Alliance for Pandemic Preparedness

March 31, 2021

Pfizer-BioNTech Announce Positive Topline Results of Pivotal COVID-19 Vaccine Study in Adolescents.

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  • [Press release, not peer-reviewed] According to a press release from Pfizer, the Pfizer-BioNTech vaccine showed 100% efficacy against COVID-19 among adolescents (n=2,260) aged 12 to 15 years old in the US without prior history of infection. 18 cases of COVID-19 were observed in the placebo group, and none in the vaccinated group. The vaccine also elicited a strong neutralizing antibody response (geometric mean titers 1,239.5) one month after the second dose, and side effects were similar to those observed among participants aged 16-25 in previous trials. The press release notes that the companies plan to submit these data to the FDA and request an amendment to the Emergency Use Authorization to expand eligibility to adolescents aged 12-15.

Pfizer Inc. (2021). Pfizer-BioNTech Announce Positive Topline Results of Pivotal COVID-19 Vaccine Study in Adolescents. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-announce-positive-topline-results-pivotal