Pfizer and BioNTech announced Monday that their Covid-19 vaccine was 100% efficacious in preventing infections in 12- to 15-year-olds, measured from seven days to four months after administration of the second dose of the vaccine.
The companies said the new data — a longer-term analysis of a Phase 3 trial conducted in 2,228 participants — will form the basis of an application to the Food and Drug Administration for an extension of their Covid-19 vaccine license to cover youths in the age group.
“These are the first and only disclosed longer-term data demonstrating the safety and efficacy of a Covid- 19 vaccine in individuals 12 to 15 years of age,” Ugur Sahin, CEO and co-founder of BioNTech, said in a statement. “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.”
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The longer-term analysis of the Phase 3 trial data showed no serious safety concerns over a follow-up period of at least six months after the second dose of the vaccine.
The 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,” Albert Bourla, Pfizer’s chairman and CEO, said in the statement.
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The vaccine has been in use in this age group since May, when the FDA extended the emergency use authorization for the vaccine to cover 12 to 15 year olds. In August, the vaccine, which the companies market under the name Comirnaty, was the first of Covid vaccines to receive a full license for individuals, 16 years of age and older.
The companies said they will also use the data to pursue regulatory approvals in other countries where the vaccine has been granted emergency use.
The Phase 3 data saw 30 Covid infections — all in the placebo arm. Efficacy was consistent across race and ethnic demographics, gender, and underlying illness status, including obesity, the companies said.