Pfizer and BioNTech say COVID-19 vaccine protects adolescents, plan to submit data to FDA
Pfizer and BioNTech said Wednesday that their COVID-19 vaccine was highly protective among children aged 12 to 15 years in a phase 3 trial.
The companies said they plan to submit the data to the FDA “in the coming weeks” for a request to expand the vaccine’s emergency use authorization for use in the lower age group. Right now, the vaccine is authorized for use in people aged 16 years or older. It is the only COVID-19 vaccine authorized in the U.S. for any pediatric population.
“We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” Pfizer Chairman and CEO Albert Bourla, DVM, PhD, said in a statement.
Bourla said the goal of the FDA submission — and regulatory submissions elsewhere in the world, including Europe — is to be able to vaccinate children in this age group “before the start of the next school year.”
The trial enrolled 2,260 children aged between 12 and 15 years in the United States. According to a news release, there were 18 cases of COVID-19 in the placebo group (1,129 children) compared with none among 1,131 children in the vaccinated group.
The companies said the vaccine, BNT162b2, elicited SARS-CoV-2 neutralizing antibody geometric mean titers (GMTs) of 1,239.5 in study participants, “demonstrating strong immunogenicity in a subset of adolescents 1 month after the second dose.” That exceeded the response recorded in a trial of participants aged 16 to 25 years, in which GMTs were 705.1.
The companies also provided an update on a trial testing the vaccine among children aged 6 months to 11 years, reporting that the first healthy children started receiving doses last week.
“Across the globe, we are longing for a normal life,” BioNTech CEO and cofounder Ugur Sahin, MD, said in a statement. “This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 variant. It is very important to enable them to get back to everyday school life and to meet friends and family while protecting them and their loved ones.