US-funded hepatitis B vaccine trial on newborns in Guinea-Bissau is cancelled after an ethics row
A proposed trial of the hepatitis B vaccine on about 14,000 newborns in Guinea-Bissau has been cancelled after an ethics row. The study, run by the Bandim Health Project and funded with $1.6 million from the US Centers for Disease Control and Prevention, would have given half the babies the WHO-recommended vaccine at birth and half at six weeks, the country's current schedule, to test the vaccine's broader health effects. Guinea-Bissau's government prohibited hepatitis B vaccine trials involving children in January and asked the Africa CDC to help assess this one; in October, Judicial Police searched Bandim's facilities in Bissau and seized vaccine batches, and a Bandim researcher has now said the trial lacked the necessary government approval and will not go ahead. The university says the trial never started: no babies were enrolled and no doses were given.
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Key points
- The proposed trial of about 14,000 newborns will not go ahead: a Bandim researcher says it lacked the necessary government approval, and the university says it never started.
- Half the babies would have had the hepatitis B vaccine at birth and half at six weeks, Guinea-Bissau's current schedule - the comparison at the heart of the ethics row.
- The WHO's country representative called withholding a proven vaccine unethical; a Duke professor called the proposal 'neocolonialism'. Both words are their positions, carried as such.
- Police searched Bandim's Bissau facilities on 19 October and seized vaccine batches; the US health department had not commented in the reporting read.
What happened
Hepatitis B is widespread in Guinea-Bissau, one of the world's poorest countries, and the WHO recommends a birth dose - which Guinea-Bissau's own schedule currently gives at six weeks. The Bandim Health Project, Danish-linked and working in the country since 1978, studies the broader effects of vaccines; that research programme is respected and contested in equal measure, and this trial became its sharpest controversy when the CDC funded it under a US health secretary known for vaccine scepticism.
The sequence matters: the government banned such trials in January, before the study's planned start; reports that it would proceed anyway brought the minister's October insistence that the ban stood, the police seizure, and finally the researchers' acknowledgement that the approval the trial needed was never there.
Both sides, in their own words
Both sides heard. Neither believed for free. Publishing a side's version is not endorsing it — the claim checks below are where verdicts live.
Side A · The critics and the WHO's position
- WHO's Guinea-Bissau representative, Walter Kazadi Mulombo: the main ethical concern is withholding an intervention already proven to protect newborns; the vaccine 'has been used for more than 30 years in more than 115 countries' and a study withholding it 'is unethical'.
- Duke University's Professor Gavin Yamey called the proposal 'neocolonialism' and questioned why it was not being conducted in Denmark.
Side B · The researchers' position
- The trial aimed to investigate whether the hepatitis B vaccine given at birth has broader health effects beyond preventing infection, and the comparison arm followed Guinea-Bissau's own current six-week schedule.
- The University of Southern Denmark says its own research ethics committee assessed the study positively - while its dean accepts that this did not replace Guinea-Bissau's approval.
- Researcher Frederik Schaltz-Buchholzer called the cancellation 'a significant setback' for African science.
Independently verified
The cancellation: the proposed trial will not go ahead. Bandim Health Project researcher Frederik Schaltz-Buchholzer said it lacked the necessary government approval; Guinea-Bissau's Council of Ministers had reaffirmed its rejection of the trial on 16 October, and the announcement that it would not proceed followed on 21 October. The University of Southern Denmark (SDU) says the trial never started - no babies were enrolled and no doses were given as part of the research. The design: the study was planned at the Bandim Health Project, a research centre operating in Guinea-Bissau since 1978, and was designed to involve about 14,000 newborns - half to receive the hepatitis B vaccine shortly after birth and half at six weeks, which is Guinea-Bissau's current schedule - to investigate whether the birth dose has broader health effects beyond preventing infection. The US CDC awarded the University of Southern Denmark $1.6 million for the study in December 2025, under Health Secretary Robert F. Kennedy Jr. The ethics objection, in its own words: the WHO's representative in Guinea-Bissau, Walter Kazadi Mulombo, told the BBC the organisation became concerned after receiving questions about the study and finding no publicly available protocol, and that the main ethical concern was withholding an intervention already proven to protect newborns: 'The vaccine has been used for more than 30 years in more than 115 countries. A study that will withhold that intervention from other newborns is unethical.' Duke University global-health professor Gavin Yamey said the proposal 'reeks of neocolonialism' and questioned why the research was not being conducted in Denmark. The government's actions: Guinea-Bissau prohibited hepatitis B vaccine trials involving children in January and asked 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. On 19 October, Judicial Police searched the Bandim Health Project's facilities in Bissau and seized a batch of hepatitis B vaccines. The researchers' position: SDU says it received a separate, positive assessment from the university's own research ethics committee, while its dean has said that assessment did not replace approval from Guinea-Bissau. Schaltz-Buchholzer described the end of the trial as a 'significant setback' for African science. The US Department of Health and Human Services had not commented in the reporting read - the BBC asked it for comment.Not yet verified
Nothing outstanding.Claim by claim
Why this label: Verified across the BBC's report (carried in full by Graphic Online and the Ghana Guardian, read via search in this run) and OkayAfrica's account of the same timeline, which agree on the missing approval, the government's prohibition and the university's 'never started' position. The cancellation is carried on the researcher's own statement plus the government's recorded position - the two parties whose agreement the trial needed.
On the ladder: a claim earns Verified from primary evidence, or from two independent sources that do not copy each other.
Why this label: Verified across the BBC's report and its republications, in agreement on the numbers, the two arms, the funder, the amount and the date. The design is stated neutrally: whether the six-week arm 'withheld' a vaccine or followed the national schedule is exactly what the two sides dispute, and both framings are in the sides panel rather than settled in this claim.
On the ladder: a claim earns Verified from primary evidence, or from two independent sources that do not copy each other.
Why this label: Verified as the critics' stated positions, quoted by the BBC report (read via search in this run) - Mulombo speaks for the WHO's country office, the body whose recommendation the birth dose is. The words 'unethical' and 'neocolonial' are attributed characterisations, carried as positions in the sides panel too, never as this page's findings.
On the ladder: a claim earns Verified from primary evidence, or from two independent sources that do not copy each other.
Show all claims (2 more)
Why this label: Verified across the BBC report and OkayAfrica's account, in agreement on the January prohibition, the Africa CDC request, the minister's October statement, the Council of Ministers' 16 October reaffirmation and the 19 October search and seizure. The authorities' inquiries into whether the project complied with safety standards were continuing on the reporting read - no outcome is claimed.
On the ladder: a claim earns Verified from primary evidence, or from two independent sources that do not copy each other.
Why this label: Verified as the researchers' stated position across the BBC report (SDU's ethics-committee assessment; HHS asked for comment) and OkayAfrica (the dean's concession on approval), with the 'significant setback' line in the fuller BBC-style report carried by the Barbados Gazette. Positions are carried as positions, in the sides panel as well.
On the ladder: a claim earns Verified from primary evidence, or from two independent sources that do not copy each other.
What we know / what we don't know yet
What we know
- The trial will not go ahead, on the researcher's own statement and the government's recorded prohibition.
- It never started: no babies were enrolled and no doses were given, on the university's account.
- The WHO's, the critics', the government's and the researchers' positions, each in their own words.
What we don't know yet
- The US Department of Health and Human Services' response - the BBC asked for comment and none is in the reporting read.
- The outcome of the authorities' inquiries into the project's compliance, which were continuing on the reporting read.
- What happens to the seized vaccine batches and to the $1.6 million CDC award.
Why it matters
The argument was never only about one trial. It asks who decides what research may be done on newborns in a poor country, whether a comparison arm that follows the local schedule is fair or is withholding, and whether a Danish university's own ethics approval can stand in for the host country's - a question Guinea-Bissau's government has now answered for this case, at the cost of a study its researchers call a setback for African science.
Background
Show the background timeline (5)
The Bandim Health Project begins operating in Guinea-Bissau.
The US CDC awards the University of Southern Denmark $1.6 million for the newborn hepatitis B trial.
Guinea-Bissau's government prohibits hepatitis B vaccine trials involving children and asks the Africa CDC to help assess the study.
Judicial Police search Bandim's Bissau facilities and seize a batch of hepatitis B vaccines.
After the Council of Ministers reaffirms its rejection, the trial's end is announced: it lacked the necessary government approval.
Update history
No silent edits. Every change is written here, with its time.
- Latest
Published in Checking state (queue MANUAL 1874 of the 05:39Z scan, 6 Nov). JUDGE AUDIT: (1) headline, slug, SEO title and summary all state the same outcome - the trial is cancelled / will not go ahead - in the trial's own terms; (2) the cancellation is Verified on the researcher's statement plus the government's prohibition, the design on the BBC report's consistent account, and every ethics characterisation is labelled a position, in claims and in a named sides panel; (3) every number (14,000 newborns, $1.6 million, December 2025, 1978, 19 October, 30 years, 115 countries) traces to its named source; (4) both sides' strongest points are present - the WHO's proven-intervention argument and the researchers' current-schedule and own-ethics-approval points; (5) the missing voice - the US health department's response - is declared in the don't-know list; (6) photo is a labelled Bissau file photo, probed 200; video check made, none verified, none attached; (7) translations added in all 13 languages in the same run, with two-sided take labels translated in kind (no FR/AR full text to drop).