FDA OKs Pfizer-BioNTech Vaccine for Adolescents

Pharmaceutical Technology Editors

Adolescents are now eligible for the Pfizer-BioNTech COVID-29 vaccine under expanded EUA.

FDA expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to include adolescents 12–15 years of age, according to a May 10, 2021 announcement. The vaccine will be administered in two doses, three weeks apart, using the same dosage and dosing regimen for people ages 16 and older.

In an ongoing clinical trial of 2260 participants, with half receiving the vaccine, the immune response measured in 190 participants, 12­–15 years of age, was at least as good as the immune response of 170 participants, 16 through 25 years of age.

An analysis of cases of COVID-19, conducted seven days after the second dose, showed no cases of COVID-19 occurred among 1005 vaccine recipients, demonstrating the vaccine was 100% effective in preventing COVID-19.

Side effects in adolescents were consistent with those reported in clinical trial participants 16 years of age and older.

FDA amended the EUA originally issued on Dec. 11, 2020 for administration in individuals 16 years of age and older. From March 1, 2020 through April 30, 2021, the Centers for Disease Control and Prevention (CDC) received reports of approximately 1.5 million COVID-19 cases in individuals 11–17 years old.

“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. “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.”

Sources: FDA