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.
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for Regulatory Action gave more details on how regulators reached the approval decision, and included references to an unpublished analysis that found the rates of post-vaccination heart inflammation were higher than any U.S. agency had found before.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.
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“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The Epoch Times has submitted Freedom of Information Act requests for the document and several unpublished analyses referenced in it, including the FDA meta-analysis.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.
Image by Marco Verch via Flickr, CC BY 2.0.
Will America-First News Outlets Make it to 2023?
Things are looking grim for conservative and populist news sites.
There’s something happening behind the scenes at several popular conservative news outlets. 2021 was bad, but 2022 is proving to be disastrous for news sites that aren’t “playing ball” with the corporate media narrative. It’s being said that advertisers are cracking down, forcing some of the biggest ad networks like Google and Yahoo to pull their inventory from conservative outlets. This has had two major effects. First, it has cooled most conservative outlets from discussing “taboo” topics like Pandemic Panic Theater, voter fraud, or The Great Reset. Second, it has isolated those ad networks that aren’t playing ball.
Certain topics are anathema for most ad networks. Speaking out against vaccines or vaccine mandates is a certain path to being demonetized. Highlighting voter fraud in the 2020 and future elections is another instant advertising death penalty. Throw in truthful stories about climate change hysteria, Critical Race Theory, and the border crisis and it’s easy to understand how difficult it is for America-First news outlets to spread the facts, share conservative opinions, and still pay the bills.
Without naming names, I have been told of several news outlets who have been forced to either consolidate with larger organizations or who have backed down on covering certain topics out of fear of being “canceled” by the ad networks. I get it. This is a business for many of us and it’s not very profitable. Those of us who do this for a living are often barely squeaking by, so loss of additional revenue can often mean being forced to make cuts. That means not being able to cover the topics properly. Its a Catch-22: Tell the truth and lose the money necessary to keep telling the truth, or avoid the truth and make enough money to survive. Those who have chosen survival simply aren’t able to spread the truth properly.
We will never avoid the truth. The Lord will provide if it is His will. Our job is simply to share the facts, spread the Gospel, and educate as many Americans as possible while exposing the forces of evil.
To those who have the means, we ask that you please donate. We have options available now, but there is no telling when those options will cancel us. We have our GivingFuel page. There have been many who have been canceled by PayPal, but for now it’s still an option. Your generosity is what keeps these sites running and allows us to get the truth to the masses. We’ve had great success in growing but we know we can do more with your assistance.
Thank you, and God Bless!
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JD Rucker – EIC