FDA grants full approval for the Pfizer COVID-19 vaccine

Today, the U.S. Food and Drug Administration granted full approval for the Pfizer COVID-19 vaccine for the prevention of COVID-19 disease in individuals 16 years of age and older.

“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. “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.”

The vaccine continues to be available under emergency use authorization (EUA) for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals. Read the FDA press release here.