On Aug. 23, the U.S. Food and Drug Administration granted full approval to the Pfizer-BioNTech coronavirus vaccine, which is a significant milestone in the pandemic. It is the first licensing of a vaccine for the novel coronavirus.
The COVID-19 vaccine now is approved by the U.S. Food and Drug Administration (FDA).
The FDA said in its press release that the vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals, the agency said.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. 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,” said Acting FDA Commissioner Janet Woodcock, MD. “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. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
The Pfizer-BioNTech COVID-19 Vaccine has been available under emergency use authorization (EUA) in individuals 16 years of age and older since Dec. 11, 2020, the FDA said, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021.
The FDA approves first COVID-19 vaccine. The U.S. Food and Drug Administration. Accessed August 23, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine