Latest developments on Pfizer and BioNTech's Comirnaty

The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Pfizer (NYSE: PFE) and BioNTech’s (Nasdaq: BNTX) COVID-19 vaccine, known as Comirnaty (COVID-19 Vaccine, mRNA), to include individuals 12 through 15 years of age.

The vaccine was previously made available to this age group in the USA under emergency use authorization (EUA), and to date more than 9 million 12- to 15-year-old adolescents in the USA have completed a primary series. In full-year 2021, Pfizer reported Comirnaty sales  of $36.8 billion.

This approval is based on data from a Phase III clinical trial of 2,260 participants 12 through 15 years of age. A two-dose primary series of the vaccine (30µg 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 (30µg 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).