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FDA Approves of Leaky Mpox Vaccine That May Cause Heart Inflammation in ‘About 1 in every 175 Persons’

Late last month, the U.S. Food and Drug Administration (FDA) approved a monkeypox vaccine that is known to “shed from the vaccination site” and cause heart inflammation in about 1 in every 175 persons.

ACAM2000, made by Emergent BioSolutions, was developed to prevent monkeypox disease in individuals determined to be at high risk for mpox infection. But according to the FDA’s own medication guide for the product, the risks of the vaccine appear to outweigh the benefits.

“Live vaccine virus is shed from the vaccination site and can be spread to other parts of the body or to other people to whom the vaccine virus has spread,” the FDA acknowledged. “Therefore, appropriate care of the vaccination site is required until it is completely healed, which may take up to six weeks.”

The agency also notes that the leaky vaccine can cause “serious complications in vaccinated individuals and their close contacts to whom the virus has spread.”

ACAM2000 may cause myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart). In studies, about 1 in every 175 persons who got the vaccine for the first time may have experienced myocarditis and/or pericarditis. Other serious side effects of ACAM2000 include swelling of the brain or spinal cord, problems with the vaccination site becoming infected, and accidental infection of the eye with the vaccine virus.

More possible side effects are listed in ACAM2000’s package insert:

Myocarditis and/or pericarditis, encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia (vaccinia necrosum), generalized vaccinia, severe vaccinial skin infections, erythema multiforme major (including Stevens-Johnson syndrome), eczema vaccinatum, accidental eye infection (ocular vaccinia) which can cause ocular complications including keratitis and corneal scarring that may lead to blindness, and fetal death in pregnant women.

The insert further states: “Historically, death following vaccination with live vaccinia virus is a rare event; approximately 1 death per million primary vaccinations and 1 death per 4 million revaccinations have occurred after vaccination with live vaccinia virus.”

Death is most often the result of sudden cardiac death, post-vaccinial encephalitis, progressive vaccinia, or eczema vaccinatum. Death has also been reported in unvaccinated contacts accidentally infected by individuals who have been vaccinated.

Emergent BioSolutions specializes in vaccines for biochemical warfare threats such as anthrax and smallpox, the Defender reported.

Dr. Meryl Nass, an internist and biological warfare expert, told The Defender that the CDC previously acknowledged the high risk of taking the ACAM2000 vaccine during a June 23, 2022, meeting.

“It’s a huge number,” Nass said. “The fact that the FDA and CDC are acknowledging it means no one should get the vaccine.”

She explained:

Myopericarditis is a life-threatening condition. It lowers your life expectancy.

Most people are never going to be exposed to mpox or smallpox. Vaccines are typically given to healthy people who are never even going to be exposed, therefore the risk posed by the vaccine needs to be low.

That’s why vaccine safety is critical — even more than drugs, because drugs are given to people who are already sick. This risk — 1 in 175 — is higher than all other licensed vaccines for which the CDC acknowledges side effects. This is the worst.

Myopericarditis is an umbrella term for myocarditis and pericarditis.

Karl Jablonowski, Ph.D., a senior research scientist at Children’s Health Defense  told The Defender that the FDA’s approval of the shot is a “public hazard, not the practice of public health.”

“You can call ACAM2000 a ‘vaccine,’ but its impact on the United States will be as a ‘disease,’” Jablonowski said.

For instance, the drug’s package insert reveals (see Table 3) that the U.S. Department of Health and Human Services (HHS) found roughly 520 per million ACAM2000 recipients contracted myocarditis or pericarditis.

That is about 1 in 2,000. But elsewhere in the package insert, the FDA acknowledges that — based on additional studies — the risk is actually 5.7 per 1,000 vaccinations. That’s about 1 in every 175 people. If the 262 million adults in the U.S. received this vaccine, an estimated 1,493,000 would contract the serious adverse reaction of myopericarditis.

Jablonowski was also alarmed by the fact that the shot contains a “live vaccinia virus” that can be spread to non-vaccinated people.

“The spread of vaccinia virus is an infliction and an assault, as an unsuspecting person cannot possibly consent,” the doctor said.

“For good reasons you would not consent to this vaccine even if you believed your benefits outweigh your risks, as you become a potential vector of a disease that is damaging to the heart and fatal to both fetus and infant,” he added.

In its Aug. 30 press release, the FDA stressed that “every person” who received ACAM2000 would be “required” to be given the drug’s FDA-approved medication guide.

“A Medication Guide is necessary,” the FDA said, “for safe and effective use of the vaccine because it could help prevent serious adverse events and inform the vaccine recipient of serious risks relative to benefit that could affect their decisions to be vaccinated.”

It wasn’t immediately clear what good a medication guide would do given the fact that the vaccine is meant for those determined to be at “high risk” for monkeypox, and those at “high risk” for monkeypox tend to be people who engage in risky, promiscuous and unprotected sex.

 

 

 

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About Debra Heine

Debra Heine is a conservative Catholic mom of six and longtime political pundit. She has written for several conservative news websites over the years, including Breitbart and PJ Media.

Photo: In this photo illustration blood test vials and a vaccine are seen in front of a screen that says "Monkeypox". (Photo Illustration by Nikos Pekiaridis/NurPhoto via Getty Images)

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