Health
US-funded hepatitis B vaccine trial for newborns cancelled amid ethics accusations
The $1.6 million US-funded study in Guinea-Bissau drew WHO ethics objections and a dispute over government approval.
The short version
- A proposed hepatitis B vaccine trial for 14,000 newborns in Guinea-Bissau has been cancelled after accusations of being unethical and neocolonial.[BBC News]
- The US-funded study, awarded to the University of Southern Denmark, would have left half the newborns without a shot shortly after birth.[BBC News]
- The WHO representative called the study unethical, and Guinea-Bissau's government had prohibited children's hepatitis B vaccine trials since January.[BBC News]
- Police seized a vaccine batch in October, and the health minister denied the study had ethical approval.[BBC News]
Key facts
- The trial was cancelled after accusations that it was unethical and neocolonial.[BBC News]
- The US Centers for Disease Control and Prevention awarded the University of Southern Denmark $1.6 million in December 2025 for the study.[BBC News]
- The study was designed to involve 14,000 newborns, with half receiving a hepatitis B vaccine shortly after birth.[BBC News]
- Guinea-Bissau's government prohibited hepatitis B vaccine trials involving children in January.[BBC News]
- Guinea-Bissau's Judicial Police searched the Bandim Health Project's facilities in Bissau on 19 October and seized a batch of hepatitis B vaccines.[BBC News]
- The WHO representative in Guinea-Bissau told the BBC the study was unethical because it would withhold a proven newborn intervention.[BBC News]
- A Bandim researcher said the trial would not proceed because it lacked the necessary governmental approval.[Al Jazeera]
What remains uncertain
- Whether the study had required local approval is disputed; the health minister denied it, while a researcher said it was never granted.[Al Jazeera · BBC News]
Sources
Outlet counts describe coverage, not independent confirmation. Reports may share a wire service or original source.