The Food and Drug Administration has formally approved Pfizer's COVID-19 vaccine. The widely anticipated decision replaces the emergency use authorisation granted by the agency last December.
The vaccine, developed by Pfizer and its partner BioNTech, is the first COVID-19 vaccine to be subject to a full review by the U.S. regulator and to get an approval that puts the vaccine on par with other marketed vaccines.
On Monday, the FDA’s acting commissioner, Dr. Janet Woodcock, said the approval should boost public confidence in the Pfizer vaccine.
“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,” Woodcock said in a statement.
The agency approved the vaccine in people aged 16 and older. Emergency-use authorisation remains in place for those aged 12 to 15. A third dose for immunocompromised individuals is also still authorised, but not yet approved.
“I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity,” Pfizer’s CEO, Albert Bourla, said in a statement after the approval was announced.