Pfizer/BioNTech has released data on their coronavirus disease 2019 (COVID-19) vaccine that indicates that its highly effective in children aged 12 to 15 years.
Although coronavirus disease 2019 (COVID-19) vaccine rollout has expanded rapidly for many adults and a small subset of the older pediatric population, the majority of children remain unable to be vaccinated. Pfizer/BioNTech has just released their topline data from their Phase 3 study of participants aged 12 to 15 years.1 The companies indicated that they will be submitting the data as soon as possible to the US Food and Drug Administration for emergency use authorization in the expanded group.
The trial included 2260 participants aged 12 to 15 years who live in the United States. There were 18 cases of COVID-19 in the placebo group (n = 1129) and 0 cases in the group that received the vaccine (1131). Receiving the vaccine generated severe acute respiratory syndrome coronavirus 2-neutralizing antibody geometric mean titers of 1,239.5, which is comparable to the geometric mean titers seen in the participants aged 16 to 25 years in the Phase 3 study released in November 2020. The side effects were also similar to the participants aged 16 to 25 years in that earlier trial.
The release also noted that the first doses have been administered in their trial for children aged 6 months to 11 years. The trial is split into 3 cohorts: children aged 5 to 11 years, 2 to 5 years, and 6 months to 2 years. The first dose of the vaccine has been administered to the 5 to 11 years cohort and the 2 to 5 years cohort is expected to receive their dose next week. The vaccine is administered with a 21 day gap between the doses.
1. Pfizer. Pfizer-BioNTech announce positive topline results of pivotal COVID-19 vaccine study in adolescents. Published March 31, 2021. Accessed March 31, 2021. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-announce-positive-topline-results-pivotal