FDA gives full approval to Pfizer’s COVID-19 vaccine

First COVID-19 vaccine to get full approval

FILE - In this July 22, 2021, file photo, health care worker fills a syringe with the Pfizer COVID-19 vaccine at the American Museum of Natural History in New York. U.S. health officials Wednesday, Aug. 18, recommended all Americans get COVID-19 booster shots to shore up their protection amid the surging delta variant and evidence that the vaccines' effectiveness is falling. (AP Photo/Mary Altaffer, File)
FILE - In this July 22, 2021, file photo, health care worker fills a syringe with the Pfizer COVID-19 vaccine at the American Museum of Natural History in New York. U.S. health officials Wednesday, Aug. 18, recommended all Americans get COVID-19 booster shots to shore up their protection amid the surging delta variant and evidence that the vaccines' effectiveness is falling. (AP Photo/Mary Altaffer, File) (Copyright 2021 The Associated Press. All rights reserved.)

The FDA has given its full approval to a COVID-19 vaccine.

Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older.

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 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.”

Read more: US regulators give full approval to Pfizer COVID-19 vaccine

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Ken Haddad is the digital special projects manager for WDIV / ClickOnDetroit.com. He also authors the Morning Report Newsletter and various other newsletters. He's been with WDIV since 2013.