Children of certain ages who received Pfizer’s COVID-19 vaccine face an elevated risk of heart inflammation, according to a new federally funded study.
Vaccinated children aged 12 to 17 face a heightened risk of myocarditis, a form of heart inflammation, and a related condition called pericarditis, U.S. Food and Drug Administration (FDA) researchers found.
The number of myocarditis and pericarditis events in that age group was high enough to meet the criteria for a safety signal, the researchers reported in the Journal of the American Medical Association on May 22.
The elevated risk was present within seven days of vaccination, according to the data.
Researchers identified 89 cases among 12- to 15-year-olds and 64 cases among 16- and 17-year-olds after reviewing records from commercial databases run by CVS Health, HealthCore, and Optum.
The claims were made from Dec. 11, 2020, when Pfizer’s vaccine was cleared by the FDA through mid-2022.
Researchers sought to see whether any of