FDA Expands Pfizer-BioNTech COVID-19 Vaccine EUA to Include Adolescents

The safety of the vaccine in this patient population was based on data from 2260 adolescent participants.

The Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 to 15 years of age. Previously, the vaccine had only been authorized to prevent COVID-19 in patients 16 years of age and older.

The safety of the vaccine in this patient population was based on data from 2260 adolescent participants enrolled in an ongoing randomized, placebo-controlled study in the United States. Participants were randomly assigned to receive either the vaccine (n=1131) or placebo (n=1129) and more than half were followed for at least 2 months following the second dose.

The most common adverse reactions reported in the trial included injection site pain, tiredness, headache, chills, muscle pain, fever, and joint pain. These side effects typically lasted 1 to 3 days and occurred more frequently following the second dose.

As for effectiveness, analysis of immunogenicity data showed that immune responses to the vaccine in the adolescent group (n=190) were noninferior to those observed in older participants (16 to 25 years; n=170).  Additionally, a review of COVID-19 cases that occurred 7 days after the second dose among 12 to 15 year olds without evidence of prior SARS-CoV-2 infection demonstrated that the vaccine was 100% effective in preventing COVID-19. No cases occurred among the 1005 participants who received the vaccine, while 16 were reported among the 978 placebo recipients.

“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, MD. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”

The Pfizer-BioNTech COVID-19 Vaccine fact sheet has been updated to include the new information. The same dosage (0.3mL) and dosing regimen (2 doses, 3 weeks apart) has been authorized for adolescents.

In a statement, the agency noted that roughly 1.5 million COVID-19 cases among 11 to 17 years olds were reported to the Centers for Disease Control and Prevention (CDC) between March 1, 2020 and April 30, 2021. The CDC’s Advisory Committee on Immunization Practices (ACIP) will be meeting on May 12, 2021 to discuss recommendations for use of the Pfizer-BioNTech COVID-19 Vaccine in adolescents 12 to 15 years of age based on the amended EUA.


Coronavirus (COVID-19) update: FDA authorizes Pfizer-BioNTech COVID-19 Vaccine for emergency use in adolescents in another important action in fight against pandemic. [press release]. Silver Spring, MD: US Food and Drug Administation. May 10, 2021.