The Pfizer-BioNTech COVID-19 vaccine was given full approval by the U.S. Food and Drug Administration on Monday.
Before Monday’s approval for those 16 and older, Pfizer’s vaccine had been given emergency use authorization by the FDA, which allowed it to be administered to that age group without its full endorsement, since December.
“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 Monday. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
When the FDA gave Pfizer emergency use authorization, it was after two-months of a study on 44,000 volunteers, 16 and older.
The FDA examined results from Pfizer’s continued study, as well as real-world data from millions of vaccinations that had been administered to Americans, to this point.
Americans in the 12 to 15-year-old category may currently receive Pfizer vaccinations under emergency use, but the vaccine has yet to be fully authorized in that age group.
Pfizer is now the first COVID-19 vaccine to receive full authorization, with Moderna and Johnson & Johnson still being under emergency use.