Pfizer and Moderna have both reported data that they say backs up the need for booster shots of their COVID-19 vaccines ahead of an FDA advisory committee meeting tomorrow, although the regulator seems less convinced. Documents published ahead of the panel by the FDA reviewers suggest that there is some evidence from observational studies that …
Ahead of FDA adcomm, Pfizer, Moderna say COVID jab efficacy dips Read More »
The European Commission is reportedly in advanced discussions with French biotech Valneva about picking up the contract to supply COVID-19 vaccines that was terminated by the UK government this week. A French government source told Reuters that the EU is considering using the VLA2001 vaccine as part of its booster campaign plans, along with a …
EU ‘negotiating with Valneva’ over COVID-19 vaccine contract Read More »
The UK government is due to announce a large-scale booster vaccine campaign against COVID-19 for all adults aged 50 and over later today, adding to its plan for third doses for people with weakened immune systems. The plan will see millions of doses of the Pfizer/BioNTech mRNA vaccine administered across the autumn and winter to …
UK poised to announce booster COVID jabs for over-50s Read More »
The UK has terminated its order for up to 190 million doses of a COVID-19 vaccine developed by French biotech company Valneva, accusing it of breaching their supply agreement. Valneva said it “strenuously denies” that allegation, but added that the €1.4 billion ($1.65 billion) contract does provide the UK government with the right to exit …
Valneva slumps as UK dumps €1.4bn order for COVID-19 jab Read More »
CMS, in collaboration with the CDC, is making it mandatory for staff at healthcare facilities participating in Medicare and Medicaid programs to get vaccinated against Covid-19. The move comes as cases rise to 150,000 and deaths to 1,500 per day.
The UK medicines regulator has cleared the use of a third dose of both the AstraZeneca and Pfizer COVID-19 vaccines, in readiness for a possible booster campaign ahead of the winter months. The decision means there is now no impediment to starting a booster drive – assuming the Joint Committee on Vaccination and Immunisation (JCVI) …
MHRA clears third doses of AZ, Pfizer COVID jabs Read More »
The UK should think twice before backing widespread use of COVID-19 booster vaccinations, as to do so could place unnecessary burden on the NHS over the winter, according to AstraZeneca chief executive Pascal Soriot. In a letter to The Daily Telegraph newspaper with AZ’s head of biopharma R&D Mene Pangalos, Soriot write that the UK …
AZ CEO Soriot urges caution on COVID booster doses Read More »
The EU regulator has started to review a marketing application filed by Pfizer and BioNTech for a third, booster dose of their Comirnaty COVID-19 vaccine given six months after the first course to people aged 16 and over. The EMA’s CHMP human medicines committee will carry out an accelerated review of the application, which comes …
EMA looks at booster data for Pfizer/BioNTech COVID-19 jab Read More »
The FDA has said it will hold an advisory committee meeting later this month to discuss Pfizer and BioNTech’s filing for approval of a third booster dose of their COVID-19 vaccine Comirnaty in people aged 16 and over. The adcomm is scheduled for 17 September and will discuss the Pfizer/BioNTech filing as well as booster …
FDA schedules adcomm for Pfizer’s COVID booster filing Read More »
As a top vaccine maker, GlaxoSmithKline has been a laggard in the COVID-19 vaccine race, but has put on a late burst of speed with a start of phase 3 trials of a second candidate that will be compared directly to the AstraZeneca shot. The move follows phase 1/2 results with SK bio’s GBP510, which …
GSK takes SK bio-partnered COVID jab into phase 3 Read More »
A study has found evidence that protection from the AstraZeneca and Pfizer/BioNTech COVID-19 vaccines starts fall off after a few months, but a UK government advisor says there’s no need to rush into a large-scale booster campaign. The results of the ZOE COVID study found that initial protection against infection a month after the second …
UK real-world study finds COVID-19 jab protection wanes Read More »
Now, Covid-19 vaccine administrators can earn an additional $35 per vaccination for up to five Medicare beneficiaries who live in a communal living space, like smaller group homes or assisted living facilities. CMS aims to boost vaccination rates with this pay increase.
Shots: The approval is based on the longer-term follow-up data from the P-III trial that showed high efficacy and favorable safety profile through 6mos. after the second dose The vaccine will now be marketed as Comirnaty and is fully approved for the prevention of COVID-19 in individuals aged ≥16 yrs. The companies also plan to …
Pfizer and BioNTech’s COVID-19 vaccine was the first to get emergency use authorisation (EUA) from the FDA, and has also become the first to get full regulatory approval in the US. The regulator has cleared the vaccine – now officially given the trade name Comirnaty – to prevent COVID-19 in people aged 16 or more, …
FDA grants full approval to Pfizer/BioNTech COVID jab Read More »
The COVID-19 pandemic accelerated the development of mRNA-based vaccines, and its influence has now extended to DNA-based shots as well, with Zydus Cadila’s ZyCoV-D getting emergency use authorisation in India. This is the first DNA vaccine to ever receive regulatory authorisation anywhere in the world, the first COVID-19 jab approved in India to treat children …
COVID prompts another milestone, as India clears first DNA vaccine Read More »
The Moderna COVID-19 vaccine has become the second jab to be authorised for use in England, Scotland and Wales in children aged 12 to 17 after getting the nod from the Medicines and healthcare products Regulatory Agency (MHRA). It joins the Pfizer/BioNTech vaccine in being an option for that age group, having been approved in …
MHRA clears Moderna COVID vaccine for 12 to 17 year olds Read More »
Pfizer and BioNTech have formally asked for FDA approval of a third dose of their COVID-19 vaccine BNT162b2 in people aged over 16, as the US prepares to get its booster campaign underway. The two companies have submitted data from a phase 1 trial in support of the booster dose to the US regulator, and …
Pfizer, BioNTech file for FDA approval of COVID booster shot Read More »
The FDA has cleared the use of third dose of either the Pfizer/BioNTech or Moderna COVID-19 vaccines for people with weakened immune systems, but stopped short of a broader booster campaign. The emergency use authorisation (EUA) for the two mRNA-based vaccines has been amended so they can be used for solid organ transplant recipients or …
FDA authorises COVID booster jabs for at-risk people Read More »
The UK government has started ordering COVID-19 vaccines for a 2022 booster campaign, including a 32 million-dose order for the Pfizer/BioNTech shot, even before third doses for 2021 have been given the go-ahead. A report in The Times claims that the government is paying £22 a dose – up from an earlier price of £18 …
UK cues up more Pfizer/BioNTech vaccines as price row looms Read More »
South Korea’s SK Bioscience has been given the all-clear to start a phase 3 trial of its COVID-19 vaccine GBP510 that will compare the shot directly with AstraZeneca’s Vaxzevria. It is the first COVID-19 vaccine developed in South Korea to reach the pivotal trial stage, and from the earliest stages of its development has been …
SK Bio’s COVID vaccine will start phase 3 study versus AZ jab Read More »
BioNTech has suggested that giving booster doses of its current Comirnaty (BNT162b2) COVID-19 vaccine may be a preferable strategy to modifying the Pfizer-partnered shot. The comments came on the German biotech’s second-quarter results call, during which BioNTech raised its forecasts for revenues it will book from sales of the vaccine to €15.9 billion (almost $19 …
BioNTech says repeat doses may be better than modified COVID-19 jab Read More »
Moderna made a massive $4.2 billion from sales of just under 200 million doses of its COVID-19 vaccine, taking its tally since approval to around $6 billion from 302 million shots. The tally makes the SpikeVax (mRNA-1273) vaccine the second biggest seller behind Pfizer/BioNTech’s Comirnaty, which pulled in $7.8 billion in the second quarter and …
Moderna COVID-19 jab sales rocket to $4.2 billion in second quarter Read More »
The UK government has confirmed that the national COVID-19 vaccination campaign will be extended to include 16 and 17-year-old children, to tackle an increase in spread of the virus in younger age groups. The moves comes on the back of new advice from the Joint Committee on Vaccine and Immunisation (JCVI), which has concluded that …
UK extends COVID vaccination to 16 and 17-year-olds Read More »
Germany’s health ministry has said it will start offering booster COVID-19 vaccines to vulnerable people from next month, amid concerns about rising cases of the delta variant of the coronavirus. Health Minster Jens Spahn said the decision was also taken because of concerns that the immune response stimulated by COVID-19 vaccines may start to diminish …
Germany confirms booster COVID jabs will start in September Read More »
AstraZeneca said this morning that it has made $1.2 billion in sales from its COVID-19 vaccine Vaxzevria in the first half of this year, but making it available at no profit had weighed on its profit margins. R&D expenses leaped 28% in the period, an increase that AZ said was “primarily” a result of its …
AZ’s COVID-19 jab sales top $1.2bn, but come at a loss Read More »
A new analysis has suggested that the rare blood clot side effects linked to AstraZeneca’s COVID-19 vaccine Vaxzevria don’t occur after a second dose. The study in The Lancet examined cases of thrombosis with thrombocytopenia syndrome (TTS) from an AZ database encompassing around 5.62 million people who had received two doses of Vaxzevria in the …
AZ says second COVID jab dose isn’t linked to rare clot reaction Read More »
Early-stage clinical data with CanSino Biologics’ inhaled COVID-19 vaccine show that it was able to stimulate neutralising antibodies against SARS-CoV-2 at a dose well below that required with intramuscular administration. Published in The Lancet, a phase 1 study conducted in China showed that a two-dose regimen of aerosolised Ad5-nCoV was similar to that achieved with …
First published data backs CanSino’s inhaled COVID vaccine Read More »
A real-world study carried out in Canada had found that COVID-19 vaccines from AstraZeneca, Pfizer/BioNTech and Moderna reduce the chances of being hospitalised or dying from variants of concern dramatically, even after a single dose. AstraZeneca’s Vaxzevria was found to 87% effective after against the delta variant, which is now thought to be one of …
Study finds jabs cut severe variant COVID disease after one shot Read More »
The EMA has kicked off a rolling review of a COVID-19 vaccine from Sanofi and GlaxoSmithKline, which started a 35,000-patient phase 3 trial in May. The vaccine – now dubbed Vidprevtyn – is based on a recombinant protein antigen developed by Sanofi’s vaccines unit Sanofi Pasteur, and also includes an immune-boosting adjuvant developed by GSK …
EMA starts review of latecomer GSK/Sanofi COVID-19 vaccine Read More »
The UK government has provided almost £20 million ($27 million) in funding for 15 research projects aiming to look into the causes of long COVID, improve diagnosis and find new treatments for the condition. Long COVID is the term used to described people who still suffer from fatigue and other symptoms like breathlessness and muscle …
UK funds ‘long COVID’ research drive as restrictions ease Read More »
The UK government has provided almost £20 million ($27 million) in funding for 15 research projects aiming to look into the causes of long COVID, improve diagnosis and find new treatments for the condition. Long COVID is the term used to described people who still suffer from fatigue and other symptoms like breathlessness and muscle …
UK funds ‘long COVID’ research drive as restrictions ease Read More »
AstraZeneca and Johnson & Johnson are both exploring ways to modify their COVID-19 vaccines to minimise the risk of severe blood clotting reactions that are seen – albeit rarely – in some people receiving the jabs. At the same time, the UK’s National Institute for Health and Care excellence (NICE) is developing guidance to help …
AZ, J&J tweaking COVID shots to reduce clotting risks; report Read More »
The EU medicines regulator has said that there is some evidence to suggest a possible link between mRNA-based vaccines for COVID-19 and rare cases of heart inflammation. According to the EMA’s pharmacovigilance risk assessment committee (PRAC), labelling for Pfizer/BioNTech’s Comirnaty and Moderna’s Spikevax should be updated to reflect “very rare cases” of myocarditis and pericarditis …
EMA finds possible link between mRNA COVID jabs and myocarditis Read More »
With the COVID-19 delta variant has become the dominant strain circulating in the US, Pfizer and BioNTech have said they will ask the FDA and other regulators to approve a third dose of their Comirnaty vaccine to guard against a winter surge in cases. The two companies have revealed data from an ongoing trial of …
Eyeing delta surge, Pfizer will file COVID-19 booster next month Read More »
The Israeli Ministry of Health has reported data suggesting that the efficacy of the Pfizer/BioNTech COVID-19 vaccine has become less effective at preventing the spread of the coronavirus after the emergence of the delta variant. The vaccine still seems to be able to prevent hospitalisation and severe cases of COVID-19, but its efficacy in preventing …
Israel says Pfizer jab less effective against COVID-19 delta Read More »
With COVID-19 vaccine hesitance an increasing concern in the US, researchers at Johns Hopkins have developed a chatbot – called Vira – that aims to explode myths about vaccination. Worried that COVID-19 vaccines have serious side effects that are being covered up, or vaccines are being used to track the population? Or just uncertain whether …
Unsure whether to get a COVID-19 jab? Just ask Vira! Read More »
Armed with new data from its development partner Bharat Biotech, Ocugen is planning to press ahead with plans to file for approval of their COVID-19 vaccine Covaxin in the US and Canada. Covaxin has already been approved for restricted emergency use in India, getting the green light in January months before the final results from …
Ocugen preps filings for COVID-19 vaccine Covaxin on new data Read More »
Zydus Cadila has filed for emergency use approval (EUA) in India of its plasmid DNA-based vaccine for COVID-19, which if given a green light could become the first shot of its type to be cleared for widespread use in humans. Leaving aside the possible technological milestone, the ZyCOV-D vaccine has a few characteristics that could …
Zydus Cadila nears world-first human plasmid DNA vaccine approval Read More »
The UK’s Joint Committee on Vaccination and Immunisation (JCVI) has recommended that the NHS should start a COVID-19 booster shot programme in September, to run alongside the annual flu vaccine drive. The programme should run in two stages, initially targeting elderly and vulnerable people and frontline health and social care workers like the initial vaccination …
UK body recommends COVID booster campaign in autumn Read More »
The UK’s Joint Committee on Vaccination and Immunisation (JCVI) has recommended that the NHS should start a COVID-19 booster shot programme in September, to run alongside the annual flu vaccine drive. The programme should run in two stages, initially targeting elderly and vulnerable people and frontline health and social care workers like the initial vaccination …
UK body recommends COVID booster campaign in autumn Read More »
A court in Belgium has ordered AstraZeneca to deliver additional doses of its COVID-19 vaccine to EU member states by 27 September, although far fewer than the amount sought by the European Commission. The EU had requested 120 million doses by the end of this month and 300 million by end-September, but the judge in …
EU and AZ both claim victory in COVID jab supply lawsuit Read More »
CureVac has just had a harsh reminder of the perilous nature of drug development, after reporting that its mRNA-based COVID-19 vaccine was just 47% effective in its 40,000-subject phase 3 trial. That is below the threshold efficacy level for a vaccine laid out by the World Health Organisation (WHO) in the early stages of the …
CureVac hit hard as its COVID jab fails to make the grade Read More »
The delta variant of COVID-19 may be holding back the lifting of lockdown restrictions in the UK, but there is some good news – the AstraZeneca/Oxford University vaccine seems to offer a high level of protection against it. Real-world data from Public Health England (PHE) suggests that the vaccine prevents 92% of hospitalisations in patients …
AZ’s COVID jab tackles delta variant, but antibody fails clinical trial Read More »
Shots: The P-III PREVENT-19 study involves assessing the efficacy, safety, and immunogenicity of NVX-CoV2373 with Matrix-M adjuvant vs PBO in 29,960 participants aged ≥18yrs. across 119 sites in the US and Mexico The study demonstrated 100% protection against mod. & sev. disease, 90.4% efficacy overall, and met the 1EPs. The study also showed 93% efficacy …
Novavax’s COVID-19 Vaccine Demonstrates 90.4% Efficacy in P-III PREVENT-19 Study Read More »
Novavax reported that its Covid-19 vaccine was 100% effective at protecting against moderate and severe disease and 90.4% effective overall. The vaccine is seen as an important alternative to messenger RNA vaccines because of its storage and distribution advantages.
The top-line phase 3 data for Novavax’ COVID-19 vaccine look good, with a 90% overall efficacy rate, but a dip in its share price indicates investors fear it could be too late for the programme. Novavax’ price spiked 9% after the data were announced today, but fell back just as quickly, despite the company’s assertions …
Novavax unveils phase 3 COVID jab data, but has it missed the boat in US? Read More »
The failings at a Baltimore, US factory making Johnson & Johnson’s COVID-19 vaccine mean that millions of doses of the shot will have to be jettisoned, according to an FDA update. The problems at the plant run by contract manufacturer Emergent BioSolutions first emerged a few weeks ago, after an FDA inspection uncovered a string …
J&J must ditch 60m COVID jabs made at US plant, but 10m are okay, says FDA Read More »
Ocugen is the first company to be affected by the FDA’s recent decision to raise the bar on emergency use authorisations for COVID-19 medicines, and will have to file for full approval of its vaccine candidate. That will hold back the biotech’s Covaxin shot by several months, and the delay put pressure on Ocugen’s share …
Ocugen gets a black eye as FDA denies emergency OK for COVID jab Read More »
Several organizations, both providers and payers, have pledged to help the White House achieve its goal of administering at least one dose of the Covid-19 vaccine to 70% of Americans over the next month. These organizations are launching various initiatives to engage the unvaccinated, including call campaigns and financial incentives.
The US government will buy 500 million more doses of the Pfizer/BioNTech COVID-19 vaccine that will be given to around 100 countries via the COVAX donation programme over the next two years. Pfizer and BioNTech are providing 200 million doses this year, and another 300 million in the first half of 2022, at a not-for-profit …
US orders 500m Pfizer/BioNTech COVID jabs for developing nations Read More »
Researchers in Scotland have identified a possible link between the Oxford University/AstraZeneca COVID-19 and a mostly mild and generally treatable bleeding disorder. The scientists examined real-world public health data from all individuals in Scotland who received either the AZ or Pfizer/BioNTech vaccines up until 14 April and found a possible association between the AZ shot …
Study links AstraZeneca COVID-19 shot to bleeding disorder ITP Read More »
CMS is increasing the payment for administering at-home Covid-19 vaccinations from around $40 to $75 per dose. The move comes amid the Biden administration’s push to boost vaccinations nationwide, including among older adults who may not be able to access vaccine sites.
Rich nations are being asked to start donating COVID-19 vaccines to other parts of the world straight away, to avoid a glut of surplus supply in the coming months that could see millions of doses going to waste. In an open letter, UNICEF and a host of A list celebrities argue that G7 countries will …
Millions of COVID jabs risk being wasted, says UNICEF Read More »
The UK government is talking to AstraZeneca about ordering additional doses of its COVID-19 vaccine that will target the beta variant of SARS-CoV-2 virus first identified in South Africa, according to Health Secretary Matt Hancock. The AZ/Oxford University vaccine and other shots from Pfizer/BioNTech and Moderna are known to have less efficacy against the beta …
UK is talking to AstraZeneca about beta variant COVID jab Read More »
Capacity to supply Moderna’s COVID-19 vaccine in Europe could be swelled by round 300 million doses a year, following an agreement to set up a new production line at contract manufacturer Lonza. The increased capacity depends on Moderna getting approval for a half dose of an updated version of the mRNA-1273 vaccine – targeting new …
Moderna ramps up EU COVID jab capacity via Lonza deal Read More »
The lawsuit alleges that the policy is akin to forcing employees to participate in a medical experiment as none of the vaccines available have received full FDA approval. But Houston Methodist rebutted these claims saying the vaccines are safe and effective, and requiring employees to get vaccinated is in the best interest of the patient.
With concern already growing about a possible third wave of COVID-19 infections, the UK has cleared the use of a fourth vaccine from Johnson & Johnson’s Janssen division. The Medicines and Healthcare products Regulatory Agency (MHRA) gave a green light to the single-dose Ad26.COV2.S vaccine in people aged 18 and over by referencing the decision …
Janssen COVID jab cleared in UK as fears of third wave mount Read More »
Shots: The approval is based on a P-III study assessing Comirnaty (two 30μg doses) in 2,260 participants aged 12-15yrs. and showed 100% efficacy in participants with/out prior SARS-CoV-2 infection, robust Ab responses and was well tolerated The approval follows CHMP’s positive opinion to authorize the vaccine in this group. The extended indication for the CMA …
GlaxoSmithKline’s COVID-19 drive has advanced on two fronts, with the start of phase 3 trials of its Sanofi-partnered vaccine candidate as well as an FDA emergency approval for antibody sotrovimab, developed with Vir Biotech. GSK and Sanofi think they could be on track for approval of the recombinant protein-based vaccine – delivered with GSK’s immune-response …
GSK, Sanofi eye Q4 approval as COVID jab starts phase 3 Read More »
Lawyers for the European Commission asked a court in Brussels today to fine AstraZeneca millions of euros for its “obvious” failure to meet the terms of its contract to supply COVID-19 vaccines to the EU. Rafael Jafferali Counsel for the Commission – Rafael Jafferali – insisted during the hearing at the Brussels Court of First …
EU asks court to fine AstraZeneca over missing COVID jab shipments Read More »
Belgium’s Ministry of Health has paused dosing of people under the age of 41 with Johnson & Johnson’s one-shot COVID-19 vaccine, following the death of a woman from what appeared to be a blood clot-related condition. The unnamed woman – who was under the age of 40 – died on 21 May after being admitted …
Belgium halts dosing of J&J COVID vaccine in under 41s after death Read More »
Moderna’s COVID-19 vaccine has joined the Pfizer/BioNTech jab in showing efficacy in younger patients in clinical trials, setting up an emergency use filing early next month. The results of the phase 2/3 TeenCOVE study in more than 3,700 adolescents aged 12 to 17 revealed no cases of COVID-19 after two doses of the mRNA-1273 shot, …
Moderna will file COVID-19 jab for teens after trial shows 100% protection Read More »
Shots: The first enrolled patient has received their immunizations as part of a new study in adults ≥65yrs. evaluating the coadministration of 20vPnC with a booster dose of the Pfizer-BioNTech’s COVID-19 vaccine The trial will include ~600 adults who will be recruited from the P-III COVID-19 vaccine trial and will have received their second dose …
Two healthcare conferences with in-person events slated for later this year will require people to be vaccinated. HIMSS’ annual conference, which will be held in Las Vegas in August, is one of them.
Shots: The FDA has expanded the EUA for Pfizer’s COVID-19 vaccine in adolescents based on the data from the P- III trial in 2,260 participants aged 12-15yrs. which showed 100% efficacy and was well-tolerated. The submission of data in children aged 6mos.- 2yrs. are expected in Q4’21 The companies have submitted the data in adolescents …
Pfizer and BioNTech Receive the US FDA’s EMA for COVID-19 Vaccine in Adolescents Read More »
By ADRIAN GROPPER As COVID-19 vaccines become widely, if not fairly, available in different regions, both the public and private sector are working to develop vaccine credentials and associated surveillance systems. Information technology applied to vaccination can be effective, but it can also be oppressive, discriminatory, and counter-productive. But these systems can be tuned to reflect and …
10 Design Considerations for Vaccine Credentials Read More »
After months of frenetic activity to get vaccines to people as quickly as possible, CVS is seeing the number of appointments decline. The retail pharmacy chain is still including a potential pediatric vaccine in its estimates, it told investors.
Despite the ongoing Covid-19 vaccine rollout, a significant percentage of Americans say they are planning to delay care in 2021 or are unsure about in-person care, a new survey shows. Virtual visit options, insurance coverage and clear information on Covid-19 safety protocols are some of the factors that will drive provider selection this year.
Shots: The P-III ENSEMBLE trial involves assessing COVID-19 vaccine vs PBO in 43,783 enrolled participants aged ≥18yrs. with both mod. and sev. COVID-19 disease The trial met all 1EP & 2EPs i.e 85% efficacy in preventing disease, vaccine efficacy was consistent against symptomatic infection including in South Africa and Brazil that showed a high prevalence …
Johnson & Johnson Publishes Results of COVID-19 Single Shot Vaccine in NEJM Read More »
With new viral variants reported across the globe, this evolving pandemic requires clinicians to explore novel ways to assuage patient fears about Covid vaccines.
Vaccine hesitancy is still a challenge to providers’ immunization plans. Florida-based AdventHealth is bringing the might of AI technology — specifically machine learning and natural language processing — to combat the issue.
The startup, which provides primary care services to Medicaid patients, plans to use the funds to expand into new states and add maternity and pediatrics services lines. It also recently launched a vaccination site in conjunction with the New York Department of Health.
Shots: The companies have started testing BNT162b2 in children aged 6-11yrs. with initial results anticipated in H2’21. The companies are planning to expand the vaccination to that age range by early 2022 The companies plan to initiate the safety of BNT162b2 (10/20/30µg) vs PBO in P-I/II trial in 144-participant Pfizer and BioNTech later plan to …
Pfizer and BioNTech Initiate COVID-19 Vaccine Trial in Children Under 12 Read More »
A top executive at Chicago-based Loretto Hospital has resigned after controversy surrounding vaccination events held at businesses with close ties to him. Mayor Lori Lightfoot said an independent investigation needs to be conducted.
Areas that have been hit hardest by the Covid-19 pandemic are falling short when it comes to vaccine access. Community leaders are pushing to bring vaccination sites to their neighborhoods.
CMS has increased the Medicare payment rate to $40 for administering single-dose Covid-19 vaccines and $80 for two-dose vaccines. The payment increase aims to support providers as they ramp up vaccine administration.
In a wide-ranging interview, UAB Health System CIO Joan Hicks shared some of the projects on her list for the year ahead, and how remote work has affected her team as well as IT hiring prospects in Alabama.
Several California counties and Washington state dropped One Medical as a partner in distributing vaccines after reports that it let people who weren’t eligible for the vaccine jump the line. A House panel is also launching an investigation into the company’s practices.
By ANISH KOKA “The patient in room 1 should be a quick one, its an addon, they just need a prescription for ivermectin” I’m a bit puzzled by this sentence from my assistant doing his best to help me through a very busy day in the clinic that I’m already behind in. I walk into …
By MIKE MAGEE This week J&J gained FDA approval for their 1-shot COVID vaccine, leading optimists like Pfizer Board member, Scott Gottlieb, to predict that we will have 100 million shots out there by the end of April, and on-demand offerings for the general public. In the race toward herd immunity, we could easily ignore …
A new CMS rule would require insurers to cover Covid-19 tests, even for asymptomatic patients. It builds on previous legislation requiring payers to cover the cost of both testing and vaccines for their members.
The protein-based Covid-19 vaccine from Clover Biopharmaceuticals has distribution and storage advantages compared to messenger RNA vaccines. If the vaccine succeeds in a Phase 2/3 test, China-based Clover will distribute it globally via COVAX.
Stamford Health has partnered with city and state officials and community organizations to execute its Covid-19 vaccine administration plans. The health system has ambitious plans to vaccinate 3,000 people a day, with a focus on health equity.
After completely exiting the ACA exchanges in 2018, CVS plan to re-enter them in 2022. Last year, enrollment through federal exchanges increased, and Aetna CEO Karen Lynch said the markets have stabilized.
An unknown user publicly shared a link to access Beaumont’s Epic-enabled vaccination scheduling services, which resulted in 2,700 people making unauthorized appointments for a Covid-19 vaccine. The Michigan-based health system had to shut down its vaccination scheduling services and cancel the appointments.
Shots: The P-III ENSEMBLE trial to evaluate the efficacy and safety of Janssen’s COVID-19 vaccine candidate in protecting mod-to-severe COVID-19 in 43,783 participants accruing 468 symptomatic cases with assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints Results: The level of protection against mod-to-severe COVID-19 infection was 72% in …
Johnson & Johnson Report Results from P-III ENSEMBLE Trial for COVID-19 Vaccine Read More »
The vaccine distribution process has begun and providers are figuring out how to make sure the doses are administered quickly, equitably and in a coordinated manner. Here is a snapshot of the IT strategies that providers are employing to achieve their vaccine administration goals.
Merck is discontinuing development of its two Covid-19 vaccine candidates. Instead, it plans to focus on two therapeutic candidates for the disease.
As states begin to roll out vaccines to the broader public, Google will make it easier for people to find out when they are eligible and where they can get a vaccine. The effort is part of a broader push, including $150 million in grants to promote vaccine education and equitable access.
Like food deserts, pharmacy deserts have cropped up across the nation, which could further hamper the much-maligned Covid-19 vaccine rollout.
Finally, the End is Near!!! I am not talking about THE end of the world but an end to our struggles with the deadly COVID-19 pandemic. Because, the COVID-19 Vaccine is on its way to us (And I mean literally, it is on the way as we are talking). According to an NDTV post on …
COVID-19 Vaccine: What to Expect with the Vaccine and Everything Else about it? Read More »
The CDC has engaged the California-based health system’s Vaccine Study Center to conduct an analysis of its Covid-19 vaccine data with the aim of pinpointing adverse events and reactions. The collaboration will continue for the next three years.
In an effort to ensure the efficient and orderly distribution of the Covid-19 vaccine, governors from New York, California and Florida are warning that they will take action against providers who are conducting vaccinations too slowly or healthcare workers who undercut priority guidelines.
A new variant of SARS-Cov-2 thought to be more transmissible was discovered in Colorado’s eastern plains and San Diego, California. At the same time, federal vaccination rates are lagging far behind projections.
A new variant of SARS-Cov-2 thought to be more transmissible was discovered in Colorado’s eastern plains and San Diego, California. At the same time, federal vaccination rates are lagging far behind projections.
CVS and Walgreens began administering the first doses of Covid-19 vaccines across long-term care facilities last week. But many questions still remain about how it will be administered to the general public.
By creating new networks for 24/7 temperature monitoring, alerts and reporting, the challenges of deploying transportation at ultra-low temperatures can be overcome. This also illustrates the crucial role that precision measurement will have to play.
Ormond Beach, FL – CO2Meter, Inc. has partnered with a national pharmacy chain to keep their customers and employees safe from the potential hazardous effects for CO2 exposure from the dry ice that is keeping the COVID-19 vaccines cold. A national pharmacy chain contacted CO2Meter on December 1st asking about devices to detect the release …
The post New COVID vaccines could revolutionize vaccination appeared first on Healthy Debate.
News that COVID-19 vaccines are up to 95 per cent effective has scientists cautiously optimistic. But questions remain. “There’s a long list of things we don’t know,” says Maria Sundaram, a postdoctoral fellow at the Centre for Vaccine Preventable Diseases at the University of Toronto. Health Canada is currently reviewing early findings from Moderna, Pfizer/BioNTech …
Shots: The companies have submitted CMA to the EMA for BNT162b2, against COVID-19. The submission completes the rolling review process initiated on Oct 6, 2020 The submitted data showed a 95% efficacy rate, efficacy was consistent across age, gender, race, and ethnicity demographics, with an observed efficacy in adults aged ≥65yrs. of >94%, favorable tolerability …
BioNTech and Pfizer Report CMA Submission of BNT162b2 to EMA for COVID-19 Read More »
Shots: The companies initiated the P-II study of their COVID-19 vaccine in China. The trial will generate data to support the BLA filing for approval of the vaccine in China The study will be conducted by Jiangsu Provincial Center for Disease Control and Prevention. The study will commence with the recruitment of 960 patients aged …
BioNTech and Fosun Pharma Initiate P-ll Study of BNT162b2 Against COVID-19 in China Read More »
By KIM BELLARD 2020 has been an awful year. Hurricanes, wildfires, murder hornets, unjustified shootings, a divisive Presidential election, and, of course, a pandemic. Most of us are spending unprecedented amounts of time sheltering in place, millions have lost their jobs, the economy is sputtering, and over a quarter million of us didn’t survive to …
By PHILLIP MEYLAN With the emergence of two vaccines with high levels of effectiveness, there’s a strong prospect of having powerful new tools to combat Covid-19 in the months ahead. But the road between a vaccine and society returning to normal is far from certain. Millions of doses will need to be produced and intelligently distributed, and critically, …
Can the Government Mandate a Covid-19 Vaccine? Will It Have To? Read More »
Shots: J&J and the US Department of Health and Human Services have expanded an agreement to support the next phase of COVID-19 vaccine candidate research and development Janssen will commit ~$604M while BARDA will commit ~$454M to support the ongoing P-lll ENSEMBLE study assessing Janssen’s JNJ-78436735 as a single-dose in ~60,000 patients globally J&J affirmed …
Shots: Novavax has signed a non-binding Heads of Terms document with the Australian Government to supply 40M doses of NVX-CoV2373 for the Australian community The delivery will start as early as H1’21, following the completion of P-III study and the TGA’s approval of the vaccine. The vaccine regimen is expected to require two doses per …
Shots: CEPI’s total investment in Clover’s S-Trimer vaccine candidate will be up to $328 M, including $69.5M previously announced have funded preclinical studies and P-l study, preparations for the global pivotal P-ll/lll efficacy study, and initial manufacturing scale-up activities The expanded collaboration will provide $258.5M for a global pivotal P-ll/lll efficacy clinical trial which is …
CEPI to Invest ~$328M in Clover’s COVID-19 Vaccine Candidate Read More »
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 …
Data hackathon analyses truth behind TB vaccine and COVID-19 Read More »
Tightening of bio-manufacturing capacity expected to occur after 2024, whilst Europe forecast to equal North America in total capacity Amsterdam: The third part of the 2020 CPhI Annual Report – released during the second week of the CPhI Festival of Pharma (5-16 October, 2020) – predicts, that if approved, COVID vaccines and therapeutics will cause an impending biomanufacturing capacity …
COVID-19 biologics will put huge pressure on large-scale bioprocessing networks Read More »
Shots: The P-I/II study of AZD1222 has resumed in Japan following the discussion with the PMDA. Additionally, the company is in talks with the US FDA to facilitate review of the information needed to decide regarding the resumption of the US trial A standard review process triggered a voluntary pause to vaccination across all global …
AstraZeneca Resumes Clinical Study of its COVID-19 Vaccine in Japan Read More »
The Hague — Governments and other stakeholders must take urgent action to ensure equity in access to disease prevention measures, which includes greater investment in vaccines and vaccination services by community pharmacists. So said the International Pharmaceutical Federation (FIP) in a call to action made today at the start of a new FIP Digital Programme to …
The post 2 billion vials. Public acceptance. The obstacles to vaccine delivery appeared first on Healthy Debate.
The post COVID-19 vaccines in the making appeared first on Healthy Debate.
Shots: BioNTech and Fosun collaborated to supply 10M doses of their BNT162 mRNA-based vaccine candidate against COVID-19 to Hong Kong SAR and Macao SAR, once approved Fosun Pharma has signed the Letter of Intent with Jacobson for contemplated distribution of 10M doses of a vaccine targeting COVID-19 in the Chinese market On Mar 13, 2020, …
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 …
Moderna’s COVID vaccine works in older people, according to new data Read More »
Edinburgh-based biotech company Ingenza Ltd. has made a significant breakthrough in the race to develop and manufacture a cost-effective vaccine against SARS-CoV-2, the virus responsible for the current COVID-19 pandemic. Ingenza has been working closely with researchers at Oxford University and the UK CPI, Wilton, since the start of the outbreak, and the collaboration is …
Shots: For smaller volume agreements, the company has priced its COVID-19 vaccine ranging from $32-$37/ dose, higher than the price of Pfizer’s vaccine candidate The company is in talks with several countries for supply agreements of its vaccine, adding that it had already received about $400M for supply. The P-III study of mRNA-1273 is being …
Moderna Prices its COVID-19 Vaccine at $32-$37 per Dose for Smaller Volume Agreements Read More »
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