Why Guinea-Bissau halted a controversial hepatitis vaccine trial for babies

What the report says

Guinea-Bissau has reportedly stopped a US-funded hepatitis B vaccine trial involving babies after months of controversy over whether the study would withhold a lifesaving shot from some infants. Al Jazeera reported that the trial, linked to the Bandim Health Project in Bissau and researchers at the University of Southern Denmark, did not receive the necessary government approval, according to a researcher involved in the project. Officials have not publicly commented on the reported halt.

The study was designed to compare babies vaccinated at birth with another group given the shot six weeks later, with about 14,000 infants expected to take part. It received $1.6m from the US Centers for Disease Control and Prevention, according to the report. Critics, including health experts and a former Guinea-Bissau health minister quoted by Al Jazeera, said the design was unethical because it could deny protection against hepatitis B, a virus that can be passed from mother to child and cause chronic liver disease and cancer.

Guinea-Bissau first paused the project in January and later opened an inquiry with the Africa Centres for Disease Control and Prevention and the World Health Organization. In mid-October, judicial police raided the research group’s facilities in Bissau and seized vaccine batches while investigators examined whether the project met local safety standards. The case has raised broader concerns about research ethics, local approval processes and vaccine access in a country where hepatitis B remains widespread.