The Food and Drug Administration (FDA) on Monday granted the Pfizer-BioNTech COVID-19 vaccine full approval in a highly anticipated move that’s expected to boost vaccinations and spark more mandates nationwide.
The federal agency reached the milestone of issuing the first complete authorization for a COVID-19 vaccine after an approximately three-month review of Pfizer and its German partner BioNTech’s application to the FDA for full approval.
The vaccine will be marketed as Comirnaty, with the full authorization applying to vaccine recipients age 16 and older, the FDA announced in a release.
The FDA's emergency use authorization will remain in place for those between the ages of 12 and 15. The emergency use authorization also still applies for a third dose for immunocompromised people.
Acting FDA Commissioner Janet Woodcock praised the authorization in a press briefing, saying it "holds the promise of altering the course of the pandemic in the United States."
"This is an unprecedented timeline given the volume of review and the meticulous manner in which it was done," she said. "But we want to underscore that our efforts to move as quickly as possible have in no way sacrifice scientific standards for the integrity of our process."
"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,” she said in a separate statement.
Some have criticized the FDA for not approving the vaccine more quickly, but Peter Marks, director of the agency's vaccine center, said it took 40 percent of the "normal clock time" for a consideration of "this magnitude."
Pfizer CEO Albert Bourla said in a statement that the FDA approval "affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed."
“I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity," he said.
With slightly more than half of the total U.S. population fully vaccinated, experts and Biden administration officials are hopeful the agency’s full approval will serve as a catalyst for vaccinations in the country.
The Pfizer-BioNTech vaccine, like the other two available in the U.S., had been given emergency use authorization, allowing it to be administered only during the public health emergency. But under the full authorization, the FDA is giving permission for patients to get the shots once the public health emergency is declared over.
More than 204 million doses of the Pfizer-BioNTech vaccine have been administered across the country under the emergency use authorization, according to Centers for Disease Control and Prevention data.
An increase in vaccine mandates is likely to follow the FDA’s full licensure of the two-dose regimen, as some businesses, organizations and universities were expected to wait until the full endorsement to enforce such requirements.
The approval is also likely to motivate some Americans to get their COVID-19 shots, based on a Kaiser Family Foundation poll that found 30 percent of unvaccinated people said they would be more willing to get vaccinated following the FDA’s full authorization.
U.S. Surgeon General Vivek MurthyVivek MurthyFauci says it's recommended to get same vaccine for COVID-19 boosters CDC director signs off on boosters of Johnson & Johnson, Moderna COVID-19 vaccines Overnight Health Care — Presented by Carequest — Boosters take a big step forward MORE told CNN’s “State of the Union” on Sunday that he thinks the number of unvaccinated people that could be persuaded by the FDA's full authorization is “small” but “still significant.”
The FDA's decision to back full authorization for the vaccine was based on updated data from the clinical trial and additional research.
Out of about 22,000 vaccine recipients and about 22,000 placebo recipients aged 16 and older in the trial, Pfizer's vaccine was found to be 91 percent effective in preventing COVID-19.
About 12,000 recipients were followed for at least six months after the second dose.
The agency also noted it "conducted a rigorous evaluation" of the safety data relating to rare cases of heart inflammation, called myocarditis and pericarditis, after the Pfizer-BioNTech vaccine.
The FDA said the data "demonstrate increased risks, particularly within the seven days following the second dose." Current short-term data indicates most heart inflammation patients see a resolution of symptoms, although "some" needed intensive care.
The Comirnaty vaccine "includes a warning about these risks," the agency said.
The FDA first granted emergency use authorization to the Pfizer-BioNTech vaccine in December, followed closely after by the Moderna vaccine. The agency granted emergency use authorization for 12- to 15-year-olds to get the Pfizer vaccine in May and for immunocompromised people to get a third dose earlier this month.
Updated at 11:52 a.m.