NEW YORK & MAINZ, Germany– Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) today 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.The updated analysis of the Phase 3 clinical trial in individuals ages 12 through 15 years was conducted in accordance with guidance from the FDA for all companies investigating COVID-19 vaccines to review safety and efficacy at key milestones. Data through up to six months after the primary vaccination series are required for licensure. These data were collected from November 2020 to September 2021.
Results from this analysis of 2,228 trial participants build upon and confirm previously released data and demonstrate strong protection against COVID-19. From the 30 confirmed symptomatic cases of COVID-19 in the trial with and without evidence of prior infection with SARS-CoV-2, 30 cases of COVID-19 were in the placebo group and 0 cases were in the Pfizer-BioNTech vaccine group, corresponding to vaccine efficacy of 100% (95% confidence interval [CI, 87.5, 100.0]).
Efficacy was consistently high across gender, race and ethnicity demographics, obesity and comorbidity status. Pfizer and BioNTech plan to submit these data for scientific peer review for potential publication.
The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada, and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.
