US-backed hepatitis B vaccine trial in African newborns halted after government denies approval

Lead researcher said study 'will not move forward'; researchers' vaccines seized

By LineZotpaper

Published21 October 2026

Read Time3 min

A controversial US-backed trial that would have tested whether withholding the hepatitis B vaccine from some newborns in Guinea-Bissau could improve overall mortality has been halted after the country's health ministry denied approval and seized the researchers' vaccines. The trial, funded with $1.6 million from the US Centers for Disease Control and Prevention (CDC) and another $1.6 million from private partners, drew global backlash over ethical concerns.

The lead researcher, Frederik Schaltz-Buchholzer, a Danish scientist, announced the halt on Wednesday, writing on LinkedIn that it was 'now clear' the study 'will not move forward in Guinea-Bissau' and that 'we were not given the necessary governmental approval.' The health minister of Guinea-Bissau, Quinhin Nantote, had previously denied the project would proceed, telling the Guardian in Portuguese last week: 'This is not even remotely true.'

The trial sought to test a hypothesis by the Danish researchers, including Christine Stabell Benn and Peter Aaby, that giving live vaccines such as the Bacillus Calmette-Guérin (BCG) may have an overall mortality benefit beyond preventing specific diseases, and that adding a hepatitis B vaccine at birth might dampen that effect. Critics strongly disputed the premise.

'There's no evidence for that, and it doesn't make biological sense,' said Paul Offit, a vaccines expert at the Children's Hospital of Philadelphia, who called the proposed study unethical. He noted that the hepatitis B vaccine is a single protein among billions encountered by the immune system daily, and that withholding it in a country with high hepatitis B rates could cause lifelong illness and death.

The government of Guinea-Bissau has now taken control of the researchers' vaccines after searching the offices of the Bandim Health Project on Monday. The government currently plans to offer the universal birth dose of hepatitis B vaccine in 2028, though Offit urged immediate rollout: 'The solution is clear here: take the money and vaccinate as many kids as you can.'

Ethical concerns also focused on informed consent. Henrik Støvring, a Danish researcher who has co-published work raising questions about previous Bandim Project research, said mothers would face coercion: if they declined participation, their child would have zero chance of receiving the vaccine; if they agreed, a 50% chance. 'So how can you say that's a non-coercive informed consent?' he asked.

Schaltz-Buchholzer acknowledged that the trial led to distrust among Bissau-Guineans, who wondered if the vaccine, proven safe over decades, was being tested on Africans because it was dangerous. He maintained that both vaccination schedules (with or without hepatitis B) are not dangerous.

The World Health Organization recommends that all infants receive a hepatitis B vaccine dose as soon as possible after birth, followed by at least two additional doses. 'WHO remains committed to working with national authorities, researchers, and partners to ensure that all newborns, in Guinea‑Bissau and worldwide, receive timely, evidence‑based protection against hepatitis B,' said WHO spokesperson Tarik Jašarević.

The CDC did not respond to questions about whether the funding would now be used to roll out the vaccine to all newborns in Guinea-Bissau.

Analysis

Why This Matters

The halted trial highlights ongoing ethical challenges in conducting medical research in low-income countries, particularly when the intervention (a proven vaccine) is withheld from some participants.
The episode could affect trust in global health initiatives and future vaccine programs in Guinea-Bissau and similar settings.
The outcome may influence how US and other funders allocate resources for vaccine research versus direct immunization campaigns.

Backrough

Hepatitis B is a major health issue in Guinea-Bissau, where the virus can cause lifelong infection, liver disease, and death. The World Health Organization recommends a birth dose of hepatitis B vaccine within 24 hours. The Bandim Health Project, a Danish-led research center, has been conducting studies in Guinea-Bissau for decades, some of which have faced scrutiny over methodology and ethics. The proposed trial was part of a longstanding line of research by the team into 'non-specific effects' of vaccines, the idea that live vaccines might train the immune system in broader ways beyond target disease.

Key Persectives

Danish researchers (Schaltz-Buchholzer, Benn, Aaby): Their hypothesis is that the hepatitis B vaccine at birth may have non-specific effects that dampen the overall mortality benefit of BCG and other live vaccines, justifying a randomized trial to compare schedules. Critics (Offit, Stø, public health experts): There is no evidence for that hypothesis; the proven benefits of hepatitis B vaccination at birth far outweigh any theoretical risk. Conducting a trial that withholds a safe, effective vaccine from newborns is unethical and potentially harmful. Guinea-Bissau government: The health minister denied approval and seized the vaccines, indicating a decision to prioritize universal birth vaccination over the research. WHO: Recommends immediate birth dose for all infants; did not comment directly on the trial but emphasized evidence-based protection.

What to Watch

Whether the CDC and private funders redirect the $3.2 million to support universal hepatitis B vaccination in Guinea-Bissau.
The fate of the seized vaccines and whether they will be used for routine immunization.
Future research activities of the Bandim Health Project in Guinea-Bissau and potential regulatory changes.
Ongoing ethical debates may influence how international health research is reviewed and approved.

Sources

Controversial US-backed vaccine trial in African newborns halted · World news | The Guardian

Checked

12 claims in this story checked against 1 source: 7 supported.

Show each claim

Partly supportedThe trial was halted after the government denied approval.World news | The Guardian: ““we were not given the necessary governmental approval.” The minister of health in Guinea-Bissau, Quinhin Nantote, previously denied that the project would move forward.”
Partly supportedThe trial would test whether withholding hepatitis B vaccine from some newborns could improve overall mortality.World news | The Guardian: “The Danish researchers, led by Schaltz-Buchholzer, Christine Stabell Benn and Peter Aaby, hypothesized giving live vaccines, like the Bacillus Calmette-Guérin (BCG), may have an overall mortality benefit beyond simply preventing illnesses like tuberculosis – but giving another vaccine like hepatitis B alongside it could dampen that effect.”
SupportedResearchers’ vaccines were seized after the government searched the Bandim Health Project offices on Monday.World news | The Guardian: “The government of Guinea-Bissau now has control over the researchers’ vaccines, which they apprehended when they searched the offices of the Bandim Health Project on Monday.”
SupportedThe trial was to receive $1.6 million from the CDC and another $1.6 million from private partners.World news | The Guardian: “The study was to be funded with $1.6m from the US Centers for Disease Control and Prevention (CDC), along with another $1.6m from private partners”
SupportedSchaltz-Buchholzer said the study “will not move forward in Guinea-Bissau” and that the researchers “were not given the necessary governmental approval.”World news | The Guardian: “It was “now clear” that the study “will not move forward in Guinea-Bissau”, Frederik Schaltz-Buchholzer, a Danish researcher, wrote on LinkedIn, adding, “we were not given the necessary governmental approval.””
Not in the sourcesStøvring asked, “So how can you say that's a non-coercive informed consent?”World news | The Guardian: ““So how can you say that’s a non-coercive informed consent?” Støvring asked.”
Partly supportedMothers would face coercion because a child whose mother declined would have no chance of getting the vaccine, while participation gave a 50% chance.World news | The Guardian: “Those who declined participation in the study would not have received the vaccines – making true informed consent impossible, experts say. “If they decide to participate in the trial, they have a 50% chance of getting the vaccine for their children. But if they stay out, they have a 0% chance of getting the vaccine.””
SupportedNantote told the Guardian in Portuguese last week, “This is not even remotely true.”World news | The Guardian: ““This is not even remotely true,” Nantote told the Guardian in Portuguese last week.”
SupportedOffit said, “There's no evidence for that, and it doesn't make biological sense,” and called the proposed study unethical.World news | The Guardian: ““There’s no evidence for that, and it doesn’t make biological sense,” he continued.”
SupportedGuinea-Bissau currently plans to offer a universal hepatitis B birth dose in 2028.World news | The Guardian: “Guinea-Bissau currently plans to offer the universal birth dose in 2028.”
SupportedSchaltz-Buchholzer said the trial led to distrust among Bissau-Guineans, and maintained that both schedules were not dangerous.World news | The Guardian: “The proposed trial led to distrust among Bissau-Guineans, who wondered if the vaccine – which has a decades-long record of being safe and effective – was being tested on Africans because it was dangerous, Schaltz-Buchholzer said in his post. It “should be clear” that both birth vaccination schedules – with or without hepatitis B – are not “dangerous to anyone”, he wrote.”
Partly supportedThe CDC did not respond to questions about whether the funding would now be used to roll out the vaccine to all newborns.World news | The Guardian: “The CDC did not respond by press time to questions about whether the funding, which was appropriated through its global health work, would now be used to roll out the vaccine to all newborns in Guinea-Bissau”

Correction

21 October 2026An earlier version of this story attributed the words 'will not move forward' to Guinea-Bissau's health minister. They were written by researcher Frederik Schaltz-Buchholzer. It also gave researcher Henrik Støvring's surname as Stø.