FDA grants full approval to Pfizer’s COVID-19 vaccine

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.

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.”

Why it matters: 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.