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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Only a Smokescreen? Big Tobacco Stands Down as Colorado and Oregon Hike Cigarette Taxes


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Big Tobacco did something unusual in Marlboro Country last fall: It stood aside while Colorado voters approved the state’s first tobacco tax hike in 16 years.

The industry, led by Altria Group, one of the world’s largest tobacco companies, has spent exorbitantly in the past to kill similar state ballot initiatives. In 2018, Altria’s lobbying arm spent more than $17 million to help defeat Montana’s tobacco tax ballot initiative. That same year, it spent around $6 million to help defeat South Dakota’s similar measure.

And four years ago, Altria was the leading funder in a successful $16 million campaign to quash Colorado’s previous proposed tobacco tax increase.

In November, by contrast, Altria didn’t spend a penny in opposition and Colorado voters overwhelmingly approved the tax with two-thirds support. Likewise, in Oregon, Big Tobacco stayed on the sidelines while a tax hike passed there.

The tax measures are major wins for anti-smoking advocates after a string of defeats but, in an example of how politics makes strange bedfellows, Colorado’s tax might not have been possible without Altria’s help. And, advocates said, the way those measures passed could provide a blueprint for states to follow in future elections.

In Colorado, Altria, the parent company of Marlboro cigarette maker Philip Morris, insisted that a minimum price be included in the proposal, according to The Colorado Sun, citing emails between political consultants and Gov. Jared Polis’ office. So while supporters see an increased tobacco tax as more revenue for the state, a disincentive for kids to smoke and a win for public health, the measure could also allow America’s premium tobacco companies to gain market share.

The Colorado measure will increase the total state-levied tax from 84 cents to eventually $2.64 per pack by 2027. The tax rate on vaping products, not currently taxed, will be 30% of the manufacturer’s list price in 2021, gradually increasing to 62% by 2027. The proposition also set the minimum price per pack of cigarettes at $7 as of Jan. 1 and that floor rises to $7.50 in 2024. The change could effectively help premium cigarette companies corner the market, since discount cigarettes would rise to at least $7.

Discount cigarette companies Liggett Group, Vector Tobacco and Xcaliber International — which funded opposition to the tax initiative, Proposition EE — tried to sue the state over the minimum tax provision, alleging “Philip Morris will reap huge benefits from the new legislation” and the changes will “destroy their ability to compete in Colorado.” In December, a federal judge rejected the company’s request for a preliminary injunction. A spokesperson for Liggett said the company plans to appeal.

“When it came to entities like Altria and other stakeholders that we engaged in the legislative process, I think that they saw the writing on the wall,” said Jake Williams, executive director of Healthier Colorado and one of the key organizers behind Proposition EE. “And it helped us get through the legislative process, not just with Democratic votes, but Republican votes to refer the measure to the ballot.”

Altria officials said in a statement that their tobacco companies oppose excise tax increases, but they did not say whether they had worked with Colorado lawmakers.

“Altria did not advocate for or against Proposition EE, and after evaluating the content and intent of this measure, Colorado voters decided to vote in favor of it, some aspects of which were focused on tobacco harm reduction and may help transition adult smokers to a non-combustible future,” the statement said.

Polis’ office did not respond to a request for comment. The Colorado Attorney General’s Office said it would not comment on matters under active litigation. State Democratic Sen. Dominick Moreno and Rep. Julie McCluskie, both state sponsors for the legislation, declined to comment for the same reason. Fellow Democrats Rep. Yadira Caraveo and Sen. Rhonda Fields, also state sponsors for the legislation, did not respond to requests for comment.

Colorado campaign finance records show Altria and Altria’s lobbying arm in 2020 contributed to funds that support both Democratic and Republican candidates in the state — a pattern playing out nationally.

Williams said Altria’s absence of public opposition wasn’t the only factor in the initiative’s success. The tax revenue will initially fund revenue lost during the covid-19 pandemic, then fund tobacco use prevention and eventually preschool education.

The American Lung Association, which supported the Colorado measure, said it believes tobacco taxes are among the most effective ways to reduce tobacco use, especially among youths, who are more sensitive to changes in price. The organization cites studies that found every 10% increase in the price of cigarettes reduces consumption by about 4% for adults and 7% for teens.

“Without tobacco industry opposition, it’s very popular among the public,” Thomas Carr, the association’s director of national policy, said of the tax increase. “We’ve long seen it in polling on the subject.”

There was no major industry opposition to the Oregon increase, either. Its tobacco tax increase — Measure 108 — also got a resounding two-thirds of support. But Oregon didn’t negotiate with Altria lobbyists or set a minimum price provision, according to Elisabeth Shepard, campaign manager for Yes for a Healthy Future.

“I don’t know what the [Colorado] deal was,” Shepard said. “All I know is that before it even made it to the ballot, Altria indicated that they were not going to oppose the measure and stuck with their word.”

While Shepard worried until Election Day whether Big Tobacco would swoop in with opposition in Oregon, it didn’t. She believes her campaign worked because the effort had early resources and money, the tax was targeted to fund the Oregon Health Plan (the state’s Medicaid), and her campaign’s coalition had 300 endorsers, including those in health and business communities.

“We had the left, we had the right, we had the far-right, we had the far-left,” Shepard said.

Her campaign paid its advisory committee members, including representatives from affected communities such as Indigenous Oregonian tribes. At least 30% of American Indian and Alaska Native adults in the state smoke cigarettes. Oregon’s measure increases tobacco taxes $2 per pack, from $1.33 to $3.33, as well as creates a new tax for e-cigarettes. The revenues will help fund an estimated $300 million for the state’s health plan.

Altria did not respond to a request for comment about Oregon tobacco taxes, but the company has previously said it opposed Oregon’s measure.

Shepard believes her campaign model could work in other states. Other anti-smoking advocates took note of the 2020 election.

“We certainly support establishing minimum prices for all tobacco products in conjunction with tobacco tax increases, as we know increasing the price of tobacco products is one of the most effective ways to reduce tobacco use,” said Cathy Callaway, director of state and local campaigns for the American Cancer Society Cancer Action Network.

It could just come down to a state’s voters and its politics, according to Mark Mickelson, a former Republican in South Dakota’s legislature. Mickelson was behind creating his state’s failed 2018 tobacco tax ballot initiative.

“We just got beat,” Mickelson said. The opposition “got ahead of us on the message. They had a lot more money and had just played on doubts that the [tax revenue] money would go to tech ed.”

The average state cigarette tax is $1.88 per pack, but it varies across the country — as high as $4.35 in New York but only 44 cents in North Dakota, where a 2016 ballot initiative to increase that to $2.20 was defeated.

Tax increases can translate into hundreds of millions of dollars in new revenue for states, said Richard Auxier, senior policy associate at the nonpartisan Urban-Brookings Tax Policy Center.

“It’s a little easier to pass a tax on someone else, which is often how this is seen — passing this tax on smokers, rather than passing it on all working people, [compared to] if you were to increase income tax or … a sales tax.”

But not all voters get a say.

In Kentucky, which isn’t a referendum state, Republican state Rep. Jerry Miller said there’s not a lot of sympathy for tobacco companies anymore.

“The agriculture community, which used to be on the same page with cigarette companies, are now always in opposition because the cigarette companies are always trying to tweak their formula to use cheaper tobacco,” he said.

Miller’s recent vaping tax bill failed in the state legislature, but he’s working on a new one.

“We don’t have that tradition or the mechanism that somebody collects 10,000 signatures and they get a referendum on a ballot,” he said. “That’s why things like this have to go through the legislature — and so it really just depends on the state [government].”

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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Trump’s Lame-Duck Status Leaves Governors to Wing It on COVID

Not long after the world learned that President Donald Trump had lost his reelection bid, states began issuing a new round of crackdowns and emergency declarations against the surging coronavirus.

Taking action this time were Republican governors who had resisted doing so during the spring and summer. Now they face an increasingly out-of-control virus and fading hope that help will come from a lame-duck president who seems consumed with challenging the election results.

President-elect Joe Biden has promised a more unified national effort once he takes office on Jan. 20, and pressure is building on Congress to pass a new financial relief package. But with record hospitalizations and new cases, many governors have decided they can’t afford to wait.

“I don’t know any governor who’s sitting there waiting for the knight to come in on the horse,” said Lanhee Chen, a fellow at the Hoover Institution and a former senior health official in President George W. Bush’s administration. “There’s no way for these guys to just sit and wait. The virus and the crisis is getting worse hour by hour, day by day.”

As new measures trickle out across states, public health policy experts worry many don’t go far enough. For those states attempting to impose meaningful restrictions, their success depends on cooperation from a population with pandemic fatigue. And people may be reluctant to curtail their holiday gatherings.

Residents of many conservative states don’t acknowledge the depth of the health problem, especially given Trump and some of his allies have stressed the crisis is being overplayed and will end quickly.

The bottom line is that many people just aren’t sufficiently scared of the virus to do what must be done to stop the spread, said Rodney Whitlock, a health policy consultant and former adviser to Sen. Chuck Grassley (R-Iowa).

“You’re dealing with folks there who definitely put liberty over everything else because they’re not afraid enough,” Whitlock said. “Even in the face of cases, even in the face of people around them getting it. They’re just not afraid.”

Among the first governors to act was outgoing Utah Gov. Gary Herbert. The day after The Associated Press called the presidential election for Biden on Nov. 7, the Republican announced Utah’s first-ever statewide mask mandate and clamped down on social gatherings and other activities until Nov. 23.

“All of us need to work together and see if there’s a better way,” Herbert said in a news conference.

Republican and Democratic governors alike followed with measures of their own in Colorado, Iowa, Michigan, Nebraska, New York, Ohio, Oregon, Pennsylvania, Washington and other states. Strategies included partial lockdowns, limits on crowds, canceling in-person classes for schools and reducing hours and capacity for bars and restaurants.

Health policy experts largely agree that the virus’s spread, not the end of the election, is what’s driving these changes — though the end of the campaign season does take political pressure off governors inclined to issue COVID-preventive policies.

“It’s much easier to act when you don’t have attention on you than when you do, but I would hope that the action is taking place regardless of what the political circumstances are,” Chen said.

No state has yet resorted to the sort of full lockdowns enacted in the spring, which resulted in mass business closures and layoffs and sent the economy crashing.

Christopher Adolph, an associate professor at the University of Washington, and his team with the university’s COVID-19 State Policy Project have been studying states’ responses to the pandemic. Some states have made a show of taking action, without much substance behind it, he said. For example, Alaska Gov. Mike Dunleavy, a Republican, declared an emergency on Nov. 12 — but only recommended, not ordered, that people wear masks and maintain social distance.

Other governors first took small steps only to follow up with tighter restrictions. In Iowa, for example, Republican Gov. Kim Reynolds, who opposed mask mandates during the presidential campaign, initially announced that all people over age 2 would be required to wear masks at gatherings of certain sizes. On Nov. 16, she issued a simpler but stricter three-week statewide mask mandate.

North Dakota Gov. Doug Burgum, a Republican, also ordered mandatory face coverings for the first time. Hospitals there have been reporting they have more patients than capacity, and the state has been leading the country in new per capita COVID cases.

At the very least, each state should make it clear that people must not gather indoors, Adolph said. Restaurants, bars, gymnasiums and large indoor events should be closed, he said, and gatherings inside people’s homes should not happen.

“We’re not seeing enough clear, broadly communicated, well-stated, unambiguous policies,” Adolph said.

An exception is Herbert, one of two governors who will leave office in January. The two-term Utah governor will turn over the reins to his current lieutenant governor, Spencer Cox, who has been a part of the state’s response to the pandemic since the beginning. Both Republicans have promised a smooth, seamless transition between administrations.

The nation’s other lame-duck governor is Montana’s Steve Bullock, a Democrat. But unlike Herbert, the term-limited Bullock will be replaced by a governor from a different party. Republican U.S. Rep. Greg Gianforte defeated Bullock’s lieutenant governor, Mike Cooney, in the Nov. 3 election. And Bullock lost his bid for the U.S. Senate.

Bullock said in a Nov. 12 news conference that he would not take additional COVID-intervention measures without a federal aid package to blunt the economic fallout. Five days later, he reversed himself to expand a previous mask requirement and limit capacity and hours in bars, restaurants and other entertainment venues.

Gianforte has not directly answered whether he would continue Bullock’s restrictions. When asked, the governor-elect has spoken instead of personal responsibility and reopening the economy while protecting the most vulnerable people. In July, he referenced the unfounded hope that the virus would be slowed by the U.S. reaching “herd immunity” by the end of the year.

Another obstacle is that a district judge essentially ruled Bullock’s mask mandate unenforceable. State health department lawyers had asked District Judge Dan Wilson to enforce the mandate against five businesses accused of flouting the measure.

“The businesses and the owners have been put on the front line of implementing a state policy that has more exceptions than directives and would be about as effective in bailing water from the leaky boat of our present health circumstances as would a colander,” the judge said in denying the request.

That leaves Bullock with the task of managing a crisis in his final weeks of office with local officials already looking past him to a new administration.

In Flathead County, where the five businesses were sued for violating the mask mandate, local leaders were already chafing from what they saw as Bullock’s heavy hand.

“He has angered a lot of people in Flathead County,” County Commissioner Randy Brodehl, a Republican, said of Bullock. “He didn’t come here, he didn’t talk to us.”

Bullock’s troubles show that even if governors take measures to stem the spread of COVID-19, they may still have a difficult time persuading people to go along with them. That’s particularly an issue in the Upper Midwest and the Rocky Mountains, libertarian-leaning COVID hot spots where the medical infrastructure is already strained.

Some Trump supporters have followed the president’s lead in downplaying the virus and others are fatigued after months of isolation and precautions, said Whitlock.

In rural and conservative areas, people protest that COVID measures come at the expense of their personal freedom and their ability to earn a living, and some feel as though they’re being talked down to by mask advocates and public health officials, Whitlock said.

It’s going to take smart and consistent messaging to change attitudes — but that means more than Biden telling people to wear masks once he takes office, Whitlock added.

“Everybody has to own it,” he said. “You have to scream at the top of your lungs at the protests, at the celebrations, at the football games, at the concerts. It has to be, ‘Stop 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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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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With COVID Vaccine Trial, Rural Oregon Clinic Steps Onto World Stage

MEDFORD, Ore. — From the outside, it appears to be just another suburban allergy clinic, a tidy, tan brick-and-cinder-block building set back from a busy highway and across the road from an auto parts store.

But inside the offices of the Clinical Research Institute of Southern Oregon, Dr. Edward Kerwin and his staff are part of the race to save the world.

Kerwin, 63, was tapped this spring to lead one of the nearly 90 U.S. clinical trial sites taking part in the large-scale, phase 3 test of a vaccine produced by biotech startup Moderna to fight the virus that causes COVID-19.

Starting in late July, Kerwin’s clinic, set in a working-class region roughly halfway between Seattle and San Francisco, began enrolling up to 40 participants a day for the two-year study. He hopes to recruit as many as 700 volunteers by the end of August.

They’ll join the 30,000 test subjects needed nationwide to determine whether the Moderna vaccine can tame a disease that has infected 5.4 million Americans and claimed the lives of more than 170,000. Another vaccine, produced by Pfizer and BioNTech, a German company, is being tested in nearly 30,000 more recruits.

“It’s a perfect opportunity for science to come to the rescue,” said Kerwin, a lanky figure in a bright-blue shirt and khaki pants. He led visitors to a conference room, took a chair well outside social-distancing range and doffed his mask, the better to explain the magnitude of this moment.

Dr. Edward Kerwin, medical director of the Clinical Research Institute of Southern Oregon, has led more than 750 clinical trials during the past quarter-century. Kerwin, an allergist and immunologist, was tapped as the principal investigator for Moderna’s COVID-19 vaccine trial at the Medford test site.(Jim Craven for KHN)

He acknowledged “it may seem like a surprise” that Medford is the site of a clinical trial to halt the world’s biggest medical challenge in a century. But Kerwin, who worked as a NASA scientist before heading to medical school and a career in allergy, asthma and immunology, has led more than 750 clinical trials over the past quarter-century, mostly focused on asthma, lung disease and skin disorders.

He moved to southern Oregon in 1993, choosing the rural Rogue Valley because of its beauty and cultural opportunities, such as the Oregon Shakespeare Festival in Ashland. As his medical expertise grew, he built a top-enrolling clinical trial site that coexists with a clinic that treats asthma and allergy patients. Along the way, he established deep roots in the valley, where he founded Bel Fiore, a $10 million winery and vineyard that features a 19,000-square-foot chateau.

Even with his experience, however, testing a vaccine to halt a global pandemic is a challenge like no other, Kerwin said. When the call came from Velocity Clinical Research — the North Carolina-based company that operates Kerwin’s clinic, known as CRISOR, and more than a dozen other COVID trial sites across the U.S. — he paused for a moment.

“You take a big gasp and say, ‘Do we have the resources to do this?’” Kerwin said. “You definitely do it, but you want to do your homework.”

So far, the testing is going well, he said. Unlike most clinical trials, for which it’s difficult to recruit enough volunteers, the COVID effort has attracted intense interest. All of Velocity’s sites are paying participants $1,962 for the two-year trial, but Kerwin’s staff of two dozen didn’t advertise widely at first.

“We would worry our phone would ring off the hook,” Kerwin said.

The Medford clinic is the only COVID vaccine clinical trial site in Oregon, so participants have come from as far as Portland, nearly 300 miles north.

It’s a prime example of the gamble drugmakers and federal trial sponsors take when deciding where to host large-scale COVID clinical trials. To gauge whether the vaccine works, you need to know there’s a good chance participants will be exposed to the virus in the environment. Ethically, in traditional phase 3 trials, you can’t deliberately infect people with COVID, a disease with no treatment or cure, though some propose doing just that in controversial human challenge trials.

Southern Oregon has not been a hot spot for COVID, with fewer than 500 confirmed cases and two deaths in Jackson County, which includes Medford. But, Kerwin said, it’s at risk of becoming one, offering the opportunity to vaccinate trial participants before the virus becomes widespread.

“It’s almost too late in New York and Arizona,” he said.

In the meantime, he’s trying to shift the odds that trial volunteers will be exposed to COVID-19 by reaching out to people at greater risk of infection.

So Kerwin’s team has contacted businesses in industries such as agriculture and food production, where the disease has been known to spread with particular virulence. Locally, that includes employers such as Harry & David, the food retailer famous for its fruit-of-the-month shipments, and Amy’s Kitchen, the maker of vegetarian frozen meals, which operates a production plant in the area.

The Medford trial site is also emphasizing enrollment of elder volunteers, those age 65 and up, who are at higher risk of serious illness or death from the coronavirus.

One of the first volunteers was Trish Malone, a 68-year-old cultural anthropologist who lives in Ashland. Like many of the other participants, she has enlisted in Kerwin’s previous clinical trials of devices to treat asthma. When clinic staffers reached out to ask whether she’d participate in the COVID trial, she didn’t hesitate.

“I said, ‘Wow, yes,’” Malone recalled. “It’s because of [Kerwin] and his expertise. Little Medford gets to have this testing.”

Participating is a way to “give back” to her community, said Malone, who sat, calm and still, on a recent Thursday as study coordinator Audrey Kuehl sank the injection into Malone’s left shoulder.

Audrey Kuehl, a study coordinator at the Clinical Research Institute of Southern Oregon, inoculates Trish Malone with Moderna’s COVID-19 vaccine on Aug. 6.(Jim Craven for KHN)

“She was fast. It was no pain, and it was fine,” Malone said.

Half of the patients in the trial will receive two doses, 28 days apart, of the Moderna vaccine, called mRNA-1273. It uses a snippet of the genetic code of the coronavirus, not the virus itself, to instruct cells to produce a protein that triggers an immune response to protect against infection. The other half will receive a placebo, or saline dummy shot.

Three study coordinators at the Medford clinic, Kuehl among them, know which patients receive which dose, but the information is kept from volunteers and other staff members — including Kerwin, the principal investigator.

Participants who receive the vaccine may experience some side effects, such as redness at the injection site, muscle soreness, fatigue or headache, Kerwin said. “It’s a sign the vaccine is working with your immune system,” he said.

Four days after her first injection, Malone was disappointed to report no reaction at all. “I am bummed, totally bummed,” she said. “I have no symptoms. I think I got the placebo.”

That may not be true, of course. Even if it is, Malone said, she’s happy to participate in an effort that may help stop the deadly virus.

“This a global pandemic,” she said. “What can I do to help?”

The study will run for two years so that investigators can track the longer-term effects of the vaccine. Malone will keep a diary of her temperature and symptoms, if any, and have regular blood tests to determine whether she has antibodies to the virus.

Kerwin is optimistic about the chances the Moderna vaccine will work, agreeing with Dr. Anthony Fauci, the nation’s top infectious disease expert, who predicted the study could demonstrate efficacy by November or December. Kerwin estimates that the vaccine could prove 90% effective, though outside infectious disease experts said it’s far too soon to tell.

Even if the trial shows the vaccine is successful, it would take months longer to produce and deliver enough injections for the U.S. and beyond.

As he enrolls patients and awaits data, Kerwin said, he’s mindful of the real-world implications of his work. His mother, in her 90s, lives in a Denver nursing home where, so far, there have been no cases of COVID-19. But the threat looms.

The tragedy of the pandemic has underscored the promise of science — and the interconnectedness of people far beyond this small corner of Oregon.

“Immunology has never been more fascinating than it is today,” he said. “This is a year that reminds us we cannot live in isolation and do not live in isolation from the world.”

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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