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A proposed clinical trial for a hepatitis B vaccine on newborns in Guinea-Bissau has been canceled following accusations that the trial was "unethical" and "neocolonial."
The trial was funded by the United States, under Health Secretary Robert F. Kennedy Jr., known for his skepticism of vaccines.
Police seized a batch of vaccines from the research center at the heart of the controversy.
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The proposed trial drew international criticism because it planned to deprive half of participating newborns of a vaccine recommended by the World Health Organization (WHO).
Some public health experts argued that the proposed trial 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 BBC has requested comment from the US Department of Health and Human Services.
Here's what you need to know.
What was the trial about?
The study was planned as part of the Bandim Health Project, a research center that has operated in Guinea-Bissau since 1978.
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It was planned to include 14,000 newborns, with half receiving a hepatitis B vaccine shortly after birth and the other half not receiving the injection.
Bandim said the trial aimed to determine whether the hepatitis B vaccine given at birth had broader health effects beyond just preventing infection.
Previous studies in Gambia and Guinea-Bissau have raised questions about a possible link to increased mortality.
The researchers argued that since Guinea-Bissau does not currently offer routine hepatitis B vaccination at birth, despite WHO recommendations, they have a unique opportunity to study its effects before the introduction of these vaccines in 2028.
But critics have questioned the ethics of depriving some babies of the vaccine, particularly in one of the world's poorest countries, where infection is widespread.
The Trump administration funded the proposed study, with the CDC granting the University of Southern Denmark (SDU) $1.6 million (£1.2 million) in December 2025.
What did the WHO say?
Walter Kazadi Mulombo, WHO representative in Guinea-Bissau, told the BBC they became concerned after receiving questions about the study and finding no publicly available protocols.
He said the main ethical problem was that the trial omitted an intervention that had already been proven effective in protecting newborns against hepatitis B.
“This vaccine has been used for more than 30 years in more than 115 countries,” he said. “A study that deprives other newborns of this intervention is unethical. »
He warned that babies could be exposed to the virus during delivery if their mothers were infected, as well as later in life.
Nearly a fifth of Guinea-Bissau's population is infected with hepatitis B, a viral infection that affects the liver.
People infected during early childhood are particularly likely to develop chronic infections, which kill up to 25% of them, mainly from liver failure or liver cancer, according to data published in 2020.
WHO is working with the government to accelerate the implementation of vaccination at birth.
“The country was expected to add it to its routine vaccination program in 2028, but authorities plan to introduce it in the first quarter of next year,” Mulombo said.
In Guinea-Bissau, children are currently vaccinated against hepatitis B at six weeks of age, meaning the vaccine is less effective.
Why did Guinea-Bissau reject the lawsuit?
In January, the government of Guinea-Bissau banned clinical trials of the hepatitis B vaccine involving children. At the time, he asked a team of experts from the Africa Centers for Disease Control and Prevention (Africa CDC) to help him evaluate the study.
Health Minister Quinhin Nantote said in October that the suspension remained in force and had not been reversed by the Council of Ministers after reports emerged that the trial would ultimately go ahead.
“We were surprised to learn from the media that the study could be carried out,” Nantote said. “We are outraged because even I, as minister responsible for this sector, was not informed of this. »
The dispute intensified after the University of Southern Guinea (SDU) said a revised study protocol had received ethical approval "from the competent authorities of Guinea-Bissau", which Nantote denied.
Dr Gavin Yamey, professor of global health and public policy at Duke University in the US, criticized the proposal.
“This trial project smacks of neocolonialism,” he told the BBC, questioning why the research was not being conducted in Denmark.
His criticism focused mainly on the decision not to administer the recommended vaccine to some newborns in a country where hepatitis B is widespread.
SDU Dean Jakob Grauslund said the trial never started, no babies were included and no vaccinations were administered as part of the research.
Has the essay been approved by anyone?
SDU University said it had received a separate positive assessment from its own research ethics committee.
Grauslund said the university had requested an additional independent assessment, although Danish law does not require one.
He added that the Danish research ethics bodies were not able to carry out this review.
Following approval from the University of Southern Denmark's ethics committee, Grauslund decided the project could go ahead.
He stressed, however, that this did not replace the separate authorization required from Guinea-Bissau authorities.
What happened to vaccines?
On October 19, Guinea-Bissau judicial police raided the Bandim health project facilities in the capital, Bissau, and seized a batch of hepatitis B vaccines.
Police said the batch was intended for childhood vaccinations, but did not specify the number of doses seized or the exact reasons for the investigation.
They stressed that this seizure did not mean, in itself, that the vaccines were defective or dangerous.
Police have not said whether their investigation is into the proposed trial, the importation of the vaccines or other circumstances surrounding the batch.
Grauslund said he could not comment on the vaccine seizure.
Who funds research?
The proposed trial was funded by the U.S. government at a time of significant changes in vaccine policy under President Donald Trump and Health Secretary Kennedy.
Under Kennedy's leadership, a U.S. vaccine committee attempted to end a long-standing recommendation to vaccinate all newborns against hepatitis B at birth, but a federal judge later blocked that measure, along with other changes to vaccine policy made by the Trump administration.
Critics have questioned whether this research could help support this policy change, although the study's stated goal is to investigate the vaccine's potential effects beyond preventing infection.
Kennedy praised the Danish researchers, calling them “vaccine research specialists,” and cited previous results of their work to support his concerns about vaccine safety. A subsequent study carried out by some of these same researchers, however, did not demonstrate any effect similar to that previously reported.
There is no evidence that the proposed lawsuit was intended to justify a change in U.S. policy.
We used AI to help translate this article, originally written in English. A BBC journalist checked the translation before publication. Learn more about how we use AI.
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