Pfizer and BioNTech announced Monday that its COVID-19 vaccine is 100% effective in adolescents 12-15 years of age, signaling the shot offers strong, long-term protection in the age group against the deadly coronavirus.
The companies released findings from a late-stage trial of more than 2,200 adolescents between November 2020 and September 2021. Of the 30 confirmed cases of COVID-19 in the study, all 30 cases were in the placebo group; zero were in the group which received the Pfizer-BioNTech vaccine.
“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,” Ugur Sahin, the CEO and Co-founder of BioNTech, wrote 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.”
The companies said they will use data from the study to submit for full regulatory approval for the age group. The Pfizer-BioNTech vaccine is currently approved for people 16 and older in the U.S., while children 5-15 are covered under emergency use authorization from the Food and Drug Administration. The vaccine was authorized for kids 12-15 in May.
“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,” Albert Bourla, Chairman and CEO, Pfizer, wrote. “We look forward to sharing these data with the FDA and other regulators.”
The companies said they saw "no serious safety concerns" in a follow-up period of at least six months after the second dose. Vaccine efficacy, they said, was consistent across genders, race and ethnicity, as well as comorbidity status.
According to the Centers for Disease Control and Prevention, as of Monday, more than 230 million Americans have received at least one dose of a COVID-19 vaccine, with over 196 million fully vaccinated.