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23 Aug 2021

Pfizer-BioNTech shot becomes first COVID-19 vaccine to gain full FDA approval

Pfizer and BioNTech’s shot on Monday became the first COVID-19 vaccine to be granted full approval by the US Food and Drug Administration.

The mRNA-based vaccine, which will now be marketed as Comirnaty, will continue to be available under emergency use authorization (EUA), including for 12-15 years of age and for the administration of a third dose in certain immunocompromised individuals.

Acting FDA Commissioner Janet Woodcock said that while millions of people have already safely received COVID-19 vaccines, the regulator recognised that for some, the FDA approval of a vaccine may instill additional confidence to get vaccinated.

“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,” she said.

The Pfizer-BioNTech shot was granted an EUA on December 11, 2020 for people aged 16 and older, and the authorization was expanded to include 12-15 year-olds on May 10 this year. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, after the agency has weighed up the risk-benefit profile.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” said Peter Marks, director of FDA’s Center for Biologics Evaluation and Research. “We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities.”

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