FDA removes Moderna vaccine document reporting myocarditis risk

The Food and Drug Administration removed from its website a document explaining why it approved Moderna’s COVID-19 vaccine after the Epoch Times asked the agency about the document’s references to the shots increasing the risk of myocarditis.

The Summary Basis for Regulatory Action provided details about an unpublished analysis that found the rates of post-vaccination heart inflammation were higher than any U.S. agency previously had reported, the Epoch Times reported.

But the document disappeared from the FDA’s website after the newspaper reviewed it and submitted questions to the agency.

An FDA spokesman said in an email Thursday to the Epoch Times that the agency is “aware of the issue and hope to have the document reposted as soon as possible.” Contacted by telephone, the spokesman had no further information after having “reached out to the website people.”

The FDA meta-analysis of the myocarditis risk was based on data from four health-care claims databases. The agency estimated that the rate of myocarditis among the most vulnerable cohort, males aged 18 to 25, 148 per 1 million vaccinated. – READ MORE