Walter EB, Talaat KR, Sabharwal C, et al. - Findings from this trial support the safety, immunogenicity, and efficacy of the COVID-19 vaccination regimen consisting of two 10-μg doses of BNT162b2 administered 21 days apart in children 5 to 11 years of age.

• In phase 1, dose-finding study, BNT162b2 vaccine was administered to a total of 48 children 5 to 11 years of age at doses of 10 μg, 20 μg, or 30 μg (16 children at each dose level).

• For further study, a dose level of 10 μg was selected on the basis of reactogenicity and immunogenicity.

• In the phase 2–3 trial, the BNT162b2 vaccine or placebo was administered to a total of 2,268 children.

• The BNT162b2 vaccine had a favorable safety profile in the 5-to-11-year-olds, as observed in other age groups.

• Geometric mean ratio of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing titers in 5-to-11-year-olds to those in 16-to-25-year-olds was 1.04 (95% confidence interval [CI], 0.93 to 1.18) post-one month from the second dose; a ratio meeting the prespecified immunogenicity success criterion (lower bound of two-sided 95% CI, > 0.67; geometric mean ratio point estimate, ≥ 0.8).

• Three recipients of the BNT162b2, vaccine vs 16 placebo recipients, contracted COVID-19 infection with onset 7 days or more after the second dose (vaccine efficacy, 90.7%; 95% CI, 67.7 to 98.3).