FDA approves first COVID-19 vaccine
The U.S. Food and Drug Administration (FDA) has approved the first novel coronavirus (COVID-19) vaccination, the Pfizer-BioNTech COVID-19 Vaccine, which will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals ages 16 years and older, according to an announcement made by the agency this week.
Since December 11, 2020, the Pfizer-BioNTech vaccine has been available under emergency use authorization in individuals ages 16 years and older. The authorization was expanded to include those ages 12 through 15 years old on May 10, 2021.
While the vaccine is fully approved for individuals ages 16 years and older, the vaccine will continue to be available under emergency use authorization, including for individuals ages 12 through 15, and for the administration of a third dose in certain immunocompromised individuals.