Guinea-Bissau hepatitis B vaccine trial on newborns called off
Health officials raised ethical concerns, and police have seized a batch of vaccines linked to the research centre at the heart of the dispute.
Key points
- A planned hepatitis B vaccine trial on newborns in Guinea-Bissau has been cancelled, according to the BBC.
- The study was US-funded and would have withheld a WHO-recommended vaccine from half of 14,000 newborns.
- Critics called the plan unethical and neocolonial, and the WHO said the vaccine is proven safe and effective.
- Guinea-Bissau's government had banned such trials in January, and police seized a vaccine batch on 19 October.
- The University of Southern Denmark says the trial never started and no babies were enrolled.
According to the BBC, a planned hepatitis B vaccine trial on newborns in Guinea-Bissau has been called off. Critics had described the study as ethically wrong and as a form of neocolonial research.
The study was funded by the United States government, at a time when Health Secretary Robert F Kennedy Jr has been openly doubtful about vaccines. Officers from the country’s Judicial Police have also removed a quantity of immunisation doses from the facility that sat at the core of the row.
What the trial would have involved
The research was to take place at the Bandim Health Project, a centre that has worked in Guinea-Bissau since 1978. Planners intended to enrol 14,000 newborns. Half would receive the hepatitis B shot soon after birth, while the other half would go without it.
The researchers said they wanted to learn whether the birth-dose vaccine had wider health effects beyond stopping infection. Earlier studies in The Gambia and Guinea-Bissau had raised questions about a possible link to higher child mortality. The team argued that Guinea-Bissau does not give birth-dose vaccines routinely, despite World Health Organization advice, so the country offered a chance to study the effects before the vaccine is introduced in 2028.
Opponents asked whether denying a shot to certain infants was ethical in a nation among the most impoverished on Earth, where the virus circulates widely. The US Centers for Disease Control and Prevention awarded the University of Southern Denmark (SDU) $1.6m (£1.2m) in December 2025 to support the work.
Concerns from health officials
The WHO’s country lead in Guinea-Bissau, Walter Kazadi Mulombo, spoke to the BBC. He explained that the agency’s concern began when questions arrived about the study and no public protocol could be found. His main objection was that the trial would deny newborns a treatment already shown to protect them against hepatitis B. He noted the vaccine has been in use for over 30 years in more than 115 countries.
Mulombo also warned that infants can catch the virus during birth if their mothers carry it, and later in life. Nearly a fifth of people in Guinea-Bissau have hepatitis B. Infection in infancy often leads to long-term disease, which according to 2020 data can kill up to 25% of those affected, mainly through liver failure or liver cancer.
Working alongside the authorities, the WHO is pushing to bring the birth-dose shot in sooner. Officials are considering a start in the first quarter of next year, rather than 2028. At present, children there receive the hepatitis B shot at six weeks, a schedule that is less effective.
Government rejection and ethics approval
Guinea-Bissau’s authorities banned hepatitis B vaccine studies on children back in January and asked the Africa Centres for Disease Control and Prevention to help review the study. Health Minister Quinhin Nantote said in October that the ban still stood and had not been lifted by the Council of Ministers, even though media reports suggested the trial might go ahead. He said he had not been informed.
The SDU said a revised protocol had won ethical approval from authorities in Guinea-Bissau, a claim Nantote rejected. The university said its own research ethics committee gave a positive assessment, and that it sought a further independent review although Danish law did not require one. SDU dean Jakob Grauslund said that approval did not replace the separate permission needed from Guinea-Bissau. He also confirmed that the trial had never begun, with no babies enrolled and no doses given.
Gavin Yamey, a professor of global health at Duke University, said the proposal showed signs of neocolonialism and asked why the study was not being run in Denmark.
Seized vaccines and US policy
On 19 October, Judicial Police in Guinea-Bissau raided the Bandim facilities in Bissau and confiscated a consignment of hepatitis B doses intended for kids. Police did not say how many doses were taken or what the grounds were. They stressed that the seizure alone did not show the vaccines were faulty. They have not said whether the case links to the trial, the import of the doses, or something else. Grauslund declined to comment on the seizure.
The funding comes amid major US vaccine policy changes under President Donald Trump and Kennedy. A US vaccine panel under Kennedy tried to end the long-standing advice that all newborns get a hepatitis B shot at birth, but a federal judge blocked that move along with other changes. Critics asked whether the study could support such a shift. The stated aim was broader effects, and there is no evidence in available information that the trial was meant to justify a policy change. Kennedy has praised the Danish researchers and cited their earlier findings, although a later study by some of the same team found no sign of the earlier effect.
Frequently asked questions
Why was the hepatitis B vaccine trial in Guinea-Bissau cancelled?
The trial drew criticism that it was unethical and neocolonial, mainly because it would have withheld a WHO-recommended vaccine from half of the newborns. Guinea-Bissauu0026#039;s government had also banned hepatitis B vaccine trials involving children in January.
Who funded the proposed hepatitis B vaccine trial?
The US government funded the study. The CDC awarded the University of Southern Denmark $1.6m (£1.2m) in December 2025 to support it.
Has any babies been enrolled in the trial?
According to the University of Southern Denmark, the trial never started. No babies were enrolled and no vaccinations were given as part of the research.
Sources
This article was written with the help of AI from reports by the outlets listed above. See our Editorial Policy. Spotted a mistake? Tell us.
