Too little too late

FDA myocarditis warnings

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.

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 marker for myocardial injury in 60% of patients.

(Late gadolinium enhancement, LGE)

Australia data, (at 6 months) 67% LGE and 35% showing fibrosis

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