BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age

Years of AgeTo the Editor: Walter et al. (Jan.6 issue) 1 report the results of a randomized, controlled trial showing that two doses of the messenger RNA (mRNA) vaccine BNT162b2 against Covid-19 were safe, immunogenic, and efficacious in children 5 to 11 years of age.However, this trial was not powered to detect potential serious side effects of mRNA vaccines.Here, we present the pooled results of the trial conducted by Walter et al. and two other randomized, controlled trials 2,3 (through November 15, 2021).Our analysis was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. 4The risks of injection-related and total adverse events after the first or second injection (Fig. 1A and1B) were significantly higher after vaccination with an mRNA vaccine than after injection of placebo.However, the risks of serious adverse events (risk ratio, 1.63; 95% confidence interval [CI], 0.45 to 5.88) (Fig. 1C) and the risks of any adverse event leading to nonreceipt of the second injection (risk ratio, 2.99; 95% CI, 0.36 to 24.93) (Fig. 1D) did not differ significantly between the vaccine and placebo groups.Two doses of mRNA vaccine effectively prevented the occurrence of Covid-19 in participants with previous severe SARS-CoV-2 infection and in those without previous infection (Fig. 1E and1F).No cases of severe Covid-19, multisystem inflammatory syndrome in children, or death were reported.Our findings provide support for the use of mRNA vaccines against Covid-19 in children and adolescents.