The Pfizer-BioNTech COVID-19 vaccine, BNT162b2, demonstrated 100% efficacy and robust antibody responses in participants aged 12 to 15 years old, according to a news release published on March 31, 2021 by Pfizer and BioNTech.
These results, from a pivotal Phase 3 trial, exceeded efficacy data originally presented in participants aged 16 to 25 years.
Adolescents (N=2260) aged 12 to 15 years of age with or without a history of previous SARS-CoV-2 infection were included in the study. In the vaccinated group (n=1131), there were 0 cases of COVID-19, compared to the placebo group (n=1129), where there were 18 cases of COVID-19.
Participants who received the BNT162b2 vaccine had a SARS-CoV-2-neutralizing geometric mean titer (GMT) of 1239.5 one month after the second dose. Comparatively, based on an earlier analysis, the GMT of participants aged 16 to 25 years was 705.1. However, the difference in GMT between participants aged 12 to 15 years and 16 to 25 years was non-inferior.
The BNT162b2 vaccine demonstrated 100% efficacy in this group of participants aged 12 to 15 years.
The companies “plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorization 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,” said Alberta Bourla, Chairman and Chief Executive Officer of Pfizer.
Pfizer and BioNTech have also begun a global Phase 1/2/3 seamless study to assess the safety, tolerability, and immunogenicity of the BNT162b2 vaccine in children aged 6 months to 11 years of age.
Pfizer-BioNTech announce positive topline results of pivotal COVID-19 vaccine study in adolescents. News release. Pfizer. March 31, 2021. Accessed March 31, 2021. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-announce-positive-topline-results-pivotal