The short version
- A proposed clinical trial in Guinea-Bissau involving 14,000 newborns has been cancelled after authorities seized vaccine supplies and cited ethical violations.
- Critics argue the study was unethical because it withheld a World Health Organization-recommended hepatitis B vaccine from half the participants in a country with high infection rates.
- The trial was funded by the US Centers for Disease Control and awarded to the University of Southern Denmark, sparking debate over research standards in low-income nations.
A controversial clinical trial designed to test the broader health effects of a hepatitis B vaccine on newborns in Guinea-Bissau has been abruptly halted. The suspension follows intense international scrutiny and domestic government action after police seized a batch of vaccines from the Bandim Health Project, the research center at the center of the dispute. The study, which had not yet begun enrolling participants or administering doses according to university officials, was planned to involve 14,000 infants. Half of these children were scheduled to receive the vaccine shortly after birth, while the other half would have been denied the shot entirely.
The trial was funded by the United States government, specifically through a $1.6 million grant awarded by the Centers for Disease Control and Prevention in December 2025. The funds were directed to the University of Southern Denmark to conduct the research. This financial backing has drawn particular attention given that the current US Health Secretary, Robert F. Kennedy Jr., has a documented history of expressing skepticism regarding vaccination programs. The BBC has requested comment from the US Department of Health and Human Services regarding the funding and oversight of the project.
Global health experts have condemned the study design as fundamentally unethical. Walter Kazadi Mulombo, the World Health Organization representative in Guinea-Bissau, stated that withholding a proven intervention from newborns is unacceptable. He noted that the hepatitis B vaccine has been used safely for over three decades in more than 115 countries. The WHO recommends administering the vaccine at birth to prevent transmission from mother to child during delivery. Mulombo emphasized that exposing infants to the virus, which can lead to chronic liver disease and cancer, violates established medical ethics.
The ethical concerns are compounded by the local epidemiological context. Approximately 20 percent of Guinea-Bissau’s population is infected with hepatitis B. Infants who contract the virus are at significant risk of developing chronic infections, which carry a mortality rate of up to 25 percent according to data published in 2020. Critics argue that conducting such a high-risk study in one of the world’s poorest nations raises serious questions about equity in global health research. Dr. Gavin Yamey, a professor at Duke University, described the proposal as reeking of neocolonialism, questioning why researchers would subject vulnerable African populations to risks they would not accept in wealthier countries like Denmark.
Proponents of the study argued that Guinea-Bissau presents a unique opportunity for research because it does not currently offer routine hepatitis B vaccinations at birth. The country typically waits until infants are six weeks old to administer the vaccine, a delay that reduces effectiveness compared to the WHO-recommended birth dose. Researchers claimed they intended to investigate whether the vaccine has health benefits beyond preventing infection, citing previous studies in The Gambia and Guinea-Bissau that raised questions about potential links between early vaccination and increased mortality. They argued that studying these effects before the country introduces routine birth-dose vaccinations in 2028 was scientifically valuable.
Despite these arguments, the Guinean government moved quickly to block the trial. In January, officials prohibited hepatitis B vaccine trials involving children and requested assistance from the Africa Centres for Disease Control and Prevention to evaluate the study’s merits. Health Minister Quinhin Nantote expressed outrage in October upon learning that media reports suggested the trial might proceed despite the ban. He stated that he had not been informed of any plans to resume the research, highlighting a breakdown in communication between the research institution and national health authorities.
Tensions escalated when the University of Southern Denmark claimed that a revised study protocol had received ethical approval from relevant authorities in Guinea-Bissau. Minister Nantote firmly denied this assertion, maintaining that the suspension remained in force and had not been overturned by the Council of Ministers. The university’s dean, Jakob Grauslund, clarified that no babies had been enrolled or vaccinated as part of the research. He also noted that the university had received a positive assessment from its own internal research ethics committee, though this did not override national regulations.
The controversy has prompted immediate changes to Guinea-Bissau’s public health strategy. The WHO is now working with the government to accelerate the introduction of the birth-dose hepatitis B vaccine. While the country had originally planned to add the vaccine to its routine immunization schedule in 2028, officials are considering bringing forward the implementation to the first quarter of next year. This shift underscores the urgency of protecting infants from a virus that remains widespread and deadly in the region.
The cancellation of the trial highlights ongoing tensions between international research interests and local ethical standards in low-income countries. It also raises broader questions about oversight mechanisms for US-funded health initiatives abroad. As Guinea-Bissau moves to strengthen its vaccination programs, the incident serves as a stark reminder of the complexities involved in conducting medical research in vulnerable populations. The seizure of vaccine supplies and the government’s firm stance signal a rejection of practices that prioritize data collection over immediate patient safety.
Future collaborations between Western institutions and African health systems will likely face heightened scrutiny regarding consent, transparency, and benefit-sharing. The lack of a publicly available protocol for the Guinea-Bissau trial contributed to early concerns from WHO officials, suggesting that greater openness could prevent similar disputes. As global health priorities evolve, ensuring that research respects local norms and protects participant welfare will remain critical to maintaining trust and achieving sustainable health outcomes.
Sources behind this briefing
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- BBC News↗Why a US-funded vaccine trial on babies was cancelled in Guinea-Bissau
