A planned hepatitis B vaccine study in in Guinea-Bissau is facing significant controversy and has been suspended pending review, raising ethical concerns among African scientists and prompting conflicting statements from international health organizations. The study, funded by the U.S. Centers for Disease Control and Prevention (CDC) and other foundations, aimed to evaluate the timing of the first dose of the hepatitis B vaccine – at birth versus the standard six weeks of age – in .
Guinea-Bissau currently has one of the highest rates of chronic hepatitis B infection in the world, with nearly one in five people affected. The virus targets the liver and can lead to serious health complications. While the World Health Organization (WHO) recommends a birth dose of the hepatitis B vaccine to prevent transmission during delivery, the proposed study deviated from this guidance by randomly assigning only half of the 14,000 newborns to receive the vaccine at birth. All infants would still receive standard vaccinations for tuberculosis and polio.
The suspension was announced by Guinea-Bissau’s Ministry of Health on , following concerns about insufficient coordination and a lack of clear consensus on the study’s design and ethical implications. “There has been no sufficient coordination in order to take a final decision regarding the study,” stated Quinhin Nantote, the minister of public health for Guinea-Bissau. “Faced with this situation, we decided to suspend it.”
The controversy stems from the study’s methodology and the researchers involved. The trial is being led by Danish researchers affiliated with the University of Southern Denmark and the Bandim Health Project, a group that has previously published research questioning the universal benefits of certain vaccines. Some scientists have condemned the study as deeply unethical, arguing that withholding a potentially life-saving vaccine from half of the newborns in a country with a high prevalence of hepatitis B is unacceptable.
The Africa Centres for Disease Control and Prevention (Africa CDC) initially indicated that the study would not proceed as planned. Yap Boum, PhD, MPH, deputy incident manager for continental mpox response for Africa CDC, stated at a briefing, “We are glad that at this point, the study has been canceled.” However, officials at the U.S. Department of Health and Human Services (HHS) disputed this claim, stating that the study was still underway and that researchers were continuing to refine the study protocol. “It is not our view that the study has been canceled,” an HHS official said, adding, “we are proceeding as planned.” This conflicting messaging further fueled the debate and raised questions about oversight and authority in international clinical research.
The $1.6 million study was funded by the CDC, the Pershing Square Foundation, and the Bluebell Foundation. The decision to award the grant to researchers with a history of questioning vaccine efficacy has also drawn criticism, particularly in light of recent actions by U.S. Health and Human Services Secretary Robert F. Kennedy Jr., who cited research from the Bandim Health Project when reducing funding for global childhood vaccinations earlier in .
Guinea-Bissau is a resource-constrained country with a high maternal and infant mortality rate. The country currently plans to implement a universal hepatitis B birth-dose policy beginning in , but structural barriers have delayed its implementation. The proposed study was seen by some as an attempt to gather further data before fully implementing the policy, while others viewed it as an unnecessary and potentially harmful intervention.
The ethical concerns extend beyond the potential risk to the newborns involved. Critics argue that the study undermines trust in public health initiatives and could exacerbate vaccine hesitancy in a region already struggling with low vaccination rates. The situation highlights the complex challenges of conducting clinical research in Africa, where historical exploitation and power imbalances can raise legitimate concerns about informed consent and the prioritization of local needs.
The suspension of the study in Guinea-Bissau underscores the need for greater transparency, collaboration, and ethical oversight in international clinical research. It also emphasizes the importance of respecting the autonomy of African nations and ensuring that research priorities are aligned with local health needs and values. The future of the study remains uncertain, pending the outcome of the technical and ethical review by Guinea-Bissau’s public-health institute.
