Study: Reports of Adverse Reactions to Pfizer-Biontech COVID-19 Vaccine for Children Ages 5-11 Were Mild-to-moderate

A study, “Safety of COVID-19 Vaccination in U.S. Children Ages 5–11 Years,” that reviewed adverse events from the Pfizer-BioNTech 2-dose COVID-19 vaccine administered to children ages 5-11 found mostly mild-to-moderate reactions within the first day or two of vaccination. The study will be published in the August 2022 Pediatrics (published online Thursday, July 14), and is available as a pre-publication release here.

Researchers analyzed data from 3 U.S. safety monitoring systems during 4 months of vaccine administration in the 5-11 age group to provide insight on adverse events. Among 48,795 children ages 5–11 years enrolled in v-safe -- a voluntary smartphone-based system that monitors reactions and health effects -- most reported reactions were mild-to-moderate, most frequently reported the day after vaccination, and were more common after the second dose. The most common reactions reported were injection site pain, fatigue, headache, fever, and muscle soreness.

The study also evaluated data from the Vaccine Adverse Events Reporting System (VAERS), a national spontaneous reporting system co-managed by CDC and FDA, and the Vaccine Safety Datalink (VSD), an active system that monitors electronic health records for prespecified events, including myocarditis. 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. Myocarditis cases were substantially lower than those found in the age 12-15 age group. In VSD, no safety signals were detected in weekly sequential monitoring after administration of 726,820 doses. The authors concluded that the Pfizer-BioNTech COVID-19 vaccine is safe for children ages 5–11 years and that adverse effects usually are clinically mild and resolve quickly.

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The American Academy of Pediatrics is an organization of 67,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety and well-being of infants, children, adolescents and young adults.