A proposed trial of a hepatitis B vaccine on newborn babies in Guinea-Bissau has been cancelled following widespread accusations that the study was unethical and neocolonial, with police seizing a batch of vaccines from the research centre at the heart of the controversy. The trial, funded by the United States under Health Secretary Robert F. Kennedy Jr., planned to withhold a vaccine recommended by the World Health Organization from half of the participating newborns.
The study was planned at the Bandim Health Project, a research centre that has operated in Guinea-Bissau since 1978. It was designed to involve 14,000 newborns, with half receiving the hepatitis B vaccine shortly after birth and the other half not receiving the shot. The researchers argued that because Guinea-Bissau does not currently offer routine hepatitis B vaccinations at birth, they had a unique opportunity to study its broader health effects before the vaccine was introduced in 2028. The Trump administration funded the study, with the US Centers for Disease Control and Prevention awarding the University of Southern Denmark $1.6 million in December 2025.
But the plan drew immediate criticism from public health experts and the World Health Organization. Walter Kazadi Mulombo, the WHO representative in Guinea-Bissau, told the BBC that the main ethical concern was that the trial would withhold an intervention already proven to protect newborns against hepatitis B. “The vaccine has been used for more than 30 years in more than 115 countries,” he said. “A study that will withhold that intervention from other newborns is unethical.” He warned that babies could be exposed to the virus during childbirth if their mothers were infected, and noted that nearly a fifth of Guinea-Bissau’s population is infected with hepatitis B, a viral infection that affects the liver and can lead to chronic illness and death.
The controversy raised broader questions about whether vulnerable populations in African countries were being asked to take risks that researchers would not accept in wealthier countries. The government of Guinea-Bissau prohibited hepatitis B vaccine trials involving children in January and requested a team of experts from the Africa Centres for Disease Control and Prevention to help evaluate the study. Health Minister Quinhin Nantote said in October that the suspension remained in force and had not been overturned by the Council of Ministers, adding that the government was outraged by reports that the study might proceed despite the ban.
The WHO is now working with the Guinean government to bring forward the birth-dose vaccine. The country had been expected to add it to its routine immunisation schedule in 2028, but officials are considering introducing it in the first quarter of next year. Guinea-Bissau currently vaccinates children against hepatitis B at six weeks, which means the vaccine is less effective. The cancellation of the trial is a victory for public health advocates who argued that the rights and safety of African newborns should never be compromised in the name of research.
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