Guinea-Bissau Cancels US-Funded Hepatitis B Trial in Newborns

What changed

Guinea-Bissau cancelled a proposed US-funded hepatitis B vaccine trial involving 14,000 newborns after authorities prohibited child vaccine trials and police seized vaccines from the Bandim Health Project. The study, funded through a $1.6m CDC award to the University of Southern Denmark in December 2025, would have given a birth-dose vaccine to half the babies and withheld it from the other half.

Why it matters

This was not simply a dispute over research design. The vaccine is recommended at birth by the WHO and has been used for more than 30 years in more than 115 countries. Guinea-Bissau currently waits until babies are six weeks old, when the protection is less effective.

The ethical problem is therefore stark: the trial would have created a control group by denying some newborns an intervention already regarded as protective. That is especially consequential in a country where nearly one-fifth of the population has hepatitis B. Babies infected early in life are more likely to develop chronic disease, which can lead to fatal liver failure or liver cancer.

Researchers said the study could clarify whether the vaccine has broader health effects, after earlier studies in The Gambia and Guinea-Bissau raised questions about possible links to higher mortality. But that scientific question now sits behind a more basic one: whether vulnerable newborns should carry the risk of answering it.

The government had expected to add birth-dose vaccination to its routine schedule in 2028. Officials are considering moving that rollout to the first quarter of next year, which would make the cancelled trial even harder to justify if the vaccine is about to become standard care.