FDA approves Pfizer-BioNTech COVID-19 vaccine

Monday, August 23, 2021

Source: Drug Discovery & Development

The FDA today issued approval for Pfizer and BioNTech’s COVID-19 vaccine, making it the first to receive full approval in the U.S.

The approval covers the prevention of COVID-19 in individuals 16 years of age and older. The vaccine remains available under FDA emergency use authorization (EUA) for people who are 12 years of age to 15 years of age, as well as for the administration of a third (booster) dose in certain immunocompromised individuals.

Such approval could bring more vaccination requirements in the U.S. as many employers and organizations around the country had been holding off on vaccine mandates until full approval was granted.

“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,” Acting FDA Commissioner Dr. Janet Woodcock said in a news release. “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.”

Pfizer and BioNTech’s mRNA-based COVID-19 vaccine will now be marketed as Comirnaty (koe-mir’-na-tee) in the U.S. The company has used that name for the vaccine in Europe.

The vaccine has been available under EUA for those 16 years of age and older since Dec. 11, 2020. Expansion to include those between 12 and 15 occurred on May 10, 2021.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. 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,” FDA Center for Biologics Evaluation and Research director Dr. Peter Marks said. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”

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