Bad newsUS-Funded Trial Planned to Delay Hepatitis B Shots for 7,000 Guinea-Bissau Newborns
A $1.6 million US-funded trial would have given half of 14,000 newborns their hepatitis B shot at six weeks, not at birth, in a country where one in five people is infected. It was cancelled after WHO called it unethical.
Read the good side of this story
Newborn Vaccine Trial in Guinea-Bissau Cancelled Before Any Baby Was Enrolled
About one in five people in Guinea-Bissau has hepatitis B, and the country gives the vaccine at six weeks, not at birth. Into that gap came a plan to leave half of 14,000 newborns, about 7,000 babies, waiting for their first shot as part of a research trial. The US Centers for Disease Control and Prevention paid $1.6 million for it. The trial has now been cancelled, BBC Africa reports, but only after almost a year of objections, a government ban, a police raid and a dispute over whether approval had ever been given.
What was proposed
The study was designed at the Bandim Health Project, a research centre in Bissau run with the University of Southern Denmark (SDU). Half the babies would receive the hepatitis B vaccine shortly after birth. The other half would not, and would get it at six weeks under the national schedule, according to Al Jazeera. Researchers would follow both groups for five years. The trial was open-label, so the researchers would know which babies had the shot, which critics said is unusual for a randomised trial.
The World Health Organization recommends the vaccine at birth. Its representative in Guinea-Bissau, Walter Kazadi Mulombo, told the BBC that the vaccine has been used for more than 30 years in more than 115 countries. He called a study that withholds it from some newborns unethical. WHO says babies can be exposed to the virus during childbirth if their mothers are infected, and later in life.
Who carries the risk
Infants are the most likely to develop chronic hepatitis B, which has no cure. The BBC cites 2020 data showing that chronic infection kills up to a quarter of those who carry it, mostly through liver failure or liver cancer. Nearly a fifth of the 2.2 million people in Guinea-Bissau are infected. The country cannot always secure enough doses, Al Jazeera reports, which is why it allows the first shot up to six weeks after birth.
The researchers argued that the years before a planned birth dose in 2028 offered a unique window to study the vaccine’s wider effects. Magda Robalo, a former Guinea-Bissau health minister, told Al Jazeera that the researchers took advantage of a country with limited research capacity. Gavin Yamey of Duke University told the BBC that the proposal was neocolonial and asked why it was not run in Denmark. Other critics, Al Jazeera reports, compared it with the Tuskegee study, in which US authorities watched untreated syphilis in Black men from 1932 to 1972 although penicillin existed.
How it unravelled
| When | What happened |
|---|---|
| December 2025 | CDC awards SDU $1.6 million for the trial |
| January 2026 | Guinea-Bissau bans hepatitis B vaccine trials involving children and opens a review with Africa CDC, and with WHO according to Al Jazeera |
| October 2026 | Health Minister Quinhin Nantote says the suspension still stands and that he was not told the study might proceed |
| 19 October | Judicial Police search Bandim and seize a batch of hepatitis B vaccines; police say that does not mean the doses were unsafe |
| 5 November | Trial reported cancelled; SDU says no baby was enrolled |
The ban did not settle it. SDU said a revised protocol had received ethical approval from the relevant authorities in Guinea-Bissau. Nantote denied that and said in October that he was outraged because he, as the responsible minister, had not been informed. SDU’s dean, Jakob Grauslund, told the BBC that the university’s own research ethics committee gave a positive assessment, that he decided the project could proceed, and that this did not replace Guinea-Bissau’s authorisation. He said Danish law did not require the extra review, and that the statutory Danish ethics bodies were unable to carry it out.
Police searched Bandim on 19 October and seized a batch of vaccines intended for vaccinating children. They did not say how many doses were taken or why. A Bandim researcher, Frederik Schaltz-Buchholzer, wrote in a LinkedIn post days later that the trial would not go ahead because government approval was not given. Grauslund said the trial never started and that no babies were enrolled.
The money and the politics
The funding came from the US government under Health Secretary Robert F Kennedy Jr, who has voiced scepticism about vaccines and has praised the Danish researchers. Under his leadership a US vaccine panel tried to end the recommendation that all newborns receive a birth dose, and a federal judge blocked that change. Critics asked whether the research could be used to support such a shift. The BBC says there is no evidence that the trial was designed to do that, and that its stated aim was to examine effects beyond preventing infection.
The researchers’ record added to the concern. Peter Aaby and Christine Stabell Benn, who chair Bandim, have theorised that some vaccines can cause deaths, and Al Jazeera reports that Danish colleagues have accused them of downplaying results. A Danish newspaper found that they had not publicised null results from an earlier trial. The BBC notes that a later study by some of the same researchers found no evidence of the mortality effect reported earlier. Benn denied any wrongdoing in a February email to Al Jazeera. In a joint statement the pair said they were not testing whether the vaccine prevents disease, but whether prevention carries a prohibitive price. One researcher involved called the end of the trial a significant setback for African science.
What is still missing
WHO is working with the government to bring the birth dose forward. Officials are considering the first quarter of next year, about a year ahead of the 2028 plan. Until that happens, newborns in Guinea-Bissau still get the first shot at six weeks. The police have not said whether their inquiry concerns the trial, the import of the doses or something else, and the US health department had not responded to the BBC. Neither report says whether the researchers will seek another site.
