Guinea-Bissau’s Minister of Health Quinhin Nantote stated on Tuesday that the African nation has not approved a proposed hepatitis B study involving newborns, contradicting claims made to a Danish ethics committee. The research would not evaluate vaccine safety or effectiveness but would instead monitor general health outcomes including overall mortality and neurodevelopmental conditions. The study has been backed by Robert F Kennedy Jr, who serves as secretary of the US Department of Health and Human Services and has a longstanding history of anti-vaccine activism.
Danish ethics committee members were informed that Guinea-Bissau officials had authorized an updated version of the study design, a claim that influenced some committee members’ votes to proceed last week. However, Nantote stated the health ministry never authorized the research and expressed surprise at media reports suggesting approval had been granted. He emphasized that any scientific research involving human subjects, particularly children, must comply with national legislation and international ethical standards. An emergency meeting was convened with local health organizations including the Bandim Health Project, which is led by Danish researchers Peter Aaby and Christine Stabell Benn.
The proposed research has faced significant criticism from the scientific community. Researcher Charlotte Strøm published findings indicating that claims in nearly all papers from Aaby and Stabell Benn are “highly misleading,” with 24 out of 25 studies showing no significant findings. Critics have characterized the trial as “horribly unethical,” “neocolonialist,” and potentially exploitative of a vulnerable population. Researchers noted that conducting such a study in resource-constrained Guinea-Bissau, rather than in Denmark where hepatitis B vaccination infrastructure and healthcare systems are robust, raises additional ethical concerns.
The trial would involve 14,000 newborns, with half vaccinated at birth and half denied immunization for six weeks, despite hepatitis B being widespread in Guinea-Bissau and capable of causing serious lifelong effects in children. The CDC has reportedly set aside $1.6 million in funding, with additional private support from the Pershing Square Foundation and the Bluebell Foundation. The HHS stated the study has not been approved, and it remains unclear whether the US intends to proceed. At least four members of the Danish ethics committee resigned after the trial was fast-tracked.
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