Federal regulators Monday granted full approval to the Pfizer-BioNTech coronavirus vaccine — a milestone that could help increase inoculation rates and spark a wave of vaccine mandates by employers and universities amid a surge of new cases and hospitalizations fueled by the ferocious delta variant.

The Food and Drug Administration action marks the first licensing of a vaccine for the coronavirus, which has swept the United States in repeated and punishing wavessince early 2020, exhausting nursing staffs, filling intensive care units and raising fears among the vaccinated and the unvaccinated.

The vaccine has been approved for two doses, three weeks apart, in people 16 and older. It remains available under emergency use authorization for adolescents ages 12 to 15.

"As the first FDA-approved covid-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product," FDA acting commissioner Janet Woodcock said in a statement.

Critics for weeks had demanded that the FDA move faster on approving the vaccine, arguing that the millions of inoculations administered since late last year under an emergency authorization demonstrated the shots' safety and effectiveness. But even as the FDA redoubled its efforts, increasing staff and computer resources dedicated to the review, the agency insisted on six months' follow-up data for people enrolled in the pivotal clinical trial.

In the end, the vaccine approval was the fastest in the agency's history, coming less than four months after Pfizer-BioNTech filed for licensing on May 7.

"It's been remarkably fast," said Holly Fernandez Lynch, a bioethics expert and lawyer at the University of Pennsylvania who said careful handling of the approval was crucial to potentially persuading the "vaccine hesitant" to receive the licensed product. "You can't have it both ways. You can't have people saying they won't get vaccinated until there's full approval and then say the FDA has to hurry up" and grant that approval.

Some experts predicted there would not be a huge bump in vaccinations following the approval, saying they were skeptical that vaccine-avoidant people would change their minds.

"It will provide an additional nudge but not make a huge difference," said Jesse Goodman, a former FDA chief scientist who is a professor of medicine and infectious diseases at Georgetown University.

A recent surge in vaccinations, he said, appears to be driven by rising concerns about the delta variant.

Others predict the full licensure will lead to more vaccine requirements by colleges, workplaces, concert venues and movie theaters.

The approval of Pfizer-BioNTech's vaccine was based on its clinical trial of 44,000 people — half of whom got the shots, the company said. The median six-month follow-up period for safety and efficacy began after participants received their second dose, Pfizer said. The vaccine was 91 percent effective when preventing severe cases of covid-19 in that trial.

The company plans to follow the enrollees for 24 months. To quality for FDA emergency use authorization last December, the company followed trial participants for a median of two months after getting their second shot.

"Based on the longer-term follow-up data that we submitted, today's approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed," Pfizer chief executive Albert Bourla said in a statement. "I am hopeful this approval will help increase confidence in our vaccine."

Unlike an emergency clearance, an approval lasts indefinitely, unless an unexpected side effect develops. To get a product licensed, a company must provide vastly more data and details on the manufacturing process and relevant facilities and is subject to in-depth inspections by the FDA. Pfizer's manufacturing process will not change as a result of this approval. The vaccine remains free to U.S. residents.

The FDA licenses not only the product but also "the process by which the vaccine is made and the manufacturing site," said Paul A. Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia. "There are protocols for every step of manufacturing, and that is not trivial."

'Confidence-builder'

Behavioral scientists and public health specialists who study vaccine acceptance say the FDA approval is a clarion signal the shots are safe and effective.

"It's a great thing that it's finally getting its approval. It will be an important confidence-builder," said London School of Hygiene & Tropical Medicine anthropologist Heidi J. Larson, who directs the Vaccine Confidence Project.

More than 200 million doses of the Pfizer vaccine have been injected into Americans. "People who say they don't want to be first in line don't have that to worry about," Larson said.

But because the vaccines were at first authorized for emergency use, this meant that, on the fact sheet that vaccine administrators are supposed to hand out to patients, the FDA had described the Pfizer vaccine as experimental. That will now be removed.

"A full approval takes away that 'Oh, it's experimental' kind of language. For some people, it might make a difference. They will feel more confident and comfortable," said University of Maryland School of Public Health professor Sandra C. Quinn, who has studied public acceptance of vaccines under emergency authorization since the H1N1 influenza outbreak in 2009.

A poll by the Kaiser Family Foundation at the end of June found that 3 in 10 unvaccinated people, and about half of those who have adopted what the pollsters called a "wait-and-see" stance, would be persuaded to get shots once a vaccine received full approval.

But Larson cautioned against expecting all of those people to roll up their sleeves. "Not everyone goes with what they say, for various reasons," she said.

Data collected by Scott C. Ratzan, an expert in health communication at the City University of New York Graduate School of Public Health & Health Policy, and his colleagues indicate 3 to 5 percent of unvaccinated Americans said they would get immunized based on this change in status. If that group does, the total U.S. vaccinated population would increase by a few million.

The biggest impact could come from employers, experts said, not from individual decisions. This summer, many employers, including federal agencies and companies such as Google and United Airlines, began to tell workers they would need to be vaccinated or face termination.

Many more companies will probably adopt comparable mandates now that the vaccine is approved.

"At the corporate level, that's where I think it's going to matter," said Ratzan, a co-founder of CONVINCE, an initiative to improve vaccine literacy. "People are supportive of their employer recommending it and requiring it. … They are willing to follow if their employer recommends it."

Quinn agreed. "My expectation is that the biggest change will likely be less from individuals and more from organizations, be they industry, municipalities, etc.," she said.

Employer vaccine requirements protect workers and reinforce vaccination as a social norm, experts said.

"The more people that do it and report that 'I had no side effects' or 'I had a sore arm for a day,' it begins to also reduce fears of others," Quinn said.

New flexibility

Full approval gives doctors flexibility in using vaccinations, as long as the uses are considered reasonable. Such "off label use" is not permitted for products under emergency authorization.

Given that increased flexibility, doctors may face pressure from patients who want to receive booster shots soon, before the FDA clears them. The Biden administration recently said the effectiveness of the Pfizer-BioNTech and Moderna vaccines at preventing mild and moderate covid-19, the illness caused by the coronavirus, appears to be waning. Officials said they plan to roll out booster shots beginning the week of Sept. 20, assuming the FDA clears the applications from the vaccine makers.

"Many of us are worried that full approval means you don't get more of the people who should get vaccinated but instead the worried well are going to get additional doses," said a federal official who spoke on the condition of anonymity because he was not authorized to talk about the issue.

Experts said it would be especially concerning if parents with children younger than 12 attempt to get their children vaccinated. Those inoculations have not yet been cleared, and scientists are still determining the correct doses.

Legal ambiguities might discourage doctors from using the products in a way that is not recommended, said Penn's Lynch. For one thing, she said, it isn't clear whether doctors using the Pfizer vaccine off label would be shielded from legal liability if someone was injured by the shot.

The Centers for Disease Control and Prevention's vaccine advisory committee is expected to meet soon to recommend use of the vaccine. Since the Advisory Committee on Immunization Practices and the CDC have recommended Pfizer for use in people 16 and older under the emergency authorization, they are virtually certain to recommend it for the licensed product.

The Pfizer-BioNTech approval is part of what is shaping up as a period of extraordinary activity on the vaccine front. Moderna, the second most widely used vaccine in the United States, filed for full approval June 1. Johnson & Johnson, maker of the third coronavirus vaccine authorized for emergency use in the United States, has said it plans to apply for approval later this year.

Pfizer-BioNTech, which has submitted early-stage data to the FDA as part of its application for a booster, is expected to add late-stage information shortly to that application. Johnson & Johnson, which unlike the two-dose Pfizer-BioNTech and Moderna vaccines is a single-shot vaccine, is expected to announce data soon from a trial testing the effect of adding a second shot.

Meanwhile, Moderna's application for using its vaccine among 12- to 17-year-olds is pending at the FDA; Pfizer-BioNTech already has clearance for its vaccine to be used in adolescents. Those companies are conducting vaccine studies in children under 12, and Pfizer-BioNTech is aiming to file data for 5- to 11-year-olds with the FDA by the end of September. Moderna is expected to follow soon after.

Officials recently recommended third shots of the Pfizer-BioNTech and Moderna shots for the immunocompromised. And the Biden administration's booster plan adds another element to an already crowded and complicated fall calendar.

By Ben Guarino, Laurie McGinley and Tyler Page, Washington Post, August 23, 2021

###

August 23, 2021

Voices4America Post Script. No more, anti-vaxxer excuses. Let the mandates begin! #VaccinationOrTermination Who’s with me? Who is with America?