The Pfizer vaccine received the strongest endorsement from the Food and Drug Administration than any COVID-19 vaccine had to date Monday: full approval.
According to the FDA, the vaccine will now be marketed as Comirnaty for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine will still be available under emergency use authorization (EUA) for kids 12-15.
“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,” acting FDA Commissioner Janet Woodcock said in a statement. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
Pfizer had originally sought full approval from the FDA back in May. Moderna joined Pfizer the following month. Earlier this month, we learned that full approval was expected to come by Labor Day.
The FDA’s initial EUA was based on a study that tracked 44,000 people 16 and older for at least two months. That’s roughly the time period when serious side effects typically arise. However, it’s also shorter than the six months of safety data normally required for full approval.
Pfizer kept that study going. According to the FDA, even after hundreds of millions of shots, serious side effects remain exceedingly rare.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” FDA Center for Biologics Evaluation and Research 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.”
The U.S. becomes the first country to fully approve the Pfizer vaccine. In a tweet, CEO Albert Bourla said he hoped “this news will instill even further public confidence in our vaccine and the science that made it possible.”
