It's official: FDA grants full approval to Pfizer COVID-19 vaccine

Vaccine is 91% effective at preventing COVID-19; clinical trial and six-month follow-up show few adverse events, but men under 40 and boys 12-17 have somewhat higher risk within days of second dose.

With an early morning announcement, the U.S. Food and Drug Administration granted “full approval” — what is officially called a BLA (or “biologics license application”) — to Pfizer for the Pfizer-BioNTech COVID-19 vaccine. The product now will be called “Comirnaty" (koe-mir’-na-tee.)

The approval is for the prevention of COVID-19 disease in individuals 16 years of age and older. Those between 12-15 may still receive the vaccination and immune compromised individuals may continue getting a three-dose regimen instead of the standard two-shot dose under emergency use authorization (EUA.)

The Pfizer vaccine was the first COVID-19 shot to get the FDA’s EUA, on Dec. 11, 2020.

The approval was based on clinical trial data involving more than 20,000 people, including 12,000 who were followed at least six months after vaccination. The vaccine was 91% effective at preventing COVID-19.

Although most side effects were minor and quickly resolved, the FDA noted that risk of adverse events was higher in males under 40 and highest in males from 12-17 years old, with risk highest within seven days of the second vaccine dose.