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A Phase III trial evaluating the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, in adolescents 12 to 15 years of age showed 100% efficacy and positive antibody responses.
Pfizer and BioNTech announced on March 31, 2021 that a Phase III trial evaluating the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, in adolescents 12 to 15 years of age showed 100% efficacy and positive antibody responses.
The trial, which included 2260 participants in the United States, observed 18 cases of COVID-19 in the placebo group, compared to no cases in the vaccinated group, and produced SARS-CoV-2–neutralizing antibody geometric mean titers of 1239.5, which resulted in strong immunogenicity in a subset of adolescents one month after the second dose, Pfizer said in a company press release. This response exceeds that of an earlier vaccine trial aimed at participants aged 16 to 25 years old.
“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,” said Albert Bourla, chairman and CEO, Pfizer, in the press release. “We plan to submit these data to FDA as a proposed amendment to our [e]mergency [u]se [a]uthorization 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.”
“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. 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,” added Ugur Sahin, CEO and co-founder of BioNTech, in the press release.