The Food and Drug Administration (FDA) on Monday granted the Pfizer-BioNTech COVID-19 vaccine full approval. 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.
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.