# FDA myocarditis warnings

Page: https://stenobird.com/podcast/dr-john-campbell-7851784/fda-myocarditis-warnings
Text version: https://stenobird.com/podcast/dr-john-campbell-7851784/fda-myocarditis-warnings.md
Podcast: [Dr. John Campbell](https://stenobird.com/podcast/dr-john-campbell-7851784)
Published: 2026-09-12T10:50:00+00:00
Episode link: https://traffic.megaphone.fm/VG9795439092.mp3
Audio file: https://traffic.megaphone.fm/VG9795439092.mp3
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JSON: https://stenobird.com/v1/public/podcasts/dr-john-campbell-7851784/episodes/fda-myocarditis-warnings
Duration seconds: 1257

## Resource

FDA Approves Required Updated Warning in Labeling of mRNA COVID-19 Vaccines Regarding Myocarditis and Pericarditis Following Vaccination https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-approves-required-updated-warning-labeling-mrna-covid-19-vaccines-regarding-myocarditis-and mRNA COVID Shots Cause Myocarditis (FDA video) Dr Vinay Prasad, Director of the Center for Biologics Evaluation and Research FDA. https://www.youtube.com/watch?v=68QzzWGc4mI June 25, 2025, FDA Safety Communication 6 months through 64 years Approximately 8.4 cases per million doses Initial and follow-up cardiac MRIs commonly showed signs of injury to the heart muscle Males 12 through 24 years Approximately 26.9 cases per million doses, 1/37,000 First reports of C-VAM Feb 2021 (VAERS) April, 2021, 2 deaths and 60 cases from Israel (details sent to FDA and CDC in April 2021) April 27th 2021, DCD statement denies myocarditis signal. April 27th 2021, CDC was aware of 14 cases reported by US military August 2021, FDA document (FOI) 1/5,000 (16 and 17 year old males) Hong Kong, 1 / 2,700 hospitalised (13 to 18 males) Vaccine safety link data, 1 / 2,000 (after 2nd dose in 18 to 24 males) Vaccine safety link data, 64% of cases missed at first First Pfizer booster, 1 / 6,800 Undoubtedly some deaths may be implicated Deaths due to fulminant myocarditis Undoubtedly people have subclinical myocarditis Severe outcomes from covid declining, new risk benefit analysis coming soon. Follow-up information on cardiovascular outcomes From longitudinal retrospective observational study. Most had received a two-dose primary series, prior to diagnosis. Follow-up of approximately 5 months post-vaccination Persistence of abnormal cardiac magnetic resonance imaging (CMR) findings, that are a ma…

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