FDA Document on Moderna Vaccine Approval Removed From Agency’s Website
February 3 | Posted by mrossol | Big Govt, Coronavirus, HealthThe Epoch Times 2/3/22 By
A Food and Drug Administration (FDA) 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for Regulatory Action gave more details on how regulators reached the approval decision, and included references to an unpublished analysis that found the rates of post-vaccination heart inflammation were higher than any U.S. agency had found before.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.
“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The Epoch Times has submitted Freedom of Information Act requests for the document and several unpublished analyses referenced in it, including the FDA meta-analysis that examined data of four health care claims databases and estimated that, among males aged 18 to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 the Vaccine Adverse Event Reporting System. The analysis 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.
Myocarditis is one type of heart inflammation that people who receive vaccines built on messenger RNA (mRNA) have experienced at higher-than-expected rates. It also occurs among people who contract the CCP (Chinese Communist Party) virus, which causes COVID-19.
Moderna’s shot, a type of mRNA vaccine, is administered in a two-dose primary series. The doses are administered about a month apart.
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.
Researchers in the UK found last month that men under 40 were much more likely, and females under 40 were more likely, to suffer from heart inflammation after Moderna’s second shot than from COVID-19 itself.
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