The Guinea-Bissau hepatitis B vaccine trial will not go ahead after authorities refused to give the government approval it needed, ending a US-funded study that planned to enrol about 14,000 newborns.
Bandim Health Project researcher Frederik Schaltz-Buchholzer announced the outcome on October 21, saying it was “now clear that the HBV-NSE trial will not move forward in Guinea-Bissau.”
The Bandim Health Project, a research group based in Bissau and part of the University of Southern Denmark, designed the study with a $1.6 million grant from the US Centers for Disease Control and Prevention, awarded in December 2025. Half the babies would have received the vaccine at birth and the other half six weeks later, and researchers planned to follow them for five years to compare deaths, hospital admissions and development.
The World Health Organization opposed the design from the start. It has recommended a birth dose for every baby since 2009, and in February it warned that delaying the vaccine for six weeks would expose newborns to serious and potentially irreversible harm. Without vaccination, up to 90% of babies exposed at birth develop chronic hepatitis B, and 15% to 25% of those infections end in early death from liver cancer or liver failure.
About one in five people in Guinea-Bissau live with chronic hepatitis B, and the country plans to introduce a universal birth dose in 2028. Guinea-Bissau’s government moved against the project in stages. It paused the study in January and opened an inquiry with the Africa Centres for Disease Control and the WHO, and Foreign Minister João Bernardo Vieira told Reuters in February that the trial was “not going to happen, period.”
On October 13, after reports that the government had approved a revised proposal, Health Minister Quinhin Nantote said it had authorised no such trial and that he and the responsible officials never received notice. He added that research involving children must follow national law, international ethics principles and formal approval procedures.
Six days later, the judicial police raided the research group’s facilities in Bissau and seized a batch of hepatitis B vaccines. The government said the doses will go through legal procedures, and police said the seizure is an investigative measure that does not point to any problem with the vaccines’ quality, safety or effectiveness.
Bandim’s leaders, Christine Stabell Benn and Peter Aaby, defended the work. They said the study did not test whether the vaccine works but whether its protection carries costs such as other health harms, and they said media coverage spread mistrust in Guinea-Bissau. The group revised its protocol to test mothers for hepatitis B before randomisation, give a birth dose to babies of infected mothers and add a saline placebo for the control group, but a researcher involved called the outcome a significant setback for African science.
The cancellation of the Guinea-Bissau hepatitis B vaccine trial has renewed debate over research ethics, informed consent and the protection of vulnerable African populations in international medical studies. Critics, including paediatrician Paul Offit and Duke University’s Gavin Yamey, argued that withholding a proven vaccine from newborns cannot meet ethical standards, and the dispute also exposed gaps in oversight.
A Danish research ethics committee approved the revised protocol, and several of its members resigned in protest, while Danish authorities said no statutory ethics review exists for research conducted abroad. The WHO’s ethics committee said reviewing the protocol fell outside its mandate.
Africa Global News publication.
