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The FDA announced some major news on Monday, approving the first COVID-19 vaccine.
On Monday, August 23, the U.S. Food and Drug Administration announced its approval of the Pfizer-BioNTech COVID-19 vaccine which will now be marketed as Comirnaty.
“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.”
The Pfizer-BioNTech vaccine has been available for individuals 16 and older since December 11, 2020. Since May 10, 2021, the age range was expanded to include children between 12 and 15.