Additional Coverage:
FDA Mandates Stronger Warnings for mRNA COVID-19 Vaccines
The FDA is requiring Pfizer/BioNTech and Moderna to strengthen the warning labels on their COVID-19 vaccines regarding the risk of rare heart inflammation, specifically myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart). While these conditions are rare and typically resolve quickly, the updated labels will highlight the potential risk for certain age groups.
Previous labels acknowledged the risk, but the new warnings will specifically address males aged 16 to 25. This change comes after an analysis of health insurance claims data revealed a slightly elevated risk of myocarditis and/or pericarditis in this demographic within seven days of vaccination. While cases remain rare, approximately 38 cases per million doses were observed in this group, compared to eight cases per million doses for individuals aged 6 months to 64 years.
The move towards more explicit labeling has been described by a Department of Health and Human Services spokesperson as an effort to increase transparency. Neither Pfizer nor Moderna have commented on the FDA’s mandate.
This update comes amidst ongoing discussion about COVID-19 vaccines. Recent research presented to the CDC’s independent vaccine advisors indicated a statistically significant, but rare, increased risk of myocarditis following vaccination between 2020 and 2022. Notably, no increased risk was observed with doses administered in subsequent years.
Meanwhile, the FDA is also refining its approach to approving updated COVID-19 boosters, potentially limiting eligibility to adults 65 and older and those with underlying health conditions. This decision reflects a desire for more robust clinical trial data, particularly for adults aged 50 to 64, before recommending boosters for broader populations.
The FDA’s vaccine advisory committee is scheduled to meet soon to discuss the strain selection for this fall’s COVID-19 vaccines.