The two-dose Pfizer-BioNTech COVID-19 vaccine regimen was 100 percent effective in preventing disease in children aged 12-15 years, the companies reported.

The numbers are from an updated analysis of phase 3 data in 2,228  subjects aged 12-15 years. From November 2020-September 2021, 30 cases of COVID-19 developed, all of which were in the placebo group, the companies said. The vaccine appeared safe as well, with no serious concerns identified in a 6-month safety analysis.

The companies plan to submit a supplemental Biologics License Application to the FDA to expand the vaccine’s approval to include children aged 12 years and older. As of right now, this population can receive the vaccine under FDA’s Emergency Use Authorization (EUA), which was granted in May.

“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, BioNTech’s co-founder and chief executive officer. “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.”

Pfizer CEO Albert Bourla described the new data as “especially important as we see rates of COVID-19 climbing in this age group in some regions, while vaccine uptake has slowed … We look forward to sharing these data with the FDA and other regulators.” — Michele G. Sullivan