Pfizer-BioNTech's COVID Vaccine Gets Full Approval From The FDA

Aug 23, 2021
Originally published on August 23, 2021 12:45 pm

Updated August 23, 2021 at 12:52 PM ET

The Food and Drug Administration has formally approved Pfizer's COVID-19 vaccine. The widely anticipated decision replaces the emergency use authorization granted by the agency last December.

The vaccine, developed by Pfizer and its partner BioNTech, is the first COVID-19 vaccine to be subject to a full review by the U.S. regulator and to get an approval that puts the vaccine on par with other marketed vaccines.

The full approval could make it easier for employers, the military and universities to mandate vaccination and may reassure some people who are hesitant about the vaccine.

"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," acting FDA Commissioner Janet Woodcock said in a statement.

Approval could lead to more vaccinations

A June poll from the Kaiser Family Foundation found that 31% of unvaccinated people said they would be more likely to get a COVID-19 vaccine once one receives full approval from the FDA.

"While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated," Woodcock said. "Today's milestone puts us one step closer to altering the course of this pandemic in the U.S."

The FDA's full approval applies to people 16 and older. Those ages 12 through 15 can still receive the vaccine under the existing emergency use authorization.

There is no timeline for children under 12

That authorization does not extend to children under the age of 12. FDA officials have acknowledged the interest in vaccination for children in that age group but were unable Monday to provide a timeline for a decision on use of the vaccine for those under 12.

"Currently there are still trials ongoing here," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, told reporters. "The agency has to wait for the companies to submit. ... Obviously, we will move swiftly, but first the trials have to be finished ... and the data need to be submitted to us."

The FDA acted Monday without convening a customary public meeting of expert advisers to vet information about the vaccine and make recommendations to the regulator.

As part of the approval process, the vaccine also got a brand name: Comirnaty. The FDA says that's pronounced "koe-mir'-na-tee."

As of Sunday, 73% of adults in the U.S. have had at least one dose of the Pfizer, Moderna or Johnson & Johnson vaccine. Pfizer's vaccine is most commonly administered, accounting for about 56% of the doses administered overall, according to data from the Centers for Disease Control and Prevention.

Moderna's COVID-19 vaccine remains under the FDA's review, but its approval is expected to follow in the near future.

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