FDA's 2025 safety communication requiring updated Comirnaty and Spikevax warnings, giving post-2023-24-formula rates of about 8 cases per million doses overall and 27 per million in males 12-24, and describing an FDA-funded cardiac MRI follow-up of roughly 300 patients.
approximately 8 cases per million doses in individuals 6 months through 64 years of age and approximately 27 cases per million doses in males 12 through 24 years of age
FDA's 2025 safety communication requiring updated Comirnaty and Spikevax warnings, giving post-2023-24-formula rates of about 8 cases per million doses overall and 27 per million in males 12-24, and describing an FDA-funded cardiac MRI follow-up of roughly 300 patients. Duplicate FDA safety-communication URL also located at fda.gov/safety/medical-product-safety-information/. Mandated long-term outcome studies were described as underway; outside experts criticized the timing in trade-press coverage.