FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Adolescents

The FDA has expanded the emergency use authorization for the COVID-19 vaccine to include individuals 12 to 15 years of age.

The FDA has authorized the Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents 12 through 15 years of age, making it the first COVID-19 vaccine available for use in this age group.1

The expanded emergency use authorization (EUA) is based on data from a phase 3 clinical trial, which demonstrated 100% vaccine efficacy in adolescent participants. The vaccine was also well tolerated in the study.1

The trial enrolled 2260 adolescents 12 to 15 years of age in the United States. Eighteen cases of COVID-19 were observed in the placebo group versus none in the vaccinated group. Vaccination also demonstrated strong immunogenicity in a subset of adolescents 1 month after the second dose, eliciting antibody geometric mean titers (GMTs) of 1,239.5. According to the data, this was shown to be noninferior to GMTs elicited by participants aged 16 to 25 years old in a previous analysis. Participants of the trial will continue to be monitored for long-term protection and safety for an additional 2 years after the second dose.1,2

Pfizer and BioNTech are also conducting a pediatric study evaluating the safety and efficacy of the vaccine in children aged 6 months to 11.2

“Since securing the EUA in December for individuals 16 years and older, we have been working tirelessly to get our COVID-19 vaccine authorized around the world so that governments can provide it to as many people as possible,” said Ugur Sahin, MD, CEO and cofounder of BioNTech.1 “Our work is not yet complete, as we continue our research into the use of our vaccine in pediatric populations. Our goal is to submit data for pre-school and school-age children in September.”

The CDC’s Advisory Committee on Immunization Practices will now meet to discuss recommendations for use of the vaccine in adolescents based on the amended EUA.1

References

1. Pfizer and BioNTech Receive First US Authorization for Emergency Use of COVID-19 Vaccine in Adolescents. News Release. Pfizer; May 10, 2021. Accessed May 11, 2021. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-first-us-authorization

2. Pfizer-BioNTech Announce Positive Topline Results of Pivotal COVID-19 Vaccine Study in Adolescents. News Release. Pfizer; March 31, 2021. Accessed May 11, 2021. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-announce-positive-topline-results-pivotal