In adolescents aged 12 to 15 years old with or without prior evidence of SARS-CoV-2 infection, the BNT162b2 vaccine demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants between 16 and 25. The vaccine was well-tolerated among the 2,260 adolescents participating in the Phase 3 trial, according to a news release.
The trial observed 18 cases of COVID-19 in the placebo group (1,129 patients) compared to zero in the vaccinated group (1,131 patients). The vaccine elicited neutralizing antibody geometric mean titers (GMTs) of 1,239.5 at one month after the second dose. Participants between 16 to 25 in earlier analysis produced GMTs of 705.1, demonstrating the effectiveness among adolescents. Side effects in the adolescent trial were consistent with those observed in participants between 16 and 25.
Pfizer and BioNTech plan to submit the data to the FDA and European Medicines Agency to receive emergency use authorization and EU conditional marketing authorization, respectively, to expand the vaccine’s use to adolescents between 12 and 15 years old as quickly as possible. Additionally, the companies intend to submit the data for scientific peer review for potential publication.
“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 & CEO Albert Bourla said in the release. “We plan to submit these data to FDA as a proposed amendment to our [EUA] in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year.”
“Across the globe, we are longing for a normal life. 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 UK variant,” added BioNTech CEO & co-founder Uguer Sahin. “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.”
In addition to the 12-15 age group, Pfizer and BioNTech said that they last week dosed the first healthy children in a global Phase 1/2/3 seamless study to evaluate tolerability and immunogenicity in the vaccine for children six months to 11 years of age. The trial is split into three groups — children between 5-11, 2-5 and six months to two years.