A proposed clinical trial in Guinea-Bissau to study hepatitis B vaccines in newborns has been cancelled amid significant controversy and accusations of ethical violations. The study was designed by the Bandim Health Project, a research centre operating in Guinea-Bissau since 1978, and was funded by the US through a $1.6m grant awarded by the CDC to the University of Southern Denmark in December 2025.
The trial was planned to enroll 14,000 newborns, with half receiving a hepatitis B vaccine shortly after birth and the other half serving as a control group without the vaccination. Researchers argued the study aimed to investigate whether the hepatitis B vaccine given at birth has broader health effects beyond preventing hepatitis B infection, citing previous studies that raised questions about possible links to increased mortality. They emphasized that Guinea-Bissau does not currently offer routine hepatitis B vaccinations at birth despite WHO recommendations, and noted they planned to introduce such vaccines in 2028.
The trial faced substantial international criticism and opposition from public health officials. The WHO representative in Guinea-Bissau raised concerns that the study would withhold an intervention already proven effective over more than 30 years and used in more than 115 countries. Critics highlighted that nearly a fifth of Guinea-Bissau’s population are infected with hepatitis B, a virus that poses significant risks to infected infants, with data from 2020 indicating chronic infections kill up to 25% of people affected. Concerns also centred on broader questions about whether vulnerable populations in African countries were being asked to accept risks researchers would not propose in wealthier nations.
Guinea-Bissau’s government prohibited hepatitis B vaccine trials involving children in January, and the health minister stated in October that the suspension remained in force. A dispute escalated when the university claimed a revised protocol had received ethical approval from relevant authorities in Guinea-Bissau, which the health minister denied. On 19 October, Guinea-Bissau’s Judicial Police searched the Bandim Health Project and seized a batch of hepatitis B vaccines, though they did not specify investigation grounds or confirm whether the seizure related to the proposed trial.
The proposed research occurred during significant policy shifts on vaccines under the Trump administration and Health Secretary Robert F Kennedy Jr, who has a documented history of expressing vaccine scepticism. Kennedy’s vaccine panel attempted to end longstanding recommendations for hepatitis B vaccination at birth, though a federal judge later blocked these changes.
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