FDA says benefits outweigh risks for Pfizer/BioNTech COVID-19 vaccine in children

The details were in briefing documents published ahead of a meeting of a panel of outside experts scheduled to vote on Tuesday whether to recommend the FDA authorize the shots for the young age group.

Both the Pfizer/BioNTech and Moderna Inc vaccines have been linked to rare cases of heart inflammation called myocarditis, especially in young men.

The FDA staff said that, assuming the number of myocarditis cases observed in the younger age group would be similar to that seen in 12 to 15 year olds, the number of COVID-19 related hospitalizations prevented would outnumber myocarditis-related hospitalizations in most scenarios analyzed.

Pfizer suggested in its own briefing documents that the rate of myocarditis in the age group was likely to be lower than observed in vaccinated 12 to 15 year olds, in part because the younger children were given a lower dose.