W.H.O. Says Monkeypox ‘Vaccine Is Not 100% Effective’ as Vax Manufacturer Ramps Up Production Capacity

Monkeypox vaccine is “not a silver bullet,” says WHO’s monkeypox lead official.

***Editor’s Note: This article’s headline was corrected because it claimed that the WHO had said the monkeypox vaccine was “causing” monkeypox infections. That is incorrect. The WHO did however say that for some vaccine recipients the vaccine failed to protect those recipients from the virus. Two bullet points in this article were also corrected to account for this.

  • The World Health Organization (WHO) has reported a number of “breakthrough cases” of monkeypox infections are occurring among the vaccinated, meaning the vaccine failed to protect from the virus.
  • “We have known from the beginning that this vaccine would not be a silver bullet, that it would not meet all the expectations that are being put on it and that we don’t have firm efficacy data or effectiveness data in this context,” the WHO’s technical lead for monkeypox, Dr. Rosamund Lewis, said during a press briefing.
  • “The fact that we’re beginning to see some breakthrough cases is also really important information because it tells us that the vaccine is not 100% effective in any given circumstance, whether preventive or post-exposure,” Dr. Lewis continued. “We cannot expect 100% effectiveness at the moment based on this emerging information.”
  • The WHO’s warning comes as monkeypox vaccine manufacturer Bavarian Nordic announces it expects to manufacture its shot, called “Jynneos,” until the end of 2023.
  • “We have completely changed gears within the company in terms of […] manufacturing,” CEO Paul Chaplin told investors during a call Wednesday.
  • Bavarian Nordic has even reopened its bulk facility in Demark, which has been shut down since last August for upgrades, and the company is “hiring more people to boost bulk production and fill-finish capacity, which was just endorsed by the FDA,” according to a press release.
  • “The measures are helping BN double bulk yield to four batches a week by the end of this year, Chaplin said. The Danish company also recently contracted Grand River Aseptic, which Chaplin said could double the fill-finish capacity of Jynneos, with the potential for further increase,” the release explained.

“We don’t have any randomized control trials of these studies in the context of this particular outbreak, so we don’t have direct clinical efficacy studies, as I say, in the context of this monkeypox outbreak at the moment,” said Dr. Lewis. “What we are beginning to see is some observational studies reporting, for example, persons who may have had post-exposure prophylaxis. After being exposed to monkeypox they may have had the vaccine. Again, just a couple of reports are coming out.”

  • American Faith is compiling a list of problems with the Jynneos monkeypox vaccine being ignored by the mainstream media:
  • 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 (herehereherehere).
  • We can now add to the list that the World Health Organization (WHO) has admitted that the monkeypox vaccine is “not 100% effective” against the virus.
  • American Faith recently reported on a Reuters analysis that revealed the Jynneos monkeypox vaccine 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 noted.
  • Vice president of clinical strategy at Bavarian Nordic, Heinz Weidenthaler, has also admitted that the Jynneos monkeypox vaccine has no conclusive data indicating the drug’s effectiveness against the virus. “[W]e’ve simply had no opportunity to test this in humans,” the Bavarian Nordic vice president told MIT Technology Review.