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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.

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

The heightened risk of vaccine-associated myocarditis/pericarditis in 16-17 year-old males made the US Food and Drug Administration’s benefit-risk determination for Pfizer Inc./BioNTech SE’s Comirnaty a close call in this subpopulation under a “worst case” scenario model of low COVID-19 incidence and diminished vaccine effectiveness.

Nevertheless, the agency concluded the benefit-risk assessment in this demographic group was favorable because COVID-19 is associated with greater disease severity and longer hospitalization compared with vaccine-induced myocarditis

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