Overview

• The FDA has mandated expanded warning labels on Pfizer’s Comirnaty and Moderna’s Spikevax to highlight rare myocarditis and pericarditis risks.
• Revised prescribing information cites about 8 myocarditis cases per million doses in recipients under 65 and 38 per million in males aged 16 to 25.
• The new warnings diverge from the CDC’s 2022 finding of no increased myocarditis reports in government vaccine injury databases, and CDC officials emphasize that post-vaccine cases are typically mild and resolve quickly.
• Health Secretary Robert F. Kennedy Jr.’s administration has reshaped vaccine advisory panels and limited booster recommendations as part of a broader move to tighten vaccine oversight.
• Some medical experts argue that research should focus on identifying individuals prone to myocarditis in order to predict and mitigate risk rather than broad label expansions.