FDA Approves Smallpox Vaccine for Monkeypox Despite High Transmission Risk

The FDA approved a vaccine (ACAM2000) in August for monkeypox despite the high risk of virus transmission from the vaccinated individual to others. The vaccine insert states, “Death has also been reported in unvaccinated contacts accidentally infected by individuals who have been vaccinated.” The vaccine has been approved for smallpox since 2007 and the CDC does not have plans to use ACAM2000 “broadly during monkeypox outbreaks.”

Another vaccine listed on the CDC website, JYNNEOS, is the recommended vaccine for those in the United States who are at risk of catching monkeypox. ACAM2000 manufacturer, Emergent BioSolutions, is announced 50,000 doses of ACAM2000 will be donated to countries in central Africa.

“Mpox has progressed to become an uncontrolled epidemic in Africa — prompting the WHO to declare a second public health emergency of international concern — creating an enormous need to use all effective tools to extinguish it as a threat,” said Dr. Amesh A. Adalja, health security and emerging infectious diseases expert.

World Health Organization Director-General Dr. Tedros Adhanom Ghebreyesus declared a global health emergency for monkeypox and the CDC recommends anyone traveling to central and eastern African countries endemic with monkeypox to get the JYNNEOS vaccine.

ACAM2000 is said to be for individuals at high risk of monkeypox infection. The Defender reported about the approval of this vaccine last month and spoke with Dr. Meryl Nass, an internist and biological warfare expert. Nass said, “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.”

The FDA medication guide states that individuals vaccinated with ACAM2000 risk “spreading the virus to unvaccinated individuals” for a period of six weeks following the inoculation. The guide says “the virus can be spread by physical contact (including sexual contact) and by sharing a bed, clothes, towels, linen, or toiletries with unvaccinated people.”

Karl Jablonowski, Ph.D., is a senior research scientist at Children’s Health Defense and told the Defender that the FDA approval of this vaccine represents a public health hazard rather than a beneficial product to promote public health.

“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,” Jablonowski said. “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.”

Smallpox has been used as a biological weapon of warfare throughout history and is said to be eradicated worldwide. In the aftermath of the COVID-19 pandemic, there has been increased concern regarding biological weapons that are created during dangerous lab experiments funded by taxpayer dollars. While this vaccine is not being actively used within the United States, it has now been approved to be used for monkeypox, which has been declared a worldwide public health emergency by the WHO.

Emergent BioSolutions creates vaccines for anthrax and smallpox, which are considered biological warfare threats. The HighWire reported about the dangerous gain-of-function research experiments that the White Coat Waste Project exposed. Justin Goodman and Dr. Bryce Nickels told The HighWire that the only reason to do these experiments is for research on biological weapons.

The theory of a lab-leak origin for the COVID-19 virus has gained more support. It has ultimately led to a debarment of EcoHealth Alliance, which was conducting the controversial gain-of-function research at the Wuhan Institute of Virology.

The approval of the ACAM2000 vaccine for monkeypox during a declared global health emergency raises similar concerns regarding bioweapons. In this case, the vaccine is considered a medical intervention, but the FDA has acknowledged the risk of shedding and causing death for up to six weeks after the vaccination.

The CDC has no plans to use the vaccine broadly for any clade II monkeypox outbreak in the United States but has approved its use under ‘expanded access‘ for a clade II outbreak domestically. The CDC lists three criteria that all need to be met for an individual to access a vaccine under the expanded access protocol. Those criteria are:

“Patient(s) have a serious or immediately life-threatening disease or condition, and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition;

The potential patient benefit justifies the potential risks of the treatment and the potential risks are not unreasonable in the context of the disease or condition to be treated; and

The expanded use of the investigational drug for the requested treatment will not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the product.”

According to the package insert, the side effects of ACAM2000 include

“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.”