The Food and Drug Administration granted full approval to the Pfizer-BioNTech two-dose COVID-19 vaccine, a move the Biden administration is hoping will convince holdouts to get the shots.
“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.
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The agency’s approval could spur new vaccination mandates across the private sector, adding to ones imposed by companies such as Google, Walmart, and Netflix. Many employers have resisted instituting mandates for fear of losing staff.
“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,” Woodcock said. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
The Pfizer-BioNTech vaccine, which will be marketed as Comirnaty, first received emergency use authorization in December, an approval pathway designed to speed up treatments and vaccines to market during a public health emergency. Despite the federal government’s endorsement of the shots late last year, many adults eligible for the shots remained apprehensive about getting them over fears that scientists prioritized speed over safety.
“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,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “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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Moderna, whose vaccine relies on the same mRNA technology as the one developed by Pfizer, filed its application for full approval in June, and it is expected to be granted this fall. Pfizer and Moderna are also in the process of testing the vaccines in young children, with clinical trial data expected to be submitted to the FDA in the fall as well.
