FDA gives official approval to Pfizer vaccine

Jenny Goldsberry |

Aug 24, 2021

By Jenny Goldsberry

The U.S. became the first country to officially approve the Pfizer COVID-19 vaccine for everyone 16 years old and older Monday. It is currently the only vaccine fully licensed by the Food and Drug Administration.

According to a statement from the FDA, the vaccine received a new name and “will now be marketed as Comirnaty (koe-mir’-na-tee).”

Today, FDA approved the first COVID-19 vaccine for the prevention of #COVID19 disease in individuals 16 years of age and older. https://t.co/iOqsxXV1fj
— U.S. FDA (@US_FDA) August 23, 2021

“The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals,” the statement read.

Then, Acting FDA Commissioner Janet Woodcock, M.D. lauded the announcement. “The approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” Woodcock said in a statement. “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.”

Next Pfizer CEO Albert Bourla made a statement to commemorate the approval. Bourla hopes this latest update “will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives.”

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