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 drug makers 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.
FDA scientists evaluated “hundreds of thousands of pages” of vaccine data, according to the U.S. agency.
Pfizer’s vaccine met the agency’s “high standards for safety, effectiveness, and manufacturing quality,” acting FDA Commissioner Janet Woodcock said in a statement. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated.”
Standard vaccine reviews generally take several months to a year or more to determine whether they are safe and effective for use in the general public. But due to the pandemic, which has killed more than 628,000 Americans, the FDA permitted the use of the shots under EUA.
Pfizer and BioNTech also plan to ask the FDA to approve a third dose as a booster shot following full approval. Last week, the Biden administration said it was preparing to offer booster shots to all eligible Americans beginning the week of Sept. 20.