Category: Covid-19 Vaccine

Of the approximately 1.4 million active duty service members, some 500,000 had received their first dose one month ago. Now, about 775,000 troops have received their first dose. The sharp increase in vaccinations was made possible as the military opened vaccinations to all service members, allowing those who weren't in the high-priority Tier 1 category to become eligible. However, it's unclear at this point if the surge in vaccinations will continue or if it will plateau.

The battle against Covid-19 has been a top priority for the Biden administration and for Defense Secretary Lloyd Austin, who has put out multiple messages and statements emphasizing the safety and efficacy of the vaccines.

On Monday, Deputy Defense Secretary Kathleen Hicks and Joint Chiefs Vice Chairman Gen. John Hyten issued a memo which called coronavirus "the greatest proximate challenge to our nation's security." Though the memo does not explicitly encourage vaccine incentives, it does urge unit leaders to "consider utilizing techniques such as stand-downs, vaccination days, organization days, and incorporating vaccination opportunities into unit training events." It goes on to encourage the use of existing policies and procedures "to the greatest extent possible, as appropriate and authorize, to encourage vaccination."

Speaking at a press briefing Thursday afternoon, Acting Assistant Secretary of Defense for Health Affairs Dr. Terry Adirim said that every combatant command overseas has "now vaccinated" people "both partially and fully at rates that are higher than the United States," during a press briefing about the Department of Defense's response to the pandemic.

"In some cases, at extraordinarily high rates," Adirim added.

Last week, the Defense Department eased mask requirements, allowing those who are fully vaccinated to remove their masks in department facilities. The new guidelines applied to both indoor and outdoor locations, and they followed updates guidance for the Centers for Disease Control.

As of Wednesday, some 351 Defense Department personnel, including civilians, dependents, and contractors, had died of coronavirus out of a total of 293,788 cases.

CNN's Ellie Kaufman contributed reporting.

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US military sees 55% jump in Covid-19 vaccinations over last month - CNN

Singapore is expecting to administer at least one dose of a coronavirus vaccine to its entire adult population by early August, authorities said on Tuesday, after a decision to widen the gap between doses to inoculate more people faster.

Close to two million of Singapore's 5.7 million people have received at least one dose, according to official data as of Monday. About 1.4 million recipients have completed the full two-dose regimen, authorities said.

"Lengthening the interval to between six to eight weeks will enable us to cover more people with the first dose of the vaccine more quickly, who will then have some protection," the health ministry said.

The same approach has been used elsewhere, including Britain, France and Germany. Singapore's current gap is three to four weeks.

The move comes as the country tackles a recent increase in infections, after months with relatively few community cases. It last week tightened restrictions on social activities and urged people and companies to work from home. read more

Singapore on Tuesday also authorised the use of the vaccine developed by Pfizer (PFE.N) and BioNTech (22UAy.DE) for those aged 12 to 15 years, to extend protection to more groups.

The health ministry said data showed the vaccine for younger people "demonstrated high efficacy consistent with that observed in the adult population," adding its safety profile was also consistent with that of the adult population.

Singapore expects to complete its vaccination programme this year, provided that supplies arrived as scheduled.

The city-state has been using the Pfizer-BioNTech and Moderna (MRNA.O) vaccines and has taken delivery of 200,000 doses of the vaccine of China's Sinovac (SVA.O), which has yet to be granted emergency use authorisation.

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Singapore seeks COVID-19 vaccination for all adults by August - Reuters

The Muppets are doing their part to encourage fans to get their COVID-19 vaccine. In a new public service announcement, Gonzo and Pepe team up with the Ad Council and COVID Collaborated to reveal some big news: they got vaccinated!

Yes, apparently, even Muppets are now eligible.

"Getting vaccinated means we're one step closer to getting back to normal," Gonzo says. The four-armed Pepe quickly adds, "S, even if you weren't normal to begin with."

Their pun-filled PSA ("Go ahead, give it a shot. See what I did?") is all about getting informed on the vaccination process, and it's not the Muppets' first video promoting COVID-19 inoculations. Elmo's dad, Louie, is now fully vaccinated, and he shares how he and his son are "feeling hopeful" in their own video.

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Even Muppets Are Eligible For the COVID-19 Vaccine! Watch Their Punny PSA - POPSUGAR

With more than 2.3 million people fully vaccinated in Colorado, some businesses are requiring proof of it.

DENVER With more than 2.3 million people fully vaccinated against COVID-19 in Colorado, some businesses are requiring proof of it. While that might not thrill some people, others might be looking for a simple way to provide that proof.

Aurora doctor Tashof Bernton said he thinks he might have found a solution. He sat down with 9NEWS to discuss his product, ImmunaBand.

(Editor's note: This interview has been edited for context and clarity.)

What is ImmunaBand?

Bernton: Its the only visible, wearable, verified symbol of vaccination that people can get. It is a way of carrying your vaccination credential along with you.

How does it work?

You just put your phone [with the camera app on] over the ImmunaBand QR code. The QR code brings up the website. You enter your PIN because these are all PIN protected, and it brings up all the information. It brings up documentation of the card.

Why was this created?

With the CDC (Centers for Disease Control and Prevention) starting to relax restrictions with the people that are fully vaccinated, it's obviously really helpful to have something. This way, you can carry your vaccination card with you if you need the documentation, and it cant get lost or stolen or mutilated.

Its a courtesy. The way I tend to see it, it lets the people around you say, "OK, Im vaccinated, so you dont really have to worry."

Would my vaccine information be protected?

The server is encrypted and HIPAA compliant. We have PIN protection, and we really work hard to ensure data security.

Where is it accepted?

We sold the ImmunaBand in all 50 states and the District of Columbia, but Colorado is No. 3 out of the 50 states because people in Colorado specifically seem to basically like the idea of the ImmunaBand.

The ImmunaBand is valid at any venue that accepts a digital copy of your vaccination card.

How much does it cost?

The bands are sold online.There are two bands. The first has the QR code and the name, and that's $24.95. The one that just has the QR code and takes you to the documentation with your name on it, that's $19.95.

Part of the profits will be donated to COVID-19 recovery efforts.

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Aurora doctor creates wristband that gives proof of COVID-19 vaccination - 9News.com KUSA

Wajid Kadar Khan, who lives in a Mumbai slum, says he received a COVID-19 vaccine only because his job required it, and his wife (left) said she didnt need one because I have God."

By Jon CohenMay. 19, 2021 , 4:45 PM

Reporting for this story was supported by the Pulitzer Center.

MUMBAI, VELLORE, AND NEW DELHI, INDIAOn a Sunday morning in early April, as Mumbai was in a daze from the first weeks of a surge of COVID-19 and had instituted nighttime curfews, Baliram Boomkar asked his neighbors in the citys Kaula Bandar slum whether they wanted a vaccine to protect them or had received one. Some said they had but only because their employers required it.One man said hed get vaccinated if his company gave him time off to recover from side effects. COVID is nothing, he said. People are only spreading rumors. Its all a lie. A woman said she was afraid to get the shot because the clinic might test her for COVID-19, find shes positive, and then force her to quarantineas happened last year. I know I cant avoid the vaccine, but I want to be the last in the queue, she said.

Lots of people [here] dont believe that COVID exists and that God will provide if something happens, said Boomkar, who lives in the slum and works as a barefoot researcher for the nongovernmental organization Pukar, which conducts health-related studies and also tries to improve living conditions. They think its all politics. The use of masks, despite the barefoot researchers distributing them and stressing their benefits, remained sparse.

A month later, Indias COVID-19 surge has become a tsunami, with hospitals overwhelmed and funeral pyres burning throughout the nights. Yet the countrys vaccination campaign is languishing, with less than 3% of Indians fully vaccinated as of 16 May. Widespread shortages of the shots have forced some vaccination clinics to shutter; at others, lines often form hours before they open. Some states are limiting doses to people older than 45, and to extend supplies, the government has recommended stretching the intervals between shots of thecountrys most heavily used vaccine, Covishield, a version of the AstraZenecaUniversity of Oxford vaccine produced by the Serum Institute of India. But supply is only half of the dilemma.

Moving vaccines into arms in this country of 1.3 billion means reaching remote, difficult-to-access regions and tackling the profound divides between the lower and upper classes. And like almost everywhere in the world, India must confront the perplexing challenge of vaccine hesitancy. Its now widespread in Indian society, far from limited to the slums that Pukar helps, but it is a new problem here. India never had vaccine hesitancy until COVID-19, says virologist Shahid Jameel, who directs the Trivedi School of Biosciences at Ashoka University.

In early April, a government hospital in Shikrapur, a rural town outside of Pune, India, had lines out the door of people waiting for their COVID-19 vaccine shots.

Past mass vaccination campaigns in India have focused on children. Adults, even the wealthiest, do not routinely get immunized against influenza, shingles, pneumococcal disease, or anything else. You wont have too many adults asking for a vaccine, and you wont have too many doctors prescribing it either, says Renu Swarup, who heads the governments Department of Biotechnology. There is a lot of advocacy that we have to do to bring the public on board.

Many blame a different surge for creating Indias unexpected reluctance toward COVID-19 vaccines: the rumors that spread constantly on social media. Its not a vaccine hesitancy that is deep rooted, like in Europe or the United States, says Sai Prasad, an executive director at Bharat Biotech, which makes Covaxin, the countrys other COVID-19 vaccine. This is literally due to disinformation or misinformation. Among the false assertions in wide circulation are that the vaccines make people impotent, are worthless because some vaccinated people become infected, or even lead to death. Adults are more finicky than children: They change their minds thanks to WhatsApp University and Twitter on a second-by-second basis, Prasad says.

India began its vaccination program on 16 January, just 1 month later than the United States and the United Kingdom. But there was little sense of urgency. The nation wasnt hit as hard by the first surge of COVID-19 in 2020 as many expected. By 1 March, India, which hasone internet portalthat allows anyone eligible for a shot to make an appointment at a local site, had vaccinated just over 12 million people with a first dose.

Even health care workers, the first in line for shots, were slow to get them. At theChristian Medical College(CMC), Vellore, in the state of Tamil Nadu, an esteemed training ground for doctors and nurses that has five campuses with more than 2700 hospital beds, 30% of the staff still had not received a shot 6 weeks after the information campaign began. By early April, after CMC administrators decided to post their own vaccination photos on social media and emphasized that 1600 unvaccinated staff had become infected and 12 had fallen critically ill, 99% of doctors and 90% of nurses and other hospital workers had received a shot.

But in Tamil Nadu, one of the countrys most urbanized and industrialized states, the broader public remained tepid toward the shots. On a morning in early April in Vellore, CMC vaccine researcher Gagandeep Kang walked downstairs from her office on the main campus to the hospitals COVID-19 vaccination clinic for her second dose. Kang paid her 250 rupees (about $3), and was vaccinated. But only a dozen other people sat in the outdoor waiting area. No one took a selfie as they got the shot or high-fived a nurse in thanks. Across town that day in the Salavanpet neighborhood government clinic where vaccine is free, only 22 people showed. The hospital had 370 doses in its refrigerator left from a batch of 500 it had received 5 days earlier.

A combination of vaccine hesitancy and limited supply hasthwartedIndias efforts to protect its massive population from COVID-19.

(Graphic) K. Franklin/Science; (Data) OUR WORLD IN DATA REPOSITORY VIA JOHNS HOPKINS CENTER FOR SYSTEMS SCIENCE AND ENGINEERING

Tamil Nadu hadnt yet been slammed by COVID-19 again. But even in parts of India where cases were mounting, COVID-19 simply wasnt always perceived as a big threat. Youre in an environment where you see death so frequently, says CMC head J. V. Peter, a critical care specialist. When you see people dying due to other illnesses at a higher frequency than COVID, why should people pump their fists and say, Hey, Ive got my vaccine! or why should they push towards getting a vaccine?

Kang faults the government for not preparing the ground earlier for a massive adult immunization program. The systems were set up for 100 people a day at immunization centers, she says. We could scale up to five times what were doing.

The challenges multiply in more rural areas. In Jawadhi Hills a few hours drive away, Kang and others at her college havea projectat the rural village of Vallithathankottai, helping the Malayali tribe with everything from clinical services to improved sanitation. The villages 99 houses are nestled up a steep mountain road, and a few dozen members of the tribe gathered one afternoon in their leaders house to discuss the pandemic with Kang andScience. Only three villagers had been vaccinated, at a clinic 5 kilometers away. Others were noncommittal. If its for our protection, we will all take the vaccine, said one villager, who like the others was not eligible at the time. But there was little fear of the virus. Its not going to come to us, said one villager. Or its simply harmless, the leader speculated. We might have got it and it would have gone without us knowing."

Baliram Poomkar, a barefoot researcher who lives and works in a Mumbai slum, says many of his neighbors dont believe the pandemic is real.

In mid-May, as cases continued to climb in Tamil Nadu but hope arose that the devastating wave of COVID-19 had peaked countrywide, varying degrees of vaccine hesitancy remained. In wealthier, urban communities, the fact that the company making Covaxin has yet to publish its efficacy data and that the version of Covishield used outside of India has been linked to clotting problems continued to feed some reluctance. Researchers speculate that many Indians would rush to get the messenger RNA vaccines currently only available abroad. Still, demand is growing. There have been few signs of hesitancy among the middle class and they are scrambling for vaccine slots, Kang now says.

Neonatologist Anita Patil-Deshmukh, who founded and runs Pukar, says the barefoot researchers report that in the Kaula Bandar slum, the surge has led at least a few pandemic doubters to change their minds, as they watched constant images of crematoria on TV and had relatives in their home villages become ill and unable to access care. But they remain exceptions. Most people are still reluctant to take [the vaccine], Patil-Deshmukh says. Vaccinating people who live in the slums is still a huge issue.

The government needs to make it easier for the poor, she says. Most people in the bottom of the pyramid do not possess the smartphones needed to do online registration, and those few who may possess it do not know how to navigate the system, she says, adding that Pukar soon hopes to set up registration stations in Kaula Bandar.

A clinic at King Edward MemorialHospital in Pune stamped the arms of everyone it gave a COVID-19 vaccine.

Kang said the Indian government should fulfill a commitment to setting up vaccination points within 2 kilometers of everyone. Were a big country, and to reach people is challenging. She suggests some areas may need vaccinators to go door to door. In India, in many places you have to think about outreach programs because the most vulnerable people are not going to get to vaccination centers.

Despite Indias huge population, the effort could pay off quickly, some researchers argue. Trying to vaccinate everybody is not the point, says Anurag Agrawal, a pulmonologist who heads the Institute of Genomics and Integrative Biology, a division of Indias Council of Scientific and Industrial Research. India has a relatively large population of young people, who may be less vulnerable to serious symptoms. If immunization becomes widespread in those who are 45 and older, particularly in those with conditions like diabetes and obesity that can worsen COVID-19, hospital admissions and death will plummet, Agrawal contends. He calculates this population only totals about 200 milliona number Indias vaccine supply should soon be able to cover.

India does not really have a vaccine problem, he says. It has a peoples outlook problem. And this upsurge may again bring people back to reality.

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Why is the world's largest COVID-19 vaccine campaign faltering? - Science Magazine

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Yes, You Can Donate Blood After Getting the COVID-19 Vaccine-Just Have This Info Available - Health.com

For the first months of 2021, the demand for COVID-19 vaccine in Erie County, New York greatly exceeded available supply the same was true is many other counties, cities and towns across the country. More recently, that script has flipped, with a now-abundant supply and waning demand.

With only about 38 percent of Americans fully vaccinated at this time, municipalities throughout the nation are grappling with the same questions: How do we give people more opportunities to receive a COVID-19 vaccine? And even more importantly, how do we get residents to step up and attend one of our vaccination clinics?

In Erie County, those simple questions we found our answer: the Shot and a Chaser program.

It is a simple idea. We partner with our burgeoning local brewery and brew pub industry to coordinate a series of vaccination clinics on-site at brew pubs and restaurants and get people in the door with the promise of a free beer.

Bringing vaccinations to familiar community sites and enabling people to receive them with a free drink at one of their favorite local watering holes injects excitement and enthusiasm to what would otherwise be a routine and even unpleasant procedure.

While the term Shot and a Chaser is humorous and perfect for a bar or pub vaccination program, that name does not fully reveal the double efficacy of this innovative idea. Promoting and protecting public health remains our core mission, and with this program we are able to bring public health directly into communities and into establishments that may not even have been considered for such action pre-pandemic.

Additionally, these establishments suffered under New York pause orders during the pandemic, so the added exposure and sales that these clinics bring to them is beneficial and gives everyone something to toast. The programs popularity has led other breweries, distilleries, and restaurants to contact us to explore the possibility of setting up clinics at their establishments as well.

As other municipalities work to boost vaccination rates, they may well want to take a similarly innovative approach to not only immunize their resident while revamping the local economy.

We know from a planning perspective that the days of COVID-19 vaccine clinics with hundreds of people standing in a line stretching down the block are over. To date, more than half of our eligible county residents have received at least one dose of COVID-19 vaccine, which leaves a slowly diminishing set of residents who need a COVID-19 vaccine and are scattered haphazardly around the county. We must be creative and willing to go where people are, even if its for a few dozen people at a time.

This creativity has extended to appealing to other age groups as well. To encourage high school sophomores, juniors and seniors to step forward and get vaccinated we held three clinics on one recent Saturday. Positioned at sites in our countys northern and southern suburbs, and at a central Buffalo location, clinic staff decorated the vaccination space to match different prom themes to enable teens to get fully vaccinated before their prom or graduation ceremonies in a fun environment. Our vaccine team also contacted local businesses to coordinate giveaways and prizes to be raffled off.

Continuing our targeted approach, we have clinics planned for child care workers, and at senior housing, work sites and large community festivals. Our vaccine teams will be stationed at any number of our beautiful County Parks with the one-dose Johnson & Johnson vaccine this summer. Even more innovative incentive programs will materialize in partnership with local businesses. Access and convenience are the hallmarks of our COVID-19 response, and will be prominent for the foreseeable future.

Our community lost nearly 1,900 neighbors to this pandemic, with thousands more hospitalized or suffering from severe illness. Many localities across the country have felt similar loss. In addition, the health impacts on COVID-19 survivors long haulers are not yet known. We are now in recovery mode, and we may be for some time. However, we are emerging from this crisis with stronger connections between our internal departments, deeper bonds with community organizations and our countys health care infrastructure and powerful lessons learned about how we approach public health.

Immunizing our communities is vital to recovery from this pandemic. Local efforts to reach residents who have not yet been compelled to get vaccinated will be crucial is so many places across the country a shot and chaser model might well help others also up their vaccination rates and boost business.

Mark C. Poloncarz is the county executive of Erie County, New York . He is the first chairman of the NYS Association of Counties Climate Resiliency Committee and also serves on the National Association of Counties Executive Committee as the Northeast Region representative. Follow him on Twitter: @markpoloncarz

Gale R. Burstein, MD. MPH, FAAP is the Erie County commissioner of health, pediatrician, co-chair of the Erie County Opiate Epidemic Task Force and leads Erie Countys COVID-19 pandemic public health response. She has served as a Centers for Disease Control and Prevention medical officer, has held numerous clinical, research and teaching positions, and has been published in many scientific peer-reviewed journals, specializing in adolescent medicine and sexually transmitted infections.

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Shot and chaser: How free beer is boosting COVID-19 vaccinations | TheHill - The Hill

Health officials are urging that teenagers get vaccinated for COVID-19, warning that youths are not immune to severe complications or to long COVID, which can leave patients sick for months.

Dr. Christina Ghaly, the L.A. County health services director, said she has heard from many families and teens who say they arent ready to be vaccinated, largely because they think the risk of getting COVID is low for adolescents in the newest eligible group, ages 12 to 15.

While the risk is lower among teens than adults of getting seriously ill or dying of COVID-19, thousands of children around the world have been hospitalized, and hundreds have died.

This is a nightmare that no parent should ever have to live through, and it is now largely avoidable for those who are age 12 and over, Ghaly said.

Though most children do recover, some will develop long COVID, which can last weeks or months and perhaps longer.

Symptoms can include cough, fatigue, muscle aches, headaches, palpitations, nausea, shortness of breath, sleep disorders, fever, stomach problems, anxiety, depression and difficulty concentrating or focusing, which some people call brain fog.

One study in Italy found that more than half of COVID-19 patients age six to 16 had at least one symptom of long COVID for more than four months, with many experiencing symptoms severe enough to impair their daily activities, Ghaly said.

Another study, from the United Kingdom, found that of teenagers infected with the coronavirus, 15% suffered from long COVID symptoms that interfered with their daily activities.

Andy Slavitt, a senior Biden administration advisor on the pandemic, said at a media briefing that one of his sons contracted COVID-19 last fall, before the vaccine was available, and still suffers from long-term symptoms.

Hes young and fit and in the prime of his life. But six months later, he still suffers from tachycardia, shortness of breath, and ongoing and frequent flu-like symptoms, Slavitt said. His hands are cold to the touch. Neither he nor his parents my wife and I are sure how long this will last. Many young people are in this situation, and many, many have it worse.

Vaccines are the single most effective tool to protect people from any type of complications resulting from COVID-19, Ghaly said.

Whether your concern is serious illness or death from COVID, or your concern is long haul symptoms from COVID, either way, the vaccine is the best way to protect yourself against either, she said.

Ghaly said as soon as eligibility opened up for vaccinations for adolescents age 12 to 15, she made an appointment for her oldest child her 13-year-old daughter who is now five weeks from being fully vaccinated, which she said will bring her peace of mind.

Last weeks authorization of the Pfizer vaccine for teenagers and adolescents is helping us to put this pandemic behind us, Ghaly said.

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Some teens don't think they need the COVID-19 vaccine - Los Angeles Times

After rollout under emergency authorisation, manufacturers of covid-19 vaccines now have their sights on regulatory approval. But whats the rush, asks Peter Doshi, and is just six months of data from now unblinded trials acceptable?

In April 2021, Pfizer and Moderna announced efficacy results at the six month mark from the phase III trials of their respective covid-19 vaccines.12

Pfizer CEO Albert Bourla said the companys data confirm the favourable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the US FDA [Food and Drug Administration].1 And on 7 May it formally initiated that application which, if successful, will earn the Pfizer-BioNTech product, BNT162b2, the distinction of becoming the first covid-19 vaccine approved by the FDA.

Because lest we forget, all covid-19 vaccines currently in use in the US are available under emergency access only.

(The situation is similar in Europe, where four covid-19 vaccines have been granted conditional marketing authorisations, a fast track mechanism that can be used in emergencies. These can be converted into standard marketing authorisations pending positive data after authorisation, but this has not yet happened for any covid-19 vaccine being administered.)

As hundreds of millions of people around the world get vaccinated, it may seem like wordsmithing to highlight the fact that none of the covid-19 vaccines in use are actually approved. Through an emergency access mechanism known as Emergency Use Authorisation (EUA), the products being rolled out still technically remain investigational.3 Factsheets distributed to vaccinees are clear: There is no FDA approved vaccine to prevent covid-19.4

The approval-authorisation distinction is often misunderstood by the media,5 even in the scientific press. But it was the focus of much discussion back in September 2020. With large phase III trials by Pfizer and Moderna well under way, and the November US presidential election looming, many worried about political pressure resulting in the rollout of an unsafe or ineffective vaccine.6

The FDA had already come under fire, accused of bending to the White House in granting EUAs for two covid-19 treatments, hydroxychloroquine and convalescent plasma. But those fears largely dissipated when the FDA published a guidance document in early October outlining its expectations for the EUA. According to the document, at least half of a trials participants would need to be followed for at least two months.7 This alone made it all but certain no vaccine could cross the line before the election.

The FDA also said it would want a vaccine at least 50% effective (with a confidence interval reaching no lower than 30%) against a primary endpoint of preventing SARS-CoV-2 infection or covid-19 disease of any severity8parameters it had previously defined as necessary for approval. Even for non-clinical parameters, like manufacturing quality, the FDA characterised its expectations for the EUA as very similar to those for approval.3

One key difference between EUA and approval (also called licensure, and which for vaccines is known as a BLA (Biologics License Application)) was the expected length of follow-up of trial participants. Unlike its clear articulation of two months for an EUA, the FDA has not committed to a clear minimum for approval.

Cody Meissner, a professor of paediatrics at Tufts University and member of the FDAs advisory committee, was curious. Is it possible to predict or estimate when conditions of safety and efficacy might be satisfied for BLA? Meissner asked at the agencys 10 December meeting which had been convened to consider the FDAs first emergency authorisation for the Pfizer vaccine.

The FDAs Doran Fink responded: I couldnt predict, but I will say that we typically ask for at least six months of follow-up in a substantial number of clinical trial participants to constitute a safety database that would support licensure.

An approval based on six months of data would represent one of the fastest for a novel vaccine in FDA history. Among the six first in disease vaccines approved by the FDA since 2006, pre-licensure pivotal trials were a median of 23 months in duration, according to a recent analysis.9

Six months also seems substantially shorter than previously conceptualised expectations. A World Health Organization expert group on covid-19 vaccines (which included FDA regulators) in August 2020 called for follow-up until at least month 12, or until an effective vaccine is deployed locally.10 Another group, composed of industry and academic authors, similarly wrote in October 2020: we recommend longer term follow-up of all participants for at least a year after randomisation.11

On paper, the phase III studies by Pfizer, Moderna, and Janssen are all of two years duration. But the FDAs official position on minimum follow-up before licensure is unclear at best.

In its formal guidance last June, the agency said that for licensure applications, it wanted participants followed for covid-19 outcomes for as long as feasible, ideally at least one to two years12 after the first injection. But the same document states that safety assessments for serious and other medically attended adverse events should be studied for at least six months after completion of all study vaccinations. Longer safety monitoring may be warranted for certain vaccine platforms.

Asked to clarify whether its guidance is asking for follow-up of at least six months or one year, a spokesperson told The BMJ: We do not have any further information beyond what is in the guidance document.

Duration of protection is not the only question that longer, placebo controlled trials can address. They also address vaccine safety.

Very often, its the fact that we have that placebo controlled follow-up over time, that gives us the ability to say that the vaccine didnt cause something at a longer period of time after vaccination, the FDAs Philip Krause explained last December.13

Yet there is a gapcurrently of unknown size but growingbetween any expectation of blinded placebo controlled data, and the reality that within weeks of the vaccines receiving an EUA the unblinding of trials commenced as placebo recipients were offered the chance to get vaccinated.

Steven Goodman, associate dean of clinical and translational research at Stanford University, told the FDA in an invited presentation last December, Once a vaccine is made widely available and encouraged, maintaining a double blinded control group for more than a nominal period is no longer in the investigators (or regulators) control and undue pressure to do so may undermine the entire vaccine testing enterprise.14

Goodmans recommendation was to rapidly convert the trials into crossover studies, enabling those on placebo to get vaccinated (and vice versa), while maintaining the blind. The companies challenged the feasibility, calling it onerous, and a crossover never occurred.15

The BMJ asked Moderna, Pfizer, and Janssen (Johnson and Johnson) what proportion of trial participants were now formally unblinded, and how many originally allocated to placebo have now received a vaccine. Pfizer declined to say, but Moderna announced that as of April 13, all placebo participants have been offered the Moderna covid-19 vaccine and 98% of those have received the vaccine.2 In other words, the trial is unblinded, and the placebo group no longer exists.

Janssen told The BMJ: We do not have specific figures on how many of our study participants have received a vaccine at this time. But the company confirmed it was implementing an amended protocol across all countries to unblind all participants in its two phase III trials, the earlier of which passed the median of two month follow-up mark in January.

How the FDA will weigh the loss of blinding and placebo controlled follow-up is unclear, but just months ago the agency said these trial properties were vital.

Continuation of placebo controlled follow-up after EUA will be important and may actually be critical to ensure that additional safety and effectiveness data are accrued to support submission of a licensure application as soon as possible following an EUA. Once a decision is made to unblind an ongoing placebo controlled trial, that decision cannot be walked back. And that controlled follow-up is lost forever, the FDA said last October.3

At its next advisory committee in December 2020, the FDA reiterated the importance of the placebo group: Placebo controlled follow-up can be very important in showing that whatever happened in the vaccine group also happened in the placebo group. Because thats our best way of knowing.13

The USs Operation Warp Speed delivered on its promise to get a novel vaccine into arms in record time (box). Millions of doses of vaccines are being administered daily across the US, making clear that lack of FDA approval is no barrier to access. So just what benefit is there in seeking, and granting, a BLA?

The BMJ asked the manufacturers why they were seeking a BLA. Moderna did not respond and Janssen only confirmed it intended to apply for a BLA later in 2021. Pfizer likewise did not answer but instead quoted an FDA webpage on medical devices, which stated: Sponsors of EUA products are encouraged to follow up the EUA with a pre-market submission so that it can remain on the market once the EUA is no longer in effect.16 But EUAs have no built-in expiry datein fact, 14 EUAs for Zika diagnostic tests remain active despite the public health emergency expiring in 2017.17

Cody Meissner told The BMJ he saw some distinct advantages of a BLA over EUA. An approved vaccine, for one, would provide an element of assurance, increasing public trust in the vaccines, particularly for those currently sitting on the fence. It would also pave the way for claims of vaccine injury to be routed through a more established compensation programme, and for adding the vaccine to government funded schemes to reach children in financial need.18 Finally, it may affect the potential for vaccine mandates: It is unlikely these vaccines will be mandated while an EUA is in place. Remember that currently these vaccines are still considered experimental.

While still under EUA, an increasing number of educational and other institutions have already mandated vaccines, but debates over the legality of these actions has hinged on the distinction between authorisation and approval.19

But approving a vaccine in order to legally support mandates or convince people of its safety arguably puts the cart before the horse. Meissner responded that a BLA would not be issued until the FDA is convinced of the short and long term safety of these vaccines.

Officials have consistently emphasised that despite shaving years off traditional timelines for producing vaccines, no compromises in the process were taken.20 However one type of study, tracking the distribution of a vaccine once injected in the body, was not conducted using any of the three vaccines currently authorised in the US.

Such biodistribution studies are a standard element of drug safety testing but are usually not required for vaccines, according to European Medicines Agency policy,21 which adds, However, such studies might be applicable when new delivery systems are employed or when the vaccine contains novel adjuvants or excipients.

In the case of covid-19 vaccines, regulators accepted biodistribution data from past studies performed with related, mostly unapproved compounds that use the same platform technology.22232425

Janssen told The BMJ its covid-19 vaccine leverages the same technology as its Ebola vaccine, which received licensure last June. Our confidence in our adenovirus vector Ad26 is based on our experience with this vector.

Pfizer and Moderna did not respond to The BMJs questions regarding why no biodistribution studies were conducted on their novel mRNA products, and none of the companies, nor the FDA, would say whether new biodistribution studies will be required prior to licensure.

Competing interests PD gave a public statement at the October and December FDA advisory committee meetings mentioned in this article (transcripts here: https://faculty.rx.umaryland.edu/pdoshi/#publications), and may continue to engage in public input towards regulatory decision making around covid-19 vaccines. PD is also employed by a university that has mandated covid-19 vaccines for all faculty, staff, and students. The views and opinions expressed here are those of the author and do not necessarily reflect official policy or position of the University of Maryland.

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Covid-19 vaccines: In the rush for regulatory approval, do we need more data? - The BMJ

Diseases & Conditions

June 01, 2021

People who get the COVID-19 vaccine may experience arm pain, rashes, aches, fever, or fatigue. Doctors say its worth the risk, since an older adults risk of dying from COVID is 3% to 11%.

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Answering your questions about the COVID-19 vaccine - Harvard Health