FDA Approves First COVID-19 Vaccine

The FDA granted approval to Pfizer’s Covid-19 vaccine for individuals 16 years and older. This is the first Covid-19 vaccine to get full approval from the FDA. This has been known as the Pfizer-BioNTech Covid-19 vaccine and will now be marketed as Comirnaty for the prevention of Covid-19 disease.

Pfizer vaccine will still 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. “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 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.