The approval caps a months-long «sprint» by the FDA to clear the shot's final remaining regulatory hurdles in record time, scrutinizing reams of the company's latest safety data and conducting inspections at Pfizer's vaccine factories around the world.«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.
Today's milestone puts us one step closer to altering the course of this pandemic in the U.S.,» said the FDA's Acting Commissioner Janet Woodcock said in a statement.Pfizer completed its submission of a «biologics license application» for the shot in May, providing the extensive documentation required for.