4.9.2021 | Pfizer/ BioNTech Vaccine Has Got Full Approval From FDA
The Food and Drug Administration has granted full approval of the Pfizer/BioNTech COVID-19 vaccine, which will now be marketed as Comirnaty, the agency announced Monday.
The vaccine's full approval—or Biologics License Application (BLA)—applies for use of a two-dose regimen, given three weeks apart, in people ages 16 years and older. It is the first BLA to be issued for a vaccine against COVID-19.
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. Today’s milestone puts us one step closer to altering the course of this pandemic in the US.”