The Food and Drug Administration on Monday granted full approval to the Pfizer-BioNTech COVID-19 vaccine for people 16 and older, making it the first vaccine against the virus to earn that status in the United States.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” Janet Woodcock, the acting FDA administrator, said in a statement. “While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, 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.”
The vaccine, which will now be marketed as Comirnaty, was given an emergency-use authorization in December, and 92 million people in the U.S. have already received a two-dose regimen, according to the Centers for Disease Control and Prevention.
FDA’s review took 97 days, a period less than half as long as the agency usually takes to consider this type of submission.
Speaking at the White House on Monday afternoon, President Joe Biden implored people who have not yet been vaccinated to get a shot.
“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,” he said. “The moment you’ve been waiting for is here. It’s time for you to go get your vaccination.
“The delta variant is dangerous and spreading, causing a pandemic of the unvaccinated,” he added. “While we’re starting to see initial signs that cases may be declining in a few places, nationwide cases are still rising, especially among the unvaccinated.”
He called on more private businesses and local officials to implement vaccine requirements, which the administration has already announced for federal workers.
Agency hopes move will boost vaccination rates
Full approval could persuade some who have been hesitant to receive the vaccine and also make it easier for schools and employers to mandate vaccinations.
Pentagon spokesman John Kirby said the shot would be mandated for all troops after the FDA’s approval. New York City will also require all of its Department of Education employees to get at least one shot by Sept. 27, according to reports. Those employees will not have an option to submit to weekly testing. New Jersey Gov. Phil Murphy, a Democrat, also announced that all of his state's school personnel would be required to be fully vaccinated by Oct. 18 or submit to once or twice weekly testing.
Mark McClellan, a former FDA commissioner and a board member of competing vaccine maker Johnson & Johnson, said the approval's impact will likely rest on whether businesses and local governments move now to require vaccinations.
“Those numbers are going to go up significantly," McClellan said of vaccine mandates. "That probably is going to drive the bigger impact of full approval on vaccination rates in this country.”
The approval comes as COVID-19 cases have risen in recent weeks, fueled by the delta variant. Peter Marks, the director of the FDA's Center for Biologics Evaluation and Research, told reporters that “there is various real world evidence that are emerging here that suggests that the vaccine is still effective against the delta variant.”
The agency is following data out of Israel suggesting that immunity from the Pfizer shot could wane, he added. The Biden administration announced a plan last week to offer a third shot to anyone who received the Pfizer or Moderna vaccine eight months after their second dose.
Marks did not give a timeline for when the agency may convene its Vaccines and Biologics Advisory Committee, known as VRBPAC, to review booster shots.
White House chief medical adviser Anthony Fauci has described full approval as something of a formality given the breadth of evidence required by the FDA for a COVID-19 vaccine emergency-use authorization, including clinical trials of tens of thousands of people and two months of safety data, as well as the extensive safety monitoring since the vaccination campaign began in the winter.
But full FDA approval could also motivate many to get a shot. About three out of every 10 people who are unvaccinated say a lack of full FDA approval is a factor, according to the Kaiser Family Foundation.
“FDA’s full approval means the vaccine has met the very high standards required of all the approved vaccines we rely on every day for ourselves and our families, and confirms that the benefits of the vaccine in preventing COVID and its complications are clear-cut and far outweigh any risks,” Jesse Goodman, a former FDA chief scientist and professor of medicine and infectious diseases at Georgetown University, said in a statement.
Young children still not eligible
Monday’s approval does not change the emergency use authorization for children between the ages of 12 and 15, who are still eligible to receive the vaccine. But Woodcock warned that full approval shouldn't lead to off-label use in younger children because the agency still does not know the proper dosage or have data on its safety and efficacy in younger children.
“They are not just small adults and we’ve learned that time and time again,” Woodcock said.
The approval includes a warning of increased risk for myocarditis, particularly within seven days of the second dose. Men under 40 are at higher risk than women and older men, and the risk is highest among boys between ages 12 and 17. Marks said that available data showed most of the affected individuals’ symptoms had gone away.
Emily Kopp and Lauren Clason contributed to this story.