COLUMBUS, Ind. – The U.S. Food and Drug Administration approved the first COVID-19 vaccine on Monday. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine and is now fully approved by the FDA for individuals age 16 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.
“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, M.D.
She added, “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.”
Since December 11, the Pfizer Vaccine has been available under emergency use authorization for individuals age 16 and older. Pfizer is the first vaccine to be granted full approval by the FDA.
