The U.S. Food and Drug Administration has granted full approval to the Pfizer-BioNTech COVID-19 vaccine.
It will now be marketed as Comirnaty for people 16 years of age and older, while the emergency use authorization (EUA) continues to be valid for children aged 12 to 15.
The announcement was made on Monday, and the FDA also continues to recommend that a third dose of the vaccine be administered to certain immunocompromised patients.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” Acting FDA Commissioner Janet Woodcock said in a news release. “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. 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.”
The FDA-approved vaccine first became available under the EUA in December 2020 along with the similar two-dose Moderna vaccine and the one-dose Johnson and Johnson vaccine, neither of which have yet been fully approved by the FDA at this time.
According to the Tennessee Department of Health, as of August 22, 2021, more than 6 million vaccines have been administered in the state, with only 41 percent of Tennesseans being fully vaccinated.
On a county level, 53 percent of Williamson County residents are fully vaccinated.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” the FDA’s Center for Biologics Evaluation and Research Director Peter Marks said. “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. 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."
More information about the COVID-19 vaccines can be found here.