“[W]e’ve simply had no opportunity to test this in humans,” says Bavarian Nordic vice president of clinical strategy.
QUICK FACTS:
- As the fifth child tests positive for monkeypox in the U.S. and governments clamor for a vaccine to treat the virus, MIT Technology Review, owned by the Massachusetts Institute of Technology, published an article on Wednesday analyzing Bavarian Nordic’s “Jynneos” monkeypox vaccine.
- MIT describes how the World Health Organization (WHO) once claimed that “vaccination against smallpox was demonstrated through several observational studies to be about 85% effective in preventing monkeypox,” that figure comming from research conducted in the late 1980s, when scientists investigated an outbreak of monkeypox in the Democratic Republic of Congo.
- The investigation had only focused on 147 people with monkeypox, who passed the infection to 47 of the 1,573 people they had been in close contact with. “The ‘attack rate,’ or chance of being infected, was 85% higher in those contacts who were unvaccinated, the team found,” according to MIT.
- But MIT then characterizes the study as being “small” and as not intending to determine the “effectiveness” of the Jynneos vaccine against monkeypox “directly.” The study “didn’t set out to directly test the effectiveness of the vaccines,” writes MIT.
- A drug’s ‘effectiveness’ is a measure of how well or poorly it produces its intended effect in “real-world use.”
- MIT then quotes Heinz Weidenthaler, vice president of clinical strategy at Jynneos manufacturer Bavarian Nordic, who also critiques the study’s small size and casts doubt on the study’s conclusion about Jynneos’ effectiveness at preventing monkeypox: “I think it’s a bit stretched to come to that conclusion,” said Weidenthaler of the study’s claim to the vaccine’s effectiveness.
- “But it’s all we have right now,” Weidenthaler adds, highlighting the fact that the Jynneos monkeypox vaccine has no conclusive data behind it indicating its effectiveness or lack thereof.
- “[W]e’ve simply had no opportunity to test this in humans,” stated the Bavarian Nordic vice president.
- The Jynneos package insert provided by the U.S. Food and Drug Administration (FDA) confirms the drug’s efficacy testing was only conducted in “animal challenge studies” and not in humans.
MONKEYPOX VACCINE DATA COLLECTION BEGINS AFTER MASS INJECTIONS, NOT BEFORE:
- The MIT piece cites an American epidemiologist based in London, who says that because the Jynneos monkeypox vaccine efficacy data is not available now, it will have to be collected only after nations begin vaccinating its citizens.
- “What we need to do now is collect the evidence and use the vaccine now as a precautionary measure in countries that have decided to use it,” said David Heymann (MD), an infectious disease epidemiologist at the London School of Hygiene and Tropical Medicine, who has investigated monkeypox outbreaks.
BACKGROUND:
- 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.
- The CDC reported how one in four (25%) women 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.
- Read the insert, provided by the FDA, below.
