Pfizer-BioNTech Vaccine Demonstrates 100% Efficacy In Adolescents

March 31, 2021

The Pfizer-BioNTech COVID-19 vaccine demonstrated 100% efficacy, robust antibody responses and was well tolerated in adolescents, according to newly released data. The findings are from a phase 3 trial of 2,260 adolescents ages 12-15. Investigators observed 18 cases of COVID-19 in the placebo group (1,129 adolescents) and zero in the vaccinated group (1,131 adolescents). 

Furthermore, results indicated that vaccination elicited SARS-CoV-2–neutralizing antibody geometric mean titers (GMTs) of 1,239.5, which demonstrated strong immunogenicity in a subset of adolescents one month after the second dose. The efficacy and antibody responses exceeded those reported in trial of vaccinated 16–25-year-old participants in an earlier analysis, according to information from the company. 

Pfizer and BioNTech plan to submit these data to the Food and Drug Administration and the European Medicines Agency (EMA) to request expansion of the Emergency Use Authorization (EUA) and EU Conditional Marketing Authorization. A study to evaluate the vaccine’s efficacy in children 6 months to 11 years old is ongoing.