Pfizer, BioNTech seek USFDA approval for COMIRNATY in adolescents aged 12-15 years
New York: Pfizer Inc. and BioNTech SE have announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the approval of COMIRNATY (COVID-19 Vaccine, mRNA) to include individuals ages 12 through 15 years.
The sBLA includes updated longer-term follow-up data from the companies pivotal Phase 3 clinical trial of 2,228 participants 12 through 15 years of age. In the trial, a two-dose series of the Pfizer-BioNTech COVID-19 Vaccine (30-µg per dose) was 100% effective (95% confidence interval [CI, 87.5, 100.0]) against COVID-19, measured seven days through over four months after the second dose. Among 30 confirmed symptomatic cases of COVID-19 in the trial with and without evidence of prior infection with SARS-CoV-2, all cases of COVID-19 were in the placebo group (n=1,129) and no cases were in the Pfizer-BioNTech vaccine group (n=1,131). The adverse event profile was generally consistent with other clinical safety data for the vaccine, with a favorable safety profile observed in individuals with at least 6 months of safety follow-up after the second dose.
Pfizer and BioNTech intend to file these data with the European Medicines Agency (EMA) and other regulatory authorities around the world in the coming weeks. The Pfizer-BioNTech COVID-19 Vaccine is currently available for use among individuals 12 through 15 years of age as part of an Emergency Use Authorization (EUA), which the U.S. Food and Drug Administration (FDA) authorized on May 10, 2021. This is the only COVID-19 vaccine authorized for this age group in the U.S. The vaccine is also currently available for individuals 12 through 15 years of age in the European Union under a Conditional Marketing Authorization.
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