BACKGROUND AND OBJECTIVES

Limited post-authorization safety data for BNT-162b2 COVID-19 vaccination among children ages 5–11 years are available, particularly for the adverse event myocarditis, which has been detected in adolescents and young adults. We describe adverse events observed during the first 4 months of the US COVID-19 vaccination program in this age group.

METHODS

We analyzed data from 3 US safety monitoring systems: v-safe, a voluntary smartphone-based system that monitors reactions and health effects; the Vaccine Adverse Events Reporting System (VAERS), the national spontaneous reporting system co-managed by CDC and FDA; and the Vaccine Safety Datalink (VSD), an active surveillance system that monitors electronic health records for prespecified events, including myocarditis.

RESULTS

Among 48,795 children ages 5–11 years enrolled in v-safe, most reported reactions were mild-to-moderate, most frequently reported the day after vaccination, and were more common after dose 2. VAERS received 7,578 adverse event reports; 97% were non-serious. On review of 194 serious VAERS reports, 15 myocarditis cases were verified; 8 occurred in males after dose 2 (reporting rate 2.2 per million doses). In VSD, no safety signals were detected in weekly sequential monitoring after administration of 726,820 doses.

CONCLUSIONS

Safety findings for BNT-162b2 vaccine from 3 US monitoring systems in children ages 5–11 years show that most reported adverse events were mild and no safety signals were observed in active surveillance. VAERS reporting rates of myocarditis after dose 2 in this age group were substantially lower than those observed among adolescents ages 12–15 years.

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Competing Interests

CONFLICT OF INTEREST DISCLOSURES: Dr. Naleway has received research funding from Pfizer and Vir Biotechnology for unrelated studies. Dr. Nelson served on the mRNA-1273 (COVID-19 vaccine candidate) External Safety Advisory Board for Moderna’s COVID-19 vaccine program and has received funding from GlaxoSmithKline for an unrelated study. Dr. Klein received research support from Pfizer for a COVID vaccine clinical trial, and from Sanofi Pasteur, Merck, GlaxoSmithKline and Protein Science (now Sanofi Pasteur) for unrelated studies. The remaining authors have nothing to disclose.