FDA removes Moderna vaccine document reporting myocarditis risk

The Food and Drug Administration removed from its website a document explaining why it approved Moderna’s COVID-19 vaccine after the Epoch Times asked the agency about the document’s references to the shots increasing the risk of myocarditis.

The Summary Basis for Regulatory Action provided details about an unpublished analysis that found the rates of post-vaccination heart inflammation were higher than any U.S. agency previously had reported, the Epoch Times reported.

But the document disappeared from the FDA’s website after the newspaper reviewed it and submitted questions to the agency.

An FDA spokesman said in an email Thursday to the Epoch Times that the agency is “aware of the issue and hope to have the document reposted as soon as possible.” Contacted by telephone, the spokesman had no further information after having “reached out to the website people.”

The FDA meta-analysis of the myocarditis risk was based on data from four health-care claims databases. The agency estimated that the rate of myocarditis among the most vulnerable cohort, males aged 18 to 25, 148 per 1 million vaccinated.

The figure is significantly higher than other government estimates.

A Centers for Disease Control and Prevention analysis of reports submitted to the Vaccine Adverse Event Reporting System, or VAERS, 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 also occurs among people who contract COVID-19. However, a U.K. study published in December found 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.

A peer-reviewed study in Hong Kong of Chinese male adolescents, as WND reported in December, found a significant rise in myocarditis and pericarditis in young male adolescents after taking a second dose of the Pfizer/BioNTech COVID-19 vaccine.

The rate was 37 per 100,000, or 370 per 1 million. The study found the onset of myocarditis came a median of two days after vaccination.

The results supported a study published in November by the Journal of the American Heart Association that found mRNA vaccines could be causing an increase in vascular events such as thrombosis, cardiomyopathy and other vascular events following vaccination.

The Epoch Times noted the FDA approved Moderna’s vaccine Jan. 31 without convening its expert vaccine panel, which is a growing trend for the agency. The CDC’s vaccine advisory committee was scheduled to meet Friday to review the data on the Moderna vaccine.

Members of an FDA panel last October that eventually approved the Pfizer vaccine for children ages 5 to 11 expressed concern about the risk of myocarditis. Eric Rubin, editor-in-chief of the New England Journal of Medicine, called myocarditis “a side effect that we can’t measure yet,” but he concluded the shots should be given to children anyway.

“We’re never going to learn about how safe the vaccine is unless we start giving it,” he argued. “That’s just the way it goes.”

‘Right into the heart’
Prominent cardiologist Dr. Peter McCullough has found from his review of studies that the rate of myocarditis produced by COVID-19 is mild and “inconsequential.” However, myocarditis caused by the vaccine can be severe, he said, citing pre-clinical studies showing the lipid nanoparticles — which deliver the spike protein in the mRNA system — “go right into the heart.”

“When the kids get myocarditis after the vaccine, 90% have to be hospitalized,” McCullough said in a podcast interview in December. “They have dramatic EKG changes, chest pain, early heart failure, they need echocardiograms.”

See McCullough’s remarks:

Dr. Robert W. Malone, the lead inventor of the mRNA technology used in the Pfizer and Moderna vaccines, cited the Hong Kong study during a livestreamed forum in Puerto Rico in December.

He pointed out that the study was an analysis of hospital records, meaning it did not include adolescents who may have developed the disease but did not seek medical attention.

Malone said the information on the risks associated with the COVID-19 vaccines is coming out despite a concerted effort by government, news media and social media to suppress it

The frequency of myocarditis in young males is so high, Malone said, “it can’t be hidden.

“What we’re finding out is that we’ve been lied to. That’s the truth.”

Malone, in a piece on his SubStack page, said there is increasing evidence that vaccinating young people for COVID-19 is “bad medicine, bad policy and shows poor decision making by the FDA on the rushed decision to grant EUA status to these vaccines, particularly for male adolescents and male young adults.”

He urged parents to “consider very carefully before making the decision to vaccinate children.”

The idea, Malone said, “that this vaccine should be mandated in our schools is absolutely wrong, and if we do not reverse these decisions by national authorities, states, and local school boards we will be sentencing a significant fraction of our youth to government-mandated heart damage.”

EDITOR’S NOTE: Last year, America’s doctors, nurses and paramedics were celebrated as frontline heroes battling a fearsome new pandemic. Today, under Joe Biden, tens of thousands of these same heroes are denounced as rebels, conspiracy theorists, extremists and potential terrorists. Along with massive numbers of police, firemen, Border Patrol agents, Navy SEALs, pilots, air-traffic controllers, and countless other truly essential Americans, they’re all considered so dangerous as to merit termination, their professional and personal lives turned upside down due to their decision not to be injected with the experimental COVID vaccines. Biden’s tyrannical mandate threatens to cripple American society – from law enforcement to airlines to commercial supply chains to hospitals. It’s already happening. But the good news is that huge numbers of “yesterday’s heroes” are now fighting back – bravely and boldly. The whole epic showdown is laid out as never before in the sensational October issue of WND’s monthly Whistleblower magazine, titled “THE GREAT AMERICAN REBELLION: ‘We will not comply!’ COVID-19 power grab ignites bold new era of national defiance.”

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This article was originally published by the WND News Center.

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