Amid growing ethical concerns, a U.S.-funded study on hepatitis B vaccination for newborns in Guinea-Bissau has been suspended, Africa CDC officials confirmed. The $1.6 million trial, led by Danish researchers, Peter Aaby and Christine Benn. under the oversight of Robert F. Kennedy Jr., sparked criticism for its plan to withhold the vaccine from half of participating infants.
“The study has been cancelled”, senior official at the Africa Centres for Disease Control and Prevention, said Yap Boum, during a press briefing on Thursday. He stressed that while research to inform health policy is important, it must adhere to ethical standards.
“The way the study was designed posed serious challenges”, Boum added, noting that Africa CDC will only allow the trial to resume after the protocol is redesigned to meet international ethical requirements.
Leaked documents revealed that the study would have vaccinated 7,000 newborns, leaving another 7,000 unvaccinated based on random assignment. Experts warned that this approach knowingly denied life-saving protection to thousands of children in a country where hepatitis B is widespread, infecting roughly 18% of adults and 11% of children under one.
Boum emphasized that Africa CDC is providing guidance to Guinea-Bissau authorities to ensure future trials comply with ethical standards. “There are ongoing discussions to ensure that if this study proceeds, it protects children and aligns with ethical regulations”, he said.
The Danish researchers defended the study, claiming that live vaccines may have nonspecific health benefits beyond the target disease, and that adding the hepatitis B vaccine could interfere with these effects. However, prior research supporting these claims has been questioned, and other Danish scientists found no statistically significant nonspecific benefits in a recent preprint study.
The controversy has also been fueled by the researchers’ failure to publish results from earlier studies on the DTP vaccine, raising concerns about transparency. While Aaby and Benn maintained that trials must be conducted in Africa to understand local effects, the ethical issues surrounding the current study led to its suspension.
The trial, originally scheduled to begin on January 5, will remain on hold until a revised, ethically sound protocol is approved.
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