The hepatitis B newborn vaccine trial halted in Guinea-Bissau will not go ahead in the country, according to its lead researcher, who said the study did not receive the required government approval. The trial, funded in part by a US Centers for Disease Control and Prevention grant according to reports, had drawn international criticism over its design and informed consent. The reported halt concerns authorisation and ethics. It is not a finding that the hepatitis B vaccine is unsafe, and the World Health Organization continues to recommend a first dose as soon as possible after birth, preferably within 24 hours. This report sets out what is reported, where accounts differ, and the public-health context. It is general information and not medical advice.
Hepatitis B newborn vaccine trial halted: key takeaways
- The lead researcher, Frederik Schaltz-Buchholzer of the Bandim Health Project, said in a social media post that the study will not move forward in Guinea-Bissau because the required governmental approval was not received.
- The health minister has said the country never agreed to the study, and one account says the Council of Ministers reaffirmed on 16 October that it would not accept the trial.
- Critics and the World Health Organization raised ethical objections to a design in which some newborns would not receive a birth dose.
- The researchers say the study never started and that no children were enrolled or vaccinated.
- The halt is not evidence against the vaccine; the birth dose remains a recommended, proven intervention.
What happened to the hepatitis B newborn vaccine trial
According to published reports, Danish researchers from the Bandim Health Project planned a randomised trial in Guinea-Bissau comparing newborns who would receive a hepatitis B birth dose with those who would receive the first dose later, at about six weeks. Reports give the target enrolment as about 14,000 newborns, with around half in the delayed group, and say the study would look at broad outcomes such as deaths, hospital stays and skin and neurodevelopmental conditions, not at whether the vaccine works against hepatitis B. We could not open the study protocol, so the design below is as reported.
The approval dispute behind the hepatitis B newborn vaccine trial halted
Accounts of approval conflict. Reports say the research team posted a letter from a national ethics committee dated 14 July 2026 approving the study, while the health ministry disputes that the trial was authorised. The health minister, Quinhin Nantote, said the country had never agreed to it, and the government is reported to have held an emergency meeting in October with the researchers and local health bodies. One account says the Council of Ministers formally reaffirmed on 16 October that it would not accept the trial. A Danish research ethics committee reportedly approved the study in early October, after which at least four of its members are reported to have resigned. We have not verified these details independently.
Why the design of the hepatitis B newborn vaccine trial halted drew criticism
The core objection, raised by critics and by the World Health Organization statement of 13 February 2026, is that a randomised trial leaving some newborns without a proven birth dose, in a country where hepatitis B is common, risks serious and irreversible harm. WHO also said the protocol assumed possible safety problems without enough credible evidence and that a no-treatment control arm is acceptable only when no proven intervention exists. Critics further argued that parents who declined to take part would have no chance of the vaccine, which they said undermines free consent. The researchers, in reports we reviewed, said neither schedule is dangerous and that the proposal had fuelled distrust locally.
What the researchers and officials say about the hepatitis B newborn vaccine trial halted
The researchers say the study never began and that no child was enrolled or vaccinated. Reports say police searched the Bandim Health Project’s offices in Bissau during the week of 19 October and sealed or seized a refrigerator of hepatitis B vaccines meant for the study; accounts differ on the word, and one says officials stated the action did not indicate any problem with the vaccines’ quality, safety or effectiveness. Another account stresses that the search followed the government’s decision. A WHO spokesperson said WHO is committed to ensuring all newborns in Guinea-Bissau receive timely protection and stands ready to support a national birth dose.
The public-health context for the hepatitis B newborn vaccine trial halted
General background: hepatitis B can be passed from a mother to her baby at birth, and infants infected early are far more likely to develop lifelong infection, which can lead to cirrhosis and liver cancer. The WHO hepatitis B fact sheet describes the birth dose, given within 24 hours, as an effective way to prevent that transmission. Reports say about one in five adults in Guinea-Bissau has the virus and that the country decided in 2024 to add the birth dose to its schedule, with introduction planned for 2028. Details on vaccination policy are on the US Centers for Disease Control and Prevention hepatitis B pages.
What is not clear about the hepatitis B newborn vaccine trial halted
- Whether any formal approval was ever valid, given the disputed ethics committee letter.
- Exactly what happened to the vaccine doses and the legal basis for the search.
- Whether the researchers will propose a different study.
- Whether CDC funding will be redirected, which the agency had not addressed in reports we saw.
Risks and caveats on the hepatitis B newborn vaccine trial halted story
- Accounts differ on approval, on the search and on the exact design.
- Several details come from single reports and have not been verified.
- The halt does not change the evidence on the vaccine itself.
- This is news reporting, not medical advice.
In our assessment, the hepatitis B newborn vaccine trial halted in Guinea-Bissau is a dispute about authorisation and research ethics, and readers should not read it as a reason to doubt routine birth-dose vaccination, which WHO continues to recommend. See also FDA Approves Hibsago: First Antisense Drug for Hepatitis B. More in our healthcare services coverage.
What to watch next on the hepatitis B newborn vaccine trial halted
- Statements from the government, the researchers and funders on next steps.
- Progress toward a national birth dose; see Africa CDC for regional health updates.
- Any independent review of the approvals process.
Frequently asked questions
Why was the hepatitis B newborn vaccine trial halted?
The lead researcher said the required government approval was not received; the government says it never agreed, and critics and WHO raised ethical objections.
Is the hepatitis B vaccine unsafe?
No. The halt was about authorisation and ethics, not a new safety finding, and WHO recommends the birth dose.
Were any babies vaccinated in the trial?
The researchers say the study never started and no children were enrolled or vaccinated.
How we reported this: we relied on published reports of 21 and 22 October 2026 and earlier coverage, the WHO statement and WHO background pages; we could not open the protocol. Conflicting accounts are flagged. Last updated: 23 October 2026. This article is news reporting and not medical advice.