FDA orders update to covid-vaxx warning labels.
https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-approves-required-updated-warning-labeling-mrna-covid-19-vaccines-regarding-myocarditis-and
FDA has required each manufacturer to update the warning about the risks of myocarditis and pericarditis to include information about (1) the estimated unadjusted incidence of myocarditis and/or pericarditis following administration of the 2023-2024 Formula of mRNA COVID-19 vaccines and (2) the results of a study that collected information on cardiac magnetic resonance imaging (cardiac MRI) in people who developed myocarditis after receiving an mRNA COVID-19 vaccine.
The warning on myocarditis and pericarditis in the Prescribing Information for Comirnaty and Spikevax has been updated to convey that the observed risk of myocarditis and pericarditis following vaccination with mRNA COVID-19 vaccines has been highest in males 12 through 24 years of age...
But it's one of those "glacial" tiny improvements. New FDA warning still greatly understates risk.
For instance, they look at population "aged 6 months to 64 years" and order, laughably, that risk of heart damage be stated at "8 per million".
Real number is vastly higher. By some studies, it's 1 per 30 (4000 times higher) for detectable or partial damage, in population of males aged 6 years to 24 years.
