Permanent US approval for Pfizer and BioNTech vaccine

More than eight months after first being granted emergency use authorization (EUA), the COVID-19 vaccine from Pfizer (NYSE: PFE) and BioNTech (Nasdaq: BNTX) has received full approval from the US Food and Drug Administration (FDA).

The vaccine, marketed as Comirnaty, has been approved for the prevention of COVID-19 in people aged 16 years and older, and continues to be available under an EUA, including for those from 12 to 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

"We recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated"Acting FDA Commissioner Janet Woodcock said: “The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for EUA, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.