FDA approves Pfizer’s COVID-19 vaccine, now called Comirnaty

Enlarge / Empty Pfizer-BioNTech COVID-19 vaccine vials (credit: AHMAD GHARABLI)

The Food and Drug Administration has granted full approval of the Pfizer/BioNTech COVID-19 vaccine, which will now be marketed as Comirnaty (koe-mir’-na-tee), 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. The vaccine will still be available under an Emergency Use Authorization (EUA) for adolescents ages 12 to 15 and for use as a third booster dose in certain people with compromised immune systems.

The name Comirnaty—already in use elsewhere, including Europe—is a mash-up of “COVID-19 immunity” and “mRNA” that is meant to evoke the word “community.”