COVID-19 Vaccines: Myocarditis Reports Could Slow Expansion Into Pediatric Age Groups

Concerns about cases of heart muscle inflammation occurring in older male adolescents and young men shortly after the second dose of Pfizer and Moderna mRNA vaccines hung over FDA advisory committee discussions on pediatric safety data requirements for COVID-19 vaccines; CDC’s ACIP will take up the myocarditis issue at an 18 June meeting.

Tip of the iceberg
One FDA panelist worries the reports of myocarditis following mRNA vaccination are just the tip of the iceberg. • Source: Alamy

An imbalance in myocarditis reports following mRNA vaccination could complicate expansion of the Pfizer Inc./BioNTech SE and Moderna, Inc. COVID-19 vaccines into younger age groups in the US.

Concerns about cases of myocarditis, inflammation of the heart muscle, occurring in older male adolescents and young men shortly after the second dose hung like a cloud over a Food and Drug Administration advisory committee's discussions about pediatric safety data requirements for emergency use authorization and licensure of COVID-19 vaccines

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