Article by Zachary Stieber from our premium news partners at The Epoch Times.
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for Regulatory Action gave more details on how regulators reached the approval decision, and included references to an unpublished analysis that found the rates of post-vaccination heart inflammation were higher than any U.S. agency had found before.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The Epoch Times has submitted Freedom of Information Act requests for the document and several unpublished analyses referenced in it, including the FDA meta-analysis.
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 meta-analysis 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.
An agenda (pdf) for the meeting says a Moderna scientist will present safety and efficacy data on the company’s shot, followed by CDC researchers discussing updates on post-vaccination heart inflammation and the benefit-risk framework in light of the most recent analyzed information.
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.
Most “Conservative” News Outlets Are on the Big Tech Teat
Not long ago, conservative media was not beholden to anyone. Today, most sites are stuck on the Big Tech gravy train.
I’ll keep this short. The rise of Pandemic Panic Theater, massive voter fraud, and other “taboo” topics have neutered a majority of conservative news sites. You’ll notice they are very careful about what topics they tackle. Sure, they’ll attack Critical Race Theory, Antifa, and the Biden-Harris regime, but you won’t see them going after George Soros, Bill Gates, the World Economic Forum, or the Deep State, among others.
The reason is simple. They are beholden to Big Tech, and Big Tech doesn’t allow certain topics to be discussed or they’ll cut you off. Far too many conservative news outlets rely on Google, Facebook, and Twitter for the bulk of their traffic. They depend on big checks from Google ads to keep the sites running. I don’t necessarily hold it against them. We all do what we need to do to survive. I just wish more would do like we have, which is to cut out Big Tech altogether.
We don’t get Google checks. We don’t have Facebook or Twitter buttons on our stories. We don’t have a YouTube Channel (banned), an Instagram profile (never made one), or a TikTok (no thanks, CCP). We’re not perfect, but we’re doing everything we can to not owe anything to anyone… other than our readers. We owe YOU the truth. We owe YOU the facts that others won’t reveal about topics that others won’t tackle. And we owe America, this great land that allows us to take hold of these opportunities.
Like I said, I don’t hold other conservative sites under too much scrutiny over their choices. It’s easy for people to point fingers when we’re not the ones paying their bills or supporting their families. I just wish there were more who would make the bold move. Today, only a handful of other major conservative news outlets have broken free from the Big Tech teat. Of course, we need help.
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JD Rucker – EIC