Guinea-Bissau Denies Approval of Controversial Hepatitis B Study Involving Newborns

Guinea-Bissau has not approved the controversial hepatitis B study in newborns that would be funded by the US government and private partners, the country’s health minister said.

The study, which would not test vaccine safety or efficacy but would monitor broader health outcomes such as overall mortality and neurodevelopment, has been promoted by Robert F. Kennedy Jr., U.S. Secretary of Health and Human Services, and a long‑time anti‑vaccine advocate.

Members of a Danish research ethics committee were told that local officials had approved an updated trial design, influencing some committee members to fast‑track the trial last week.

However, the health ministry never agreed to or authorized the trial, said Minister Quinhin Nantote at a press briefing, referring to the study as “tests”.

“The ministry did not authorize the tests under the terms presented in the publications currently in circulation,” he added. Officials were surprised by media reports suggesting the country had granted approval.

He emphasized that any scientific research involving humans, especially children, must strictly comply with national legislation, international ethical principles, and proper evaluation and approval mechanisms.

After convening an emergency meeting with the Bandim Health Project, the local ethics committee, the National Institute of Public Health (Inasa) and the Expanded Vaccination Program (PAV), he addressed the issue.

The Bandim Health Project is led by Danish researchers Peter Aaby and Christine Stabell Benn, whose work has faced scrutiny in the past year. Kennedy has praised their research, claiming it reveals widespread vaccine injuries.

Aaby, Stabell Benn and Frederik Schaltz‑Buchholzer did not respond to the Guardian’s inquiries about why Danish ethics members were told the trial was approved locally and why it could not be conducted in Denmark.

Denmark does not give the hepatitis B birth dose to infants of negative parents, has low virus incidence, and a robust health system that can track outcomes, making it a potential site for such a study.

Critics have condemned the African experiment as “horribly unethical and cruel”, “neo‑colonialist” and “damaging”.” One researcher noted that Guinea‑Bissau’s resistance to exploitation of its children is a powerful statement of sovereignty.

It would cost about $13,200 to purchase enough vaccines through Unicef and Gavi to immunize all newborns in Guinea‑Bissau each year, she said, urging that “every baby should receive the birth dose of hepatitis B vaccine – a 20‑cent shot that saves lives”.

It is unclear whether the U.S. will proceed, despite the CDC earmarking $1.6 million for the trial this year, to be matched by private funding from the Pershing Square Foundation and the Bluebell Foundation. The HHS told Reuters the study has not been approved and has not responded to further Guardian questions.

At least four Danish committee members resigned after the trial’s approval was fast‑tracked; the committee’s rules had to be changed because randomized controlled trials were outside its remit. When they asked for details on the Guinea‑Bissau approval, no further information was provided.

The proposed trial would enroll 14,000 newborns in Guinea‑Bissau, with half receiving the vaccine at birth and half remaining unvaccinated for the first six weeks. Hepatitis B is prevalent there and can cause severe lifelong health problems.

Guinea‑Bissau, which has a transitional military government after a November coup, requested assistance from the Africa Centres for Disease Control and Prevention in January to evaluate the study. The minister indicated at the time that the trial was “cancelled or suspended”.

Other officials, including Foreign Minister João Bernardo Vieira, have firmly opposed the research, stating it “is not going to happen, period”.

The World Health Organization has offered support to roll out the hepatitis B birth dose to all newborns in Guinea‑Bissau, saying it stands ready to assist as the country moves forward and accelerates vaccine implementation.

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