FDA approves first COVID-19 vaccine
WASHINGTON - Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine.
The vaccine, which has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty.
The vaccine is 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, including for individuals 12 through 15 years of age and for the administration of the third dose in certain immunocompromised individuals.
“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, M.D.
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021.
