Guinea-Bissau Rejects Approval Claims for Controversial US-Funded Infant Vaccine Trial

Guinea-Bissau has denied granting authorization for a controversial, US-funded hepatitis B trial in newborns, according to the African nation's health minister. The announcement follows reports that members of a Danish research ethics committee were told local officials had approved an updated design for the study, a claim that influenced some members to vote in favor of advancing the trial.

Health Minister Quinhin Nantote stated during a press briefing that the government never agreed to or authorized the testing under the terms currently circulating in public reports. Nantote expressed surprise at media coverage indicating the country had approved the project, emphasizing that any scientific research involving human subjects, particularly children, must adhere strictly to national laws, international ethical standards, and proper evaluation mechanisms.

Scope and Funding of the Proposed Study

The proposed trial aims to enroll 14,000 newborns in Guinea-Bissau, where hepatitis B is widespread and early infection can cause severe long-term complications. Under the trial design, half of the infants would receive the hepatitis B vaccine at birth, while the other half would be denied the immunization for their first six weeks of life. Rather than testing the vaccine's safety or efficacy, the study intends to monitor nonspecific health outcomes, such as neurodevelopmental conditions and overall mortality.

The study has been advocated by Robert F. Kennedy Jr., secretary of the US Department of Health and Human Services (HHS). Although reports indicate the US Centers for Disease Control and Prevention (CDC) allocated $1.6 million for the trial this year—to be matched by private funds from the Pershing Square Foundation and the Bluebell Foundation—HHS stated to Reuters that the study has not been approved.

Ethics Concerns and Resignations

The project is led by Danish researchers Peter Aaby and Christine Stabell Benn of the Bandim Health Project, alongside Frederik Schaltz-Buchholzer. Their methodology has faced severe scrutiny from external experts, including Danish researcher Charlotte Strøm, who noted that Aaby and Stabell Benn had no significant findings in 24 out of 25 studies and called their work highly misleading and unethical.

Following the fast-tracked approval of the trial in Denmark, at least four members of the Danish ethics committee resigned. Committee rules were altered to encompass randomized controlled trials, and members were reportedly given no further details when requesting proof of local authorization from Guinea-Bissau.

Medical experts and researchers have criticized the trial as unethical, noting that a safe and effective hepatitis B vaccine has existed for decades. According to Stand Up for Science CEO Colette Delawalla, purchasing enough vaccines through Unicef and Gavi to immunize every newborn in Guinea-Bissau annually would cost approximately $13,200. Following an emergency meeting with local health agencies and ethics bodies, Guinea-Bissau requested a team of experts from the Africa Centres for Disease Control and Prevention to help evaluate the study proposal.