Federal regulators on 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 waves since early 2020, exhausting nursing staffs, filling intensive care units and raising fears among the vaccinated and the unvaccinated.
The vaccine is 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.
President Biden touted the FDA’s full approval of the vaccine Monday and implored unvaccinated Americans to get the shot.
“Let me say this loudly and clearly,” he said in remarks from the White House. “If you’re one of the millions of Americans who said that they will not get the shot … until it has full and final approval of the FDA, it has now happened. The moment you’ve been waiting for is here. It’s time for you to go get your vaccination and get it today.”
But some unvaccinated Americans said news of the FDA approval wasn’t enough to sway them, and others said they weren’t following regulators’ decision-making.
Ed Boone, 51, who lives in Oceana County, Mich., said he and his family weren’t aware the FDA had approved the vaccine until reached by a Washington Post reporter.
“We work in a bakery, so we’re here pretty early in the morning,” Boone said, adding that he wanted to do his own research on the FDA’s decision. “I’d want to see it for myself.”
Boone said he remained skeptical of the need for the vaccine, saying he’d already been infected by the coronavirus and noting that the delta variant had led to a rise in breakthrough infections.
“I know people that have had [the vaccine] — and they have still gotten the new variant. And I guess, if it doesn’t do anything for the new variant, what am I putting it in my body for?” Boone said.
The president also renewed his call to public- and private-sector leaders to mandate vaccines. Last month, Biden announced he was requiring all federal workers to get vaccinated or comply with weekly testing.
“The reason most people in America don’t worry about polio, smallpox, measles, mumps and rubella today is because of vaccines,” Biden said. “It only makes sense to require a vaccine to stop the spread of covid-19. With today’s FDA full approval, there’s another good reason to get vaccinated.”
The Pentagon moved forward Monday with plans to mandate coronavirus vaccinations for U.S. troops following the Pfizer-BioNTech approval. The vaccine has been encouraged by commanders but was voluntary pending full authorization by the FDA, and Monday’s decision may accelerate the military’s timetable for mandating vaccination.
In New York, Mayor Bill de Blasio (D) decreed that all of the city’s public school teachers and staffers must be vaccinated. Under the mandate announced Monday, the city’s 148,000 public school employees cannot forgo vaccination and choose testing instead. They will be required to have at least one shot by Sept. 27.
Approval in record time
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 cases of covid-19, the illness caused by the virus, in that trial.
The company plans to follow the enrollees for 24 months. To qualify 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, which Pfizer will market under the name Comirnaty, 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.”
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, et cetera,” 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.
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.
But the Centers for Disease Control and Prevention said in a statement Monday that off-label uses of coronavirus vaccines beyond those approved by the FDA is not recommended. Off-label use could affect providers’ liability protection and their reimbursement for costs to administer the vaccine, the statement said.
“The only people that providers should be offering the approved Pfizer vaccine to are those 16 and older for their two-dose series,” CDC spokeswoman Kristen Nordlund said. “They should not be offering this to kids under 12, because we don’t have safety data yet, or to people who want their booster doses early.”
The FDA’s Woodcock also discouraged off-label use Monday, saying that giving an additional dose to people who are not immunocompromised “is something where FDA will need to review the data and is not part of this approval.” Officials recently recommended third shots of the Pfizer-BioNTech and Moderna vaccines for the immunocompromised.
Still, doctors may face pressure from patients who want to receive booster shots soon, even as the FDA considers whether to allow them. The Biden administration recently said the effectiveness of the Pfizer-BioNTech and Moderna vaccines at preventing mild and moderate covid-19 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 attempted 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 CDC’s vaccine advisory committee has scheduled an Aug. 30 meeting 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.
Dan Diamond, Alex Horton, Brittany Shammas and Lena H. Sun contributed to this report.
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