The U.S. drug regulator has granted full approval to the Pfizer Inc BioNTech Covid-19 vaccine. The vaccine was granted emergency-use authorization in December, making it the first to secure such Food and Drug Administration approval

The vaccine will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of Covid-19 disease in individuals above 16 years of age.

The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 to 15 years of age.

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 emergency use authorization, 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,” said Acting FDA Commissioner Janet Woodcock, M.D.

The FDA's approval is based on updated data from the company's clinical trial.

"Based on the longer-term follow-up data that we submitted, today's approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed," Albert Bourla, CEO of Pfizer, said in a statement.