The Food and Drug Administration announced Monday that it has approved the first COVID-19 vaccine Pfizer and BioNTech’s COVID-19 vaccine for people 16 and older, making it the first to be fully licensed for use in the United States.
After final approval from FDA, the Pfizer-BioNTech COVID-19 Vaccine 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 said in a statement.
“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 Janet Woodcock, M.D, Acting FDA Commissioner said in a statement.
“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,” Woodcock added.
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