By Karim Hammam
A proposed hepatitis B vaccine trial on newborn babies in Guinea-Bissau has been cancelled after accusations that the study was unethical and neocolonial. The trial, funded by the United States under Health Secretary Robert F Kennedy Jr, planned to withhold the World Health Organization's recommended birth-dose vaccine from half of 14,000 participating infants.
Trial Design and Ethics Concerns
The study was to be conducted at the Bandim Health Project, a research centre operating in Guinea-Bissau since 1978. Researchers from the University of Southern Denmark (SDU) aimed to investigate whether the hepatitis B vaccine given at birth has broader health effects beyond preventing infection. Previous studies in The Gambia and Guinea-Bissau had raised questions about a possible link to increased mortality. Because Guinea-Bissau does not yet offer routine hepatitis B vaccination at birth despite WHO recommendations, researchers argued they had a unique opportunity to study the vaccine's effects before its planned introduction in 2028.
Critics, however, questioned the ethics of denying a proven vaccine to newborns in one of the world's poorest countries, where nearly a fifth of the population is infected with hepatitis B. Infection during infancy often leads to chronic disease, which kills up to 25% of those affected, mostly through liver failure or cancer.
WHO and Government Opposition
Walter Kazadi Mulombo, the WHO representative in Guinea-Bissau, said the main ethical concern was withholding an intervention already proven to protect newborns. "A study that will withhold that intervention from other newborns is unethical," he told the BBC. The WHO is working with the government to introduce the birth-dose vaccine as early as the first quarter of next year, rather than the previously scheduled 2028.
Guinea-Bissau's government prohibited hepatitis B vaccine trials involving children in January and requested an evaluation from the Africa Centres for Disease Control and Prevention. Health Minister Quinhin Nantote said in October that the suspension remained in force and had not been overturned by the Council of Ministers. Nantote expressed outrage that the study might proceed without her knowledge, contradicting SDU claims that a revised protocol had received ethical approval from relevant Guinean authorities.
Funding and Policy Context
The US Centers for Disease Control and Prevention awarded SDU $1.6 million in December 2025 for the proposed study. The funding came amid significant changes to US vaccine policy under President Donald Trump and Health Secretary Kennedy. Kennedy's vaccine panel attempted to end the longstanding recommendation that all newborns receive a hepatitis B vaccine at birth, but a federal judge blocked that move along with other policy changes. Kennedy has praised the Danish researchers and cited their earlier work in support of vaccine safety concerns, though a subsequent study by some of the same researchers found no evidence of the previously reported effect.
Police Seizure of Vaccines
On 19 October, Guinea-Bissau's Judicial Police searched the Bandim Health Project's facilities in the capital, Bissau, and seized a batch of hepatitis B vaccines. Police said the batch was intended for vaccinating children but did not disclose the number of doses or the specific grounds for the investigation. They stressed the seizure did not mean the vaccines were defective or unsafe. SDU dean Jakob Grauslund said the trial had never started, no babies had been enrolled, and no vaccinations had been administered as part of the research.
