Live Updates On Monday, the U.S. Food and Drug Administration issued the first full authorization for a COVID-19 vaccine, giving full approval to the Pfizer two-dose shot. The Pfizer-BioNTech vaccine, which will be marketed as Comirnaty, is fully authorized for people 16-years-old and older, while people aged 12 through 15 can still receive the vaccine under the emergency use grant. Pifzer’s shot was granted emergency use authorization in December 2020. Administration of a third dose, or booster shot, is also still under emergency use approval for individuals with suppressed immune systems or certain medical conditions, though booster shots will be available to all U.S. citizens in the coming weeks. Janet Woodcock, M.D., the acting FDA commissioner, said in a press release the approval of Comirnaty was a “milestone” for battling the 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,” Woodcock said. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval… Read full this story
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