@US_FDA — Getting vaccinated is still the best way to avoid the worst outcomes of #COVID19 for both children and adults.
@US_FDA — Today, FDA provided important updates on the risk of myocarditis after receiving an mRNA COVID-19 vaccine, noting the risk is higher in young men.
On July 3, 2025, Dr. Vinay Prasad, serving as the Chief Medical and Scientific Officer of the FDA and Director of the Center for Biologics Evaluation and Research (CBER), issued a statement following an extensive review of safety data concerning mRNA COVID-19 vaccines. The analysis revealed a rare but significant risk, prompting the FDA to mandate a warning label on these vaccines. Specifically, the data indicates a 1 in 37,000 chance of myocarditis or pericarditis in males aged 12 to 24 years following vaccination. This condition is associated with inflammation of the heart muscle (myocarditis) or the surrounding sac (pericarditis), with evidence suggesting potential irreversible damage to the heart muscle in affected individuals. The warning aims to inform healthcare providers and the public of this risk to ensure informed decision-making regarding vaccination.
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