Monkeypox Vax: ‘Little Data’ and ‘No Clinical Trials’ to Evaluate Efficacy in Humans (Reuters Analysis)

The monkeypox jab “has not undergone clinical trials to evaluate the vaccine’s ability to prevent monkeypox in humans,” Reuters reports.

  • Reuters, an international news agency, published an analysis revealing that the monkeypox vaccine (“Jynneos” by Bavarian Nordic) has too “little data” and “no clinical trials” to determine whether the drug is effective against the virus in humans.
  • “Indeed, the Bavarian Nordic shot has not undergone clinical trials to evaluate the vaccine’s ability to prevent monkeypox in humans, though initial studies suggest it will provide some protection,” Reuters reports.
  • The news agency goes on to quote Dr. Dimie Ogoina, a professor of medicine at Niger Delta University in Nigeria and member of the World Health Organization’s (WHO) monkeypox emergency committee, who said that the “whole vaccination strategy for monkeypox is associated with a lot of uncertainties.”
  • The concerning revelation comes as monkeypox has now been found in all 50 U.S. states and the Biden administration plans to stretch supplies of the shot by giving people “fractional doses” in order to vaccinate as many as possible.
  • The FDA package insert for Bavarian Nordic’s ‘Jynneos’ monkeypox vaccine says that heart problems of “special interest” occur in 1 in 75 vaccine recipients who have not already been vaccinated against smallpox, but also in 1 in 48 vaccine recipients who have already been vaccinated against smallpox. The insert indicates Bavarian Nordic added “tromethamine,” a drug given to treat heart attacks, to the Jynneos vaccine.
  • The CDC reported how one in four women (25%) who became pregnant after being injected with the Jynneos monkeypox vaccine suffered a “spontaneous abortion.”
  • The Jynneos insert also says the vaccine “has not been evaluated” for “[i]mpairment of male fertility.”
  • It is not known whether the vaccine is excreted in human breastmilk: “Data are not available to assess the effects of JYNNEOS in the breastfed infant or on milk production/excretion,” according to the FDA insert.
  • The insert also warns that the Jynneos vaccine “has not been evaluated for carcinogenic or mutagenic potential,” meaning it is unknown whether the vaccine causes cancer or genetic mutations in humans.
  • MIT reported earlier this month how Bavarian Nordic’s vice president of clinical strategy, Heinz Weidenthaler, admitted the effectiveness of the company’s monkeypox vaccine has not yet been tested: “[W]e’ve simply had no opportunity to test this in humans,” said Weidenthaler.
  • There are no long-term studies evaluating how the monkeypox vaccine will interact with the COVID-19 vaccine, which is already linked to heart disease (here, here, here, here).
  • American Faith recently reported how a group linked to the World Economic Forum predicted there would be “more than 270 million [monkeypox] deaths by the end of December 2023.”
  • The group published a paper in 2021 that contained a timeline of future events surrounding a hypothetical monkeypox outbreak, including when the outbreak would occur, how many people would die, and when they would die.
  • The paper accurately predicted the outbreak would occur on May 15, 2022, just seven days after the first monkeypox infection in the U.K. (May 8) and three days before the first infection in the U.S. (May 18).
  • The group also accurately predicted the number of worldwide monkeypox infections to the week, forecasting that by June 5, 2022, there would be 1,421 cases. By June 14—just nine days after NTI’s prediction—POLITICO reported more than 1,600 confirmed cases across at least 39 countries.