The vaccine makers wrote in a news release that the findings from the Phase 3 trial will support planned submissions for full regulatory approval of the vaccine in this age group, both in the U.S. and around the world. In the U.S., the Pfizer/BioNTech vaccine is currently available for individuals 12 through 15 years of age after the Food and Drug Administration granted emergency use authorization in May.
"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 release said.
The Phase 3 trial – conducted in 2,228 participants – found that of the 30 confirmed symptomatic cases of COVID-19 in the trial with and without evidence of prior infection with the SARS-CoV-2 virus, 30 cases of COVID-19 were in the placebo group and zero cases were in the Pfizer/BioNTech vaccine group.
Efficacy was consistent across gender, race and ethnicity demographics, as well as obesity and co-morbidity status.
Data was collected from November 2020 to September 2021, and the release notes that data through up to six months after the primary vaccination series are required for licensure.
No serious safety concerns were observed in individuals with at least six months of safety follow-up after the second dose, and the adverse event profile was "generally consistent with other clinical safety data for the vaccine."
"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," Pfizer CEO Albert Bourla said in a statement. "This is especially important as we see rates of COVID-19 climbing in this age group in some regions, while vaccine uptake has slowed."
The data gathered, the release said, will be used to form the basis for a planned supplemental Biologics License Application (sBLA) to be submitted to the FDA, with the aim of expanding vaccine approval for those 12 years and older.
In August, the FDA announced the first approval of a COVID-19 vaccine – the Pfizer/BioNTech COVID-19 vaccine, marketed under the name Comirnaty – for individuals 16 years of age and older.
The companies said they would also use the data to pursue regulatory approvals in countries where the vaccine has been authorized for emergency use.
Pfizer and BioNTech plan to submit their findings for scientific peer review and possible publication.