Overview

• The expanded labels instruct that analyses of health insurance claims show roughly 8 cases of myocarditis or pericarditis per million doses among recipients aged 6 months to 64 years and about 27 cases per million in males ages 12 to 24.
• The FDA has required Pfizer and Moderna to conduct studies on the long-term cardiac outcomes of individuals who developed myocarditis following mRNA COVID-19 vaccination.
• Public health officials note that vaccine-associated myocarditis and pericarditis remain rare and generally resolve quickly with rest or treatment.
• Some experts, including Amesh Adalja, warn that the timing of the update could discourage vaccination, while others like Robert Morris advocate for research to identify and protect individuals at higher risk.
• Secretary Robert F. Kennedy Jr. dismissed all 17 previous ACIP members and appointed advisers with varied vaccine safety perspectives, setting up potential shifts in COVID-19 recommendations.