JACKSON, Wyo. — Pfizer’s COVID-19 vaccine has received official approval from the Food and Drug Administration (FDA), according to an announcement from the FDA Monday morning.
The vaccine, produced by Pfizer and BioTech, was granted emergency use authorization (EUA) in December, allowing pharmacists and doctors to deliver it to eligible arms for free. The FDA’s full approval replaces its EUA status for people 16 and older. Kids ages 12-15 can still get vaccinated under emergency use authorization.
Pfizer’s is the first COVID-19 vaccine to receive full FDA approval. The vaccine will now be marketed as Comirnaty (koe-mir’-na-tee)
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D., said in a statement. “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.”
The FDA analyzed effectiveness data from roughly 20,000 vaccine and 20,000 placebo recipients 16 and older, according to the announcement. Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D., in a statement. “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.”
