FDA Document on Moderna Vaccine Approval Removed From Agency's Website

A Food and Drug Administration document explaining why the agency approved Moderna's COVID-19 vaccine was removed from the agency's website overnight.

The Summary Basis for Regulatory Action gave more details on how regulators reached the approval decision, and included references to an unpublished analysis that found the rates of post-vaccination heart inflammation were higher than any U.S. agency had found before.

After The Epoch Times reviewed the document and sent questions about it to FDA spokespersons, it disappeared from the agency's website.

Barbara Loe Fisher, president of the National Vaccine Information Center, a nonprofit that advocates for informed consent, told The Epoch Times in an email that "The public has the right to review the evidence FDA is using to license new mRNA vaccines as safe and effective."

"Lack of transparency only fosters distrust in government agencies charged with protecting the public health. FDA should immediately release all information related to the incidence of myocarditis and other serious adverse events following mRNA COVID-19 vaccinations, whether that information has been provided to the agency by vaccine manufacturers or discovered through in-house analyses of additional data collected by federal officials," she added.

The FDA approved Moderna's vaccine on Jan. 31 without convening its expert vaccine advisory panel, a growing trend for the agency.

The CDC's vaccine advisory committee is scheduled to meet on Friday to go over data on the jab.

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