Guinea-Bissau Denies US$1.6m Vaccine Trial

HEALTH · GUINEA-BISSAU

Guinea-Bissau’s health ministry says it has not authorised a US-funded hepatitis B vaccine trial on newborns in the West African country. Public Health Minister Quinhin Nantote rejected stories that the study had won clearance, in a statement on Tuesday 13 October.

The study matters to US readers because the US Centers for Disease Control and Prevention (CDC) is funding it with US$1.6 million. Critics say its results could be used in Washington’s own fight over vaccinating babies at birth.

The Bandim Health Project, a Bissau-based research group linked to the University of Southern Denmark, says the vaccine trial still awaits government authorisation. Both sides therefore agree that recruitment has not begun, even as they differ over what has been approved.

What the Ministry Said

Nantote, a navy commodore who serves in Guinea-Bissau’s transitional government, set out the position at a press conference in Bissau. He called the information circulating in national and international media and on social networks “nonexistent”.

“The Ministry of Public Health clarifies that it did not give its consent nor authorise the alleged hepatitis B vaccine tests on newborn children, in the terms described in those publications,” he said. His statement was carried by the Bissau newspaper O Democrata and by RTP África, the Africa service of Portugal’s public broadcaster.

Nantote said any research on humans, and on children above all, must follow national law, international ethical principles and informed-consent rules. He warned that no institution should consider itself authorised on the basis of unconfirmed reports or claimed approvals without formal proof.

The minister also recalled that the government discussed a hepatitis B birth dose in January 2026 and voiced reservations about the study at the time. RTP África said he spoke after a meeting with the heads of health projects working in the country.

What the Researchers Say

The Bandim Health Project published an update on Tuesday 13 October saying a revised version of the study had received ethical approval. It said Guinea-Bissau’s national ethics committee, known as CNEPS, approved the revised protocol on 14 July 2026.

The research ethics committee of the University of Southern Denmark followed on 30 September 2026, approving the project and its consent documents. The group stressed that ethical approval and government authorisation are separate steps, and that recruitment cannot start before both.

Bandim says the health ministry has asked Guinea-Bissau’s vaccination committee for a technical assessment of the study. The remaining national authorisation must be completed before any mother is asked to enrol her baby.

The revised design screens mothers for hepatitis B first, and babies of mothers who test positive receive the birth dose at once. Babies in the comparison group get a saline placebo instead of no injection, and mothers are offered voluntary HIV testing.

All babies in both groups still receive the routine hepatitis B-containing vaccines at six, ten and 14 weeks of age. The researchers say the question is whether an extra birth dose affects overall infant health, not whether the vaccine prevents hepatitis B.

Why the Vaccine Trial Is Contested

The original plan, announced in a US government notice in December 2025, covered about 14,000 newborns, half vaccinated at birth and half from six weeks. The World Health Organization’s director-general, Tedros Adhanom Ghebreyesus, called that design unethical at a press conference on Wednesday 11 February 2026.

He argued that leaving some newborns without a proven vaccine in a country where hepatitis B is common could expose them to infection. Chronic hepatitis B can lead to cirrhosis, liver failure and liver cancer.

In January 2026, Nantote and the director-general for public health, Armando Sifna, told a briefing by Africa CDC that the study was suspended pending technical review. Africa CDC, the African Union’s public health agency, said the final decision belonged to Guinea-Bissau alone.

Africa CDC’s checklist for trials on the continent requires written approval from the national medicines regulator, a national ethics committee green light and explicit government clearance. By Bandim’s own account, the study now has ethics approval but still lacks government authorisation.

On Sunday 11 October, the Portuguese news agency Lusa reported that Guinean authorities had approved the study, citing international press reports. The ministry’s denial two days later answered that story directly.

What It Means for US Readers

The money comes from the CDC, part of the US Department of Health and Human Services led by Robert F. Kennedy Jr. The Portuguese health outlet HealthNews describes him as known for his critical positions on vaccines.

Experts quoted by the Spanish news agency EFE accused Washington of seeking data to justify less vaccination in the US health system. Paul Offit, an infectious-disease specialist at Children’s Hospital of Philadelphia, has said Kennedy wants the study to end the US newborn dose.

For US travellers, investors and aid groups in Guinea-Bissau, nothing changes on the ground for now. No vaccine trial recruitment can begin until the government signs off, and the minister said any approval must come through formal channels.

Guinea-Bissau has put off adding a hepatitis B birth dose to its national schedule until 2028. Under the protocol, recruitment ends as soon as that national birth dose is introduced.

Readers following the country’s politics can start with Guinea-Bissau Explained 2026 and Guinea-Bissau Says 6 December Election Cannot Go Ahead. Both set out how the transitional authorities took charge and what lies ahead.

What Is Not Known

It is not known whether the ministry’s denial covers the revised protocol, or only the original design described in the press. Nantote’s wording, “in the terms described”, leaves room for either reading.

There is no public date for the vaccination committee’s technical assessment, and no published decision from the national medicines regulator. It is also unclear how long the US funding remains available if the start slips further.

Bandim’s update, last revised on Wednesday 14 October, did not respond to the minister’s denial directly. Whether the ministry and the researchers will set out a joint timeline is also unknown.

Frequently Asked Questions

Did Guinea-Bissau approve the hepatitis B vaccine trial?

The health ministry says it did not authorise tests on newborns as described in the press. The researchers say only ethical approval has been granted and government authorisation is still pending.

Who is paying for the study?

The US Centers for Disease Control and Prevention awarded the study a US$1.6 million grant. The Bandim Health Project, linked to the University of Southern Denmark, runs the study.

Why did the World Health Organization object?

It said leaving some newborns without a birth dose in a country with high hepatitis B prevalence was unethical. Its director-general warned this could expose babies to infection and serious liver disease.

What changed in the revised protocol?

Mothers are screened first, and babies of infected mothers get the birth dose immediately. The comparison group receives a saline placebo, and mothers are offered voluntary HIV testing.

Does this affect US travellers to Guinea-Bissau?

No, the dispute concerns a research study that has not started recruiting. Routine infant vaccination in Guinea-Bissau continues on the national schedule at six, ten and 14 weeks.

Sources: O Democrata (Bissau), 14 October 2026 · RTP África, 14 October 2026 · Bandim Health Project, 13 October 2026 · HealthNews, 11 October 2026 · CIDRAP, 22 January 2026 · RTP, World Health Organization statement

This article was produced by The Rio Times’ automated newsroom system. How we use AI · Report an error · Editorial responsibility: Matthias Camenzind, Editor-in-Chief