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Only myocarditis/pericarditis and seizures occurred at higher rates in adolescents and children vaccinated for COVID-19 when compared with historical rates of those outcomes, according to an analysis of safety data from the FDA's Biologics Effectiveness and Safety (BEST) Initiative.

Data gathered from over 4 million children revealed that myocarditis or pericarditis occurred at higher rates than before the vaccines were introduced among 12- to 17-year-olds after receiving the original monovalent Pfizer-BioNTech BNT162b2 (Comirnaty) vaccine, Patricia Lloyd, PhD, ScM, of the FDA in Silver Spring, Maryland, and colleagues reported in JAMA Network Open.

"The new statistical signal for seizure observed in our study should be interpreted with caution," Lloyd and study co-authors wrote, adding that further study is warranted. "Because febrile seizures can be common in young children for a variety of reasons, the analysis may have identified febrile seizures unrelated to the vaccination." Head over to MedPage Today to read more about it.