The Food and Drug Administration on Monday granted full approval to Pfizer and BioNTech Covid-19 vaccine – becoming the first in the U.S. to win the coveted designation and giving even more businesses, schools and universities greater confidence to adopt vaccine mandates.
Up until now, the mRNA vaccine, which will be marketed as Comirnaty, was on the U.S. market under an Emergency Use Authorization that was granted by the FDA in December. Since then, more than 204 million of the Pfizer shots have been administered, according to data compiled by the Centers for Disease Control and Prevention.
Federal health officials had been under mounting pressure from the scientific community and advocacy groups to fully approve Pfizer and BioNTech’s vaccine ever since the drugmakers submitted their application to the agency in early May. The companies submitted a Biologics License Application, which secures full approval, to the FDA on May 7 for patients age 16 and up.