu shots to adults. And last year, Oregon became the first state to allow dentists to give any vaccine to any patient, whether a child or an adult.

So far, more than 200 dentists and dental students in Oregon have completed the training course offered by the Oregon Health & Science University’s School of Dentistry, with 60 others expected to finish by the end of December, said Mary Pat Califano, an instructor who helped develop the hands-on part of the training.

Students spend around 10 hours in online classes. They then undergo hands-on training during which they practice injections on a shoulder pad before practicing injecting a partner with saline. They’re taught how to counsel patients about vaccines and avoid injuring patients’ shoulders when giving the shots.

Once dentists pass an exam, they can register with the Oregon Health Authority and begin getting their staff trained to handle vaccines and procuring a fridge to store them.

The goal, Califano said, is not to replace family doctors or primary care physicians, but to supplement them. The federal Agency for Health Research and Quality found that, in 2017, 31.1 million Americans saw a dentist but not a physician.

“We just need as many people as possible to give flu shots and COVID-19 vaccines when they’re available,” Califano said. “If it happens that they’re in a dental office, and that provider is educated and capable of giving a vaccine, why not?”

In California, the state dental association is exploring options for gaining vaccine authority, which would likely require the legislature to step in. This year, California passed a law allowing pharmacists to administer COVID vaccines approved by the U.S. Food and Drug Administration.

Wood, who carried that measure, hasn’t yet committed to sponsoring a bill that would let dentists give vaccines, but says he supports the idea.

“We give injections in the mouth all day long, and these are very precise kinds of injections,” Wood said. “I think the learning curve for a dentist would be small.”

Dr. Bill Schaffner, a professor of preventive medicine and infectious disease at Vanderbilt University, said these proposals for expanding the vaccine workforce are promising. Flu vaccines, which are relatively low-risk and simple to administer, would be the perfect candidate to stock in dental and optometric fridges to start.

But Schaffner doesn’t believe dentists and optometrists will play a major role in the COVID immunization effort. It would take too long to pass legislation to expand the scope of practice for every professional who wants it in every state, he said. And since some COVID vaccines have specific shipping and subzero storing requirements, they will probably be distributed only to specially trained personnel at a small number of locations, he said.

There’s also the question of payment. It’s hard — but not impossible — to make a profit administering vaccines, Schaffner said.

Providers have to decide each season how many doses to buy, and any that go bad or remain in the fridge at the end of their shelf life equal monetary losses.

“Unless you’re very assiduous about moving the vaccine from the fridge into arms, you’re not going to make money,” Schaffner said. “People who do that can augment their income, but nobody is going to drive a Porsche because of vaccines.”

Jeff McCombs, an associate professor of health economics at the University of Southern California School of Pharmacy, agreed it might not make business sense for most dentists to start vaccinating. He said it would be hard to keep a well-stocked vaccine fridge with enough variety to meet patients’ needs without wasting doses. Generally, adults who choose not to get vaccinated do so because they’re uneducated about vaccines or afraid, he said, not because they can’t access them.

“I don’t think it’s going to harm people,” McCombs said. “I just don’t think they’ll make any money at it.”

While the California Department of Public Health said the state’s current vaccine infrastructure is sufficient for flu shots and routine immunizations, it is “carefully considering the need to include additional types of immunizers” to get Californians vaccinated against COVID-19, according to a statement from the department.

The California Optometric Association said it is in talks with Gov. Gavin Newsom’s vaccine task force about how to get optometrists into the mix, and is exploring legislative options as well.

“We can serve the dual role of assisting with vision needs and protecting from COVID,” said David Ardaya, an optometrist in Whittier who chairs an association committee that is looking into the issue. “Our whole hope is to assist our nation in regaining its health and in returning to a sense of normal.”

But three years after AB-443 was signed, the regulations implementing it have yet to be finalized.

That didn’t stop Frank Giardina, an optometrist in Nipomo, from going through a certification program anyway.

The 20-hour course, which includes online lectures, hands-on lessons and an exam, is the same course pharmacists take when learning how to give all vaccines to people of all ages.

Giardina pointed to the shingles, or herpes zoster, virus as an example of why optometrists are well suited to give vaccines. The virus can infect the eyes, and even though he’s allowed to treat shingles, he can’t give a vaccine to prevent it.

For now, he’s holding out hope he will get permission to administer vaccines, including for COVID-19. He envisions a world in which a patient comes in for contact lenses and he can offer them a flu or COVID vaccine while they’re there.

“We’re another member of the health care team. It’s a waste of manpower not to,” Giardina said. “If you’re trying to vaccinate all these people, especially in rural areas, you need whoever you can find.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Feds Look to Pharmacists to Boost Childhood Immunization Rates

Torey Watson is trained as a pharmacist but aims to do more than simply fill prescriptions.

Pharmax Pharmacy — a small drugstore chain where Watson works as a clinical services coordinator, about an hour and 30 minutes southwest of St. Louis — will soon allow him to offer childhood vaccines to patients without a doctor’s prescription. This change came after the federal government expanded pharmacists’ ability to administer routine immunizations to children as young as 3.

As a father of two young boys, Watson, 30, understands how difficult it can be to give a child a shot. Many pharmacists are accustomed to administering vaccines to adults, he said. Doing the same for children requires extra skill.

“We’re going to have parents asking questions,” he said. His other thought: “Holy cow, I don’t think I can give a shot to a 3-year-old.”

Federal officials are banking on pharmacists like Watson to undergo additional training and help reverse the slump in child immunization rates caused by the coronavirus pandemic. Fears over COVID-19 have led parents to avoid the doctor’s office and pediatricians to curtail in-person care. As a result, many children are missing routine vaccinations.

Children who fall behind on vaccinations usually don’t pose a health risk if kids around them are immunized, said Dr. Sean O’Leary, vice chair of the American Academy of Pediatrics committee for infectious diseases. However, large groups of children are now behind, and highly contagious vaccine-preventable diseases circulating in other parts of the world are only a plane ride away, he said.

“That’s a big deal,” he said in an email.

In August, the Department of Health and Human Services took steps to override restrictions in many states that kept state-licensed pharmacists from immunizing children.

“Today’s action means easier access to lifesaving vaccines for our children, as we seek to ensure immunization rates remain high during the COVID-19 pandemic,” HHS Secretary Alex Azar said in announcing the policy change.

However, challenges remain in getting pharmacists fully integrated into the nation’s framework of childhood vaccinations, immunization experts said.

A key issue is that few pharmacists participate in the Vaccines for Children program, a federal initiative that purchases vaccines for the nation’s neediest kids. Half of children in the U.S. receive immunizations through the program, which purchases government-recommended vaccines for kids ages 0 to 18 who are low-income, uninsured or belong to an indigenous group. Compared with last year, VFC-funded orders for vaccines overall are down 9.6 million doses as of Nov. 9, said a spokesperson from the Centers for Disease Control and Prevention. Measles-containing vaccines are down an estimated 1.3 million doses.

Weekly orders of non-flu vaccines and measles-containing vaccines have begun to rebound to levels seen last year, though the volume could again be affected if current COVID surges have a chilling effect on doctors’ visits.

Without solving the issues that keep pharmacists from participating in the Vaccines for Children program, said Claire Hannan, executive director of the Association of Immunization Managers, the steps to give parents more access to immunizations through drugstores may ultimately help only Americans wealthy enough to use it.

“Yes, we have a situation with the pandemic that has caused a drop in routine vaccinations,” Hannan said. “But I don’t want to see us go to a solution that is only serving those who can pay.”

Drugstores serve as a convenient access point. Nearly 90% of Americans in 2018 lived within 5 miles of a community pharmacy. In contrast, about 5% of rural counties in 2019 had no family physicians, according to a report from researchers at the University of Washington. Thirty-five percent of rural counties had no pediatricians. Additionally, KFF found over 51% of children in 2017 did not have a medical home, meaning they do not have a primary care doctor that manages their care. (KHN is an editorially independent program of KFF.)

“We need our pharmacists to be vaccinators” in order to catch children up on their immunizations, said L.J Tan, chief strategy officer at the Immunization Action Coalition, a national organization of physicians and health experts focused on vaccine education.

Congress established the Vaccines for Children program to remedy the immunization disparities uncovered by a measles epidemic in the early 1990s that killed hundreds of people. While doctors jumped on board, pharmacist engagement lags far behind.

This pattern continues. As of Oct. 6, out of nearly 38,000 participating providers, a CDC spokesperson said, about two-thirds work in private practices. Seventy-one are pharmacies.

Stephanie Wasserman, executive director of Immunize Colorado, an Aurora-based nonprofit organization, said boosting the number of pharmacists in VFC will be “a really critical piece” to the success of the federal authorization. However, “just because they can participate doesn’t mean they necessarily will jump on it” unless pharmacists think the program is well-supported and will help their business, she said.

Enrollees must adhere to strict storage and handling requirements that involve expensive thermometers and refrigerators used only for products delivered under the government program. And if there isn’t enough demand, said vaccine experts, the investment may not be worth it.

For rural pharmacies, said Michaela Newell, president of the Community Pharmacy Enhanced Services Network of Missouri, the cost of paying for the equipment and personnel needed to handle the administrative work may price them out before they apply.

“I guess it hasn’t been worth the squeeze,” said Hannan.

Added Newell: “I just think that the barriers right now are too high for the pharmacists to enter into it.”

On the flip side, state administrators have trouble keeping up with the demands of the program, too. One study from 2019 showed limited success in getting Michigan pharmacies to administer the human papillomavirus vaccine through the Vaccines for Children program because the state’s health department didn’t have the personnel to conduct on-site inspections.

The strain on state resources has only grown worse during the pandemic, said Hannan.

“You can’t call them out for not having the bandwidth,” said Rebecca Snead, executive vice president and chief executive officer of the National Alliance of State Pharmacy Associations. “They’ve been compromised.”

Payment also poses a challenge to recruit and maintain providers in the program, immunization experts said.

Medicaid, the government-sponsored health insurance program that offers health coverage for many of the children supported by the vaccine initiative, does not pay providers enough to cover expenses. Participating clinicians lose an average of $5 to $15 for every vaccine they administer through Vaccines for Children, according to a report from Immunize Colorado.

Pharmacists cannot deny a vaccine to eligible children if the family is unable to pay.

Some states run their Medicaid programs using a managed-care model, which may make it harder for pharmacists to get paid, the report said. Children enrolled in these programs are often required to obtain care from designated providers. If their local pharmacist is not on the list of approved providers, they may not get paid.

The possibility of little to no pay hasn’t stopped pharmacist and drugstore owner Tim Mitchell from offering vaccines at his three pharmacies in Neosho, Missouri, about 30 minutes from the Oklahoma state line. He said he’s been immunizing patients since the late 1990s after he realized children coming into his pharmacies were missing routine vaccinations.

“I saw it as a way to help my community,” he said, “but I also saw it as a business opportunity.”

Mitchell, 53, views offering vaccines as a way to stand out from his competitors and bring more customers to his pharmacies. He said he submitted the paperwork to enroll in Vaccines for Children.

Although he welcomes the federal authorization, he acknowledged that not all his peers can afford to offer the service.

“We can’t work for free,” said Mitchell.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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How Pharma Money Colors Operation Warp Speed’s Quest to Defeat COVID

April 16 was a big day for Moderna, a Massachusetts biotech company on the verge of becoming a front-runner in the U.S. government’s race for a coronavirus vaccine. It had received roughly half a billion dollars in federal funding to develop a COVID shot that might be used on millions of Americans.


This story also ran on Daily Beast. It can be republished for free.

Thirteen days after the massive infusion of federal cash — which triggered a jump in the company’s stock price — Moncef Slaoui, a Moderna board member and longtime drug industry executive, was awarded options to buy 18,270 shares in the company, according to Securities and Exchange Commission filings. The award added to 137,168 options he’d accumulated since 2018, the filings show.

It wouldn’t be long before President Donald Trump announced Slaoui as the top scientific adviser for the government’s $12 billion Operation Warp Speed program to rush COVID vaccines to market. In his Rose Garden speech on May 15, Trump lauded Slaoui as “one of the most respected men in the world” on vaccines.

The Trump administration relied on an unusual maneuver that allowed executives to keep investments in drug companies that would benefit from the government’s pandemic efforts: They were brought on as contractors, doing an end run around federal conflict-of-interest regulations in place for employees. That has led to huge potential payouts — some already realized, according to a KHN analysis of SEC filings and other government documents.

  • Slaoui owned 137,168 Moderna stock options worth roughly $7 million on May 14, one day before Trump announced his senior role to help shepherd COVID vaccines. The day of his appointment, May 15, he resigned from Moderna’s board. Three days later, on May 18, following the company’s announcement of positive results from early-stage clinical trials, the options’ value shot up to $9.1 million, the analysis found. The Department of Health and Human Services said Slaoui sold his holdings May 20, when they would have been worth about $8 million, and will donate certain profits to cancer research. Separately, Slaoui held nearly 500,000 shares in GlaxoSmithKline, where he worked for three decades, upon retiring in 2017, according to corporate filings.
  • Carlo de Notaristefani, an Operation Warp Speed adviser and former senior executive at Teva Pharmaceuticals, owned 665,799 shares of the drug company’s stock as of March 10. While Teva is not a recipient of Warp Speed funding, Trump promoted its antimalarial drug hydroxychloroquine as a COVID treatment, even with scant evidence that it worked. The company donated millions of tablets to U.S. hospitals and the drug received emergency use authorization from the Food and Drug Administration in March. In the following weeks, its share price nearly doubled.
  • Two other Operation Warp Speed advisers working on therapeutics, Drs. William Erhardt and Rachel Harrigan, own financial stakes of unknown value in Pfizer, which in July announced a $1.95 billion contract with HHS for 100 million doses of its vaccine. Erhardt and Harrigan were previously Pfizer employees.

“With those kinds of conflicts of interest, we don’t know if these vaccines are being developed based on merit,” said Craig Holman, a lobbyist for Public Citizen, a liberal consumer advocacy group.

An HHS spokesperson said the advisers are in compliance with the relevant federal ethical standards for contractors.

These investments in the pharmaceutical industry are emblematic of a broader trend in which a small group with the specialized expertise needed to inform an effective government response to the pandemic have financial stakes in companies that stand to benefit from the government response.

Slaoui maintained he was not in discussions with the federal government about a role when his latest batch of Moderna stock options was awarded, telling KHN he met with HHS Secretary Alex Azar and was offered the position for the first time May 6. The stock options awarded in late April were canceled as a result of his departure from the Moderna board in May, he said. According to the KHN analysis of his holdings, the options would have been worth more than $330,000 on May 14.

HHS declined to confirm that timeline.

The fate of Operation Warp Speed after President-elect Joe Biden takes office is an open question. While Democrats in Congress have pursued investigations into Warp Speed advisers and the contracting process under which they were hired, Biden hasn’t publicly spoken about the program or its senior leaders. Spokespeople for the transition didn’t respond to a request for comment.

The four HHS advisers were brought on through a National Institutes of Health contract with consulting firm Advanced Decision Vectors, so far worth $1.4 million, to provide expertise on the development and production of vaccines, therapies and other COVID products, according to the federal government’s contracts database.

Slaoui’s appointment in particular has rankled Democrats and organizations like Public Citizen. They say he has too much authority to be classified as a consultant. “It is inevitable that the position he is put in as co-chair of Operation Warp Speed makes him a government employee,” Holman said.

The incoming administration may have a window to change the terms under which Slaoui was hired before his contract ends in March. Yet making big changes to Operation Warp Speed could disrupt one of the largest vaccination efforts in history while the American public anxiously awaits deliverance from the pandemic, which is breaking daily records for new infections. Warp Speed has set out to buy and distribute 300 million doses of a COVID vaccine, the first ones by year’s end.

“By the end of December we expect to have about 40 million doses of these two vaccines available for distribution,” Azar said Wednesday, referring to front-runner vaccines from Pfizer and Moderna.

Azar maintained that Warp Speed would continue seamlessly even with a “change in leadership.” “In the event of a transition, there’s really just total continuity that would occur,” the secretary said.

Pfizer, which didn’t receive federal funds for research but secured the multibillion-dollar contract under Warp Speed, on Friday sought emergency authorization from the FDA; Moderna is expected to do so in the coming days. In total, Moderna received nearly $1 billion in federal funds for development and a $1.5 billion contract with HHS for 100 million doses.

While it’s impossible to peg the precise value of Slaoui’s Moderna holdings without records of the sale transactions, KHN estimated their worth by evaluating the company’s share prices on the dates he received the options and the stock’s price on several key dates — including May 14, the day before his Warp Speed position was announced, and May 20.

However, the timing of Slaoui’s divestment of his Moderna shares — five days after he resigned from the company’s board — meant he did not have to file disclosures with the SEC confirming the sale, even though he was privy to insider information when he received the stock options, experts in securities law said. That weakness in securities law, according to good-governance experts, deprives the public of an independent source of information about the sale of Slaoui’s stake in the company.

“You would think there would be kind of a one-year continuing obligation [to disclose the sale] or something like that,” said Douglas Chia, president of Soundboard Governance and an expert on corporate governance issues. “But there’s not.”

HHS declined to provide documentation confirming that Slaoui sold his Moderna holdings. His investments in London-based GlaxoSmithKline — which is developing a vaccine with French drugmaker Sanofi and received $2.1 billion from the U.S. government — will be used for his retirement, Slaoui has said.

“I have always held myself to the highest ethical standards, and that has not changed upon my assumption of this role,” Slaoui said in a statement released by HHS. “HHS career ethics officers have determined my contractor status, divestures and resignations have put me in compliance with the department’s robust ethical standards.”

Moderna, in an earlier statement to CNBC, said Slaoui divested “all of his equity interest in Moderna so that there is no conflict of interest” in his new role. However, the conflict-of-interest standards for Slaoui and other Warp Speed advisers are less stringent than those for federal employees, who are required to give up investments that would pose a conflict of interest. For instance, if Slaoui had been brought on as an employee, his stake from a long career at GlaxoSmithKline would be targeted for divestment.

Instead, Slaoui has committed to donating certain GlaxoSmithKline financial gains to the National Institutes of Health.

Offering Warp Speed advisers contracts might have been the most expedient course in a crisis.

“As the universe of potential qualified candidates to advise the federal government’s efforts to produce a COVID-19 vaccine is very small, it is virtually impossible to find experienced and qualified individuals who have no financial interests in corporations that produce vaccines, therapeutics, and other lifesaving goods and services,” Sarah Arbes, HHS’ assistant secretary for legislation and a Trump appointee, wrote in September to Rep. James Clyburn (D-S.C.), who leads a House oversight panel on the coronavirus response.

That includes multiple drug industry veterans working as HHS advisers, an academic who’s overseeing the safety of multiple COVID vaccines in clinical trials and sits on the board of Gilead Sciences, and even former government officials who divested stocks while they were federal employees but have since joined drug company boards.

Dr. Scott Gottlieb and Dr. Mark McClellan, former FDA commissioners, have been visible figures informally advising the federal response. Each sits on the board of a COVID vaccine developer.

After leaving the FDA in 2019, Gottlieb joined Pfizer’s board and has bought 4,000 of its shares, at the time worth more than $141,000, according to SEC filings. As of April, he had additional stock units worth nearly $352,000 that will be cashed out should he leave the board, according to corporate filings. As a board member, Gottlieb is required to own a certain number of Pfizer shares.

McClellan has been on Johnson & Johnson’s board since 2013 and earned $1.2 million in shares under a deferred-compensation arrangement, corporate filings show.

The two also receive thousands of dollars in cash fees annually as board members. Gottlieb and McClellan frequently disclose their corporate affiliations, but not always. Their Sept. 13 Wall Street Journal op-ed on how the FDA could grant emergency authorization of a vaccine identified their FDA roles and said they were on the boards of companies developing COVID vaccines but failed to name Pfizer and Johnson & Johnson. Both companies would benefit financially from such a move by the FDA.

“It isn’t a lower standard for FDA approval,” they wrote in the piece. “It’s a more tailored, flexible standard that helps protect those who need it most while developing the evidence needed to make the public confident about getting a Covid-19 vaccine.”

About the inconsistency, Gottlieb wrote in an email to KHN: “My affiliation to Pfizer is widely, prominently, and specifically disclosed in dozens of articles and television appearances, on my Twitter profile, and in many other places. I mention it routinely when I discuss Covid vaccines and I am proud of my affiliation to the company.”

A spokesperson for the Duke-Margolis Center for Health Policy, which McClellan founded, noted that other Wall Street Journal op-eds cited his Johnson & Johnson role and that his affiliations are mentioned elsewhere. “Mark has consistently informed the WSJ about his board service with Johnson & Johnson, as well as other organizations,” Patricia Shea Green said.

Johnson & Johnson’s vaccine is in phase 3 clinical trials and could be available in early 2021.

Still, while they worked for the FDA, Gottlieb and McClellan were subject to federal restrictions on investments and protections against conflicts of interest that aren’t in place for Warp Speed advisers.

According to the financial disclosure statements they signed with HHS, the advisers are required to donate certain stock profits to the NIH — but can do so after the stockholder dies. They can keep investments in drug companies, and the restrictions don’t apply to stock options, which give executives the right to buy company shares in the future.

“This is a poorly drafted agreement,” said Jacob Frenkel, an attorney at Dickinson Wright and former SEC lawyer, referring to the conflict-of-interest statement included in the NIH contract with Advanced Decision Vectors, the Warp Speed advisers’ employing consulting firm. He said documents could have been “tighter and clearer in many respects,” including prohibiting the advisers from exercising their options to buy shares while they are contractors.

De Notaristefani stepped down as Teva’s executive vice president of global operations in October 2019, but according to corporate filings he would remain with the company until the end of June 2020 in order to “ensure an orderly transition.” He’s been working with Warp Speed since at least May overseeing manufacturing, according to an HHS spokesperson.

When Erhardt left Pfizer in May, U.S. COVID infections were climbing and the company was beginning vaccine clinical trials. Erhardt and Harrigan, whose LinkedIn profile says she left Pfizer in 2010, have worked as drug industry consultants.

“Ultimately, conflicts of interest in ethics turn on the mindset behavior of the responsible persons,” said Frenkel, the former SEC attorney. “The public wants to know that it can rely on the effectiveness of the therapeutic or diagnostic product without wondering if a recommendation or decision was motivated for even the slightest reason other than product effectiveness and public interest.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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AstraZeneca, Oxford are latest to unveil Covid-10 vaccine results

The partners pooled results from two trials and two different dosing regimens, one appearing to be more effective than the other. They hope to produce 3 billion doses in 2021 with an emphasis on serving poorer countries.

Dec. 3 Web Briefing: What Happens Once There is a COVID-19 Vaccine? Key Challenges to Vaccinating America

Encouraging reports about several COVID-19 vaccine candidates is raising hopes that there will soon be one or more vaccines proven safe and effective, starting a race to produce, distribute, and administer it to essential workers, people at high risk, and the public, including those who may start out with skepticism about the risks posed byMore

States Are Getting Ready to Distribute COVID-19 Vaccines. What Do Their Plans Tell Us So Far?

This brief summarizes the information contained in the all available draft COVID-19 vaccination plans submitted by states to the CDC, focusing in particular in critical areas such as identifying critical/priority populations, identifying and recruiting providers to administer vaccines, the completeness of state-level vaccine data collection and reporting systems, and communication plans. States report widely varying levels of progress.

Government-Funded Scientists Laid the Groundwork for Billion-Dollar Vaccines

When he started researching a troublesome childhood infection nearly four decades ago, virologist Dr. Barney Graham, then at Vanderbilt University, had no inkling his federally funded work might be key to deliverance from a global pandemic.

Yet nearly all the vaccines advancing toward possible FDA approval this fall or winter are based on a design developed by Graham and his colleagues, a concept that emerged from a scientific quest to understand a disastrous 1966 vaccine trial.

Basic research conducted by Graham and others at the National Institutes of Health, Defense Department and federally funded academic laboratories has been the essential ingredient in the rapid development of vaccines in response to COVID-19. The government has poured an additional $10.5 billion into vaccine companies since the pandemic began to accelerate the delivery of their products.

The Moderna vaccine, whose remarkable effectiveness in a late-stage trial was announced Monday morning, emerged directly out of a partnership between Moderna and Graham’s NIH laboratory.

Coronavirus vaccines are likely to be worth billions to the drug industry if they prove safe and effective. As many as 14 billion vaccines would be required to immunize everyone in the world against COVID-19. If, as many scientists anticipate, vaccine-produced immunity wanes, billions more doses could be sold as booster shots in years to come. And the technology and production laboratories seeded with the help of all this federal largesse could give rise to other profitable vaccines and drugs.

The vaccines made by Pfizer and Moderna, which are likely to be the first to win FDA approval, in particular rely heavily on two fundamental discoveries that emerged from federally funded research: the viral protein designed by Graham and his colleagues, and the concept of RNA modification, first developed by Drew Weissman and Katalin Karikó at the University of Pennsylvania. In fact, Moderna’s founders in 2010 named the company after this concept: “Modified” + “RNA” = Moderna, according to co-founder Robert Langer.

“This is the people’s vaccine,” said corporate critic Peter Maybarduk, director of Public Citizen’s Access to Medicines program. “Federal scientists helped invent it and taxpayers are funding its development. … It should belong to humanity.”

Moderna, through spokesperson Ray Jordan, acknowledged its partnership with NIH throughout the COVID-19 development process and earlier. Pfizer spokesperson Jerica Pitts noted the company had not received development and manufacturing support from the U.S. government, unlike Moderna and other companies.

The idea of creating a vaccine with messenger RNA, or mRNA — the substance that converts DNA into proteins — goes back decades. Early efforts to create mRNA vaccines failed, however, because the raw RNA was destroyed before it could generate the desired response. Our innate immune systems evolved to kill RNA strands because that’s what many viruses are.

Karikó came up with the idea of modifying the elements of RNA to enable it to slip past the immune system undetected. The modifications she and Weissman developed allowed RNA to become a promising delivery system for both vaccines and drugs. To be sure, their work was enhanced by scientists at Moderna, BioNTech and other laboratories over the past decade.

Another key element in the mRNA vaccine is the lipid nanoparticle — a tiny, ingeniously designed bit of fat that encloses the RNA in a sort of invisibility cloak, ferrying it safely through the blood and into cells and then dissolving, thereby allowing the RNA to do its work of coding a protein that will serve as the vaccine’s main active ingredient. The idea of enclosing drugs or vaccines in lipid nanoparticles arose first in the 1960s and was developed by Langer and others at the Massachusetts Institute of Technology and various academic and industry laboratories.

Karikó began investigating RNA in 1978 in her native Hungary and wrote her first NIH grant proposal to use mRNA as a therapeutic in 1989. She and Weissman achieved successes starting in 2004, but the path to recognition was often discouraging.

“I keep writing and doing experiments, things are getting better and better, but I never get any money for the work,” she recalled in an interview. “The critics said it will never be a drug. When I did these discoveries, my salary was lower than the technicians working next to me.”

Eventually, the University of Pennsylvania sublicensed the patent to Cellscript, a biotech company in Wisconsin, much to the dismay of Weissman and Karikó, who had started their own company to try to commercialize the discovery. Moderna and BioNTech later would each pay $75 million to Cellscript for the RNA modification patent, Karikó said. Though unhappy with her treatment at Penn, she remained there until 2013 — partly because her daughter, Susan Francia, was making a name for herself on the school’s rowing team. Francia would go on to win two Olympic gold medals in the sport. Karikó is now a senior officer at BioNTech.

In addition to RNA modification and the lipid nanoparticle, the third key contribution to the mRNA vaccines — as well as those made by Novavax, Sanofi and Johnson & Johnson —- is the bioengineered protein developed by Graham and his collaborators. It has proved in tests so far to elicit an immune response that could prevent the virus from causing infections and disease.

The protein design was based on the observation that so-called fusion proteins — the pieces of the virus that enable it to invade a cell — are shape-shifters, presenting different surfaces to the immune system after the virus fuses with and infects cells. Graham and his colleagues learned that antibodies against the post-fusion protein are far less effective at stopping an infection.

The discovery arose in part through Graham’s studies of a 54-year-old tragedy — the failed 1966 trial of an NIH vaccine against respiratory syncytial virus, or RSV. In a clinical trial, not only did that vaccine fail to protect against the common childhood disease, but most of the 21 children who received it were hospitalized with acute allergic reactions, and two died.

About a decade ago, Graham, now deputy director of NIH’s Vaccine Research Center, took a new stab at the RSV problem with a postdoctoral fellow, Jason McLellan. After isolating and obtaining three-dimensional models of the RSV’s fusion protein, they worked with Chinese scientists to identify an appropriate neutralizing antibody against it.

“We were sitting in Xiamen, China, when Jason got the first image up on his laptop, and I was like, oh my God, it’s coming together,” Graham recalled. The prefusion antibodies they discovered were 16 times more potent than the post-fusion form contained in the faulty 1960s vaccine.

Two 2013 papers the team published in Science earned them a runner-up prize in the prestigious journal’s Breakthrough of the Year award. Their papers, which showed it was possible to plan and create a vaccine at the microscopic structural level, set the NIH’s Vaccine Research Center on a path toward creating a generalizable, rapid way to design vaccines against emerging pandemic viruses, Graham said.

In 2016, Graham, McLellan and other scientists, including Andrew Ward at the Scripps Research Institute, advanced their concept further by publishing the prefusion structure of a coronavirus that causes the common cold and a patent was filed for its design by NIH, Scripps and Dartmouth — where McLellan had set up his own lab. NIH and the University of Texas — where McLellan now works — filed an additional patent this year for a similar design change in the virus that causes COVID-19.

Graham’s NIH lab, meanwhile, had started working with Moderna in 2017 to design a rapid manufacturing system for vaccines. In January, they were preparing a demonstration project, a clinical trial to test whether Graham’s protein design and Moderna’s mRNA platform could be used to create a vaccine against Nipah, a deadly virus spread by bats in Asia.

Their plans changed rapidly when they learned on Jan. 7 that the epidemic of respiratory disease in China was being caused by a coronavirus.

“We agreed immediately that the demonstration project would focus on this virus” instead of Nipah, Graham said. Moderna produced a vaccine within six weeks. The first patient was vaccinated in an NIH-led clinical study on March 16; early results from Moderna’s 30,000-volunteer late-stage trial showed it was nearly 95% effective at preventing COVID-19.

Although other scientists have advanced proposals for what may be even more potent vaccine antigens, Graham is confident that carefully designed vaccines using nucleic acids like RNA reflect the future of new vaccines. Already, two major drug companies are doing advanced clinical trials for RSV vaccines based on the designs his lab discovered, he said.

In a larger sense, the pandemic could be the event that paves the way for better, perhaps cheaper and more plentiful vaccines.

“It’s a silver lining, but I think we are definitely pushing forward the way everyone is thinking about vaccines,” said Michael Farzan, chair of the department of immunology and microbiology at Scripps Research’s Florida campus. “Certain techniques that have been waiting in the wings, under development but never achieving the kind of funding they needed for major tests, will finally get their chance to shine.”

Under a 1980 law, the NIH will obtain no money from the coronavirus vaccine patent. How much money will eventually go to the discoverers or their institutions isn’t clear. Any existing licensing agreements haven’t been publicized; patent disputes among some of the companies will likely last years. HHS’ big contracts with the vaccine companies are not transparent, and Freedom of Information Act requests have been slow-walked and heavily redacted, said Duke University law professor Arti Rai.

Some basic scientists involved in the enterprise seem to accept the potentially lopsided financial rewards.

“Having public-private partnerships is how things get done,” Graham said. “During this crisis, everything is focused on how can we do the best we can as fast as we can for the public health. All this other stuff is going to have to be figured out later.”

“It’s not a good look to become extremely wealthy off a pandemic,” McLellan said, noting the big stock sales by some vaccine company executives after they received hundreds of millions of dollars in government assistance. Still, “the companies should be able to make some money.”

For Graham, the lesson of the coronavirus vaccine response is that a few billion dollars a year spent on additional basic research could prevent a thousand times as much loss in death, illness and economic destruction.

“Basic research informs what we do, and planning and preparedness can make such a difference in how we get ahead of these epidemics,” he said.



This KHN story first published on California Healthline, a service of the California Health Care Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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KHN’s ‘What the Health?’: Transition Interrupted

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Five days after the election was called for President-elect Joe Biden, President Donald Trump has not conceded — and instead ordered his administration not to begin the transition of power. That could have serious ramifications for health care, particularly as nearly every state is experiencing a spike in COVID-19 cases.

One piece of good news is that early results for a coronavirus vaccine made by Pfizer look promising. But that vaccine, even if it is approved soon, won’t likely be ready for wide distribution for several months.

And for the third time in eight years, the Supreme Court heard a case that could invalidate the Affordable Care Act. Judging from the oral arguments, though, it appears the justices are likely to leave most or even all of the law intact.

This week’s panelists are Julie Rovner of Kaiser Health News, Joanne Kenen of Politico, Stephanie Armour of The Wall Street Journal and Shefali Luthra of the 19th News.

Among the takeaways from this week’s podcast:

  • The transition teams advising Biden cannot officially contact current government officials. But many team members have long-standing relationships with people in the government and were talking to those officials before the election, so they have a good sense of what is happening in the administration.
  • The pandemic further complicates the handoff. The new administration will need to hit the ground running to distribute any coronavirus vaccine, so communication with Trump administration officials would be beneficial for the Biden team.
  • Two members of Biden’s COVID task force, Drs. Vivek Murthy, former surgeon general, and David Kessler, former commissioner of the Food and Drug Administration, have been briefing the former vice president since March on the threats of the coronavirus.
  • Since Democrats may not control the Senate — and if they do have control, it will be by the slimmest majority — Biden may be forced to make changes to health policy through executive actions and regulations. That will limit his ambitions.
  • Still, even these smaller moves can have major results, such as allowing Planned Parenthood to again participate in federal health programs to expand the number of providers from which low-income women can seek care.
  • The Pfizer vaccine requires extremely cold temperatures for storage, complicating the logistics for distribution. It is an obstacle but not an insurmountable one for most areas in this country.
  • Supreme Court justices signaled this week they might not strike the Affordable Care Act in its entirety. Several of the conservatives, including Justice Brett Kavanaugh, who was appointed by President Donald Trump, suggested that any ruling that the mandate to have insurance is unconstitutional does not have to doom the rest of the law.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read too:

Julie Rovner: KHN and The Washington Post’s “In Medical Schools, Students Seek Robust and Mandatory Anti-Racist Training,” by Elizabeth Lawrence

Joanne Kenen: KHN’s “Trump’s Anti-Abortion Zeal Shook Fragile Health Systems Around the World,” by Sarah Varney

Stephanie Armour: KHN’s “Biden Plan to Lower Medicare Eligibility Age to 60 Faces Hostility From Hospitals,” by Phil Galewitz

Shefali Luthra: Stat News’ “With a Meteoric Rise in Deaths, Talk of Waves Is Misguided, Say Covid-19 Modelers,” by Elizabeth Cooney

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcherGoogle PlaySpotify, or Pocket Casts.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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¿Es hora de discutir los potenciales efectos secundarios de las vacunas para COVID? Científicos dicen que sí

Se espera que la farmacéutica Pfizer solicite permiso federal para lanzar su vacuna para COVID-19 a fines de noviembre. Una medida que promete acorralar la pandemia, pero que no ofrece mucho tiempo para asegurarse de que los consumidores estén bien informados.

Esta vacuna, y probablemente las otras, requerirá de dos dosis para funcionar, inyecciones que deben administrarse con semanas de diferencia, según muestran los protocolos de la compañía.

Los científicos anticipan que las vacunas causarán efectos secundarios parecidos a los de la gripe, que incluyen dolor en los brazos, dolores musculares y fiebre, que podrían durar días e impedir trabajar o estudiar.

E incluso si una vacuna demuestra una efectividad del 90%, la tasa que Pfizer promociona para su producto, uno de cada 10 receptores seguiría siendo vulnerable. Eso significa que, al menos a corto plazo, a medida que aumenta la inmunidad a nivel de la población, las personas no pueden dejar de usar máscaras y respetar el distanciamiento social.

Por el impulso de tener una vacuna lo antes posible, se ha dejado de lado un plan a gran escala para comunicar de manera efectiva sobre esos temas con anticipación, dijo el doctor Saad Omer, director del Instituto Yale para la Salud Global.

“Necesitas estar listo”, dijo. “No puedes buscar tus materiales de comunicación el día después que se autorice la vacuna”.

Omer, quien no quiso comentar sobre informes que indican que está siendo considerado para un puesto en la nueva administración del presidente electo Joe Biden, pidió el lanzamiento de una sólida campaña de mensajes basada en la mejor evidencia científica sobre las dudas, y la aceptación, de la vacuna.

Los Centros para el Control y Prevención de Enfermedades (CDC) han creado una estrategia llamada “Vacunar con confianza”, pero carece de los recursos necesarios, dijo Omer.

“Necesitamos comunicarnos, y necesitamos comunicarnos de manera efectiva, y debemos comenzar a planificar esto ahora”, dijo.

Este alcance amplio será necesario en un país donde, a mediados de octubre, solo la mitad de los estadounidenses dijeron que estarían dispuestos a recibir una vacuna para COVID-19.

Al principio, las dosis iniciales de cualquier vacuna serían limitadas, pero expertos predicen que pueden estar disponibles de manera amplia a mediados del próximo año. Discutir los posibles efectos secundarios temprano podría contrarrestar la información errónea que exagera o distorsiona el riesgo.

“La mayor tragedia sería si tuviéramos una vacuna segura y eficaz que la gente no se atreva a recibir”, dijo la doctora Preeti Malani, directora de salud y profesora de medicina de la Universidad de Michigan en Ann Arbor.

Pfizer y su socio, la firma alemana BioNTech, dijeron el lunes 9 de noviembre que su vacuna parece proteger a nueve de cada 10 personas de contraer el coronavirus que causa COVID-19, aunque no revelaron datos subyacentes. Es la primera de cuatro vacunas para COVID en la etapa de pruebas de eficacia a gran escala en los Estados Unidos en publicar resultados.

Los datos de los primeros ensayos de varias vacunas contra COVID-19 sugieren que los consumidores deberán estar preparados para los efectos secundarios que, aunque técnicamente leves, podrían alterar la vida diaria.

Un alto ejecutivo de Pfizer dijo al sitio de noticias Stat que los efectos secundarios parecen ser comparables al de las vacunas estándar para adultos, pero peores que la vacuna contra la neumonía de la compañía, Prevnar, o las vacunas típicas contra la gripe.

Por ejemplo, la vacuna Shingrix, de dos dosis, que protege a los adultos mayores contra el virus que causa el doloroso herpes zóster o culebrilla, provoca dolor en los brazos en el 78% de los receptores y dolor muscular y fatiga en más del 40% de los que la reciben.

Las vacunas contra la gripe común, y Prevnar, pueden causar dolor en el área de la inyección, molestias y fiebre.

“Les pedimos a las personas que se pongan una vacuna que va a doler”, dijo el doctor William Schaffner, profesor de medicina preventiva y políticas de salud en el Centro Médico de la Universidad de Vanderbilt. “Hay muchos brazos adoloridos y un número considerable de personas que se sienten mal, con dolores de cabeza y dolores musculares, durante uno o dos días”.

Persuadir a las personas que experimentan estos síntomas para que regresen en tres o cuatro semanas para una segunda dosis, y una segunda ronda de síntomas similares a los de la gripe, podría ser difícil de lograr, dijo Schaffner.

La forma en que expertos en salud pública expliquen estos efectos es importante, dijo Omer. “Hay evidencia que sugiere que si se enmarca el dolor como un indicador de la efectividad, es útil”, dijo. “Si te duele un poco, está funcionando”.

Al mismo tiempo, una buena comunicación ayudará a los consumidores a planificar en base a estos potenciales efectos. Se espera que una vacuna para COVID-19 se distribuya primero al personal de atención médica y a otros trabajadores esenciales, que es posible que no puedan trabajar si se sienten enfermos, dijo el doctor Eli Perencevich, profesor de medicina interna y epidemiología en la Universidad de Atención de Salud de Iowa.

“Mucha gente no tiene licencia por enfermedad. Muchos de nuestros trabajadores esenciales no tienen seguro médico”, dijo, y sugirió que a estos empleados se les debería otorgar tres días de licencia paga después de recibir la vacuna. “Estas son las cosas que debería proporcionar un gobierno que funciona bien, para que nuestra economía vuelva a funcionar”.

También es crucial asegurarse de que los consumidores sepan que una vacuna para COVID-19 probablemente requerirá dos dosis, y que podría tomar un mes para que se active la efectividad total.

El ensayo de fase 3 de Pfizer, que ha inscrito a casi 44,000 personas, comenzó a finales de julio. Los participantes recibieron una segunda dosis 21 días después de la primera. La eficacia informada del 90% se midió siete días después de la segunda dosis.

La comunicación eficaz será vital para garantizar que los consumidores se coloquen la segunda dosis y, suponiendo que se aprueben varias vacunas, que la primera y segunda dosis sean del mismo fabricante.

Omer dijo que, hasta que se active la protección total, las personas deben seguir tomando medidas para protegerse: usar máscaras, lavarse las manos, respetar el distanciamiento social. Es importante que las personas sepan que tomar las medidas adecuadas ahora brindará frutos más adelante.

“Si solo les mostramos el túnel, no la luz, entonces eso da como resultado esta negación masiva”, dijo. “Necesitamos decir, ‘tendrás que continuar haciendo esto a mediano plazo, pero el panorama futuro es bueno”.

Puede haber una mejor comunicación una vez que se presenten los datos completos del ensayo de Pfizer y otros, señaló el doctor Paul Offit, experto en vacunas del Hospital Infantil de Philadelphia, que forma parte del consejo asesor de la Administración de Alimentos y Medicamentos (FDA), que evalúa las vacunas para COVID-19.

“Cuando observas esos datos, puedes definir con mayor precisión qué grupos de personas tienen más probabilidades de tener efectos secundarios, cuál es la eficacia, qué sabemos sobre cuánto dura esa eficacia, por cuánto tiempo se ha analizado la seguridad”, dijo. “Creo que tienes que prepararte para comunicar eso. Y puedes empezar a prepararte ahora”.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Understanding the emergency use authorization process for COVID-19 vaccines

As the world continues to feel the impact of the COVID-19 pandemic, the biopharmaceutical industry is working around the clock to develop safe and effective vaccines to prevent infection, as well as new therapies to treat the coronavirus. A wide range of approaches are currently being tested in robust clinical trials, with participants from all walks of life, to improve the odds that one or more vaccine candidates will be successful in meeting this pressing need. These trials look at how the immune system responds to a vaccine, its effectiveness in producing immunity and the safety profile.

Time to Discuss Potentially Unpleasant Side Effects of COVID Shots? Scientists Say Yes.

Drugmaker Pfizer is expected to seek federal permission to release its COVID-19 vaccine by the end of November, a move that holds promise for quelling the pandemic, but also sets up a tight time frame for making sure consumers understand what it will mean to actually get the shots.


This story also ran on NBC News. It can be republished for free.

This vaccine, and likely most others, will require two doses to work, injections that must be given weeks apart, company protocols show. Scientists anticipate the shots will cause enervating flu-like side effects — including sore arms, muscle aches and fever — that could last days and temporarily sideline some people from work or school. And even if a vaccine proves 90% effective, the rate Pfizer touted for its product, 1 in 10 recipients would still be vulnerable. That means, at least in the short term, as population-level immunity grows, people can’t stop social distancing and throw away their masks.

Left out so far in the push to develop vaccines with unprecedented speed has been a large-scale plan to communicate effectively about those issues in advance, said Dr. Saad Omer, director of the Yale Institute for Global Health.

“You need to be ready,” he said. “You can’t look for your communication materials the day after the vaccine is authorized.”

Omer, who declined to comment on reports he’s being considered for a post in the new administration of President-elect Joe Biden, called for the rollout of a robust messaging campaign based on the best scientific evidence about vaccine hesitancy and acceptance. The Centers for Disease Control and Prevention has created a strategy called “Vaccinate with Confidence,” but it lacks the necessary resources, Omer said.

“We need to communicate, and we need to communicate effectively, and we need to start planning for this now,” he said.

Such broad-based outreach will be necessary in a country where, as of mid-October, only half of Americans said they’d be willing to get a COVID-19 vaccine. Initial doses of any vaccine would be limited at first, but experts predict they may be widely available by the middle of next year. Discussing potential side effects early could counter misinformation that overstates or distorts the risk.

“The biggest tragedy would be if we have a safe and effective vaccine that people are hesitant to get,” said Dr. Preeti Malani, chief health officer and a professor of medicine at the University of Michigan in Ann Arbor.

Pfizer and its partner, the German firm BioNTech, on Monday said their vaccine appears to protect 9 in 10 people from getting COVID-19, although they didn’t release underlying data. It’s the first of four COVID-19 vaccines in large-scale efficacy tests in the U.S. to post results.

Data from early trials of several COVID-19 vaccines suggests that consumers will need to be prepared for side effects that, while technically mild, could disrupt daily life. A senior Pfizer executive told the news outlet Stat that side effects from the company’s COVID-19 vaccine appear to be comparable to standard adult vaccines but worse than the company’s pneumonia vaccine, Prevnar, or typical flu shots.

The two-dose Shingrix vaccine, for instance, which protects older adults against the virus that causes painful shingles, results in sore arms in 78% of recipients and muscle pain and fatigue in more than 40% of those who take it. Prevnar and common flu shots can cause injection-site pain, aches and fever.

“We are asking people to take a vaccine that is going to hurt,” said Dr. William Schaffner, a professor of preventive medicine and health policy at Vanderbilt University Medical Center. “There are lots of sore arms and substantial numbers of people who feel crummy, with headaches and muscle pain, for a day or two.”

Persuading people who experience these symptoms to return in three to four weeks for a second dose — and a second round of flu-like symptoms — could be a tough sell, Schaffner said.

How public health experts explain such effects is important, Omer said. “There’s evidence that suggests that if you frame pain as a proxy of effectiveness, it’s helpful,” he said. “If it’s hurting a little, it’s working.”

At the same time, good communication will help consumers plan for such effects. A COVID-19 vaccine is expected to be distributed first to health care staffers and other essential workers, who may not be able to work if they feel sick, said Dr. Eli Perencevich, a professor of internal medicine and epidemiology at the University of Iowa Health Care.

“A lot of folks don’t have sick leave. A lot of our essential workers don’t have health insurance,” he said, suggesting that essential workers should be granted three days of paid leave after they’re vaccinated. “These are the things a well-functioning government should provide for to get our economy going again.”

Making sure consumers know that a COVID-19 vaccine likely will require two doses — and that it could take a month for full effectiveness to kick in — is also crucial. The Pfizer phase 3 trial, which has enrolled nearly 44,000 people, started in late July. Participants received a second dose 21 days after the first. The reported 90% efficacy was measured seven days after the second dose.

Communicating effectively will be vital to ensuring that consumers follow through with the shots and — assuming several vaccines are approved — that their first and second doses are from the same maker. Until full protection kicks in, Omer said, people should continue to take measures to protect themselves: wearing masks, washing hands, social distancing. It’s important to let people know that taking appropriate action now will pay off later.

“If we just show them the tunnel, not the light, then that results in this mass denial,” he said. “We need to say, ‘You’ll have to continue to do this in the medium term, but the long term looks good.”

The best communication can occur once full data from the Pfizer trial and others are presented, noted Dr. Paul Offit, a vaccinologist at the Children’s Hospital of Philadelphia who sits on the federal Food and Drug Administration’s advisory board considering COVID-19 vaccines.

“When you look at those data, you can more accurately define what groups of people are most likely to have side effects, what the efficacy is, what we know about how long the efficacy lasts, what we know about how long the safety data have been tested,” he said. “I think you have to get ready to communicate that. You can start getting ready now.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Cinco preguntas críticas sobre la vacuna contra COVID-19 de Pfizer

El anuncio de Pfizer de que su vacuna contra COVID-19 prevendría que nueve de cada 10 personas contraigan la enfermedad hizo que el precio de sus acciones se disparara. Muchos titulares describieron a la vacuna como si fuera la liberación de la pandemia, aunque se dieron pocos detalles.

Ciertamente hay para presumir: la vacuna de Pfizer consiste en material genético llamado ARNm encerrado en partículas diminutas que lo transportan a las células. Desde allí, estimula al sistema inmune para que produzca anticuerpos que protejan contra el virus.

Se emplea una estrategia similar en otras potenciales vacunas contra COVID-19 que lideran esta carrera. Si las vacunas de ARNm pueden proteger contra el virus y, presumiblemente, otras enfermedades infecciosas, será una noticia trascendental.

“Esta es una novedad verdaderamente histórica”, dijo el doctor Michael Watson, ex presidente de Valera, una subsidiaria de Moderna que actualmente está realizando ensayos avanzados de su propia vacuna de ARNm contra COVID-19. “Tenemos una nueva clase de vacunas en nuestras manos”.

Pero históricamente, los anuncios científicos importantes sobre vacunas se realizan a través de artículos de investigación médica revisados ​​por colegas, que han sido objeto de un escrutinio exhaustivo desde el diseño del estudio hasta sus resultados, no a través de comunicados de prensa de la farmacéutica.

Entonces, ¿merecían las acciones de Pfizer su aumento porcentual de dos dígitos? Las respuestas a las siguientes cinco preguntas nos ayudarán a saberlo.

  1. ¿Cuánto tiempo protegerá la vacuna a los pacientes?

Pfizer dice que, hasta la semana del 2 de noviembre, 94 personas de las aproximadamente 40,000 en el ensayo habían desarrollado COVID-19. Si bien no dijeron exactamente cuántos de los enfermos se habían vacunado, la cifra de eficacia del 90% sugiere que fue un número muy pequeño.

El anuncio de Pfizer cubre a las personas que recibieron dos vacunas entre julio y octubre. Pero no indica cuánto tiempo durará la protección o con qué frecuencia se pueden necesitar refuerzos.

“Es una apuesta razonable, pero sigue siendo una apuesta decir que la protección durante dos o tres meses es similar a seis meses o un año”, dijo el doctor Paul Offit, miembro del panel de la Administración de Alimentos y Medicamentos (FDA) que probablemente revisará la vacuna para su aprobación en diciembre.

Normalmente, las vacunas no reciben una licencia hasta que demuestran que pueden proteger por uno o dos años.

La empresa no dio a conocer ninguna información de seguridad. Hasta la fecha, no se han revelado efectos secundarios graves, y la mayoría tiende a ocurrir dentro de las seis semanas posteriores a la vacunación.

Pero los científicos deberán estar atentos a efectos raros como una reacción adversa del sistema inmune o alguna enfermedad grave en personas vacunadas, dijo el doctor Walt Orenstein, profesor de medicina en la Universidad Emory y ex director del programa de inmunización de los Centros para el Control y Prevención de Enfermedades (CDC).

  1. ¿Protegerá a los más vulnerables?

Pfizer no reveló qué porcentaje de los voluntarios del ensayo representan a los grupos con más probabilidades de ser hospitalizados o de morir por COVID-19, incluidas las personas de 65 años o más y las que padecen diabetes u obesidad.

Este es un punto clave porque muchas vacunas, particularmente las de la influenza, pueden no proteger a los adultos mayores, pero sí a los más jóvenes. “¿Cuán representativas son esas 94 personas de la población general, especialmente las que están en mayor riesgo?”, se preguntó Orenstein.

Tanto la Academia Nacional de Medicina como los CDC han instado a que las personas mayores estén entre los primeros grupos en recibir la vacuna. Es probable que las que están desarrollando Novavax y Sanofi, que probablemente comiencen los ensayos clínicos de fase 3 a finales de este año, sean mejores para los mayores, apuntó Offit. Esas vacunas contienen partículas inmunoestimulantes como las que tiene la vacuna Shingrix, que es muy eficaz para proteger a las personas mayores contra el herpes zóster o culebrilla.

  1. ¿Se puede implementar con eficacia?

La vacuna de Pfizer, a diferencia de otras que están en la última fase de pruebas, debe mantenerse muy bien enfriada, en hielo seco a unos 100 grados bajo cero, desde el momento en que se produce hasta unos días antes de que se inyecte. El ARNm se autodestruye rápidamente a temperaturas más altas.

Pfizer pondrá en marcha un elaborado sistema para transportar la vacuna a los sitios de vacunación en camiones y cajas especialmente diseñadas. Ya se está capacitando a trabajadores de salud para manejar la vacuna, pero no se sabe con certeza qué tan bien funcionará si los frascos con las dosis se dejan bajo el sol de Arizona por mucho tiempo.

Un mal manejo de la vacuna en el camino de la fábrica al paciente la volvería ineficaz, por lo que las personas que la reciban podrían pensar que están protegidas cuando no lo están, explicó Offit.

  1. ¿Un anuncio prematuro podría dañar las futuras vacunas?

Actualmente no hay forma de saber si la vacuna de Pfizer será la mejor en general, o para grupos de edad específicos. Pero si la FDA la aprueba rápidamente, eso podría dificultar que los fabricantes de otras vacunas realicen sus estudios. Si las personas saben que existe una vacuna eficaz, es posible que no quieran participar en ensayos clínicos, en parte debido a la preocupación de que puedan recibir un placebo y no estar protegidas. De hecho, puede ser poco ético usar un placebo en tales ensayos.

Pero se necesitarán muchas vacunas para satisfacer la demanda mundial de protección contra COVID-19, por lo que es crucial continuar con estudios adicionales.

  1. ¿Podría el estudio de Pfizer acelerar futuras vacunas?

Los científicos están sumamente interesados ​​en saber si el pequeño número que recibió la vacuna real pero que se enfermó produjo niveles más bajos de anticuerpos que los individuos vacunados que se mantuvieron sanos. Los estudios de sangre de esas personas ayudarían a los científicos a saber si existe un “correlato de protección” para COVID-19, un nivel de anticuerpos que puede predecir si alguien está protegido contra la enfermedad.

Si tuvieran ese conocimiento, los funcionarios de salud pública podrían determinar si otras vacunas en producción serían efectivas sin tener que probarlas necesariamente en decenas de miles de personas.

Pero es algo difícil de hacer. Los científicos nunca han establecido correlaciones de inmunidad para la tos ferina, por ejemplo, aunque se han usado vacunas contra esas bacterias durante casi un siglo.

Aún así, ésta es una buena noticia, dijo el doctor Joshua Sharfstein, vicedecano de la Escuela de Salud Pública Bloomber de Johns Hopkins y ex comisionado adjunto de la FDA. “Espero que esto haga que la gente se dé cuenta de que no estamos atrapados en esta situación para siempre. Hay esperanza, ya sea con esta vacuna o con otra”, dijo.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Five Important Questions About Pfizer’s COVID-19 Vaccine

Pfizer’s announcement on Monday that its COVID-19 shot appears to keep nine in 10 people from getting the disease sent its stock price rocketing. Many news reports described the vaccine as if it were our deliverance from the pandemic, even though few details were released.

There was certainly something to crow about: Pfizer’s vaccine consists of genetic material called mRNA encased in tiny particles that shuttle it into our cells. From there, it stimulates the immune system to make antibodies that protect against the virus. A similar strategy is employed in other leading COVID-19 vaccine candidates. If mRNA vaccines can protect against COVID-19 and, presumably, other infectious diseases, it will be a momentous piece of news.

“This is a truly historic first,” said Dr. Michael Watson, the former president of Valera, a subsidiary of Moderna, which is currently running advanced trials of its own mRNA vaccine against COVID-19. “We now have a whole new class of vaccines in our hands.”

But historically, important scientific announcements about vaccines are made through peer-reviewed medical research papers that have undergone extensive scrutiny about study design, results and assumptions, not through company press releases.

So did Pfizer’s stock deserve its double-digit percentage bump? The answers to the following five questions will help us know.

1. How long will the vaccine protect patients?

Pfizer says that, as of last week, 94 people out of about 40,000 in the trial had gotten ill with COVID-19. While it didn’t say exactly how many of the sick had been vaccinated, the 90% efficacy figure suggests it was a very small number. The Pfizer announcement covers people who got two shots between July and October. But it doesn’t indicate how long protection will last or how often people might need boosters.

“It’s a reasonable bet, but still a gamble that protection for two or three months is similar to six months or a year,” said Dr. Paul Offit, a member of the Food and Drug Administration panel that is likely to review the vaccine for approval in December. Normally, vaccines aren’t licensed until they show they can protect for a year or two.

The company did not release any safety information. To date, no serious side effects have been revealed, and most tend to occur within six weeks of vaccination. But scientists will have to keep an eye out for rare effects such as immune enhancement, a severe illness brought on by a virus’s interaction with immune particles in some vaccinated persons, said Dr. Walt Orenstein, a professor of medicine at Emory University and former director of the immunization program at the Centers for Disease Control and Prevention.

2. Will it protect the most vulnerable?

Pfizer did not disclose what percentage of its trial volunteers are in the groups most likely to be hospitalized or to die of COVID-19 — including people 65 and older and those with diabetes or obesity. This is a key point because many vaccines, particularly for influenza, may fail to protect the elderly though they protect younger people. “How representative are those 94 people of the overall population, especially those most at risk?” asked Orenstein.

Both the National Academy of Medicine and the CDC have urged that older people be among the first groups to receive vaccines. It’s possible that vaccines under development by Novavax and Sanofi, which are likely to begin late-phase clinical trials later this year, may be better for the elderly, Offit noted. Those vaccines contain immune-stimulating particles like the ones contained in the Shingrix vaccine, which is highly effective in protecting older people against shingles disease.

3. Can it be rolled out effectively?

The Pfizer vaccine, unlike others in late-stage testing, must be kept supercooled, on dry ice around 100 degrees below zero, from the time it is produced until a few days before it is injected. The mRNA quickly self-destructs at higher temperatures. Pfizer has devised an elaborate system to transport the vaccine by truck and specially designed cases to vaccination sites. Public health workers are being trained to handle the vaccine as we speak, but we don’t know for sure how well it will do if containers are left out in the Arizona sun too long. Mishandling the vaccine along the way from factory to patient would render it ineffective, so people who received it could think they were protected when they were not, Offit said.

4. Could a premature announcement hurt future vaccines?

There’s presently no way to know whether the Pfizer vaccine will be the best overall or for specific age groups. But if the FDA approves it quickly, that could make it harder for manufacturers of other vaccines to carry out their studies. If people are aware that an effective vaccine exists, they may decline to enter clinical trials, partly out of concern they could get a placebo and remain unprotected. Indeed, it may be unethical to use a placebo in such trials. Many vaccines will be needed in order to meet global demand for protection against COVID-19, so it’s crucial to continue additional studies.

5. Could the Pfizer study expedite future vaccines?

Scientists are vitally interested in whether the small number who received the real vaccine but still got sick produced lower levels of antibodies than the vaccinated individuals who remained well. Blood studies of those people would help scientists learn whether there is a “correlate of protection” for COVID-19 — a level of antibodies that can predict whether someone is protected from the disease. If they had that knowledge, public health officials could determine whether other vaccines under production were effective without necessarily having to test them on tens of thousands of people.

But it’s difficult to build such road maps. Scientists have never established correlates of immunity for pertussis, for example, although vaccines have been used against those bacteria for nearly a century.

Still, this is good news, said Dr. Joshua Sharfstein, a vice dean at the Johns Hopkins Bloomberg School of Public Health and a former FDA deputy commissioner. He said: “I hope this makes people realize that we’re not stuck in this situation forever. There’s hope coming, whether it’s this vaccine or another.”



This KHN story first published on California Healthline, a service of the California Health Care Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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With 90% efficacy against Covid-19, Pfizer/BioNTech’s vaccine jumps ahead in global race

Finish line ahead

The news sent the stock market soaring as it represents a key milestone in developing and distributing a vaccine for the virus. Still public confidence in vaccines need to be boosted, an expert noted.

As Faith in Vaccines Falters, Biden Is Under Pressure to Name New FDA Chief Stat

President-elect Joe Biden made COVID-19 a linchpin of his campaign, criticizing President Donald Trump’s leadership on everything from masks and packed campaign rallies to vaccines.

That was the easy part. Biden now has the urgent job of filling top health care positions in his administration to help restore public trust in science-driven institutions Trump repeatedly undermined, and oversee the rollout of several coronavirus vaccines to a skeptical public who fear they were rushed for political expediency.

At the top of that list is a new commissioner of the Food and Drug Administration, an agency where Biden faces immense pressure to move faster than any other modern president as the pandemic rages and COVID deaths are expected to surge through the winter. That agency and its beleaguered personnel will be relied on to give the green light to vaccines and therapeutics to fight the COVID pandemic.

Biden is expected to swiftly announce his choices to lead the FDA and the Centers for Disease Control and Prevention, given their importance in informing the federal government’s COVID strategy, according to interviews with Biden advisers, former agency officials and Democrats with knowledge of the transition team’s inner workings. But how soon they’ll be able to begin work after Biden’s Jan. 20 inauguration is unclear.

The CDC director does not need Senate confirmation, avoiding a hurdle that could slow that process. That is not the case for the FDA commissioner, who now appears increasingly likely to face a Republican-controlled Senate that may not be as keen as Democrats to swiftly clear Biden’s nominees. As a result, even if Biden moves at breakneck speed to replace outgoing Commissioner Stephen Hahn, it could be weeks after Biden is in the White House before his pick could get to work.

In the meantime, the FDA will face critical decisions about vaccines needed to help put the nation on its path out of the pandemic. Biden will have to rely on a temporary head of the FDA to steer the 17,000-employee agency during one of the most challenging times in its history.

“It’s not ideal timing, for sure,” a former FDA official said. “It’s a huge job.”

The transition of power will occur at one of the most high-profile times for the FDA, as it vets multiple coronavirus vaccine candidates that could reach the public before the inauguration. The Trump administration could oversee emergency authorizations of initial vaccines from two front-runners, Pfizer and Moderna, that would be prioritized for health care workers and other groups at higher risk of severe COVID complications. But other companies’ vaccines that could be available for many more Americans — such as teachers, adults at lower risk of severe health consequences if they get sick, and children — are all but certain to fall under Biden’s FDA for review because the data on safety and efficacy isn’t expected until next year.

FDA’s credibility in vetting the safety and benefits of COVID products has been in question for months, fueled by Hahn’s inaccurate statements about certain treatments for sick patients. Further, infighting between officials there and political appointees at the White House and the Department of Health and Human Services persisted even in the weeks leading up to the election, with HHS Secretary Alex Azar openly plotting Hahn’s removal because of disagreements over vaccine standards, Politico reported in October.

In September, eight senior FDA officials who have served in multiple administrations took the extraordinary step of publishing an op-ed in USA Today stating they would work with agency leadership “to maintain FDA’s steadfast commitment to ensuring our decisions will continue to be guided by the best science.”

“Protecting the FDA’s independence is essential if we are to do the best possible job of protecting public health and saving lives,” the officials wrote.

“Trust has eroded so significantly in these institutions that have undermined public confidence, especially on vaccines,” a Biden adviser said of the FDA and CDC. “Change in leadership is critical.”

Getting new people into the federal government — where Biden is charged with filling roughly 4,000 jobs held by political appointees — is a mammoth slog on its own, let alone while moving to take over the U.S. pandemic response. Former President Barack Obama set the record for presidential appointments in the first 100 days, securing Senate confirmation for 69 appointees. The FDA commissioner wasn’t among them — Dr. Margaret Hamburg was not nominated until March 2009 and became commissioner that May. A similar timeline held for Trump’s first FDA commissioner, Dr. Scott Gottlieb, who began in May 2017.

“It is a difficult period because you’re going to have a lot of folks who need to get into place,” said Max Stier, CEO of the Partnership for Public Service, which advises presidential candidates and their teams installing new administrations. “The track record has not been good on getting people in quickly.”

At the outset of the Biden administration, it’s expected there will be a fair number of “acting” agency heads rather than Senate-confirmed appointees, Stier said. Biden has said he’ll trust the government’s scientists on COVID vaccines. Former FDA officials said in interviews that if there’s an acting official in charge when a specific vaccine is under review, it should not make a difference because the agency’s longtime scientists conduct the necessary scientific evaluations.

Where it could make a difference is in messaging and accountability, not just to the new president but to the public: The traditionally lower profile and temporary nature of an acting FDA commissioner is at odds with the highly visible role the commissioner is expected to play during a public health emergency, particularly in convincing people that vaccines are safe.

“An agency needs a face, and it’s hard for an ‘acting’ to be the face of the agency,” a former senior agency official said. “The work could be done, but the communication is always better if there’s an FDA commissioner who’s willing to take responsibility.”

The messaging role has taken on extraordinary importance since public confidence in a coronavirus vaccine has eroded significantly. A September Pew Research Center poll found that only 51% of U.S. adults would definitely or probably get a vaccine to prevent COVID-19 if it were available, a drop of 21 percentage points since May.

“Things can only be better,” said Michael Carome, director of the health research group at Public Citizen, a left-leaning group that advocates for consumer interests. “I think an acting commissioner under a Biden administration will be far more trusted than the current FDA commissioner, who has been kowtowed by the White House.”

FDA staffing policy outlines who should be the agency’s acting head in the event there isn’t a permanent commissioner. The most recent version, from 2016, says the position is delegated to the deputy commissioner for foods and veterinary medicine, a title that has since been recast as deputy commissioner for food policy and response. The job is currently held by Frank Yiannas, a longtime food safety expert who joined the agency in 2018 after the retirement of Stephen Ostroff, a veteran FDA scientist who served as acting commissioner twice. The FDA did not respond to questions about whether it had a new staffing policy.

Some administrations, however, have ignored that policy. The Trump administration, for example, briefly installed senior HHS official Brett Giroir, a political appointee, as acting FDA commissioner, a move criticized by Democrats in Congress.

But critical decisions await the new appointee.

The earliest officials would know whether COVID vaccines from Johnson & Johnson and AstraZeneca work is January or February, said Moncef Slaoui, the top scientific adviser for Operation Warp Speed, which is funding multiple coronavirus vaccines and treatments. Other efficacy trials won’t be completed until spring, he said in October.

Safety will take even longer to assess — Johnson & Johnson’s and AstraZeneca’s late-stage clinical trials were already paused earlier this year for safety reasons —and companies will seek emergency authorization or FDA approval only once both metrics are known.

After four years of politicization of the science agency, a Biden adviser said, most important was having a “trusted, credible voice to restore trust in a vaccine.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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VA Joins Pentagon in Recruiting Volunteers for COVID Vaccine Trials

The Department of Veterans Affairs is recruiting 8,000 volunteers for the Phase 3 clinical trials of at least four COVID-19 vaccine candidates at 20 federal medical facilities across the U.S., according to officials with the VA and Operation Warp Speed, the Trump administration’s initiative to fast-track a coronavirus vaccine.

The largely unpublicized effort follows a Department of Defense announcement in September that it has partnered with AstraZeneca to recruit volunteers at five of its medical facilities, which are separate from the VA system.

DOD is also is in talks with developers of other vaccine candidates, although officials won’t say which ones.

Both federal departments have long experience in medical research and diverse populations — a crucial component of effective clinical trials, said J. Stephen Morrison, senior vice president and director of global health policy at the Center for Strategic and International Studies, a bipartisan think tank in Washington, D.C.

Since active troops are essential to national security, and veterans are extremely vulnerable to COVID-19, both departments have a vested interest in supporting the development of safe, effective vaccines, Morrison said.

“On the DOD active servicemen and -women side, it’s a question of making sure they’re ready, they are protected,” Morrison said. “With VA, their population, all elderly and infirm with underlying conditions, they could really be suffering if we don’t get a vaccine.”

According to a VA website, of its 20 medical centers involved, 17 would be part of the Johnson & Johnson vaccine trial, while the three others are recruiting — or have completed recruitment — for advanced-stage trials for Moderna, AstraZeneca and Pfizer vaccines.

Dr. Matthew Hepburn, head of vaccine development at Operation Warp Speed, said the VA effort lets veterans contribute to the overall well-being of the country.

“This is another way they can continue to serve in this way, fighting the pandemic as a volunteer,” Hepburn said during a discussion of vaccine and therapeutics development hosted by the Heritage Foundation on Oct. 27.

It’s not unusual for the military to participate in multicenter trials for treatments of ailments as diverse as cancer and trauma. Historically, many vaccines have been tested first by the military.

In the general population, clinicians often have difficulty recruiting African Americans and other minorities for medical research, and “the military provides a rich opportunity to find volunteers for those groups,” said retired Rear Adm. Thomas Cullison, a doctor and former deputy surgeon general for the Navy.

Military health facilities are held to the same standards as private research facilities, he said.

No service members will be required to participate in the COVID vaccine trials. All volunteers will be paid by the developer.

Support for routine vaccinations runs high in the military, but some have expressed concerns about new vaccines and mandatory inoculations, especially for anthrax. In a 2002 federal study, 85% of those who received that vaccine reported an adverse reaction, with just under half noticing minor redness at the injection site. But nearly a quarter of the side effects reported were more systemic, including fevers, chills, fatigue and joint pain.

That survey of a small group of National Guard and Reserve members found that, while 73% said they believe immunizations are effective, two-thirds said they did not support the mandatory anthrax program and 6 in 10 said they were not satisfied with the information they were given on the vaccines.

To quell concerns over the military’s role in supporting COVID vaccine development, the Pentagon has reiterated that troops or their dependents interested in participating in the research must provide voluntary written consent, and they will be allowed to take part only if they will be in the same location for the length of the research, expected to last at least two years.

In addition, active-duty members such as new recruits and boot camp participants will not be allowed to volunteer because they are “considered vulnerable from an ethical and regulatory standpoint,” an official said.

At the VA, officials are seeking to recruit healthy veterans from 18 to 65 years old who are not pregnant and may be at risk for exposure. As with trials conducted in civilian facilities, participants will be paid by the developer, VA spokesperson Christina Noel said.

Also, VA nurses and caseworkers also are being asked to identify their sickest, highest-risk patients to determine who should be at the top of the list once a vaccine is approved, according to a VA nurse and other health officials who asked not to be identified because they were not authorized to speak with the press.

The U.S. military has a long history of contributing to research on vaccines, including a key role in developing inoculations against yellow fever and adenovirus, and the Walter Reed Army Institute of Research is developing its own vaccine against the coronavirus.

Some segments of the population remain skeptical of federal medical experiments. A survey by AP-NORC in May found that Black people are particularly reluctant to get the coronavirus vaccine. Many have concerns about federal research in part because of associations with the infamous Tuskegee Institute syphilis experiments, in which U.S. Public Health Service officials intentionally withheld a cure from Black men infected with the disease.

But Morrison, of the Center for Strategic and International Studies, said the Defense Department and VA are a “natural fit” for the COVID vaccine trials.

“DOD has lots of expertise. They know how to vaccinate; they know how to reach communities. They have a whole science infrastructure and research-and-development infrastructure. And when you are thinking what the mission of VA is, [VA] sees this is part of their mission,” Morrison said.

The Defense Department announced its agreement with AstraZeneca in September, shortly before the drugmaker’s vaccine trial was put on hold to study a serious medical condition that one participant reported. That research was approved by the Food and Drug Administration to begin again Oct. 23. The military plans to restart its efforts to recruit 3,000 volunteers.

The Pentagon has also signed an agreement with another vaccine developer, the head of the Defense Health Agency, Army Lt. Gen. Ronald Place, told reporters Oct. 8. He wouldn’t provide the company’s name.

Democratic Sens. Elizabeth Warren of Massachusetts and Mazie Hirono of Hawaii have called, unsuccessfully, for the Senate Armed Services Committee to investigate what they say is a lack of Pentagon transparency on its role in vaccine development and distribution.

The Defense Department has awarded more than $6 billion in Operation Warp Speed contracts through an intermediary, Advanced Technology International, and the two senators want more information about those contracts.

“There may well be a valuable role for DoD officials in [Operation Warp Speed] — particularly given the department’s logistical capacity,” they wrote to the committee chair and ranking member. “But it is important that Congress conduct appropriate oversight of, and understand, DoD’s activities in this area.”

Neither department has disclosed the financial arrangements they have made with developers to support the vaccine research.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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The ‘failure’ of clinical trials in the search for COVID-19 treatments

Professor Jean-Pierre Boissel outlines the urgent need for disruptive R&D approaches that can tackle the search for COVID-19 treatments more effectively.

It may not be appropriate to use the word ‘failure’ when summarising the utility of clinical trials in the search for a curative or preventative treatment for disease. For the purposes of this text, let us assume that ‘success’ and ‘failure’ will be used in reference to the objective of clinical trial designers: to obtain sufficient evidence that a treatment under evaluation is of benefit to patients.

SARS-Cov-2, responsible for the COVID-19 infection, rarely kills those who are infected, but unfortunately, the number of deaths caused by the virus now exceeds 1.2 million worldwide and continues to increase despite the global public health measures that have been put in place. As time goes on, the number of individuals requiring access to intensive care facilities exceeds capacity. The main measure available to fight against the spreading of the virus, social distancing, is becoming ever more difficult to bear.

Compared to the number of deaths and the millions of those infected with COVID-19, the number of patients included in randomised clinical trials, the only type of investigation able to provide the necessary evidence for the safety and efficacy of potential new treatments, is ridiculous: less than 10,000 in total for the Recovery and Discovery trials, for which we have initial data, plus an equivalent number for a US NIH trial, a WHO study, and trials launched in China or by the industry.

Despite hundreds of trials on their way there are only a dozen drugs being tested currently with reduction of death as endpoint and yet there are as many as 150 drugs already on the market for other related indications and hundreds more that could potentially have a role to play, targeting the viral proteins, the virus interactions with the target cells or on the human systems that are solicited by the infection.

“Most of the trials are underpowered to demonstrate efficacy on mortality and long-term consequences of the disease… It is not surprising there is no recommended drug treatment for COVID-19, except dexamethasone and remdesivir, despite little evidence that this drug reduces mortality”

If, as it is likely, it will be necessary to combine drugs to obtain a cure, and even personalize these combinations to individuals, the number of ongoing or completed trials appears insignificant compared to the scale of the disease. However, in vitro or binding-based efficacy insight needs to be confirmed by reliable clinical evidence, as shown by the outcomes of COVID-19 trials with remdesivir and hydroxychloroquine.

Most of the trials are underpowered to demonstrate efficacy on mortality and long-term consequences of the disease. The scale of the impact of COVID-19 dwarfs the clinical data obtained to date so it is probably not surprising there is currently no recommended drug treatment for COVID-19, except dexamethasone and, in some countries, remdesivir, despite little evidence that this drug reduces mortality.

We have ‘half-successes’ such as dexamethasone for Recovery, which might only be effective in subgroups of patients, and still needs to be confirmed by at least one other trial, or ‘half-failures’ such as Discovery, the complexity of which is poorly suited in the context of caring for severely ill patients hospitalised in intensive care units. Recruitment into trials is difficult, or outcomes are uninformative as with remdesivir, or like the hydroxychloroquine trial in China, inadequately powered. Even Solidarity, the WHO trial, is some way from yielding strong data.

The only relatively well-argued result we have today is the ineffectiveness of hydroxychloroquine, which was predictable. Also, evidence in favour of a reduction of mortality with lopinavir/ritonavir is elusive. Evidence regarding efficacy of remdesivir on mortality is awaited, the NIAID trial results published recently did not show a statistically significant reduction of mortality

At this rate, how many years might it take, unless luck or serendipity strikes, to test all the options and finally find a cure for the most severe patients?

The picture is hardly more promising for vaccines: the number of approaches, difficulty in finding patients in which to carry out pivotal trials, irrelevant choice of endpoints … the outlook is far from promising.

There are many reasons as to why so few eligible patients are being recruited into clinical trials even though infection numbers are high. The exhortation by the late Thomas C Chalmers to “randomise the first patient” which would translate into the best ethical behaviour by doctors has never been put into practice. If it had been applied to COVID-19, at the very least 2,000 molecules or combinations could have been tested so far against mortality: taking 200 as an average number of endpoints per trial (quite a large number indeed!) and the death toll today. However, this is pure speculation since the story of randomised clinical trials which began more than half a century ago shows us that Chalmers’ words are, sadly, wishful thinking.

The traditional approach to R&D, with its high failure rate, is not acceptable when it comes to COVID-19: the expected time to efficient treatment or vaccine (ETETV) is unbearable compared to the rate of growth of the burden of the disease. Repurposing existing drugs with prior evidence of PK and safety for the potential treatment of COVID-19 only marginally improves the inefficient series of decision-making stages in the traditional R&D process

There is therefore an urgent need to turn to a disruptive approach, modeling and simulation (M&S), to make efforts to tackle COVID-19 more efficiently.

A solution?

The M&S approach should be integrative, from the molecular level to the clinical and population outcomes. It should be conceived both as a proof of concept tool and a MIDD (Model Informed Drug Development, to use the FDA jargon) tool for potential treatments, including vaccines, and combinations of drugs. It will allow inefficacious treatments to be dropped earlier, sparing time, resources and patients. Also, as a knowledge integrator, enabling the assimilation of large amounts of knowledge that scientists will gather on the virus and the disease. Once the model is achieved and validated, simulations to test hundreds of treatments or vaccines can be run in parallel by sponsors in a just couple of days.

For COVID-19, this can be achieved through a series of connected modules:

  1. the SARS-cov2 virus, its dissemination dynamics, entry into the cell, replication, interactions between viral intracellular activities and energy metabolism, the regulation and phenotype and age-related distribution of ACE2, the infected cell fate;
  2. the systems level and responses (innate and adaptive immune system, inflammation, complement, vascular system and coagulation;
  3. alveolar and gas exchange changes and dynamics of organ irrigation changes;
  4. dynamics of organ failure (heart, gut, kidney, nervous system);
  5. patient level and clinical outcomes, including chronic lung fibrosis and chronic fatigue syndrome;
  6. population level (ways and dynamics of viral penetration, role of social connections, social context, Covid-19 prevention measures).

An M&S approach will enable the prediction of major impairments due to COVID-19. Not only death, but also the chronic fatigue syndrome (‘Long COVID’) which is a major burden for some patients.

Eventually, the model could help to individualise treatment for patients.

About the author

Professor Jean-Pierre BoisselProfessor Jean-Pierre Boissel is co-founder and chair of the scientific advisory board, Novadiscovery.

Jean-Pierre is a cardiologist by training. He was until recently an Emeritus Professor of Clinical Pharmacology at the University of Claude Bernard Lyon 1, and has been a scientific director at the French Institute for Health and Medical Research (Inserm), advisor to the General Surgeon and is still a member of a number of scientific societies in Europe and the United States.

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Wide Variations in Flu Vaccination Rates Across States Highlight Challenges as State and Local Authorities Plan to Distribute a COVID-19 Vaccine

When a COVID-19 vaccine becomes available, all or most people living in the country will need to get vaccinated in order to maximize its benefits and provide adequate immunity nationwide. That could present a daunting challenge for state and local health officials, as a new KFF analysis shows vaccination rates for the annual flu vaccineMore

KHN’s ‘What the Health?’: As Cases Spike, White House Declares Pandemic Over

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White House chief of staff Mark Meadows said this week that “we’re not going to control the pandemic,” effectively conceding that the administration has pivoted from prevention to treatment. But COVID-19 cases are rising rapidly in most of the nation, and the issue is playing large in the presidential campaign. President Donald Trump is complaining about the constant news reports about the virus, prompting former President Barack Obama to say Trump is “jealous of COVID’s media coverage.”

Meanwhile, as the case challenging the constitutionality of the Affordable Care Act heads to the Supreme Court on Nov. 10, open enrollment for individual health insurance under the law begins Sunday.

This week’s panelists are Julie Rovner of Kaiser Health News, Joanne Kenen of Politico, Tami Luhby of CNN and Anna Edney of Bloomberg News.

Among the takeaways from this week’s podcast:

  • Whichever candidate wins the presidency next week will have a heavy lift in mounting a strong public response to battle COVID-19. Polls suggest about a third of people do not believe some of the basic science about the virus or its prevention, such as that using masks can help stem transmission.
  • Dr. Scott Gottlieb, who once served as Food and Drug Administration commissioner under Trump, called for a temporary national mask mandate in his column in The Wall Street Journal. He suggested that masks should not be a political issue.
  • Gottlieb’s column has been supported by other commentators who suggest that masks need to become a social and cultural norm and compare the debate over their use to similar debates in the past about seat belts, smoking bans and harsh punishments for driving while intoxicated. Those measures all faced opposition from people who complained about civil liberties but gradually became accepted. The difference now is that public health advocates are looking for a quick acceptance of masks.
  • Part of the resistance to wearing face masks is that many people don’t understand their purpose and presume masks are for their own protection. But public health officials advocate masks as a way to protect others, especially vulnerable people, from any virus a mask wearer might shed, often without even realizing it.
  • Drugmakers and health experts are rolling back expectations about the timing of a COVID vaccine as the trials seek more data. One issue may be that not enough people in the placebo groups have contracted the coronavirus. That could be because people who volunteer for such an endeavor may be more aware of health issues and cautious about the disease.
  • Once a vaccine is approved, FDA and other federal health officials will face a number of complicating issues. Among them: How should trials of other vaccine candidates continue and how should the vaccine be distributed?
  • Enrollment for insurance plans on the Affordable Care Act’s marketplaces begins Sunday, but many consumers could be forgiven for not knowing that. There is precious little marketing or advertising for the plans, and some people think the Supreme Court is going to overturn the ACA, anyway, and its plans will go away. That’s not known yet and it may well be summer 2021 before there is an answer on that.

Also this week, Rovner interviews KHN’s Anna Almendrala, who reported the latest NPR-KHN “Bill of the Month” installment, about a patient who did everything right and got a big bill anyway. If you have an outrageous medical bill you would like to share with us, you can do that here.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read, too:

Julie Rovner: The New York Times’ “A Chance to Expand Medicaid Rallies Democrats in Crucial North Carolina,” by Abby Goodnough

Joanne Kenen: The New Yorker’s “A President Looks Back on His Toughest Fight,” by Barack Obama

Tami Luhby: KHN’s “Florida Fails to Attract Bidders for Canada Drug Importation Program,” by Phil Galewitz

Anna Edney: The Wall Street Journal’s “Health Agency Halts Coronavirus Ad Campaign, Leaving Santa Claus in the Cold,” by Julie Wernau, James V. Grimaldi and Stephanie Armour

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcherGoogle PlaySpotify, or Pocket Casts.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Científicos advierten que se espera demasiado de una vacuna para COVID

La Casa Blanca y muchos estadounidenses han depositado sus esperanzas de derrotar a la pandemia de COVID-19 en una vacuna que se está desarrollando a la “velocidad de la luz”. Pero algunos científicos advierten que se espera demasiado, y demasiado pronto.

“Todos piensan que COVID-19 desaparecerá con una vacuna”, dijo el doctor William Haseltine, presidente de Access Health International, una fundación que aboga por una atención asequible.

Los ensayos clínicos en curso están diseñados principalmente para mostrar si las vacunas para COVID-19 previenen algún síntoma de la enfermedad, que podría ser tan leve como dolor de garganta o tos.

Pero estos ensayos, que estudian a unos 30,000 a 60,000 voluntarios, serán demasiado breves y demasiado pequeños en número de participantes, para demostrar que las vacunas evitarán lo que la gente más teme, tener que ser hospitalizadas o morir, para cuando los primeros fabricantes presenten una solicitud de autorización de emergencia, algo que se espera que ocurra a finales de este año, expicó Haseltine.

Estados Unidos debería esperar una vacuna óptima, con capacidades más probadas, argumentó Haseltine. Otros dicen que el abrumador número de víctimas de la pandemia, que ha matado al menos a 225,000 estadounidenses, exige que el país acepte la mejor vacuna que pueda lograr en los próximos meses, incluso si persisten dudas importantes después de su lanzamiento.

“Existe una tensión entre obtener cada pieza de información y obtener una vacuna a tiempo para salvar vidas”, dijo el doctor William Schaffner, profesor de medicina preventiva y políticas de salud en el Centro Médico de la Universidad Vanderbilt.

“¿Nos gustaría saber si la vacuna reduce la enfermedad o la mortalidad? Por supuesto”, dijo el doctor Peter Lurie, ex funcionario de la FDA y actual presidente del Center for Science in the Public Interest. “Pero hay una presión de tiempo real. Esta es una pandemia”.

Los investigadores debatieron cuán rigurosamente probar las vacunas para COVID-19 en una reunión pública del comité asesor sobre vacunas de la Administración de Alimentos y Medicamentos (FDA).

“La simple prevención de los casos leves no es suficiente y puede que no justifique los riesgos asociados con la vacunación”, dijo Peter Doshi, profesor asociado de la Escuela de Farmacia de la Universidad de Maryland, quien detalló sus preocupaciones en un editorial de The BMJ.

Pero expertos en vacunas dicen que hay buenas razones para centrarse en los casos más leves de COVID-19.

Las vacunas que previenen enfermedades leves también suelen prevenir enfermedades graves, dijo el doctor Arnold Monto, epidemiólogo de la Escuela de Salud Pública de la Universidad de Michigan y presidente temporal del comité de vacunas.

Por ejemplo, los estudios originales de la vacuna contra el sarampión mostraron que solo prevenía el sarampión, no las hospitalizaciones o las muertes, dijo la doctora Kathleen Neuzil, directora del Centro de Desarrollo de Vacunas y Salud Global de la Universidad de Maryland.

Pero estudios posteriores encontraron que estas vacunas reducían drásticamente la mortalidad. Según la Organización Mundial de la Salud (OMS), las muertes por sarampión en todo el mundo disminuyeron en un 73% entre 2000 y 2018 debido a las vacunas.

“Simplemente no existe un ejemplo en la inmunización con vacunas que sean efectivas contra enfermedades leves que no sean más efectivas en cuadros graves”, dijo el doctor Philip Krause, subdirector de la oficina de vacunas del Centro de Evaluación e Investigación Biológica de la FDA.

El doctor Paul Offit, quien desarrolló la vacuna contra el rotavirus, comparó la prevención del coronavirus con la lucha contra un incendio.

“Si apagas un pequeño incendio en la cocina, no tienes que preocuparte de que toda la casa se incendie”, dijo Offit, miembro del comité asesor de vacunas de la FDA.

Demostrar que una vacuna previene enfermedades graves y la muerte es más difícil que demostrar que protege contra enfermedades leves porque las hospitalizaciones y las muertes son mucho más raras. Eso es especialmente cierto entre el tipo de personas conscientes de su salud que se ofrecen como voluntarias para los ensayos de vacunas, y que seguramente tienen más probabilidades que otras de usar máscaras y distanciarse socialmente, dijo Schaffner.

“Cuando analizamos las hospitalizaciones en adultos mayores con influenza, fueron ensayos de dos años”, dijo Neuzil. En un estudio en curso, en el que “estamos analizando las vacunas contra la fiebre tifoidea en casi 30.000 niños, es una prueba de dos años”.

La pandemia de COVID-19 ha infectado oficialmente a unos 8,7 millones de estadounidenses. Pero teniendo en cuenta que se estima que el número real de infectados es de seis a 10 veces mayor que lo informado, la tasa de mortalidad es de aproximadamente el 0,6%, dijo el doctor Amesh Adalja, investigador principal del Centro de Seguridad Sanitaria de la Universidad Johns Hopkins.

Los científicos están de acuerdo en que la vacuna ideal proporcionaría “inmunidad esterilizante”, lo que significa prevenir no solo los síntomas de la enfermedad, sino también cualquier infección por el virus, dijo el doctor Corey Casper, experto en vacunas del Centro de Investigación del Cáncer Fred Hutchinson y director ejecutivo del Instituto de Investigación de Enfermedades Infecciosas en Seattle.

Por ejemplo, dos dosis de vacunas contra el sarampión evitan que el 97% de las personas se infecten con ese virus.

Pocos esperan que las vacunas para COVID-19 sean tan efectivas. “Estamos tratando de bajar esa expectativa y determinar cuánto más bajo es aceptable”, dijo Casper.

La prevención de una enfermedad leve podría frenar la enfermedad y prevenirla, dijo Casper.

“Probablemente no vamos a tener la vacuna perfecta”, agregó. “Pero creo que es probable que tengamos vacunas que, si podemos demostrar que son seguras, pueden poner un punto de inflexión en esta pandemia. Creo que sigue siendo importante tener una vacuna que tenga algún efecto incluso en enfermedades leves”.

Las vacunas contra la gripe no son muy eficaces, con una efectividad anual que oscila entre el 19% y el 70%, pero siguen siendo extremadamente útiles, dijo Casper.

Durante la temporada de influenza 2018-19 en los Estados Unidos, la vacunación previno aproximadamente 4,4 millones de enfermedades por gripe, 2,3 millones de visitas médicas, 58,000 hospitalizaciones y 3,500 muertes asociadas a este virus, según los Centros para el Control y Prevención de Enfermedades (CDC).

Un ensayo de 30,000 a 60,000 personas ya es bastante grande según los estándares históricos. Expandir drásticamente el tamaño más allá de eso no es práctico en un marco de tiempo limitado, dijo Krause.

“Si el criterio de valoración del ensayo es una enfermedad grave, es posible que los ensayos tengan que ser unas 10 veces más grandes”, explicó. “Y esos ensayos serían inviables y nunca obtendríamos una vacuna”.

Por otro lado, “si hay una vacuna que parece tener una alta eficacia o parece ser capaz de salvar vidas, uno no quiere frenarla, si existe una posibilidad significativa de que salve vidas”, dijo Krause.

Aunque los ensayos de la vacuna contra el coronavirus miden la enfermedad grave o la muerte, estos son “criterios de valoración secundarios”, lo que significa que el tamaño actual del estudio no es lo suficientemente grande como para producir una respuesta estadísticamente significativa, dijo Neuzil.

Si las vacunas reducen la enfermedad grave y la muerte se aclarará en estudios posteriores, después de que se distribuyan las vacunas, dijo Neuzil.

Offit dijo que el debate gira en torno a una pregunta: “¿Con cuánta incertidumbre estamos dispuestos a vivir, sabiendo que nos enfrentamos a un virus que nos ha puesto de rodillas?”.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Readers and Tweeters Shed Light on Vaccine Trials and Bias in Health Care

Letters to the Editor is a periodic feature. We welcome all comments and will publish a selection. We edit for length and clarity and require full names.

On the ‘Subject’ of Vaccine Trial Participants

In the piece about the AstraZeneca vaccine trial subject who suffered severe spinal cord inflammation, that person was repeatedly referred to as a “patient” (“NIH ‘Very Concerned’ About Serious Side Effect in Coronavirus Vaccine Trial,” Sept. 14). Once someone is enrolled in a trial, everything that happens to them is because they are a “subject,” not a patient. A patient is someone getting health care; a subject is willingly participating to be exposed to something that has nothing to do with their health or wellness. Please use the right term so that the reader can be reminded that the person was participating in this trial. Nice piece.

— Robin Chalmers, Atlanta

Don’t worry about Trump rushing a #vaccine. Worry about pharma companies hiding data from the FDA and NIH.https://t.co/BoxSZILoyx

— Mike’s Hard Left Turn🏴 🏴‍☠️ (@ozofperception) September 17, 2020

— Michael Berger, Canton, Ohio

Just read the story by Arthur Allen and Liz Szabo on risk/benefit of vaccine trials where a serious illness occurs. It hit home. I took Proscar for seven years in a prostate cancer prevention trial. I was in the third cohort. At some point short of the planned 10 cohorts, the test was aborted: Benefits were so great that the placebo would be unethical. I was lucky. My little blue pill was the real thing. That earned me a spot in the selenium/vitamin E trial to see if that combo prevented prostate cancer. That trial was aborted when serious health effects were diagnosed and there was a causal link. Good. I didn’t get both but I don’t know whether I got selenium or vitamin E. No problems. I know I did not get the placebo.

Now I’m doing the Pfizer COVID-19 vaccine trial at Cincinnati Children’s Hospital/Gamble Institute. So far, two shots, no immediate problems. Ask me in two years.

It’s important to say: A trial can stop because benefits wildly outweigh risks or because harms become obvious. I’ve had every vaccine relevant to my life and work for 82 years. I’ve seen smallpox and measles in southern Africa and polio in my hometown, Minneapolis. I got a typhus jab before going out to Africa from London almost 60 years ago. I’m a believer. Thanks for your clear-headed and well-written and -edited reporting. We need it more than ever.

Ben Kaufman, Cincinnati

Regardless of widespread distrust caused by @realDonaldTrump ‘too many cooks’ syndrome on vaccine vetting has scientists saying such plans by individual states could backfire, confusing public & eroding confidence in any eventual #coronavirus vaccine. https://t.co/gCufRJ2FjJ

— Lindsay Resnick (@ResnickLR) October 7, 2020

— Lindsay Resnick, Chicago

Racial sensitivity training is essential. The healthcare system is not made to support people of color. Providers should not be another obstacle to receiving equitable healthcare #MedTwitter

Unconscious Bias Crops Up In Health Care, Even During A Pandemic https://t.co/tDwkCOO6qH

— Taylor Ross (@taycraye) October 21, 2020

— Taylor Ross, Columbia, Missouri

A Universal Problem

I want to let Karla Monterroso from the April Dembosky piece on unconscious bias in health care (“‘All You Want Is to Be Believed’: The Impacts of Unconscious Bias in Health Care,” Oct. 21) know that I have no doubt her experience was horrific, and I do not want to, in any way, disagree or diminish that it is related to unconscious bias. However, I am a skinny, white woman (and a nurse and nurse practitioner, by the way, and therefore better able to advocate for myself), and my interface with emergency, primary care and a few specialty practices in the “health care” system during the time of COVID-19 has also been most unfortunately and horrifically similar.

I, too, am utilizing my resources to speak up and speak out, knowing that for everyone who speaks up there are hundreds if not thousands who don’t. So please convey my gratitude to her, and to KHN for publishing her story. I hope that it and Kaiser Permanente’s research shed some light, not only on unconscious bias, but also the realities of today’s medical-industrial complex.

— Christine Fasching Maphis, Harrisonburg, Virginia

The Need for Trust Between Physician and Patient

Throughout history, there has been an extreme level of mistrust between health care providers and African American communities. So in 2020, when being asked to enter a trial for a coronavirus vaccine, the answer is easily no, without hesitation (“COVID Vaccine Trials Move at Warp Speed, But Recruiting Black Volunteers Takes Time,” Sept. 16).

Misconduct and mistreatment of patients presently and in the past, such as Henrietta Lacks and the many lives lost during the Tuskegee Syphilis Study, have forever been etched in the minds of many individuals, and trust is not easily given. When strengthening the relationship between patient and provider, trust must first be built before Black communities would even consider being test subjects.

What Dr. Vladimir Berthaud has been able to provide Robert Smith and the rest of his patients with is comfort, which is developed when the care is patient-centered. Effectively communicating with patients to ensure they understand what’s going on and what’s at stake, listening to their concerns, and respecting their preferences when it comes to receiving care can affect the decision patients decide to make in this very difficult time.

With over 8 million cases of COVID-19 in the United States, Black people make up 17.6% of reported cases from states who provided data on race/ethnicity, according to the CDC. With little to no volunteers willing to enter the trial, the likelihood of finding a vaccine to build the immune systems of all citizens is becoming further from achievable and even more difficult. Representation for people of color is needed, and providers need to take the extra step to encourage the Black community to participate in the trial that affects them, just as much as any other race.

— Tre’Jenae Mack, Baltimore

(Today is day 1 for me. An hour until vaccine or placebo) As COVID-19 Vaccine Trials Move At Warp Speed, Recruiting Black Volunteers Takes Time https://t.co/T4zkkUJ7qZ

— Ty Russell (@TRussellCBS4) September 29, 2020

— Ty Russell, Miami

Ghosting Your Friends This Year

Regarding your story about Halloween safety (“How Families Are Keeping Halloween From Turning Into a COVID Nightmare,” Sept. 23), a mother is quoted as saying she will host a small sleepover with relatives instead of trick-or-treating. Isn’t having non-household members over to spend the night considered a high-risk thing to do? I’m confused.

— Sarah Kishler, San Jose, California

Editor’s note: Indeed. With COVID cases on the rise in at least 36 states, especially in the Midwest, CDC Director Robert Redfield said recently: “What we’re seeing as the increasing threat right now is actually acquisition of infection through small household gatherings.”

Such a good way to put it: We pay farmers not to plant. Shouldn’t we pay bars to stay closed? via @NYTOpinion https://t.co/vQWww4B6r0

— leslie ehrlich (@leslieehrlich) October 22, 2020

— Leslie Ehrlich, New York City

A Eureka Moment on Bar Closings

I am a professor at the School of Social Work at the University of Michigan-Ann Arbor. I teach courses in policy management, leadership and community organization. I am in the “wholesale” branch of social work, not the “retail” (clinical) side.

I want to congratulate you on your recent piece on closing the bars (“Analysis: Winter Is Coming for Bars. Here’s How to Save Them. And Us,” Oct. 22). More specifically, your linking the farm program of paying farmers not to grow to paying bars not to open. Reading that I had a eureka moment — stupendous! An idea with broad applications. I have taught about “policy borrowing,” but that idea never crossed my mind — brilliant — one of those once-in-a-lifetime inspirations. The potential application of farm subsidies to other policy arenas opens a door (as in “The Secret Garden”).

I just had to find a way to tell you how intellectually exciting that is.

— John Tropman, Ann Arbor, Michigan

@RosenthalHealth⁩ It’s not just bars that are a central problem in creating “heterogenous” explosive outbreaks. It is bar owners, banded together fiercely opposing reasonable temporary controls. Witness the tavern league in Wisconsin. https://t.co/QQd8qoWVHM

— Steve Morrison (@MorrisonCSIS) October 22, 2020

— Steve Morrison, Washington, D.C.

Plagued by Misinformation

Should you wear a mask? Should you stay home? Is it worse than the flu? Don’t ask the United States government because you won’t get a consistent answer (“Signs of an ‘October Vaccine Surprise’ Alarm Career Scientists,” Sept. 21). Since COVID-19 began to afflict the U.S. in early March, the Trump administration has consistently disseminated unreliable messages leading to surges in cases, mass personal protective equipment shortages and over 220,000 deaths. Inconsistent statements that contradict evidence-based recommendations from well-regarded government agencies have plagued the government’s response to the novel coronavirus.

The administration is, again, pushing controversial treatments and contradicting experts in the premature release of the COVID-19 vaccination, making it one of its most dangerous maneuvers yet. A politically charged release of a vaccine that has not been fully tested will result in low trust levels. While this cutting-corners approach may appear to increase the chance of reelection, it puts the scientific community’s reputation in jeopardy, possibly destroying confidence in vaccination, a topic scientists have been battling for decades. The U.S. is currently leading the world in cases and deaths, proving that an unclear and decentralized approach to the crisis is ineffective. It’s imperative that elected officials begin to work together and take America’s health seriously.

— Amelia Flocchini, Madison, Wisconsin

This is a terrifying scenario. If it comes to this, I promise to actually (gulp) speak up against vaccines. I hope and pray we don’t go down this road.

(In the meantime: existing, approved #VaccinesWork… Go get your flu shot!) https://t.co/ypIl3LojjP

— Megan Ranney MD MPH 🗽 (@meganranney) September 21, 2020

— Dr. Megan Ranney, Providence, Rhode Island

Buckling Down on Analogies

In Elisabeth Rosenthal’s “Analysis: We Follow Laws on Seat Belts and Smoking. Why Not on Masks? (Oct. 1), the seat belt analogy doesn’t quite fit. Seat belts primarily help the user. You should instead use speed limits or laws against driving drunk. Those help others primarily, like masks.

— Thomas Kahn, St. Louis

@gavin4annapolis Useful article given the large number of non-mask wearing scofflaws I routinely see down at the harbor. There is police “presence” but no obvious enforcement efforts. https://t.co/bneoV3WHzN

— Phelim Kine “老 康“ (@PhelimKine) September 30, 2020

— Phelim Kine, Annapolis, Maryland

The Crisis of 911 Mental Health Calls

Reading your story about Daniel Prude, I assume this interests KHN because of the failures in mental health care (“You’re Going to Release Him When He Was Hurting Himself?” Sept. 29). The narrative seems to be that this sort of thing happens only to people of color and not that the proportion of officer-involved use-of-force incidents are far greater among those in mental health crisis than solely because of race. Take this story, for example, in which a Minnesota crisis unit was called twice, refusing first to assist, then a second time not arriving before the child was gassed out of a home where he was alone and shot 11 times on a sunny Friday morning in his own front yard. Then the district attorney used protected health information (PHI) to make a case to justify the killing.

— Don Amorosi, Wayzata, Minnesota

As we focus more on the intersection of the justice system & racial equity, how we approach mental healthcare is – & should be – part of the discussion. The tragic circumstances of Daniel Prude’s death in Rochester shines a spotlight on this. https://t.co/CIt9AGCgxB

— Kody H. Kinsley 😷 (@KodyKinsley) October 2, 2020

— Kody H. Kinsley, Raleigh, North Carolina

This story brought light to the serious problem of lack of access to inpatient psychiatric care. State laws are too restrictive, and hospitals are legally aware and wary. Strong Memorial Hospital clearly did not take into account the patient’s behavior that caused his family and police to act to have him hospitalized. Nevertheless, while I highly appreciate the facts this article brings to light, I am somewhat dismayed that the highlighted topic is race rather than the risk of all mentally ill patients of being denied access to inpatient care. There appears to be a trend of viewing events and news primarily through these identity lenses. My father was Hispanic and also had problems getting access to care before he committed suicide. Thank you for covering this story.

— Christina Nuñez Daw, Greenbelt, Maryland

Heartbreaking Bills, Lawsuit and Bankruptcy — Even With Insurance https://t.co/Ws6dNPfMsJ via @khnews In any other developed country in the world, he would have been taken care of. #Medicare4All now

— Kathy Staub (@mrsstaub) September 25, 2020

— Kathy Staub, Manchester, New Hampshire

When Illness Leaves a Patient Little Choice

I write to expand on Laura Ungar’s Sept. 25 article, “Bill of the Month: Heartbreaking Bills, Lawsuit and Bankruptcy — Even With Insurance.” The article follows the story of a man diagnosed with a rare condition — flu-induced heart disease — who received surprise medical bills, which led to a lawsuit and his filing for bankruptcy. Ungar notes that “a hospital representative suggested [the patient] apply for financial assistance. She followed up by sending him a form, but it went to the wrong address because [the patient] was in the process of moving.”

Though nonprofit hospitals are required to provide some sort of financial aid for indigent patients — according to 26 C.F.R. §1.501(r) of the Internal Revenue Code — the statute does not define exactly how a hospital must provide that aid. For example, a hospital can offer financial assistance but require patients complete extensive documentation to discourage patients from using it. Though it is unclear in Ungar’s article whether the hospital attempted to resend the form or to contact the patient after the form went to the wrong address, it is unlikely. If the hospital was willing to pursue legal action — leading to the patient’s bankruptcy — it is possible the hospital did not attempt to contact the patient again as a tactic to avoid providing financial assistance, a tactic allowed under the IRC.

Ungar failed to mention how patients with chronic conditions would fare in similar circumstances. As someone with a chronic condition, I know firsthand that those with chronic conditions do not pick and choose when they have expensive surgeries or procedures; often, the condition makes that choice. A patient with ulcerative colitis or Crohn’s disease does not choose when he has a flare that might require an emergency colonoscopy or surgery to remove part of their intestines. A flare, by definition, occurs randomly and violently. Often, procedures and surgeries to quell such flares require expensive treatment options. Scheduling such procedures is desirable but unrealistic. Even the patient in the article — who suffered a rare acute condition — did not choose when he needed care; his health made the choice. The article should address chronic conditions but as another example to emphasize her point about how debilitating medical bills can be.

— Daniel Klapper, Pittsburgh

1. Why the “Breaking Bad” plot line (cooking meth to cover cancer treatment costs) is an “only in America” story; 2. Why patient investment in high-connection wellness/care solutions has an ROI given US healthcare system costs. https://t.co/TxWjpYUGqe

— Jim Eischen (@JimEischenEsq) September 25, 2020

— Jim Eischen, San Diego

Oh, Canada Health Care!

Regardless of the platitudinous praises our health care system typically receives, Canada is the only country with a universal plan (theoretically, anyway) that doesn’t also fully cover medications (“New Laws Keep Pandemic-Weary California at Forefront of Health Policy Innovation,” Oct. 1). The bitter pill is: Many low-income outpatients cannot afford to fill their prescriptions and resultantly end up back in the hospital system, thus burdening the system far more than if those patients’ generic-brand medication was also covered. This lesson was learned and implemented by enlightened European nations with genuinely universal all-inclusive health care systems that also cover necessary medication.

Within our system are important treatments that seem to be either universally nonexistent or, more to the point, universally inaccessible, except to those with relatively high incomes and/or generous employer health insurance coverage. The only two health professions’ appointments for which I’m fully covered by the public health plan are the readily pharmaceutical-prescribing psychiatry and general practitioner health professions. Such non-pharmaceutical-prescribing mental health specialists as psychotherapists and counselors (etcetera) are not at all covered.

Logic says we cannot afford to maintain such an absurdity that costs Canada billions extra annually. It’s not coincidental that the absence of universal medication coverage also keeps the pharmaceutical industry’s profits soaring.

— Frank Sterle Jr., White Rock, British Columbia

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Scientists Warn Americans Are Expecting Too Much From a Vaccine

The White House and many Americans have pinned their hopes for defeating the COVID-19 pandemic on a vaccine being developed at “warp speed.” But some scientific experts warn they’re all expecting too much, too soon.

“Everyone thinks COVID-19 will go away with a vaccine,” said Dr. William Haseltine, chair and president of Access Health International, a foundation that advocates for affordable care.

Ongoing clinical trials are primarily designed to show whether COVID-19 vaccines prevent any symptoms of the disease — which could be as minor as a sore throat or cough. But the trials, which will study 30,000 to 60,000 volunteers, will be too short in duration and too small in size to prove that the vaccines will prevent what people fear most — being hospitalized or dying — by the time the first vaccine makers file for emergency authorization, expected to occur later this year, Haseltine said.

The United States should hold out for an optimal vaccine, with more proven capabilities, Haseltine argued. Others say the crushing toll of the pandemic — which has killed at least 225,000 Americans — demands that the country accept the best vaccine it can achieve within the next few months, even if significant questions remain after its release.

“There’s a tension between getting every piece of information and getting a vaccine [out] in time to save lives,” said Dr. William Schaffner, a professor of preventive medicine and health policy at the Vanderbilt University Medical Cancer.

“Would we like to know if the vaccine reduces illness or mortality? Of course,” said Dr. Peter Lurie, a former FDA official and the current president of the Center for Science in the Public Interest. “But there is a real time pressure. This is a pandemic. It’s explosive.”

Researchers debated how rigorously to test COVID-19 vaccines at a Thursday public meeting of the Food and Drug Administration advisory committee on vaccines.

“Simply preventing mild cases is not enough and may not justify the risks associated with vaccination,” said Peter Doshi, an associate professor at the University of Maryland School of Pharmacy who detailed his concerns in an editorial in The BMJ.

But vaccine experts say there are good reasons to focus on milder cases of COVID-19.

Vaccines that prevent mild disease typically prevent severe disease, as well, said Dr. Arnold Monto, an epidemiologist at the University of Michigan’s School of Public Health and temporary chair of the vaccine committee.

For example, the original studies of the measles vaccine showed only that it prevented measles, not hospitalizations or deaths, said Dr. Kathleen Neuzil, director of the University of Maryland’s Center for Vaccine Development and Global Health.

Later studies found that measles vaccines dramatically reduce mortality. According to the World Health Organization, worldwide deaths from measles fell by 73% from 2000 to 2018 because of vaccines.

“There simply does not exist an example in vaccinology of vaccines that are effective against mild disease that are not more effective in severe disease,” said Dr. Philip Krause, deputy director of the vaccine office at the FDA’s Center for Biologics Evaluation and Research, at Thursday’s hearing.

Dr. Paul Offit, who developed the rotavirus vaccine, compared preventing the coronavirus to fighting a fire.

“If you put out a small fire in the kitchen, you don’t have to worry about the whole house catching fire,” said Offit, a member of the FDA advisory committee on vaccines.

Proving that a vaccine prevents severe illness and death is harder than showing it protects against mild illness because hospitalizations and deaths are much rarer. That’s especially true among the type of health-conscious people who volunteer for vaccine trials, who are probably more likely than others to wear masks and socially distance, Schaffner said.

“When we looked at hospitalizations in older adults with influenza, those were two-year trials,” Neuzil said. In an ongoing study, in which “we’re looking at typhoid vaccines in nearly 30,000 children, it’s a two-year trial.”

The COVID-19 pandemic has officially infected about 8.7 million Americans. Considering that the true number of Americans infected is estimated to be six to 10 times higher than reported, the mortality rate is about 0.6%, said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security.

Scientists agree that the ideal vaccine would provide “sterilizing immunity” — which means preventing not only disease symptoms but any infection with the virus, said Dr. Corey Casper, a vaccinologist with the Fred Hutchinson Cancer Research Center and chief executive officer at the Infectious Disease Research Institute in Seattle.

For example, two doses of measles vaccines prevent 97% of people from even becoming infected with that virus.

Few expect COVID-19 vaccines to be that effective. “We’re trying to lower that bar and determine how much lower is acceptable,” Casper said.

Preventing mild disease could curb disease and prevent illness, Casper said.

“We’re probably not going to have the perfect vaccine,” he said. “But I do think we’re likely to have vaccines that, if we can show they’re safe, can put an inflection point on this pandemic. … I think it’s still important to have a vaccine that has some effect even on mild illness.”

Flu shots aren’t super effective — with effectiveness each year ranging from 19% to 70% — but they’re still extremely useful, Casper said.

During the 2018-19 U.S flu season, vaccination prevented an estimated 4.4 million influenza illnesses, 2.3 million medical visits, 58,000 hospitalizations and 3,500 influenza-associated deaths, according to the Centers for Disease Control and Prevention.

A trial of 30,000 to 60,000 people is already fairly large by historical standards. Dramatically expanding the size beyond that isn’t practical in a compressed time frame, Krause said.

“If the endpoint of the trial is severe disease, the trials may need to be almost 10 times as big,” he said at the meeting. “And those trials would be infeasible and we would never get a vaccine.”

On the other hand, “if there is a vaccine that appears to have high efficacy or appears to be capable of saving lives, one doesn’t want to stop that vaccine if there is a significant chance that it will save lives,” Krause said.

Although the coronavirus vaccine trials are measuring severe disease or death, these are “secondary endpoints,” meaning the current size of the study isn’t large enough to produce a statistically significant answer, Neuzil said.

Whether vaccines reduce severe disease and death will become clear in later studies, after vaccines are distributed, Neuzil said.

Offit said the debate revolves around one question: “How much uncertainty are we willing to live with, knowing that we’re facing a virus that has brought us to our knees?”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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KHN on the Air This Week

KHN chief Washington correspondent Julie Rovner discussed the impact of the election and the upcoming Supreme Court challenge on the Affordable Care Act with New Hampshire Public Radio’s “The Exchange” and WNYC’s “The Brian Lehrer Show” on Wednesday. Rovner also spoke with Newsy’s “Morning Rush” on Thursday about the roles of health care and COVID-19 in the presidential campaign.

KHN Midwest correspondent Lauren Weber discussed COVID vaccine distribution with “Newsy Reports” on Oct. 16.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Data hackathon analyses truth behind TB vaccine and COVID-19

Is a century-old vaccine a ‘game-changer’ for COVID-19? Anita de Waard from Elsevier and Radoslav Kirkov from Estafet tells us how a hackathon is harnessing data science to look beyond the hype and seek definitive clinical evidence.

Today, the notion of ‘data science’ has permeated almost every area of society. Words like machine learning, artificial intelligence and deep learning have entered the everyday business lexicon. From government agencies to online retailers, a ‘big data strategy’ is a must-have. This year, as the COVID-19 pandemic has spread, there has been increased talk of statistics, modelling, predictive analytics, and using data to solve the serious issues we face.

But often, what purports to be data science is actually just a random correlation between different data sets. The phrase ‘data science’ is often used to represent any form of data analysis, however rudimentary, and regardless of whether it is based on scientific understanding. Given the amount of faith we increasingly put in algorithms to make decisions on our behalf, whether in our hospitals, our courts, or our education system, we need a much deeper understanding of how these correlations are drawn, and what they are based on, in order to apply data science for good.

This is especially true in the search for effective therapies to fight COVID-19, and a vaccine. Speed is truly of the essence, but at the same time, the integrity of the science underpinning any clinical recommendations must be maintained. With so many research projects, collaborations and clinical trials taking place in an attempt to limit and prevent the virus, we have to be clear on how decisions are being made and what the data behind an apparent breakthrough is really telling us.

“In a worst-case scenario, misplaced hype could lead to a sudden rush to buy doses of the BCG vaccine. In nations where TB is widespread, this could put many lives at stake”

Understanding the link between COVID-19 and the BCG vaccine

A good example of this phenomenon is the sudden hype around the Bacillus Calmette–Guérin (BCG) vaccine, which is primarily used against tuberculosis (TB). This century-old vaccine came to prominence recently, when a number of early ecological studies (those which study population factors in epidemiology) seemed to show a strong correlation between receiving the vaccine and having immunity against COVID-19.

Some studies suggested the link was a “game-changer” and a “silver bullet”. The studies claimed to show a strong correlation between the BCG vaccination and protection against COVID-19, but closer examination revealed a tenuous correlation, from which clear conclusions can’t be drawn. Indeed, the World Health Organization said that, “Such ecological studies are prone to significant bias from many confounders, including differences in national demographics and disease burden, testing rates for COVID-19 virus infections, and the stage of the pandemic in each country.”

The world-leading TB researcher Prof. Madhukar Pai was also quick to warn of the serious limitations with this approach and the need to be cognizant of confounding variables. In a worst-case scenario, misplaced hype could lead to a sudden rush to buy doses of the BCG vaccine. For developed nations with low TB rates, this would have little impact. But in nations where TB is more widespread, such as India, the potential implications of a sudden shortage of BCG vaccine could put many lives at stake.

The aim now must be on providing stronger clinical trial evidence of the link between the BCG vaccination and incidence of COVID-19, to enable data-led decisions to be made. There are clear shortcomings with current ecological studies, which take aggregated data and look to make inferences at an individual level. If the data are not representative or confounders are not taken into account, the results will be inaccurate.

Establishing an evidence-backed link

The only way to truly understand the correlation between COVID-19 and the BCG vaccine is to conduct randomised trials combined with deep analysis of existing data. To that end, Estafet and Elsevier have initiated a two-stage hackathon. The groups are working together with the BCG World Atlas team, which is led by an infectious disease specialist at the University of Ottawa, Dr Alice Zwerling. The BCG Atlas is an open-source database of global BCG vaccination policies and practices, founded in 2011.

Many of the aforementioned ecological studies were based on data from the BCG Atlas, so the first stage of the hackathon aimed to augment and improve the Atlas; with additional data and health records available on BCG vaccinations. These have been found through natural language processing (NLP) methods. With thirty volunteers globally, including judges, organisers, and data gatherers, prizes were awarded to those deemed to have extended the data most. The winner was Dimitrina Zlatkova of Sofia University, who contributed 57 additional data points, followed by developer Marouane Benmeida of Morocco who added 33 additional data points.

The hackathon now moves to stage two, where the volunteers will seek to answer a series of questions, such as whether the BCG vaccination is causally related to reduced COVID‐19 mortality, or if other factors like lockdowns and average age of the population are responsible for the different mortality rates. If the BCG vaccination does reduce COVID-19 mortality, what are the key factors. For example. how long does the immunity from BCG last after that vaccination? Does the strain of BCG vaccination impact immunity? The team is now looking for more volunteers to get involved as the hackathon progresses. Once complete this most valuable insights from the task will be shared with the ongoing BCG COVID-19 clinical trials.

Data science for good

When it comes to COVID-19, data science will certainly be critical – but it is the blend of scientific understanding and technical acumen through data science that is vital.

It is a job for all of us engaged in data science projects – whether in academia or commercial or government research – to stem the hype. It is important to assess the veracity of a claim before accepting any conclusions, and empower the public to do the same. This habit of mind is important not only in the development of treatments and vaccinations, but paramount to establishing a broad public trust in data-led decision making.

About the authors

Anita de Waard is VP research collaborations at Elsevier and Radoslav Kirkov is technology director at Estafet.

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GSK Presents Results of Maternal & Older Adults RSV Vaccines at IDWeek 2020

Shots:

  • GSK reported that its RSV vaccines for maternal immunization (GSK3888550A) and older adults (GSK3844766A) were well-tolerated and highly immunogenic in P-I/II clinical studies. Both the candidate vaccines contain a recombinant RSVPreF3, that triggers the required immune response
  • The GSK3844766A was first tested in 48 healthy adults (18-40yrs.) & then in 1005 healthy older adults (60-80yrs.) with different dosages of antigen & adjuvant. The interim data 1mos. post-immunization elicited a robust humoral and cellular immunity while the vaccine includes AS01 adjuvant system to boost the immune response
  • GSK3888550A was tested with 3 different doses vs PBO in 502 healthy non-pregnant women over monthly visits (day 8, 31 & 91 post immunization). The study results demonstrated that vaccine rapidly boost pre-existing immunity at all dose levels & @day8 it showed a 4-fold increase in RSV-A and RSV-B neutralizing Abs titers. P-III studies of both the vaccines are expected to initiate in the coming months

Click here ­to­ read full press release/ article | Ref: GSK | Image: Reuters

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Analysis: Winter Is Coming for Bars. Here’s How to Save Them. And Us.

If we really want to stem the spread of the coronavirus as winter looms and we wait for a vaccine, here’s an idea: The government should pay bars, many restaurants and event venues to close for some months.

That may sound radical, but it makes scientific sense and even has a political precedent. We pay farmers not to cultivate some fields (in theory, at least, to protect the environment), so why not compensate owners to shut their indoor venues (to protect public health)?

In the past nine months, we’ve learned a lot about this particular coronavirus and how it’s most likely to spread. Drinking establishments and indoor event venues have emerged as ideal environments for transmission. And there’s good scientific logic to explain that.

Viruses are not villains who go after their prey; they’re passive opportunists. Some spread through food or when left on surfaces. Others, like this coronavirus, can be transmitted through tiny droplets that can linger in the air after an infected person coughs, talks or breathes. The virus spreads most easily indoors and particularly in crowded, poorly ventilated places.

More important, people can be infectious while their bodies are incubating this virus for a couple of days before they develop symptoms, or even if they never develop symptoms at all. So you might go to a bar or a wedding feeling top-notch, or just maybe a little off. Drink, kiss and dance till you drop. Then you wake up the next morning feeling awful. It’s not just a hangover. It’s COVID-19.

That explains why this virus is exceedingly contracted at “superspreader” events. (More so than the flu, according to the Centers for Disease Control and Prevention.) A person who is shedding a good deal of the virus still feels well enough to hang out in a tight (likely indoor) space where people mingle boisterously with others they don’t know or don’t see often. And they can’t wear masks, because they’re drinking.

No wonder bars are a problem.

In scientific parlance, the coronavirus is more of a “heterogeneous” than a homogeneous spreader, according to Bjarke Frost Nielsen, a researcher at the Niels Bohr Institute at the University of Copenhagen. Along with his colleague Kim Sneppen, he uses mathematical modeling to study the pattern of the spread of the virus. That heterogeneous spread means that it tends to expand in burst-like outbreaks, often centered on a meeting place — a hot spot — rather than oozing slowly across a country.

There is some good news in this finding, Nielsen told me: “You can close down certain types of gatherings and a few types of places and tamp down the majority of the spread of the disease. And you can carry on with the rest as pretty normal.”

Back when we knew little about the novel coronavirus, the government responded with a hammer. The Paycheck Protection Program treated all small businesses equally, providing them with loans to shut down so long as they paid their employees. Now we can use more delicate instruments.

Food and clothing stores — indeed, most any kind of shop — can function safely with masking and attention to distancing and sanitizing. We don’t go to these places to chat, and we can all wear masks inside them. Factories and assembly lines can protect workers with masking and spacing. Schools can do the same for students.

Even movie theaters can arguably safely operate with masked patrons, quality ventilation systems and spacing between viewers or viewing groups. They just won’t be able to sell as many seats.

But bars and restaurants that depend on packed indoor dining and concert halls with dance floors? Most are attractive for exactly the reasons that make them such petri dishes for the coronavirus — the crowding, the drinking, the carousing with new, different people.

That’s why some bar and restaurant owners say they would welcome a program that compensated them to shut their doors this winter. Peter Kurzweg, who co-owns three of what he calls “drink forward” establishments in Pittsburgh that used to have bustling happy hours, says that “bars and restaurants are unique in that to be really safe, they have to mitigate to a point that it’s not a bar or restaurant experience anymore.”

He and his partners have so far weathered the pandemic with outdoor seating on the sidewalk and in an alley. They have taken advantage of government loan programs. They have invested in tents and heaters and encouraged patrons to “lean in” to having fun outside. But as fall turns to winter in Pittsburgh, he knows it won’t last. “I walk around saying, ‘Winter is coming. Winter is coming.’ We need to do everything we can to survive.”

Some states have allowed restaurants to open indoors at 25% or 50% capacity — indeed, that is permitted now in Pittsburgh. But Kurzweg has not done so, because he doesn’t feel it’s safe. Anyway, he added, “No bar or restaurant can make it at that capacity — on the best days in normal years, our profit margin is 10%.”

Some very spacious high-end restaurants, and those in temperate climates, might be able to make it work. Most can’t.

Bars and other venues that depend on drinks are not essential services. We want them to survive so that in the future we can enjoy them. So why not pay owners who cannot keep their businesses afloat safely this COVID-tainted year an average of their normal monthly income to shut down for some months? They would keep paying their employees and help break the chain of coronavirus transmission. Maybe we could get creative and ask them to use their kitchens to help feed Americans who are going hungry.

With bars closed, you could still drink and socialize with smaller groups of people at home or outdoors, when the weather allows it. That may not be quite as much fun, but nothing is much fun while the coronavirus is around.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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KHN’s ‘What the Health?’: Trump vs. COVID

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President Donald Trump’s COVID-19 diagnosis — and that of two dozen or more other officials in the White House and Capitol Hill — has scrambled an already confusing autumn. The president’s illness has thrown into doubt the remaining two presidential debates, and positive tests for several Republican senators may threaten the effort to push through a new Supreme Court justice before Election Day.

Meanwhile, it looks increasingly unlikely Congress will approve another round of economic relief before the election, even though that would be good for the president’s political fortunes and could help Democrats, too. And the Food and Drug Administration and the Centers for Disease Control and Prevention continue to fight for scientific credibility.

This week’s panelists are Julie Rovner of Kaiser Health News, Alice Miranda Ollstein of Politico, Kimberly Leonard of Business Insider and Erin Mershon of Stat News.

Among the takeaways from this week’s podcast:

  • Trump’s physician, Dr. Sean Conley, has been heavily criticized for his lack of transparency about the president’s health while battling the coronavirus. Conley repeatedly said federal rules under the HIPAA law limited his ability to answer reporters’ questions. That’s because HIPAA (the Health Insurance Portability and Accountability Act of 1996) requires a patient’s consent to release medical information.
  • Nonetheless, Trump’s COVID diagnosis renews questions about whether the public has a right to know the details of a president’s health status, especially this year when both candidates are older than 70. Trump’s opponent, former Vice President Joe Biden, has released only limited information, too.
  • Trump’s decision to unilaterally call off negotiations on a coronavirus relief package baffled and concerned Republican lawmakers and strategists because it undermines their narrative that the Democrats have refused to budge during talks.
  • Although the president has said he would support smaller stimulus bills that would help specific industries or consumers, it’s not clear what Congress would be willing to push out before the election. So, many Republican lawmakers are turning their attention to the upcoming hearings on the Supreme Court nomination of Amy Coney Barrett to rally support.
  • The widespread cases of COVID-19 tied to the White House highlight the president’s messages about masks, social isolation and other protective measures and have the potential to alienate voters, especially those who have lost loved ones or know people who have been afflicted with the disease.
  • Trump’s comments after coming home from the hospital urging the public to not be afraid of the virus or let it “dominate your life” have tapped into frustration by many people who have suffered from the economic consequences of the pandemic and are eager to put the issue behind them.
  • In the vice presidential debate Wednesday, Democratic Sen. Kamala Harris was criticized by Vice President Mike Pence for undermining public confidence in a vaccine when she said she wouldn’t take it if it were being pushed by Trump and not endorsed by public health officials. It’s a tricky issue for Democrats who believe Trump is using the vaccine trials to generate political support and his promise of approval by Election Day is politicizing the process. Yet, they know the public is eager for a successful vaccine.

This week, Rovner also interviews Amy Howe, co-founder of SCOTUSblog and host of the “SCOTUStalk” podcast. Howe explains what the Supreme Court might do with the latest case challenging the constitutionality of the Affordable Care Act.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read too:

Julie Rovner: The Atlantic’s “Trump’s Doctor Comes From a Uniquely American Brand of Medicine,” by Eleanor Cummins

Alice Miranda Ollstein: The New York Times’ “How Much Would Trump’s Coronavirus Treatment Cost Most Americans?” by Sarah Kliff

Kimberly Leonard: Business Insider’s “Meet the 30 Leaders Under 40 Who Are Transforming the Future of Hhealthcare in 2020,” by Lydia Ramsey Pflanzer

Erin Mershon: Kaiser Health News’ “Not Pandemic-Proof: Insulin Copay Caps Fall Short, Fueling Underground Exchanges,” by Markian Hawryluk

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Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Flu Season 2020: Why it’s time to talk to your doctor today about getting a flu shot

As America’s biopharmaceutical companies work around the clock to combat COVID-19, another virus with deadly consequences is right around the corner. The COVID-19 pandemic has led to more than 7.5 million infections and tragically more than 210,000 deaths. The influenza virus, more commonly known as the flu, is starting to circulate in the U.S. This year, already-strained health systems across the U.S. are preparing for a double whammy: flu season compounded by the ongoing COVID-19 pandemic.

In Debate, Pence and Harris Offer Conflicting Views of Nation’s Reality

The Trump administration’s pandemic response: decisive action that saved lives, or the greatest failure of any presidential administration? During Wednesday’s vice presidential debate, Vice President Mike Pence and the Democratic challenger, Sen. Kamala Harris of California, offered drastically different takes — from behind  plexiglass screens — on how the president has handled the COVID-19 crisis.

Pence touted problematic claims, such as that President Donald Trump’s ban on travel from China helped the nation respond to the coronavirus (PolitiFact rated a similar claim “False”) and that the country would have a vaccine in less than a year (the director of the Centers for Disease Control and Prevention said a vaccine, yet to be approved, will not be widely available until next year).

Harris said the Trump administration misled the public about how serious the virus is, pointing to briefings Trump and Pence received in January. Trump told journalist Bob Woodward in a recorded interview that he purposely downplayed it.

Our partners at PolitiFact broke down a whole gamut of claims — on fracking, the economic recovery and the Supreme Court. The highlights regarding health care and coronavirus policies follow:

Kamala Harris: “The president said [the coronavirus] was a hoax.”Rating: False

This often-repeated statement falsely attributed to Trump has its roots in a Feb. 28 rally in North Carolina. But it’s a mischaracterization of what he actually said, which was an attack on Democrats’ response to the virus.

Trump cast the Democrats’ criticism of his work as foisting a hoax on the public. “They tried the impeachment hoax,” he said. “That was not a perfect conversation. They tried anything. They tried it over and over. They’d been doing it since you got in. It’s all turning. They lost. It’s all turning. Think of it. Think of it. And this is their new hoax.”

Mike Pence: The Rose Garden event with Judge Amy Coney Barrett “was an outdoor event, which all of our scientists regularly and routinely advised.”Wrong

The event included an indoor component, during which Trump, Barrett and others posed for photos without masks. Public health officials do say outdoor activities are less risky — provided masks are worn — than indoor events, where it might be harder to keep people apart and there’s less ventilation. But attendees of the Sept. 26 White House event for the nomination of Barrett to the Supreme Court did not practice social distancing, and many did not wear masks throughout the event.

Pence: Trump “suspended all travel from China. … Joe Biden opposed that decision. He called it xenophobic and hysterical.”Misleading

There were exemptions in Trump’s travel restrictions on China. On Jan. 21, the CDC confirmed the first U.S. case of the new coronavirus: a patient in Washington state who had traveled from Wuhan, China. On Jan. 31, the Trump administration announced a ban on travelers from China, but it exempted several categories of people, including U.S. citizens and lawful permanent residents. It took effect Feb. 2.

According to The New York Times, about 40,000 people traveled from China to the United States in the two months after Trump announced travel restrictions, and 60% of people on direct flights from China were not U.S. citizens.

As for the “xenophobic and hysterical” comment, Biden has not directly said the travel restrictions were xenophobic. Around the time the Trump administration announced the restrictions, Biden said Trump had a “record of hysteria, xenophobia and fearmongering.” Biden also used the word “xenophobic” in reply to a Trump tweet about limiting entry to travelers from China in which the president described the coronavirus as the “Chinese virus.”

Harris: Obama “created within the White House an office that basically was responsible for monitoring pandemics. They got rid of it. There was a team of disease experts that President Obama and Vice President Biden dispatched to China to monitor what is now predictable and what might happen. They pulled them out.” Largely accurate

Harris described two pieces of Washington’s operation to protect against new viral threats. There was a division within the White House National Security Council. And there was a CDC office in China.

In May 2018, the top White House official in charge of the U.S. response to pandemics left the administration. Then-national security adviser John Bolton reorganized the White House global health team. Homeland security adviser Tom Bossert, who recommended strong defenses against disease and biological warfare, had left in April 2018. Neither Bossert nor the official overseeing the U.S. pandemic response was replaced. Nor were their teams, some of whose responsibilities were farmed out to other corners of the administration.

In China, the CDC program specifically charged with spotting new infectious diseases went from four American staff members in 2017 to none by 2019.

Pence: Biden’s “own chief of staff, Ron Klain, would say last year that it was pure luck, that they did everything possible wrong [with H1N1]. And we learned from that.”Needs context

Klain, Biden’s former chief of staff, spoke about H1N1 during a biosecurity conference in May 2019: “A bunch of really talented, really great people working on it, and we did every possible thing wrong. And it’s, you know, 60 million Americans got H1N1 in that period of time. And it’s just purely a fortuity that this isn’t one of the great mass casualty events in American history. It had nothing to do with us doing anything right. It just had to do with luck.”

Klain has since told Politico and FactCheck.org that his comments were taken out of context, and that they were specifically in reference to the Obama administration’s difficulties meeting the public demand for an H1N1 vaccine. He was not talking about Biden directly.

Pence: The Obama administration “left the strategic national stockpile empty.”Rating: Mostly False

The Obama administration did not leave an “empty” national stockpile. Just months before COVID cases popped up in the U.S., the former director of the stockpile described it as an $8 billion enterprise with extensive holdings of many needed items. But N95 masks, for example, had been depleted after the H1N1 outbreak in 2009.

Pence: On the nation’s COVID response, “the reality is, when you look at the Biden plan, it reads an awful lot like what President Trump and I and our task force have been doing every step of the way.”Misleading

At first glance, the Biden plan does track closely with some of the talking points advanced by the Trump administration: the need to develop and distribute a vaccine, provide COVID tests free, reduce costs for COVID treatments, and produce necessary protective equipment and ventilators. But Biden’s plan proposes many other priorities that the Trump administration has not pursued. Biden also has, throughout the campaign, followed recommendations about mask-wearing and social distancing that the administration has defied — a pattern that’s being blamed for Trump’s own infection with COVID-19 and the outbreak at the White House.

Pence: The Obama administration “left an empty and hollow plan.”Misleading

The Obama administration left a “playbook” that detailed steps to take in the event of an infectious disease outbreak. The 69-page document from 2016 was a National Security Council guidebook created to assist leaders “in coordinating a complex U.S. government response to a high-consequence emerging disease threat anywhere in the world.”

Harris: “Today they still don’t have a plan” to deal with the pandemic.Needs context

Biden said the same thing during the first presidential debate. The Trump administration does have a plan to distribute vaccines once they are produced. But experts say the administration has failed to produce a national testing plan or a national strategy to address the COVID pandemic. The administration maintains its emphasis has been on helping the economy reopen. However, it has fallen short in executing a coordinated response between the federal government and states to combat the coronavirus. More than 210,000 Americans have died of COVID-19, more deaths than in any other country.

Pence (to Harris): “The fact that you continue to undermine public confidence in a vaccine, if a vaccine emerges during the Trump administration, I think is unconscionable.”Needs context

Harris said during the debate that she would not take Trump’s word that a vaccine is effective, insisting she would instead trust the opinion of an expert, such as Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases: “I will be the first in line to take it, absolutely.” Harris recently suggested Trump would push a vaccine before it was ready to help his electoral chances. But Harris is voicing concerns shared by many Americans. Last month, a Pew poll found Americans are divided on whether to get a COVID vaccine, with 78% saying they are worried it will be approved too quickly.

Harris: “The president hasn’t been transparent in terms of health records.” Accurate

After Trump announced his COVID diagnosis and was admitted to Walter Reed National Military Medical Center for treatment, his physician, Dr. Sean Conley, briefed reporters on the president’s health. Conley provided selective information and declined to answer questions, such as when the president first tested positive for the disease or the condition of his lungs. Conley said he couldn’t share this information, citing HIPAA — the Health Insurance Portability and Accountability Act of 1996. Experts told us HIPAA does prohibit Conley from sharing any health information the president hasn’t authorized him to share. However, if Trump wanted his doctor to be transparent, he could waive HIPAA protections. Beyond the recent questions about his COVID infection, Trump has shared less general health information than past presidents. But no law requires presidents to disclose information about their health.

Pence: Biden and Harris support abortion “all the way up to the moment of birth.”Misleading

Biden and Harris have not said they support abortion up to the moment of birth. They say they support Roe v. Wade, the landmark Supreme Court case that legalized abortion while giving states the ability to regulate it after a certain point. Biden and Harris say they want to codify Roe v. Wade into law and are against state laws that they say violate the rulings in the case. Supporting Roe is not the same as supporting abortion up to the moment of birth, experts say.

“Because Roe allows states to prohibit abortion once a fetus is viable, agreement with the case does not indicate support for abortions ‘up to the moment of birth,’” said Darren Hutchinson, a professor at the University of Florida’s Levin College of Law.

KHN reporters Emmarie Huetteman and Victoria Knight and PolitiFact staff writers Daniel Funke, Jon Greenberg, Louis Jacobson, Noah Y. Kim, Bill McCarthy, Samantha Putterman, Amy Sherman and Miriam Valverde contributed to this report.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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FDA issues Covid-19 vaccine guidance as White House reportedly relents

The guidance calls for a median two months’ worth of follow-up safety data from well-designed Phase III studies as a precondition for a vaccine receiving an EUA. The Wall Street Journal reported that the White House had backed down in its opposition to the guidance, which pushes the date of an EUA past Election Day.

Distrusting Trump, States Plan to Vet COVID Vaccines Themselves. Bad Idea, Say Experts.

As trust in the Food and Drug Administration wavers, several states have vowed to conduct independent reviews of any COVID-19 vaccine the federal agency authorizes.

But top health experts say such vetting may be misguided, even if it reflects a well-founded lack of confidence in the Trump administration — especially now that the FDA has held firm with rules that make a risky preelection vaccine release highly unlikely.

At least six states and the District of Columbia have indicated they intend to review the scientific data for any vaccine approved to fight COVID-19, with some citing concern over political interference by President Donald Trump and his appointees. Officials in New York and California said they are convening expert panels expressly for that purpose.

“Frankly, I’m not going to trust the federal government’s opinion and I wouldn’t recommend [vaccines] to New Yorkers based on the federal government’s opinion,” New York Gov. Andrew Cuomo said last month.

“We want to make sure — despite the urge and interest in having a useful vaccine — that we do it with the utmost safety of Californians in mind,” Dr. Mark Ghaly, California’s health and human services secretary, said at a recent news conference.

The District of Columbia, Colorado, Michigan, Oregon and West Virginia also have said they’ll review vaccine data independently.

But scientists who study vaccine policy said such plans could backfire, confusing the public, eroding confidence in any eventual vaccine and undermining the best strategy to end the pandemic, which has sickened nearly 7.5 million Americans and killed more than 210,000.

“Do you really want a situation where Texas, Alabama and Arkansas are making drastically different vaccine policies than New York, California and Massachusetts?” asked Dr. Saad Omer, an epidemiologist who leads the Yale Institute for Global Health.

Separate state vaccine reviews would be unprecedented and disruptive, and a robust regulatory process already exists, said Michael Osterholm, an epidemiologist and director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

“States should stay out of the vaccine review business,” Osterholm said. “I think the Food and Drug Administration is doing their job right now. Unless there’s something that changes that, I do believe that they will be able to go ahead.”

The administration has given reasons for states to worry. Trump has repeatedly signaled a desire for approval of a vaccine by the Nov. 3 election, arousing fears that he will steamroll the normal regulatory process.

The president wields “considerable power” over the FDA because it’s part of the executive branch of government, said Lawrence Gostin, faculty director of the O’Neill Institute for National and Global Health Law. The president nominates the FDA commissioner and can replace that official at any time.

Trump has already contradicted the advice of his own scientific advisers in order to promote unproven therapies to fight COVID-19. The FDA approved two treatments — hydroxychloroquine and convalescent plasma — without strong evidence of safety and efficacy after Trump pushed for the therapies to be widely available.

Late Monday, The New York Times reported that top White House officials planned to block FDA guidelines that would bolster requirements for emergency authorization of a COVID vaccine — because the new guidelines would almost certainly delay approval until after the election.

The White House’s actions undermine the agency, said Dr. Paul Offit, an infectious disease expert at Children’s Hospital of Philadelphia and a member of the FDA advisory committee on vaccines.

“Trump has perverted the FDA,” Offit said. “He has scared people into thinking that normal systems aren’t in place there anymore.”

But the FDA seems to be maintaining plans that would make it virtually impossible for a vaccine to be approved by Election Day.

Dr. Peter Marks, who heads the FDA division responsible for vaccine approval, has repeatedly said career scientists at the agency are working to ensure that political pressure isn’t a factor in any decision.

FDA reviewers are determined to “keep our hands over our ears to the noise that’s coming in from all sides and keep our eyes on the prize,” Marks said Monday in a JAMA webinar.

On Tuesday, the FDA pushed back against White House interference by publishing stricter guidance for vaccine developers on its website. The document instructs vaccine companies to follow patients for two months after their last shot in order to give researchers more time to detect serious side effects and ensure the vaccine works.

For now, supporters of the normal regulatory process are pinning their hopes on two advisory groups of respected scientists who will evaluate vaccines for safety and efficacy and send their recommendations to federal agencies.

The FDA’s advisory group, known as VRBPAC, will review data submitted by the pharmaceutical companies and the agency for any vaccine. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, or ACIP, will weigh in on its use. Their recommendations aren’t binding, but the federal government has rarely contravened them.

Before jumping to independent reviews, states should allow ACIP and VRBPAC to do their jobs, said Dr. Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials. That’s the best defense against any political pressure, he said, and individual states likely wouldn’t have access to the data — or, perhaps, the expertise — to conduct their own reviews.

ACIP Chairman Dr. José Romero, who also is the chief medical officer for the Arkansas Department of Health, said the group has been meeting regularly since spring to discuss COVID vaccines and they’ve been able to proceed “in an unfettered fashion.”

“I have not felt pressured by the CDC, other government agencies or pharmaceutical companies to arrive at any particular recommendation,” he said.

Other safeguards are in place as well. Trump cannot simply override the FDA’s authority to approve drugs and vaccines, which comes from Congress.

“The president can influence the FDA, but it must be consistent with the FDA’s statutory mandate,” Gostin said. “The White House may not, for example, direct the agency to ignore science or use a lower scientific standard.”

Congress could sue the FDA for failing to follow its own standards, and a judge could issue a temporary restraining order blocking release of a COVID vaccine, Gostin said. Courts would require the FDA commissioner or health and human services secretary to have “valid, evidence-based reasons” for any decision.

“The commissioner or secretary may not act arbitrarily or according to political preferences alone,” Gostin said.

Individual states could not overrule the FDA’s authorization or approval of a vaccine, but they could wield their power in other ways. States distribute vaccines through contracts with the CDC, noted Dr. Kelly Moore, associate director of immunization education for the Immunization Action Coalition. They could say, “‘We will not place any orders until we’re sure,’” she said.

States probably could not prevent private companies, such as pharmacy chains, from distributing vaccines that are shipped directly to them. Pharmacies would likely sue any states that try to prevent them from distributing vaccines, Gostin said.

Although federal and state agencies play a crucial role in ensuring patient safety, they’re not the only entities looking out for patient interests, said Dr. Joshua Sharfstein, a former FDA deputy commissioner who is now a vice dean at the Johns Hopkins Bloomberg School of Public Health. Doctors and other medical providers won’t recommend a vaccine they don’t trust, he said.

“We have an entire health care system standing between politics and the patients,” Sharfstein said. “I think doctors are going to be very concerned if a vaccine is rushed.”

Even pharmaceutical companies that stand to profit from vaccines have a huge stake in protecting the integrity of the approval process. Nine rival vaccine makers took the unusual step last month of pledging not to release a COVID vaccine until it has been thoroughly tested for safety.

The bigger consideration, however, is how state-by-state vetting would affect consumer trust in a COVID vaccine — or any vaccine in the future, Plescia said. A recent KFF poll found 54% of Americans would not submit to a COVID vaccine authorized before Election Day.

“Are people going to mistrust the entire process?” he said. “We will get through COVID one way or another, but if we undermine confidence in public health, that would be a disaster.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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5 Things to Know About a COVID Vaccine: It Won’t Be a ‘Magic Wand’

President Donald Trump makes no secret he would like a COVID-19 vaccine to be available before the election. But it’s doubtful that will happen and, even after a vaccine wins FDA approval, there would be a long wait before it’s time to declare victory over the virus.

Dozens of vaccine candidates are in various testing stages around the world, with 11 in the last stage of preapproval clinical trials — including four in the U.S. One or more may prove safe and effective and enter the market in the coming months. What then?

Here are five things to consider in making vaccine dreams come true.

1. A vaccine is vital in fighting the virus, but it won’t be a quick pass back to our old lives.

Vaccines have helped rid the world of scourges like smallpox, but the process takes time and there are no guarantees. Until clinical trials have been completed on this first round of vaccine candidates, no one knows how effective they might prove to be.

The minimum requirement by the Food and Drug Administration for any COVID-19 vaccine is that it should at least prove 50% effective when compared with a placebo — that is, a neutral saline solution.

By comparison, the annual influenza vaccine ranges between 40% and 60% effective in preventing the illness, depending on the recipient and the season examined. In contrast, a full course of the measles vaccine is about 97% effective.

“It’s very unlikely that a first-generation vaccine will be something like a measles vaccine,” notes Dr. Amesh Adalja, a physician with expertise in infectious diseases and senior scholar at the Johns Hopkins University Center for Health Security.

2. After vaccines gain approval, the real-world evaluation ensues.

Vaccines undergo a protracted testing process involving thousands of subjects. They win FDA approval only after they demonstrate safety and meet at least the minimum standard of effectiveness. Monitoring continues after they hit the market; effectiveness and any rare side effects or safety issues become more apparent after millions of doses are given.

Hypothetically, let’s say the first new COVID vaccines prove 70% effective at preventing the disease. That would mean seven of every 10 people who roll up their sleeves will be protected, but three will not.

While that’s good news for those protected, questions remain about who is covered and who is still vulnerable. It’s possible, Adalja said, that the vaccine would reduce the severity of disease in the remaining three people, thereby helping cut hospitalizations and severe side effects.

But it’s also true that regulators are focused on whether a vaccine prevents disease. Some vaccines can keep you from getting sick without preventing infection, in which case you could still spread the virus even without exhibiting symptoms.

Mysteries remain, at least for now. Scientists don’t know how long the protection will last, for instance. Will protection fade, requiring annual shots, as with influenza? Or will it last for years?

Also, the COVID vaccine candidates are being tested only in adults so far. Most vaccine makers have delayed testing among children or pregnant and breastfeeding women, for example. That could mean an initial lag in safety and efficacy data for those groups, complicating vaccination efforts for children or even front-line health care workers, many of whom are women of childbearing age.

For all those reasons — “if you are looking for a magic wand, you won’t find one in vaccines,” said Dr. William Schaffner, a professor of preventive medicine and infectious disease at Vanderbilt University Medical Center in Nashville, Tennessee. “That said, vaccines will play a substantial role in reducing the epidemic.”

3. After a vaccine is approved, you still may need to wait awhile to get your shot.

Making vaccines is complicated. And so is distributing them. Vaccine makers say they are already producing vaccine in advance of knowing whether they will win approval. But simply having ample vaccine supply doesn’t mean manufacturers will have all the needed glass bottles, syringes or injectors to ship them right away. Indeed, some experts fear that a shortage of both production-line capabilities (special facilities are needed to make vaccines under strict sterile conditions) and limited supplies could hamper distribution of an approved vaccine. Many of the vaccine candidates must be shipped and stored at super-low temperatures, adding to the complexity.

“Even if you have the vaccine, that doesn’t mean you can ship it out. There are multiple, multiple steps, and all of them have to work,” said Dr. Ezekiel Emanuel, a vice provost at the University of Pennsylvania who has warned of potential shortages.

The Centers for Disease Control and Prevention and the National Academy of Sciences have issued a framework for who should get priority for the initial vaccine. State and local health departments will also have a say in how supplies roll out.

Current recommendations say first in line will be health care workers and people with medical conditions that put them at highest risk if they get the virus. People living in nursing homes and other congregate settings will also be higher on the list. Further down are average healthy adults.

Pay attention, and go when it’s your turn, said Schaffner.

“If they say it’s time for people who are middle-aged and have chronic underlying illness such as diabetes, heart disease and lung disease, you have to know what you have and understand it’s your turn,” he said. “You also have to understand if it’s not your turn yet. Be patient.”

Finally, many of the vaccines under consideration will require two doses spaced a few weeks apart, which would add to the delay. If more than one vaccine is approved, which is likely, people will need the second dose to come from the same manufacturer as the first. That could prove a record-keeping nightmare and lead to more delays — depending on how vaccine supplies hold up.

In testimony before Congress in mid-September, CDC Director Robert Redfield said that tens of millions of doses of vaccine may start to become available by late November or December. But the logistics of vaccine distribution means the country won’t be able to return to “regular life” until “late second quarter, third quarter 2021,” Redfield predicted.

4. So don’t throw out your masks yet.

Because any vaccine is likely to fall short of 100% effectiveness and won’t be in widespread distribution for a while, the use of masks and maintaining social distance will be required well into next year, experts say.

“The vaccine will be a start, but we’ll still need to do the things we’ve been discussing throughout — hand hygiene, wearing masks and continuing to remain specifically distant,” said Dr. Krutika Kuppalli, an assistant professor of infectious disease at the Medical University of South Carolina. “Those are the arsenal of tools we will need to use.”

5. What if I don’t want to get vaccinated?

Polls show a good percentage of Americans either don’t want a vaccine or want to wait a bit before getting one. Can they be required to get a shot?

Certain employers, such as hospitals or food production plants, could require their workers to be vaccinated, but a federal mandate is highly unlikely and probably would be unconstitutional, said professor Dorit Rubinstein Reiss, an expert on employer and vaccine law at the University of California-Hastings College of Law.

The likely approach of public health authorities is to educate people about the benefits and potential side effects of a vaccine — down to whether one might experience a sore arm.

“That’s what we do for every vaccine,” said Adalja of Johns Hopkins. A requirement of vaccination for the general public would create resistance and “foster conspiracy theories,” he said.

Most regulation of public health falls to state and local governments and health agencies, Reiss said. States would be “more likely to have narrow or specific mandates that could survive judicial review,” she said.

Schools, of course, require students to be vaccinated against a wide range of illnesses. But a school-age COVID vaccine mandate is doubtful, at least in the near term, because the vaccine hasn’t been tested on school-aged children.

Generally speaking, employers, including the federal government, have the power to require vaccinations, especially if they don’t have a unionized workforce with a contract that might limit their power. All employers, however, face limits set by civil rights and disability laws and may have to provide alternatives for people who can’t or won’t get vaccinated, Reiss said.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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The Role of Meat and Dairy Viruses in Cancer

“Nearly 20% of cancer cases arising worldwide can be linked to infectious agents, including viruses.” Seven viruses are now conclusively tied to human cancers, and, as new viruses enter into human populations, the incidence and causes of cancer will likely change accordingly.

The foundation of modern tumor virology was laid more than a century ago with the discovery of a cancer-causing chicken virus, for which a Nobel Prize was awarded. Another Nobel Prize went to the “medical doctor-turned-virologist” who discovered that the HPV virus was causing cervical cancer. In his acceptance speech, he mused that there may be a bovine polyoma virus—a multiple tumor virus in cattle—that could be playing a role in human colon cancer, lung cancer, and breast cancer, but no polyoma virus had ever been discovered in meat…until now.

As I discuss in my video The Role of Burger Viruses in Cancer, polyomaviruses are a particular concern—not only because they are known to be carcinogenic, but also because they can survive cooking temperatures. Since a single burger these days can contain meat from “many dozens of animals,” researchers felt “this could present an ideal situation for virus-hunting…” Researchers from the National Cancer Institute purchased meat samples from three separate supermarkets and found three different polyomaviruses in ground beef, as you can see at 1:52 in my video. Now, just because three types of “polyomavirus species are commonly detectable in food-grade ground beef” doesn’t necessarily mean they are causing human disease. What made this Nobel laureate suspect them? Well, for one thing, some people got cancer right where they had been vaccinated for smallpox—a whole bunch of different cancers, in fact. The vaccine had been harvested from the skin of calves, so “it is possible” there could have been some cancer-causing cow virus.

“Many people are exposed to potentially virus-contaminated meat and dairy products” through their diets, but those in the industry, “such as farm workers, butchers, veterinarians, and employees in dairies,” would be even more exposed. Do these groups have higher cancer incidence? Indeed, it now appears to be clear “that workers in the meat industry are at increased risk of developing and dying from cancer.”

Another reason to suspect the involvement of some kind of bovine infectious factor in colorectal cancer is the fact that there appear to be relatively low rates of colorectal cancer in countries where not a lot of beef is eaten. And, when meat consumption suddenly increases, rates shoot up, as you can see at 3:15 in my video. “The only exception is Mongolia where they have low rates of colon cancer and eat a lot of red meat, but there they eat yak.” Maybe yaks don’t harbor the same viruses.

Can’t you just avoid steak tartare? Even steak cooked “medium” may not reach internal temperatures above 70° Celsius, and it takes temperatures higher than that to inactivate some of these viruses, so we would expect viruses to survive both cooking and pasteurization. In fact, researchers followed up with a paper suggesting the consumption of dairy products may “represent one of the main risk factors for the development of breast cancer” in humans. The recent discovery of a larger number of presumably new viruses in the blood, meat, and milk of dairy cows should be investigated, since one might speculate that infectious “agents present in dairy products possess a higher affinity to mammary [breast] cells,” since they came from breast cells. The fact that people with lactose intolerance, who tend to avoid milk and dairy throughout their lives, have lower rates of breast and other cancers could be seen as supporting this concept. Though, there are certainly other reasons dairy may increase cancer risk, such as increasing levels of the cancer-promoting growth hormone IGF-1 or adversely affecting our gut microbiome. Or, for that matter, maybe the plant-based milks they’re drinking instead could be protective. That’s the problem with population studies: You can’t tease out cause and effect. It doesn’t matter how many viruses are found in retail beef, pork, and chicken, as you can see at 5:16 in my video, if we can’t connect the dots.  

Can’t we just look for the presence of these viruses within human tumors? Researchers have tried and did find some, but even if you don’t find any, that doesn’t necessarily mean viruses didn’t play a role. There’s a “viral hit-and-run” theory of cancer development that suggests that certain viruses can slip in and out of our DNA to initiate the cancer, but be long gone by the time the tumor matures.

There’s still a lot of work to be done. But, if the link between bovine polyomaviruses and human disease pans out, the National Cancer Institute researchers envision the development of a high potency vaccine. So, just like the HPV vaccine may prevent cervical cancer from unsafe sex, perhaps one day, vaccines may prevent breast and colon cancer from unsafe sirloin.


This reminds me of the story of bovine leukemia virus and breast cancer. For more on that, see:

What about chicken? Check out The Role of Poultry Viruses in Human Cancers and Poultry and Penis Cancer.

One of the problems with eating other animals is that we put ourselves at risk of their diseases. Not once have I diagnosed anyone with Dutch Elm Disease or a really bad case of aphids. See Eating Outside Our Kingdom for more on this concept.

In health,

Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:

 

 

COVID + Influenza: éste es un buen año para vacunarse, aconsejan expertos

La temporada de influenza se verá diferente este año, ya que los Estados Unidos se enfrentan a una pandemia de coronavirus que ya ha matado a más de 176.000 personas.

Muchos estadounidenses son reacios a ir al médico y los funcionarios de salud pública temen que las personas eviten vacunarse.

Aunque a veces se considera incorrectamente como un resfriado, la gripe también mata a decenas de miles de personas en el país cada año. Los más vulnerables son los niños pequeños, los adultos mayores y las personas con enfermedades subyacentes. Cuando se combina con los efectos de COVID-19, los expertos en salud pública dicen que es más importante que nunca vacunarse contra la gripe.

Si una cantidad suficiente de la población se vacuna, más del 45% lo hizo la temporada de gripe pasada, podría ayudar a evitar un escenario de pesadilla este invierno, con hospitales llenos de pacientes con COVID-19 y los que sufren los efectos graves de la influenza.

Además de la posible carga para los hospitales, existe la posibilidad de que las personas contraigan ambos virus y “nadie sabe qué sucede si se contrae influenza y COVID simultáneamente porque nunca sucedió antes”, dijo la doctora Rachel Levine, secretaria de Salud de Pennsylvania, a reporteros.

En respuesta, este año los fabricantes están produciendo más suministros de vacunas, entre 194 y 198 millones de dosis, unas 20 millones más de las que se distribuyeron la temporada pasada, según los Centros para el Control y Prevención de Enfermedades (CDC).

Mientras se acerca la temporada de gripe, aquí hay algunas respuestas a preguntas frecuentes:

P: ¿Cuándo debo vacunarme contra la gripe?

La publicidad ya ha comenzado y algunas farmacias y clínicas ya tienen sus suministros. Pero, debido a que la efectividad de la vacuna puede disminuir con el tiempo, los CDC recomiendan no recibir la dosis en agosto.

Muchas farmacias y clínicas comenzarán las inmunizaciones a principios de septiembre. Generalmente, los virus de la influenza comienzan a circular a mediados o fines de octubre, pero se expanden masivamente más tarde, en el invierno. Se necesitan aproximadamente dos semanas después de recibir la inyección para que los anticuerpos, que circulan en la sangre y frustran las infecciones, se acumulen.

“Las personas jóvenes y sanas pueden comenzar a vacunarse contra la gripe en septiembre, y las personas mayores y otras poblaciones vulnerables pueden hacerlo en octubre”, dijo el doctor Steve Miller, director clínico de la aseguradora Cigna.

Los CDC recomiendan que las personas “se vacunen contra la influenza a fines de octubre”, pero señalaron que se puede recibir la vacuna más tarde porque “aún puede ser beneficiosas y la vacunación debe ofrecerse a lo largo de toda la temporada de influenza”.

Aun así, algunos expertos recomiendan no esperar demasiado este año, no solo por COVID-19, sino también en caso de que haya escasez debido a la abrumadora demanda.

P: ¿Cuáles son las razones por las que las que debería ofrecer mi brazo para vacunarme?

Hay que vacunarse porque brinda protección contra la gripe y, por lo tanto, contra la propagación a otras personas, lo que puede ayudar a disminuir la carga para los hospitales y el personal médico.

Y hay otro mensaje que puede resonar en estos tiempos extraños.

“Le da a la gente la sensación de que hay algunas cosas que pueden controlar”, dijo Eduardo Sánchez, director médico de prevención de la American Heart Association.

Si bien una vacuna contra la gripe no evitará COVID-19, recibirla podría ayudar al médico a diferenciar entre las dos enfermedades si se desarrolla algún síntoma (fiebre, tos, dolor de garganta) que ambas infecciones comparten, explicó Sánchez.

Y aunque las vacunas contra la gripe no evitarán todos los casos de gripe, vacunarse puede reducir la gravedad si la persona se enferma, dijo.

Todas las personas elegibles, especialmente los trabajadores esenciales, los que sufren de afecciones subyacentes y aquellos en mayor riesgo, incluidos los niños muy pequeños y las mujeres embarazadas, deben buscar protección, dijeron los CDC. La entidad recomienda la vacunación a partir de los 6 meses.

P: ¿Qué sabemos sobre la efectividad de la vacuna de este año?

Se deben producir nuevas vacunas contra la gripe cada año, porque el virus muta y la efectividad de la vacuna varía, dependiendo de qué tan bien coincida con el virus circulante.

Se calculó que la formulación del año pasado tuvo una eficacia de aproximadamente un 45% para prevenir la gripe en general, con una efectividad de aproximadamente un 55% en los niños. Las vacunas disponibles en el país este año tienen como objetivo prevenir al menos tres cepas diferentes del virus, y la mayoría cubre cuatro.

Todavía no se sabe qué tan bien coincidirá el suministro de este año con las cepas que circularán en los Estados Unidos. Las primeras indicaciones del hemisferio sur, que atraviesa su temporada de gripe durante nuestro verano, son alentadoras. Allí, las personas practicaron el distanciamiento social, usaron máscaras y se vacunaron en mayor número este año, y los niveles mundiales de gripe son más bajos de lo esperado. Sin embargo, expertos advierten que no se debe contar con una temporada igual de suave en los Estados Unidos, en parte porque los esfuerzos por usar mascara facial y de distanciamiento social varían ampliamente.

P: ¿Qué están haciendo diferente los seguros y sistemas de salud este año?

Las aseguradoras y los sistemas de salud contactados por KHN dicen que seguirán las pautas de los CDC, que exigen limitar y espaciar la cantidad de personas que esperan en las filas y las áreas de vacunación. Algunos están programando citas para vacunas contra la gripe para ayudar a controlar el flujo.

Health Fitness Concepts, una compañía que trabaja con UnitedHealth Group y otras empresas para establecer clínicas de vacunación contra la gripe en el noreste del país, dijo que está “fomentando eventos más pequeños y frecuentes para apoyar el distanciamiento social” y “exigiendo que se completen todos los formularios y arremangarse las camisas antes de entrar al área de vacunación contra la influenza”.

Se requerirá que todos usen máscaras.

Además, a nivel nacional, algunos grupos médicos contratados por UnitedHealth instalarán carpas, para que las inyecciones se puedan administrar al aire libre, dijo un vocero.

Kaiser Permanente planifica las vacunas directamente en autos en algunos de sus centros médicos y está probando los procedimientos de detección y registro sin contacto en algunos lugares.

Geisinger Health, un proveedor de salud regional en Pennsylvania y Nueva Jersey, dijo que también tendría programas de vacunación contra la influenza al aire libre en sus instalaciones.

Además, “Geisinger exige que todos los empleados reciban la vacuna contra la influenza este año”, dijo Mark Shelly, director de prevención y control de infecciones del sistema. “Al dar este paso, esperamos transmitir a nuestros vecinos la importancia de la vacuna contra la influenza para todos”.

P: Por lo general, me vacunan contra la gripe en el trabajo. ¿Seguirá siendo una opción este año?

Con el objetivo de evitar riesgosas reuniones en interiores, muchos empleadores se muestran reacios a patrocinar las clínicas de gripe en oficinas como han ofrecido en años anteriores. Y con tanta gente que sigue trabajando desde casa, hay menos necesidad de llevar las vacunas contra la gripe al lugar de trabajo. En cambio, muchos empleadores están alentando a los trabajadores a que reciban vacunas de sus médicos de atención primaria, en farmacias u otros entornos comunitarios. El seguro generalmente cubrirá el costo de la vacuna.

Algunos empleadores están considerando ofrecer cupones para vacunas contra la gripe a sus trabajadores sin seguro o a aquellos que no participan en el plan médico de la compañía, dijo Julie Stone, directora general de salud y beneficios de Willis Towers Watson, una firma consultora.

Estos cupones podrían, por ejemplo, permitir a los trabajadores obtener la vacuna en un laboratorio en particular sin costo.

Algunos empleadores están comenzando a pensar en cómo podrían usar sus estacionamientos para administrar vacunas contra la gripe enlos autos, dijo el doctor David Zieg, líder de servicios clínicos para el consultor de beneficios Mercer.

Aunque la ley federal permite a los empleadores exigir a los empleados que se vacunen contra la gripe, ese paso generalmente lo toman solo los centros de atención médica y algunas universidades donde las personas viven y trabajan en estrecha colaboración, dijo Zieg.

Pero sucede. El mes pasado, el sistema de la Universidad de California emitió una orden ejecutiva que requiere que todos los estudiantes, profesores y personal se vacunen contra la gripe antes del 1 de noviembre, con limitadas excepciones.

P: ¿Qué están haciendo las farmacias para alentar a las personas a vacunarse contra la gripe?

Algunas farmacias están haciendo un esfuerzo adicional para salir a la comunidad y ofrecer vacunas contra la gripe.

Walgreens, que tiene casi 9,100 farmacias en todo el país, continúa una asociación iniciada en 2015 con organizaciones comunitarias, iglesias y empleadores que ha ofrecido alrededor de 150,000 clínicas de gripe móviles hasta la fecha.

El programa pone especial énfasis en trabajar con poblaciones vulnerables y en áreas desatendidas, dijo el doctor Kevin Ban, director médico de la cadena de farmacias.

Walgreens comenzó a ofrecer vacunas contra la gripe a mediados de agosto y está animando a las personas a no demorar en vacunarse.

Tanto Walgreens como CVS están estimulando a las personas a programar citas y hacer trámites en línea este año para minimizar el tiempo que pasan en los locales.

En los CVS MinuteClinic, una vez que los pacientes se han registrado para recibir la vacuna contra la gripe, deben esperar afuera o en su automóvil, ya que las áreas de espera interiores ahora están cerradas.

“No tenemos un arsenal contra COVID”, dijo Ban, de Walgreens. “Pero quitar la presión del sistema de atención médica proporcionando vacunas por adelantado es algo que sí podemos hacer”.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Republican Convention, Day 4: Fireworks … and Shining a Light on Trump’s Claims

President Donald Trump accepted the Republican Party’s nomination for president in a 70-minute speech from the South Lawn of the White House on Thursday night.

Speaking to a friendly crowd that didn’t appear to be observing social distancing conventions, and with few participants wearing masks, he touched on a range of topics, including many related to the COVID pandemic and health care in general.

Throughout, the partisan crowd applauded and chanted “Four more years!” And, even as the nation’s COVID-19 death toll exceeded 180,000, Trump was upbeat. “In recent months, our nation and the entire planet has been struck by a new and powerful invisible enemy,” he said. “Like those brave Americans before us, we are meeting this challenge.”

At the end of the event, there were fireworks.

Our partners at PolitiFact did an in-depth fact check on Trump’s entire acceptance speech. Here are the highlights related to the administration’s COVID-19 response and other health policy issues:

“We developed, from scratch, the largest and most advanced testing system in the world.” 

This is partially right, but it needs context.

It’s accurate that the U.S. developed its COVID-19 testing system from scratch, because the government didn’t accept the World Health Organization’s testing recipe. But whether the system is the “largest” or “most advanced” is subject to debate.

The U.S. has tested more individuals than any other country. But experts told us a more meaningful metric would be the percentage of positive tests out of all tests, indicating that not only sick people were getting tested. Another useful metric would be the percentage of the population that has been tested. The U.S. is one of the most populous countries but has tested a lower percentage of its population than other countries.

The U.S. was also slower than other countries in rolling out tests and amping up testing capacity. Even now, many states are experiencing delays in reporting test results to positive individuals.

As for “the most advanced,” Trump may be referring to new testing investments and systems, like Abbott’s recently announced $5, 15-minute rapid antigen test, which the company says will be about the size of a credit card, needs no instrumentation and comes with a phone app through which people can view their results. But Trump’s comment makes it sound as if these testing systems are already in place when they haven’t been distributed to the public.

“The United States has among the lowest [COVID-19] case fatality rates of any major country in the world. The European Union’s case fatality rate is nearly three times higher than ours.”

The case fatality rate measures the known number of cases against the known number of deaths. The European Union has a rate that’s about 2½ times greater than the United States.

But the source of that data, Oxford University’s Our World in Data project, reports that “during an outbreak of a pandemic, the case fatality rate is a poor measure of the mortality risk of the disease.”

A better way to measure the threat of the virus, experts say, is to look at the number of deaths per 100,000 residents. Viewed that way, the U.S. has the 10th-highest death rate in the world.

“We will produce a vaccine before the end of the year, or maybe even sooner.”

It’s far from guaranteed that a coronavirus vaccine will be ready before the end of the year.

While researchers are making rapid strides, it’s not yet known precisely when the vaccine will be available to the public, which is what’s most important. Six vaccines are in the third phase of testing, which involves thousands of patients. Like earlier phases, this one looks at the safety of a vaccine but also examines its effectiveness and collects more data on side effects. Results of the third phase will be submitted to the Food and Drug Administration for approval.

The government website Operation Warp Speed seems less optimistic than Trump, announcing it “aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021.”

And federal health officials and other experts have generally predicted a vaccine will be available in early 2021. Federal committees are working on recommendations for vaccine distribution, including which groups should get it first. “From everything we’ve seen now — in the animal data, as well as the human data — we feel cautiously optimistic that we will have a vaccine by the end of this year and as we go into 2021,” said Dr. Anthony Fauci, the nation’s top infectious diseases expert. “I don’t think it’s dreaming.”

“Last month, I took on Big Pharma. You think that is easy? I signed orders that would massively lower the cost of your prescription drugs.”

Quite misleading. Trump signed four executive orders on July 24 aimed at lowering prescription drug prices. But those orders haven’t taken effect yet — the text of one hasn’t even been made publicly available — and experts told us that, if implemented, the measures would be unlikely to result in significant drug price reductions for the majority of Americans.

“We will always and very strongly protect patients with preexisting conditions, and that is a pledge from the entire Republican Party.”

Trump’s pledge is undermined by his efforts to overturn the Affordable Care Act, the only law that guarantees people with preexisting conditions both receive health coverage and do not have to pay more for it than others do. In 2017, Trump supported congressional efforts to repeal the ACA. The Trump administration is now backing GOP-led efforts to overturn the ACA through a court case. And Trump has also expanded short-term health plans that don’t have to comply with the ACA.

“Joe Biden recently raised his hand on the debate stage and promised he was going to give it away, your health care dollars to illegal immigrants, which is going to bring a massive number of immigrants into our country.”

This is misleading. During a June 2019 Democratic primary debate, candidates were asked: “Raise your hand if your government plan would provide coverage for undocumented immigrants.” All candidates on stage, including Biden, raised their hands. They were not asked if that coverage would be free or subsidized.

Biden supports extending health care access to all immigrants, regardless of immigration status. A task force recommended that he allow immigrants who are in the country illegally to buy health insurance, without federal subsidies.

“Joe Biden claims he has empathy for the vulnerable, yet the party he leads supports the extreme late-term abortion of defenseless babies right up to the moment of birth.”

This mischaracterizes the Democratic Party’s stance on abortion and Biden’s position.

Biden has said he would codify the Supreme Court’s ruling in Roe v. Wade and related precedents. This would generally limit abortions to the first 20 to 24 weeks of gestation. States are allowed under court rulings to ban abortion after the point at which a fetus can sustain life, usually considered to be between 24 and 28 weeks from the mother’s last menstrual period — and 43 states do. But the rulings require states to make exceptions “to preserve the life or health of the mother.” Late-term abortions are very rare, about 1%.

The Democratic Party platform holds that “every woman should have access to quality reproductive health care services, including safe and legal abortion — regardless of where she lives, how much money she makes, or how she is insured.” It does not address late-term abortion.

PolitiFact’s Daniel Funke, Jon Greenberg, Louis Jacobson, Noah Y. Kim, Bill McCarthy, Samantha Putterman, Amy Sherman, Miriam Valverde and KHN reporter Victoria Knight contributed to this report.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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COVID + Influenza: This Is a Good Year to Get a Flu Shot, Experts Advise

Flu season will look different this year, as the country grapples with a coronavirus pandemic that has killed more than 172,000 people. Many Americans are reluctant to visit a doctor’s office and public health officials worry people will shy away from being immunized.

Although sometimes incorrectly regarded as just another bad cold, flu also kills tens of thousands of people in the U.S. each year, with the very young, the elderly and those with underlying conditions the most vulnerable. When coupled with the effects of COVID-19, public health experts say it’s more important than ever to get a flu shot.

If enough of the U.S. population gets vaccinated — more than the 45% who did last flu season — it could help head off a nightmare scenario in the coming winter of hospitals stuffed with both COVID-19 patients and those suffering from severe effects of influenza.

Aside from the potential burden on hospitals, there’s the possibility people could get both viruses — and “no one knows what happens if you get influenza and COVID [simultaneously] because it’s never happened before,” Dr. Rachel Levine, Pennsylvania’s secretary of health, told reporters this month.

In response, manufacturers are producing more vaccine supply this year, between 194 million and 198 million doses, or about 20 million more than they distributed last season, according to the Centers for Disease Control and Prevention.

As flu season approaches, here are some answers to a few common questions:

Q: When should I get my flu shot?

Advertising has already begun, and some pharmacies and clinics have their supplies now. But, because the effectiveness of the vaccine can wane over time, the CDC recommends against a shot in August.

Many pharmacies and clinics will start immunizations in early September. Generally, influenza viruses start circulating in mid- to late October but become more widespread later, in the winter. It takes about two weeks after getting a shot for antibodies — which circulate in the blood and thwart infections — to build up. “Young, healthy people can begin getting their flu shots in September, and elderly people and other vulnerable populations can begin in October,” said Dr. Steve Miller, chief clinical officer for insurer Cigna.

The CDC has recommended that people “get a flu vaccine by the end of October,” but noted it’s not too late to get one after that because shots “can still be beneficial and vaccination should be offered throughout the flu season.”

Even so, some experts say not to wait too long this year — not only because of COVID-19, but also in case a shortage develops because of overwhelming demand.

Q: What are the reasons I should roll up my sleeve for this?

Get a shot because it protects you from catching the flu and spreading it to others, which may help lessen the burden on hospitals and medical staffs.

And there’s another message that may resonate in this strange time.

“It gives people a sense that there are some things you can control,” said Eduardo Sanchez, chief medical officer for prevention at the American Heart Association.

While a flu shot won’t prevent COVID-19, he said, getting one could help your doctors differentiate between the diseases if you develop any symptoms — fever, cough, sore throat — they share.

And even though flu shots won’t prevent all cases of the flu, getting vaccinated can lessen the severity if you do fall ill, he said.

You cannot get influenza from having a flu vaccine.

All eligible people, especially essential workers, those with underlying conditions and those at higher risk — including very young children and pregnant women — should seek protection, the CDC said. It recommends that children over 6 months old get vaccinated.

Q: What do we know about the effectiveness of this year’s vaccine?

Flu vaccines — which must be developed anew each year because influenza viruses mutate — range in effectiveness annually, depending on how well they match the circulating virus. Last year’s formulation was estimated to be about 45% effective in preventing the flu overall, with about a 55% effectiveness in children. The vaccines available in the U.S. this year are aimed at preventing at least three strains of the virus, and most cover four.

It isn’t yet known how well this year’s supply will match the strains that will circulate in the U.S. Early indications from the Southern Hemisphere, which goes through its flu season during our summer, are encouraging. There, people practiced social distancing, wore masks and got vaccinated in greater numbers this year — and global flu levels are lower than expected. Experts caution, however, not to count on a similarly mild season in the U.S., in part because masking and social distancing efforts vary widely.

Q: What are insurance plans and health systems doing differently this year?

Insurers and health systems contacted by KHN say they will follow CDC guidelines, which call for limiting and spacing out the number of people waiting in lines and vaccination areas. Some are setting appointments for flu shots to help manage the flow.

Health Fitness Concepts, a company that works with UnitedHealth Group and other businesses to set up flu shot clinics in the Northeast, said it is “encouraging smaller, more frequent events to support social distancing” and “requiring all forms to be completed and shirtsleeves rolled up before entering the flu shot area.” Everyone will be required to wear masks.

Also, nationally, some physician groups contracted with UnitedHealth will set up tent areas so shots can be given outdoors, a spokesperson said.

Kaiser Permanente plans drive-thru vaccinations at some of its medical facilities and is testing touch-free screening and check-in procedures at some locations. (KHN is not affiliated with Kaiser Permanente.)

Geisinger Health, a regional health provider in Pennsylvania and New Jersey, said it, too, would have outdoor flu vaccination programs at its facilities.

Additionally, “Geisinger is making it mandatory for all employees to receive the flu vaccine this year,” said Mark Shelly, the system’s director of infection prevention and control. “By taking this step, we hope to convey to our neighbors the importance of the flu vaccine for everyone.”

Q: Usually I get a flu shot at work. Will that be an option this year?

Aiming to avoid risky indoor gatherings, many employers are reluctant to sponsor the on-site flu clinics they’ve offered in years past. And with so many people continuing to work from home, there’s less need to bring flu shots to employees on the job. Instead, many employers are encouraging workers to get shots from their primary care doctors, at pharmacies or in other community settings. Insurance will generally cover the cost of the vaccine.

Some employers are considering offering vouchers for flu shots to their uninsured workers or those who don’t participate in the company plan, said Julie Stone, managing director for health and benefits at Willis Towers Watson, a consulting firm. The vouchers could allow workers to get the shot at a particular lab at no cost, for example.

Some employers are starting to think about how they might use their parking lots for administering drive-thru flu shots, said Dr. David Zieg, clinical services leader for benefits consultant Mercer.

Although federal law allows employers to require employees to get flu shots, that step is typically taken only by health care facilities and some universities where people live and work closely together, Zieg said.

Q: What are pharmacies doing to encourage people to get flu shots?

Some pharmacies are making an extra push to get out into the community to offer flu shots.

Walgreens, which has nearly 9,100 pharmacies nationwide, is continuing a partnership begun in 2015 with community organizations, churches and employers that has offered about 150,000 off-site and mobile flu clinics to date.

The program places a special emphasis on working with vulnerable populations and in underserved areas, said Dr. Kevin Ban, chief medical officer for the drugstore chain.

Walgreens began offering flu shots in mid-August and is encouraging people not to delay getting vaccinated.

Both Walgreens and CVS are encouraging people to schedule appointments and do paperwork online this year to minimize time spent in the stores.

At CVS MinuteClinic locations, once patients have checked in for their flu shot, they must wait outside or in their car, since the indoor waiting areas are now closed.

“We don’t have tons of arrows in our quiver against COVID,” Walgreens’ Ban said. “Taking pressure off the health care system by providing vaccines in advance is one thing we can do.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Moderna’s COVID vaccine works in older people, according to new data

Moderna has said that its coronavirus vaccine stimulated an immune response in older people in phase 1 trials, suggesting that the jab is effective in the age groups most susceptible to COVID-19.

An analysis of the latest data from a phase 1 trial showed that in 20 older adults given the vaccine – ten between the ages of 56 and 70 and ten aged 71 and older – the vaccine produced neutralising antibodies and T-cells in comparable levels to those aged 18 to 55-years-old.

These antibody levels were also higher than those typically seen in people recovering from the virus, the company said.

There were also no serious adverse events reported. Some patients reported fatigue, chills, headaches and pain at the injection site, though the majority of symptoms resolved within two days. 

Each participant received two 100 microgram doses of the vaccine 28 days apart – the same dose used in the vaccine’s ongoing phase 3 trials.

Moderna said the results show that the vaccine works as well in older adults as it does in people aged 18 to 55-years-old.

Death rates from COVID-19 are much higher in older people, but often people in these age groups show smaller immune responses from vaccines than younger adults.

The company’s shares rose about 6% on the news.

Health officials had previously expressed concerns that Moderna’s phase 1 study was small and that results may differ for other populations, including older people. This analysis may allay those concerns.

The company has also noted that 18% of the participants enrolled in its phase 3 study are Black, Latino, Native American or Alaska Native – groups that are often underrepresented in clinical studies but have been hard-hit by COVID-19.

Moderna has received funding from the US government to expand its late-stage trial. The US has also bought 100 million doses of the mRNA vaccine for more than $1.5 billion – a deal that sparked controversy when the consumer advocacy group Public Citizen said that taxpayers were “paying twice” for the jab.

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LA Hospital Seeks Vaccine Trial Participants Among Its Own High-Risk Patients

The patients at Dr. Eric Daar’s hospital are at high risk for serious illness from COVID-19, and he’s determined to make sure they’re part of the effort to fight the disease.

He also hopes they can protect themselves in the process.

When Daar and his colleagues at Harbor-UCLA Medical Center on Wednesday announce the start of enrollment for a trial to test a COVID-19 vaccine produced by AstraZeneca, they will also unveil the hospital’s community-based recruitment strategy.

Harbor-UCLA wants to recruit most, if not all, of the trial’s 500 participants from among the high-risk patients it already treats: people over 65, those with chronic illnesses and members of underserved racial and ethnic groups. Hospital officials also expect that the recruitment task will not be easy.

“It’s a priority and obligation to make sure our community is well represented in these trials,” said Daar, chief of HIV medicine at Harbor-UCLA and a researcher at the UCLA-affiliated Lundquist Institute, who dropped his other research projects last spring to focus on a COVID-19 vaccine.

The safety-net hospital in Torrance, California, serves patients in the South Bay area of Los Angeles County who are predominantly Black, Latino and Pacific Islander. Many live in crowded homes and do “essential” work that requires them to expose themselves to the virus to make a living: They’re orderlies and cooks and house cleaners, day laborers and bus drivers and sanitation workers.

The area has high rates of heart disease and stroke.

“If you don’t have a community represented in the trial, it’s hard to extrapolate your results to the community,” said Dr. Katya Corado, one of Daar’s colleagues. “We want to find something to protect our patients and loved ones.”

Latinos and Blacks in the United States are nearly three times more likely than non-Hispanic whites to be diagnosed with COVID-19 and nearly five times more likely to be hospitalized with the disease. In Los Angeles County, Latinos in particular have been disproportionately stricken by the virus.

Eight of 10 COVID-19 deaths nationwide occur among people 65 and older, according to the Centers for Disease Control and Prevention.

Historically, Blacks and Latinos have been less likely to be included in clinical trials for disease treatment, despite federal guidelines that urge minority and elder participation.

The National Institutes of Health and the Food and Drug Administration have urged infectious disease researchers to focus on these vulnerable populations in the large phase 3 trials that will test how well vaccines prevent COVID-19.

Harbor-UCLA, a public teaching hospital owned and operated by Los Angeles County, is one of roughly 100 sites nationwide testing the AstraZeneca vaccine candidate, which was developed in collaboration with Oxford University in Britain. Phase 3 trials of about the same size for vaccine candidates produced by Moderna and Pfizer are already underway. Each of the three companies seeks to recruit 30,000 people, 20,000 of whom will get the vaccine and 10,000 a placebo, or harmless saline solution, to test whether the vaccine prevents coronavirus disease.

Recruitment at Harbor-UCLA will include patients with well-controlled chronic diseases such as diabetes and hypertension, and people with HIV who’ve kept the virus under control with medication, Daar said.

According to the AstraZeneca trial protocol, patients will get up to $100 for each of 15 to 20 visits during the two-year trial. The Harbor-UCLA team will also offer car services to bring people to the hospital through L.A. traffic.

To reach its targeted recruits, the hospital will distribute leaflets to clinics and community organizations and create targeted social media campaigns, in addition to taking any free publicity it can get, Daar said.

Recruitment of high-risk patients in other COVID-19 trials so far has been mixed. Moderna, which began the first phase 3 trial of the experimental vaccines on July 27, announced Friday that 18% of its 13,000-plus enrollees so far were Black, Latino or Native American — a high percentage as clinical trials go, but only about one-third of the goal set by NIH officials.

Other AstraZeneca trial sites have also publicized their efforts to reach those most at risk from the virus. The University of Southern California’s Keck School of Medicine placed one of its AstraZeneca recruitment sites in Vernon, south of downtown Los Angeles in an area with many factories and meatpacking plants, which have experienced high COVID-19 infection rates.

Clinicians suspect that the higher rates of disease and hospitalization in minority groups are due both to health conditions — such as undertreated diabetes and heart disease — and to higher exposure to the virus in workplaces and crowded housing. Environmental factors like polluted neighborhoods may also have an impact.

While there’s little evidence that vaccines affect Blacks or Latinos differently than white people, the subject hasn’t really been studied, said Dr. Akilah Jefferson Shah, an allergist/immunologist and bioethicist at the University of Arkansas for Medical Sciences. That’s another reason for making sure these groups are well represented in trials, she said.

“We know now there are subgroup responses to drugs by sex, but no one figured it out until they started including women in these studies,” Jefferson Shah said. “Race is not genetic. It’s a social construct. But there are genetic variants more prevalent in certain populations. We won’t know until we look.”

Perhaps most important, diversity in the research will be needed to build trust and uptake of the vaccine, Corado said. In a May poll from the Associated Press-NORC Center for Public Affairs Research, just 25% of Blacks and 37% of Hispanics said they would definitely seek vaccination against the coronavirus, compared with 56% of whites.

In July, the Harbor-UCLA vaccine team began holding weekly Zoom meetings with about 25 activists and clergy members to learn what their communities were saying about the vaccine and get tips on how to design educational materials for the trial.

What they’ve heard suggests they’ll have an uphill recruitment battle.

One member of the community council, HIV activist Dontá Morrison, noted that people frequently say on social media that the vaccine is designed to give them COVID-19 as part of a plot to get rid of Black voters. (None of the vaccines contains infectious COVID virus.)

“It may seem far-fetched, but those are the conversations because we have an administration that has not shown itself to be trustworthy,” Morrison said.

He noted that the first challenge UCLA researchers face is to convince community leaders, particularly clergy members, of the vaccine’s safety. Church leaders worry they’ll be blamed for supporting the trial if the vaccine ends up making their congregants sick, he said.

If done right, the trial could build trust in medical science while helping minorities help themselves — and the rest of us — find a way out of the current mess, Morrison said.

Dr. Raphael Landovitz, another UCLA scientist working on the trial, agreed.

“We’re hoping that people understand this is a chance — if we succeed — to take back some power and control in this situation that has made so many of us feel so powerless,” he said.


This KHN story first published on California Healthline, a service of the California Health Care Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Rather Than Give Away Its COVID Vaccine, Oxford Makes a Deal With Drugmaker

In a business driven by profit, vaccines have a problem. They’re not very profitable — at least not without government subsidies. Pharma companies favor expensive medicines that must be taken repeatedly and generate revenue for years or decades. Vaccines are often given only once or twice. In many parts of the world, established vaccines cost a few dollars per dose or less.

Last year only four companies were making vaccines for the U.S. market, down from more than 20 in the 1970s. As recently as Feb. 11, Dr. Anthony Fauci, the government’s top infectious disease expert, complained that no major drug company had committed to “step up” to make a coronavirus vaccine, calling the situation “very difficult and frustrating.”

Oxford University surprised and pleased advocates of overhauling the vaccine business in April by promising to donate the rights to its promising coronavirus vaccine to any drugmaker.

The idea was to provide medicines preventing or treating COVID-19 at a low cost or free of charge, the British university said. That made sense to people seeking change. The coronavirus was raging. Many agreed that traditional vaccine development, characterized by long lead times, manufacturing monopolies and weak investment, was broken.

“We actually thought they were going to do that,” James Love, director of Knowledge Ecology International, a nonprofit that works to expand access to medical technology, said of Oxford’s pledge. “Why wouldn’t people agree to let everyone have access to the best vaccines possible?”

A few weeks later, Oxford—urged on by the Bill & Melinda Gates Foundation—reversed course. It signed an exclusive vaccine deal with AstraZeneca that gave the pharmaceutical giant sole rights and no guarantee of low prices—with the less-publicized potential for Oxford to eventually make millions from the deal and win plenty of prestige.

Other companies working on coronavirus vaccines have followed the same line, collecting billions in government grants, hoarding patents, revealing as little as possible about their deals—and planning to charge up to $37 a dose for potentially hundreds of millions of shots.

Even as governments shower money on an industry that has not made vaccines a priority in the past, critics say, failure to alter the basic model means drug industry executives and their shareholders will get rich with no assurance that future vaccines will be inexpensively available to all.

“If there were ever an opportunity” to change the economics of vaccine development, “this would have been it,” said Ameet Sarpatwari, an epidemiologist and lawyer at Harvard Medical School who studies drug-pricing regulation. Instead, “it is business as usual, where the manufacturers are getting exclusive rights and we are hoping on the basis of public sentiment that they will price their products responsibly.”

In the United States and other developed nations, the solution to drug-company reluctance was to shower them with billions of dollars in public funds to persuade them to help. The Trump administration has announced deals worth more than $10 billion with seven companies to try to turn basic research—often funded by the government—into effective, widely distributed vaccines—but with no guarantee they would be widely affordable or available.

That approach has driven up stock prices in the past four months and enriched drug executives betting with somebody else’s money.

AstraZeneca stock and options owned by CEO Pascal Soriot have increased by nearly $15 million in value since early April, according to calculations by KHN based on company disclosures. The stock hit an all-time high in July. The stock market value of Novavax, a biotech that never recorded a profit in more than two decades, soared tenfold to $10 billion after a nonprofit and the Trump administration agreed to give it $1.6 billion to make a vaccine.

Companies “say we have to charge high prices because we are taking a risk,” said Mohga Kamal-Yanni, an independent consultant on global health based in the United Kingdom. “Actually, the public is taking the risk. The public is paying for the cost of research and development and probably the cost of manufacturing as well.”

Moderna, another company working on a vaccine candidate, received nearly $1 billion from the U.S. government to pay essentially all costs to research the product and get it approved by regulators. It’s using a vaccine designed in large part by the National Institutes of Health and academic scientists using federal grants.

If the vaccine works, the company gets an additional $1.5 billion to cover 100 million doses, a deal that U.S. Rep. Lloyd Doggett, a Texas Democrat, likened to giving taxpayers “the privilege of purchasing that same vaccine that we already paid for.”

That deal comes to $15 a dose. Moderna told Wall Street analysts it might charge as much as $37 a dose for smaller-volume contracts.

“This is greedy, and the taxpayers who have funded all of this should have expected better negotiation on the part of the U.S. government,” said Margaret Liu, a globally respected vaccine scientist who once worked for Merck and is now chairperson of the International Society for Vaccines.

The U.S. Health and Human Services Department “conducted extensive market research and price analysis” to ensure prices are fair, said a senior HHS official who asked for anonymity. “We are prohibited from disclosing price discussions and details.”

Even if Moderna distributed a successful vaccine at a loss to make it widely available, it would reap enormous benefits because government support would have helped validate its technology for future products, Liu said. Moderna did not respond to requests for comment.

Nonprofits such as Oxfam and Doctors Without Borders have been pressuring drug companies to change for years. Exclusive patents and high prices that sometimes make lifesaving medicines unaffordable in rich countries often render them completely unavailable in the poor world, they argue.

One workaround has been enormous private and government subsidies, including from the U.K., the United States and the Gates Foundation, to promote developing-nation vaccines through the Geneva nonprofit Gavi, formerly known as the Global Alliance for Vaccines and Immunization.

The Gates Foundation helped launch another non-governmental organization, the Coalition for Epidemic Preparedness Innovations, in 2017. CEPI was created to fight something exactly like the coronavirus: potential infectious threats ignored or slighted by pharmaceutical companies.

CEPI’s early principles of “equitable access” drew praise from reformers. The group asked for public data disclosure from drug-company grantees, “transparent” accounting to show true vaccine cost and the right to step in and take over a vaccine project if the developer failed to deliver.

The pharma industry immediately objected. Even though they were bankrolled by public money, drug companies were “concerned about the precedent that could be set if they allowed an outside entity, in this case CEPI, to set [the] price of a product unilaterally,” CEPI reported in February. The nonprofit backed down, removing most references to prices in a new policy that Doctors Without Borders called “an alarming step backwards.”

The original policy was intended to be “interim,” and CEPI’s “commitment to equitable access as a principle is the same,” said spokesperson Rachel Grant.

Some thought the worst infectious disease crisis in a century, along with the enormous public investments, would change industry behavior.

Governments could have demanded transparency and low prices. They could have offered developers cash prizes for vaccines that would have incentivized science but let the public retain the marketing rights, said Love, of Knowledge Ecology International.

Agreement by researchers to publish the virus genome in January set the stage for global scientific cooperation, many believed.

“The full sequence was shared with the world without any strings attached,” said Manuel Martin, a U.K.-based adviser to Doctors Without Borders on access to medical innovations.

The World Health Organization set up a “COVID-19 Technology Access Pool” to promote the sharing of patents and other knowledge. Oxford stepped forward and said it would offer nonexclusive, royalty-free licenses for its vaccine, meaning multiple parties could sell it at a low cost.

“I personally don’t believe that in a time of pandemic there should be exclusive licenses,” Adrian Hill, director of Oxford’s Jenner Institute, which is developing the vaccine, told The New York Times in April.

Instead, little has changed. No vaccine maker has offered open licenses, although NIH is sharing key technology it developed with multiple vaccine companies. Governments are signing lucrative deals with manufacturers to ensure vaccines for their own populations. WHO has made no announcements about contributions to its COVID-19 shared technology pool since it launched in May, patent experts said. WHO officials did not respond to a reporter’s queries.

After Oxford announced the exclusive AstraZeneca deal, the company said it would sell vaccines at no profit—but only during the pandemic. Johnson & Johnson’s pledge to earn no vaccine profit is similarly limited.

With financial information kept confidential, no one will be able to confirm whether the vaccines are truly being sold at cost. And if vaccine immunity is only temporary and endemic coronavirus strains require regular shots for years, the companies will make plenty of money down the road, critics say.

Under its deal with AstraZeneca, Oxford will receive no royalties during the pandemic but could make millions after it ends through a web of patents including those held by Vaccitech, a for-profit spinoff. Vaccitech’s ownership includes a 50% stake held directly or indirectly by Oxford and 5.25% each owned by Hill and Jenner’s other top vaccine scientist, Sarah Gilbert, U.K. regulatory filings show.

The potential for vaccine profits at Vaccitech was first reported by The Wall Street Journal.

Pharma company officials say that only decades of industry research could have made it even possible to produce a coronavirus vaccine at the present speed.

“The federal government cannot research, develop and manufacture vaccines and other new treatments on its own,” said Andrew Powaleny, a spokesperson for the Pharmaceutical Research and Manufacturers of America, a lobbying group. Large and early government investment “is a well-accepted approach to addressing public health crises,” he said.

Many argue that a health crisis is not the time to worry about overpaying for vaccines or backing some candidates that won’t deliver. Getting a good vaccine as quickly as possible requires spreading bets, they say.

“Spending some extra billions on vaccines is the right choice when human life is at stake and trillions in economic loss is at risk,” said Edward Scolnick, a top scientist at the Broad Institute and former head of research for Merck. He owns no stock in Merck or other pharma companies, he said.

Oxford backed off from its open-license pledge after the Gates Foundation urged it to find a big-company partner to get its vaccine to market.

“We went to Oxford and said, Hey, you’re doing brilliant work,” Bill Gates told reporters on June 3, a transcript shows. “But … you really need to team up.” The comments were first reported by Bloomberg.

AstraZeneca, one of the U.K.’s two major pharma companies, may have demanded an exclusive license in return for doing a deal, said Ken Shadlen, a professor at the London School of Economics and an authority on pharma patents—a theory supported by comments from CEO Soriot.

“I think IP [intellectual property, or exclusive patents] is a fundamental part of our industry and if you don’t protect IP, then essentially there is no incentive for anybody to innovate,” Soriot told the newspaper The Telegraph in May.

Some see the Gates Foundation, a heavy funder of Gavi, CEPI and many other vaccine projects, as supporting traditional patent rights for pharma companies.

“[Bill] Gates has staked out this outsized role in the vaccine world,” Love said. “He has an ideological belief that the intellectual property system is a wonderful mechanism that is necessary for innovation and prosperity.”

The Gates Foundation requires all its grantees to commit to making products “widely available at an affordable price,” a spokesperson said.

Oxford officials, including Hill and Gilbert, did not respond to requests for comment. AstraZeneca, for its part, would set a “reasonable” post-pandemic price and is “committed to ensure equitable access, globally” in the meantime, a spokesperson said. The company has signed deals with CEPI, Gavi and the Serum Institute of India to bring more than a billion doses to low- and middle-income countries, he said.

If nothing else, governments and vaccine makers should be open about their relationships, including making contracts public, said Duncan Matthews, a patent law professor at the Queen Mary University of London.

“We simply don’t know what’s in these deals,” he said. “The biopharma industry is applying old rules of commercial confidentiality in a situation that is unprecedented.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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