FDA expands use of Pfizer COVID-19 vaccine to Include Adolescents

The FDA previously approved EUA for the administration of this vaccine in individuals 16 years of age and older by December 11, 2020. "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, M.D. "Today's action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. 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."

Safety Evaluation:

The approval was based on the safety 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 side effects reported were injection site, tiredness, headache, chills, muscle pain, fever and joint pain which typically lasted for 1-3 days. They also reported some rare severe allergic reactions, including anaphylaxis. Therefore, the experts recommended, "The Pfizer-BioNTech COVID-19 Vaccine should not be given to anyone with a known history of a severe allergic reaction, including anaphylaxis—to any component of the vaccine."

Efficacy evaluation:

As for effectiveness, the EUA in adolescents down to 12 years of age is based on immunogenicity and analysis of COVID-19 cases.

In this analysis, they noted that the immune response of adolescents (n=190;12- 15 years of age)was non-inferior to (at least as good as) the immune response of the older participants (n=170; 16-25 years of age).

Dr Peter Marks, MD, PhD, the director of the FDA's Center for Biologics Evaluation and Research said, "There is no difference in the way that the Pfizer-BioNTech COVID-19 vaccine will be administered to those 12 through 15 years of age. If endorsed for use by the CDC Advisory Committee on Immunization Practices, they will be administered as a series of two doses three weeks apart using the same dose that is currently being given to adults."

The FDA also updated the fact sheets for vaccine providers and for recipients and caregivers with information to reflect the use of the vaccine in the adolescent population, including the benefits and risks of the Pfizer-BioNTech COVID-19 vaccine.

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.

For further information:

US FDA Press release