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for Regulatory Action gave more details on how regulators reached the approval decision, and included references to an unpublished analysis that found the rates of post-vaccination heart inflammation were higher than any U.S. agency had found before.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.
“We are aware of the issue and hope to have the document reposted as soon as possible,” a spokesperson told The Epoch Times in an email on Thursday.
Reached by phone and asked for more details about the issue, the spokesperson said: “I reached out to the website people. I don’t really have any more information to tell you.”
The Epoch Times has submitted Freedom of Information Act requests for the document and several unpublished analyses referenced in it, including the FDA meta-analysis that examined data of four health care claims databases and estimated that, among males aged 18 to 25, the rate of myocarditis following Moderna’s primary series was 148 per million males vaccinated.
That figure is higher than other government estimates, including a Centers for Disease Control and Prevention (CDC) analysis of reports submitted to Vaccine Adverse Event Reporting System that found about 10.7 cases per million males aged 18 to 24 who got Moderna’s first shot and 56 cases per million among those who received Moderna’s second shot.
The vaccine, built on messenger RNA, is administered in a two-dose primary series. The doses are administered about a month apart.
The FDA approved Moderna’s vaccine 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.