Comirnaty Demonstrated 100% Efficacy Against Adolescent COVID-19 in Multi-Month Analysis
Germany-based BioNTech SE and Pfizer Inc. announced topline results from a longer-term analysis of the safety and efficacy of their Comirnaty COVID-19 vaccine in individuals 12 through 15 years of age on November 22, 2021.
The updated findings from the companies’ pivotal Phase 3 trial analysis of 2,228 trial participants show that a two-dose series of Comirnaty (30-µg per dose) was 100% effective against COVID-19, measured seven days through over four months after the second dose.
Furthermore, the adverse event profile was generally consistent with other clinical safety data for the vaccine, with no serious safety concerns observed in individuals with at least six months of safety follow-up after the second dose.
From the 30 confirmed symptomatic cases of COVID-19 in the trial with and without evidence of prior infection with the SARS-CoV-2 coronavirus, 30 instances of COVID-19 were in the placebo group, and 0 cases were in the Pfizer-BioNTech vaccine group.
This corresponds to a vaccine efficacy of 100% (95% confidence interval [CI, 87.5, 100.0]).
These longer-term follow-up data will form the basis for a planned supplemental Biologics License Application to be submitted to the FDA to expand approval of the vaccine for use in individuals 12 years and older.
Comirnaty is currently available for individuals 12 through 15 years of age under Emergency Use Authorization, granted by the U.S. FDA in May 2021.
The companies also plan to submit these data to pursue regulatory approvals for this age group in other countries where emergency use authorizations or equivalents were initially granted.
“As the global health community works to increase the number of vaccinated people around the world, these additional data provide further confidence in our vaccine’s safety and effectiveness profile in adolescents. This is especially important as we see rates of COVID-19 climbing in this age group in some regions, while vaccine uptake has slowed,” said Albert Bourla, Chairman and CEO, Pfizer.
“We look forward to sharing these data with the FDA and other regulators.”
“These are the first and only disclosed longer-term data demonstrating the safety and efficacy of a COVID-19 vaccine in individuals 12 through 15 years of age,” said Ugur Sahin, CEO, and Co-founder of BioNTech, in a press release.
“The growing body of data we have compiled from clinical trials and real-world surveillance to date strengthen the base of evidence supporting the strong efficacy and favorable safety profile of our COVID-19 vaccine across adolescent and adult populations.”
The Comirnaty vaccine is based on BioNTech’s proprietary mRNA technology, developed by both BioNTech and Pfizer.
BioNTech is the Marketing Authorization Holder in the U.S., the European Union, the United Kingdom, Canada, and other countries, and the holder of emergency use authorizations or equivalents in the U.S. (jointly with Pfizer) and other countries.