WASHINGTON (KFOR) — U.S. regulators have given full approval to Pfizer’s COVID-19 vaccine, the FDA announced on Monday.
“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,” said Acting FDA Commissioner Janet Woodcock, M.D. “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’s application for full approval, submitted in late May, includes the latest data from a large study that tracked participants 16 and older for six months after their second dose. The vaccine is given to people as young as 12, and Pfizer also intends to submit data needed for full approval in that age group.
The FDA says the vaccine will now be marketed as Comirnaty for individuals 16-years-old and older for the prevention of COVID-19. The vaccine will continue to be available under emergency use authorization for individuals 12-years-old through 15-years-old.
“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,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “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.”
The way the FDA’s vaccine program is designed should help it in its efforts to expedite the full approval of COVID vaccines. This is because manufacturers with COVID vaccines approved for emergency use—Johnson & Johnson, Moderna, and Pfizer—had to follow the same FDA guidelines used for all vaccines.
Full approval for Moderna’s COVID vaccine is likely to follow a few months after Pfizer’s. Pfizer announced that it had applied for full approval of its vaccine for people ages 16+ on May 7. It did not receive priority status from the FDA until two months later.
U.S. health officials Wednesday recommended all Americans get COVID-19 booster shots to shore up their protection amid the surging delta variant and evidence that the vaccines’ effectiveness is falling.