FDA Approval

NEWS: Pfizer COVID Vaccine Receives Full FDA Approval

The U.S. Food and Drug Administration (FDA) gave full approval for the Pfizer COVID vaccine Monday, Aug. 23 for patients 16 and older. This is the first COVID vaccine to be granted full approval from the FDA.

“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,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement.

In December of 2020, the Pfizer vaccine was granted Emergency Use Authorization (EUA) by the FDA and has been administered to millions of people nationwide with high success rates. In May 2021, Pfizer submitted to the FDA’s Biologics License Application for the 16 and older population and was granted approval today.

To receive approval, the FDA reviewed data that has been updated since initial clinical trials (data that allowed for the EUA in December) which included tracking outcomes in even more patients over a longer period of time after receiving the vaccine doses.

The Pfizer vaccine, now marketed as Comirnaty, is still approved for use under the FDA’s EUA for patients ages 12 – 15 and for a third dose in certain immunocompromised individuals.

Moderna, which also received EUA in December 2020, began the process for full FDA approval earlier this summer and approval is expected later this year, but because every vaccine is different timing may vary. Johnson & Johnson has not yet begun the process for full FDA approval but has issued statements that they plan to submit for approval later in 2021.

NOAH offers all three COVID vaccines at health center around the Valley. To request a vaccine for people 12 and older, call 480-882-4545 or request a vaccine appointment online.