Pfizer's COVID Vaccine Gets Full Approval From The FDA

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.

This 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.

Updated August 23, 2021 at 9:46 AM ET

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

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," acting FDA Commissioner Janet Woodcock said in a statement. "Today's milestone puts us one step closer to altering the course of this pandemic in the U.S."

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 of Sunday, 73% of adults 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 FDA's review, but its approval is expected to follow in the near future. [Copyright 2021 NPR]