The Food and Drug Administration (FDA) has removed a document from its website that gave insight to their decision to approve Moderna's COVID vaccine. The Summary Basis for Regulatory Action is a document that provided more details about how FDA regulators came to decide on approving the COVID vaccine, including references to an unpublished analysis which revealed that the rates of post-vaccination heart inflammation were higher than any U.S. agency research has found before.
The Epoch Times (ET) reviewed the document and submitted questions about it to FDA spokespersons. Interestingly, the document was taken off the FDA website after that. When asked about it, a spokesperson said via email dated February 3, "We are aware of the issue and hope to have the document reposted as soon as possible."
When pressed again via telephone about why the FDA took the document off its website, a spokesperson said, "I reached out to the website people. I don't really have any more information to tell you."
ET then submitted Freedom of Information Act requests for the Summary Basis for Regulatory Action, as well as several unpublished analyses referenced in it and the FDA meta-analysis.
National Vaccine Information Center president Barbara Loe Fisher, argued, "the public has the right to review the evidence FDA is using to license new mRNA vaccines as safe and effective." Her organization is a non-profit that champions informed consent.
"Lack of transparency only fosters distrust in government agencies charged with protecting the public health," Fisher argued. "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."
According to the NOQ Report, the FDA meta-analysis found that the rate of myocarditis after two shots of the Moderna COVID vaccines was 148 per 1 million males who were inoculated. The data was drawn following the examination of data of four health care claims databases. The 148 out of a million statistic is higher than other government estimates, including that of the Centers for Disease Control and Prevention (CDC).
The CDC's analysis of reports that appear in the Vaccine Adverse Event Reporting System or VAERS reveal that there were about 10.8 cases per million among males aged 18 to 24 following one shot of the Moderna COVID vaccine and 56 cases per million among males of the same age that got the second shot of the Moderna jab.
Myocarditis, a type of heart inflammation, has been recognized by health authorities as a side effect of mRNA-based COVID vaccines such as that of Moderna and Pfizer. Studies have shown that those who received the Moderna and Pfizer vaccines have experienced "higher-than-expected rates" of myocarditis.
In fact, a yet to be peer reviewed study titled "Risk of myocarditis following sequential COVID-19 vaccinations by age and sex" showed that men aged 40 and below are more likely to experience heart inflammation following a booster shot of Pfizer's COVID vaccine versus COVID itself. The incidence rate of myocarditis was 7.6 in the 28 days after getting vaccinated with a Pfizer booster, researchers from the University of Oxford and other UK institutions found.
