1 Out of 48 Monkeypox Vax Recipients Have ‘Cardiac Adverse Events of Special Interest’: F.D.A. Package Insert

Monkeypox vaccine insert says heart problems were reported to occur in “1.3% (95/7,093) of JYNNEOS recipients who were smallpox vaccine-naïve” and “2.1% (16/766) of JYNNEOS recipients who were smallpox vaccine-experienced.”

  • As mainstream alarm increases over the reported monkeypox outbreak, so too is demand for a vaccine to treat the virus.
  • Biotech company Bavarian Noric manufactures its “Jynneos” vaccine, one of two monkeypox vaccines licensed in the United States, according to the U.S. Centers for Disease Control and Prevention (CDC).
  • The U.S. government earlier this month ordered 2.5 million more doses of Jynneos, the additional order bringing the total number of monkeypox vaccines in the U.S. to 7 million by mid 2023.
  • The package insert for the Jynneos vaccine states that heart problems of “special interest” occur in 1 in 75 vaccine recipients who have not already been vaccinated against smallpox and in 1 in 48 vaccine recipients who have already been vaccinated against smallpox.
  • “Cardiac AESIs were reported to occur in 1.3% (95/7,093) of JYNNEOS recipients” who were “smallpox vaccine-naïve” (had not received a smallpox vaccine in the past), according to page six (6) of the insert published on the U.S. Food and Drug Administration’s (FDA) website.
  • But the risk of heart disease after vaccination nearly doubles for individuals who have received a smallpox vaccine in the past. “Cardiac AESIs were reported to occur in 2.1% (16/766) of JYNNEOS recipients who were smallpox vaccine-experienced,” the vaccine package insert reads.
  • Bavarian Nordic added “tromethamine,” a drug given to treat cardiac arrest (heart attack), as an ingredient in the Jynneos vaccine, according to the insert.
Screenshot from fda.gov taken July 17, 2022
Screenshot from fda.gov taken July 17, 2022
  • The Jynneos monkeypox vaccine package insert warns that data is “insufficient” to determine whether pregnant women who receive the vaccine will experience “major birth defects” or “miscarriage.” Page six (6) of the insert reads: “Available human data on JYNNEOS administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.”
  • The insert also warns it is “not known” whether Jynneos vaccine is excreted in human milk. “Data are not available to assess the effects of JYNNEOS in the breastfed infant or on milk production/excretion,” the insert says.
  • The CDC held a virtual meeting in October 2020 in which Dr. Brett Petersen presented a slide explaining how four female study participants became pregnant after receiving the Jynneos vaccine despite being “advised to avoid becoming pregnant.” Dr. Petersen describes how one out of these four pregnant women suffered a “spontaneous abortion”: “These pregnancies were followed up to delivery, and three participants delivered healthy babies, while one experienced a spontaneous abortion at an estimated 37 weeks of gestation based on her last menstrual period,” stated Petersen.
  • The Jynneos insert warns on page eight (8) that the vaccine “has not been evaluated” for “impairment of male fertility.”
  • The insert also warns the Jynneos vaccine “has not been evaluated for carcinogenic or mutagenic potential,” meaning it is not known whether the vaccine causes cancer or genetic mutations in humans.
  • In April 2020, two years before the first monkeypox infection was reported in the United States, the U.S. Department of Health and Human Services (DHHS) placed an order for up to 1.4 million liquid-frozen doses of Bavarian Nordic’s Jynneos monkeypox vaccine valued at $202 million.
  • At the time, Bavarian Nordic said it “expects to start manufacturing in 2022,” the same year monkeypox cases happened to spike.
  • In 2021, the Nuclear Threat Initiative (NTI)—in partnership with the World Economic Forum and funded by the Bill & Melinda Gates Foundation, the Rockefeller Foundation, and the Carnegie Corporation—published a paper outlining the group’s “exercise scenario” that predicted “a deadly, global pandemic involving an unusual strain of monkeypox virus.”
  • NTI said in their 2021 publication that the monkeypox outbreak would be “caused by a terrorist attack using a pathogen engineered in a laboratory with inadequate biosafety and biosecurity provisions and weak oversight.”
  • Dr. Richard Bartlett, former appointee to then-Texas Gov. Rick Perry’s Health Disparities Task Force, recently told American Faith that he believes a “Plan-demic is in the works,” meaning the release of monkeypox and the sale of vaccines to treat the virus had been planned.
  • Read NTI’s 2021 paper below.