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

 
• By Sue Sutter

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.

Scale
US FDA concluded Comirnaty's benefits outweighed its risks in older male adolescents even under a "worst case" modeling scenario. • Source: Alamy

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