Today, the U.S. Food and Drug Administration formally approved the Pfizer COVID-19 vaccine. The widely anticipated decision replaces the emergency use authorization granted by the agency last December.
This is the first COVID-19 vaccine to be subject to a full review by the U.S. regulator and to get approval that puts it on par with other marketed vaccines. The Pfizer vaccine will now be marketed as Comirnaty for the prevention of COVID-19 disease in individuals 16 years of age and older.
Full FDA approval could make it easier for employers, the military, and universities to mandate vaccination and may reassure some people who are hesitant about the vaccine.
“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,” says Acting FDA Commissioner Dr. Janet Woodcock.
The vaccine continues to be available under emergency use authorization for 12 to 15-year-olds and for third-dose administration in some with weak immune systems.
A June poll from the Kaiser Family Foundation found that 31% of unvaccinated people said they would be more likely to get a COVID-19 vaccine once one receives full approval from the FDA, NPR reports.
“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,” says Dr. Peter Marks, director of 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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Currently, no COVID-19 vaccines are approved for use in children under 12. Trials are ongoing, Marks says.
As of Sunday, 73% of adults have had at least one dose of the Pfizer, Moderna or Johnson & Johnson vaccine, according to data from the Centers for Disease Control and Prevention.
Moderna’s COVID-19 vaccine remains under FDA review, but is expected to be approved in the near future.
