Frequency of local, systemic reactions reported for teens enrolled in v-safe similar to preauthorization clinical trials<\/p>\n<\/h3>\n
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TUESDAY, Aug. 3, 2021 (HealthDay News) — For U.S. adolescents aged 12 to 17 years receiving Pfizer-BioNTech COVID-19 vaccination, most adverse events are nonserious, according to research published in the July 30 early-release issue of the U.S. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report<\/em><\/em>.<\/p>\n Anne M. Hause, Ph.D., from the CDC COVID-19 Response Team, and colleagues further characterized the safety of the Pfizer-BioNTech vaccine by reviewing adverse events reported to the Vaccine Adverse Event Reporting System and adverse events and health impact assessments reported in v-safe (a smartphone-based surveillance system) after receipt of the vaccine for U.S. adolescents aged 12 to 17 years from Dec. 14, 2020, to July 16, 2021.<\/p>\n About 8.9 million U.S. adolescents aged 12 to 17 years had received the Pfizer-BioNTech vaccine as of July 16, 2021. The researchers found that the Vaccine Adverse Event Reporting System received 9,246 reports after Pfizer-BioNTech vaccination among 12- to 17-year-olds: 90.7 percent were for nonserious adverse events and 9.3 percent were for serious adverse events, including 4.3 percent for myocarditis. Local and systemic reactions were reported with a frequency similar to that reported in preauthorization clinical trials among about 129,000 U.S. adolescents enrolled in v-safe (63.4 and 48.9 percent, respectively). Systemic reactions occurred more often after the second dose.<\/p>\n “The initial safety findings of Pfizer-BioNTech vaccine administered to U.S. adolescents aged 12 to 17 years are similar to those described in the clinical trials, with the exception of myocarditis, a rare serious adverse event associated with receipt of mRNA-based COVID-19 vaccines; follow-up of reported myocarditis cases is ongoing,” the authors write.<\/p>\n