FDA Authorizes Pfizer/BioNTech Coronavirus Vaccine for Use in Adolescents

The FDA has expanded the Emergency Use Authorization (EUA) for Pfizer and BioNTech’s mRNA-based vaccine, allowing the inoculation to be used in patients 12 to 15 years old.

The highly effective two-dose vaccine was the first COVID-19 vaccine to receive an EUA when the agency originally authorized it for use in patients 16 and up in December 2020. The FDA’s amended EUA, issued Monday evening, now enables the U.S. to begin vaccinating adolescent patients with the shot.

The agency evaluated safety data comprising 2,260 U.S. trial participants aged 12 to 15, finding that side effects in adolescents were consistent with the ones seen in trial participants 16 years of age and older.

It also evaluated effectiveness data based on immunogenicity and an analysis of COVID-19 cases, which compared the immune response of 190 participants ages 12 to 15 with the responses of 170 participants ages 16 through 25. The vaccine was found to be fully effective in preventing COVID-19 amongst the patient population, with no cases seen in 1,005 adolescent vaccine recipients compared to 16 cases seen in the placebo group.