Pfizer Inc. and BioNTech SE announced the U.S. Food and Drug Administration (FDA) approved the companies’ supplemental Biologics License Application (sBLA) for their COVID-19 vaccine, known as COMIRNATY (COVID-19 Vaccine, mRNA), to include individuals 12 through 15 years of age, according to a news release.
The vaccine was previously made available to this age group in the U.S. under emergency use authorization (EUA), and to date more than 9 million 12- to 15-year-old adolescents in the U.S. have completed a primary series.
Approval is based on data from a Phase 3 clinical trial of 2,260 participants 12 through 15 years of age. A two-dose primary series of the vaccine (30-µg dose) elicited SARS-CoV-2–neutralizing antibody geometric mean titers (GMTs) of 1,239.5, demonstrating strong immunogenicity in a subset of adolescents one month after the second dose. This compared well (was non-inferior) to GMTs elicited by participants aged 16 to 25 years old (705.1 GMTs) in an earlier analysis.
In the trial, a two-dose primary series of the vaccine (30-µg dose) was also 100% effective (95% confidence interval [CI, 87.5, 100.0]) in preventing COVID-19, measured between a week and more than four months after the second dose. During this time, all 30 cases of confirmed symptomatic COVID-19 were in the placebo group (n=1,109) and no cases were in the COMIRNATY group (n=1,119).
The only SARS-CoV-2 variant of concern identified from the confirmed COVID-19 cases in this age group was Alpha as the efficacy analysis was conducted between November 2020 and May 2021, which was before the Delta and Omicron surges. No cases of severe disease occurred in either the COMIRNATY or placebo group. The adverse event profile was generally consistent with other clinical data for the vaccine, with a favorable safety profile observed across 6 months of safety follow-up data after the second dose.
Pfizer and BioNTech also filed these data with the European Medicines Agency (EMA) and other regulatory authorities around the world.
COMIRNATY is now the only COVID-19 vaccine approved by the FDA as a two-dose primary series for individuals 12 years and older. An EUA for a primary series in U.S. adolescents ages 12 through 15 years was previously granted in May 2021 based on initial data from the same pivotal Phase 3 clinical trial. Longer-term follow-up data, announced in November 2021, confirmed the safety and effectiveness of COMIRNATY in adolescents 12-15 years of age and were required for licensure. In the European Union the conditional marketing authorization in this age group was granted by EMA in August 2021.