Pfizer has received full approval in the U.S. for its COVID-19 vaccine.
It had been administered under an emergency use order since the middle of last December for those 16 and older, later expanding to 12 and older in May.
The U.S. Food and Drug Administration gave full approval today.
“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,” says Acting FDA Commissioner Dr. Janet Woodcock.
Dr. Woodcock hopes FDA approval will ease concerns of those still hesitant about getting the vaccine.
The emergency use designation will still apply for the 12 to 15 age group for now.
The vaccine is also being administered under an emergency use approval in Canada.
No word if Health Canada plans to follow the U.S. move.