Based on data from three U.S. safety monitoring systems, adverse events were mild-to-moderate, and myocarditis occurred rarely<\/p>\n<\/h3>\n
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MONDAY, July 11, 2022 (HealthDay News) — Among children aged 5 to 11 years, most reported adverse events to BNT162b2 COVID-19 vaccination are mild-to-moderate, with few reports of myocarditis, according to a study recently published in Pediatrics<\/em>.<\/em><\/p>\n Anne M. Hause, Ph.D., M.S.P.H., from the U.S. Centers for Disease Control and Prevention COVID-19 Response Team in Atlanta, and colleagues describe adverse events observed during the first four months of the U.S. COVID-19 vaccination program among children ages 5 to 11 years. Data were analyzed from three U.S. safety monitoring systems: v-safe, a voluntary smartphone-based system that monitors reactions and health effects; the Vaccine Adverse Events Reporting System (VAERS), a national spontaneous reporting system; and the Vaccine Safety Datalink (VSD), an active surveillance system that monitors electronic health records for prespecified events.<\/p>\n The researchers found that most reported reactions among the 48,795 children aged 5 to 11 years enrolled in v-safe were mild-to-moderate, most were reported the day after vaccination, and they occurred more often after the second dose. A total of 7,578 adverse event reports were received by VAERS; 97 percent were nonserious. Fifteen cases of myocarditis were verified on review of 194 serious VAERS reports; eight occurred in boys after dose 2 (reporting rate, 2.2 per million doses). No safety signals were identified in weekly sequential monitoring after administration of 726,820 doses in VSD.<\/p>\n “The updated safety findings presented here, collected during the administration of ~16 million doses of BNT162b2 vaccine to children ages 5 to 11 years, are consistent with previous findings for this age group and demonstrate a favorable safety profile,” the authors write.<\/p>\n Several authors disclosed financial ties to the pharmaceutical industry, including companies involved in manufacturing COVID-19 vaccines.<\/p>\n