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Pfizer Vaccine’s Benefit-Risk Assessment In Older Male Adolescents A Close Call Due To Myocarditis

Executive Summary

For males 16-17 years old, excess cases of myocarditis/pericarditis from Comirnaty would exceed COVID-19 hospitalizations and deaths under ‘worst case’ scenario modeled by US FDA; agency nevertheless deemed approval warranted in this subpopulation, citing prevention of nonhospitalized COVID cases and public health benefits from vaccination.

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