Hepatitis B Vaccine Study Cancelled in Africa – Controversy Erupts
- Danish researchers are facing criticism over a study suggesting the DTP vaccine might negatively impact overall health, possibly due to a conflict with pre-existing beliefs about vaccine safety.
- The study's protocols haven't been publicly released, but a version was leaked and published by inside Medicine.
- The researchers propose that certain vaccines may offer nonspecific health benefits beyond protection against the targeted disease.
The controversial US-funded study on hepatitis B vaccines among newborns in Guinea-Bissau has been halted, according to Yap Boum, a senior official at the Africa Centres for Disease Control and Prevention (CDC).
“the study has been cancelled,” Boum told journalists at a press conference on Thursday morning.
The $1.6m study, funded under the purview of Robert F Kennedy Jr, a longtime vaccine skeptic and the secretary of the US Department of Health and Human Services (HHS) , drew outrage and criticism over ethical questions about withholding vaccines proven to prevent hepatitis B in a country with a very high burden of the disease.
“It’s of importance for Africa CDC to have evidence that can be translated in policy, but this has to be done within the norm. So we are glad that at this point the study is being cancelled,” Boum said.The study was halted because it raised critical questions on the ethics of the trial, he said, adding: “The way the study was designed was a big challenge.”
Officials in Guinea-Bissau say the trial will still happen, according to one journalist on the press call. But Africa CDC officials said the trial would only move forward once it has been redesigned to address ethical issues. There were “still some conversations happening” between Guinea-bissau officials and the US on how to conduct a trial like this ethically, and Africa CDC, which is not affiliated with the HHS, had assembled a team to make sure Guinea-Bissau officials “receive the adequate support to ensure that this study, if it has to happen, will also fit the ethical regulations”, Boum said.
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The design of the study has not been made public by the researchers or by health officials, but a leaked version was published by Inside Medicine on Thursday. An HHS official told the Guardian after publication that the
Danish researchers are facing criticism over a study suggesting the DTP vaccine might negatively impact overall health, possibly due to a conflict with pre-existing beliefs about vaccine safety. Journalist Gunver lystbæk Vestergård reported on the study, which has sparked debate within the scientific community.
The study’s protocols haven’t been publicly released, but a version was leaked and published by inside Medicine. Researcher Frederik Schaltz-Buchholzer also shared details on social media. Dr. Yele Aluko, a public health physician, expressed concerns about the methodology.
The researchers propose that certain vaccines may offer nonspecific health benefits beyond protection against the targeted disease. They suggest adding vaccines like hepatitis B could disrupt these potential benefits. Though, this claim relies on the researchers’ previous work, which has faced scrutiny.
Other Danish researchers have analyzed the studies and found no statistically important evidence to support the claims. The debate highlights the complexities of vaccine research and the importance of obvious methodology.