The United States Food and Drug Administration (FDA) 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.
The approval comes in a week prior to federal health officials' earlier estimates that the agency would complete its review by Labor Day.
"The FDA's approval of this vaccine is a milestone as we continue to battle the Covid-19 pandemic," 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".
The full approval indicates that Pfizer has shown enough effectiveness and safety data to meet the stringent Biologics License Application (BLA) requirements, which includes at least six months of safety data from a majority of the volunteers in a large, final stage clinical trial.
The vaccine remains available under emergency use authorization to children aged 12 to 15, but because it has now been fully approved, physicians may prescribe it to children under 12 if they believe it will be beneficial.
