New Data From Trial of Pfizer-BioNTech COVID-19 Vaccine Support Safety and High Efficacy in Adolescents 12 -15

Pfizer Inc. and BioNTech SE announced topline results from a longer-term analysis of the safety and efficacy of their COVID-19 vaccine in individuals 12 through 15 years of age. The updated findings from the companies’ pivotal Phase 3 trial show that a two-dose series of the Pfizer-BioNTech COVID-19 Vaccine (30-µg per dose) was 100% effective against COVID-19, measured seven days through over four months after the second dose.

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 6 months of safety follow-up after the second dose.

“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 Chief Executive Officer, 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. “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.”

These longer-term follow-up data will form the basis for a planned supplemental Biologics License Application (sBLA) to be submitted to the FDA to expand approval of the vaccine for use in individuals 12 years and older. The vaccine is currently available for individuals 12 through 15 years of age under Emergency Use Authorization (EUA), granted by the 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.