Health Ministry Press Briefing and Official Rejection
Guinea-Bissau’s Ministry of Health has formally denied approving a controversial, US-funded clinical trial that planned to track health outcomes in newborns by withholding or delaying the standard birth dose of the hepatitis B vaccine, as reported by The Guardian. Speaking at a press briefing in Portuguese on Tuesday, Health Minister Quinhin Nantote stated that the ministry never agreed to or authorized the study, describing the proposed undertaking as unauthorized tests. “The ministry did not authorize the tests under the terms presented in the publications currently in circulation,” Nantote said, adding that officials were surprised by media reports suggesting local authorization had been granted. He stressed that any scientific research involving human subjects, particularly children, must strictly comply with national legislation, international ethical standards, and competent regulatory oversight.
The ministerial denial follows statements by members of a Danish research ethics committee who were previously informed that local officials had authorized an updated protocol for the study. That information influenced some committee members to approve the trial last week, though at least four members subsequently resigned after the proposal was fast-tracked and rules regarding randomized controlled trials were altered. The study is championed by US Health Secretary Robert F. Kennedy Jr. and led by Danish researchers Peter Aaby and Christine Stabell Benn through the Bandim Health Project.
Study Design and Public Health Concerns
The proposed clinical trial would enroll 14,000 newborns in Guinea-Bissau, dividing them into two groups: half would receive the standard birth dose of the hepatitis B vaccine, while the other half would be denied the immunization for the first six weeks of life. Proponents argue the design aligns with local care standards since the birth dose is not yet routinely administered in the country, though national health authorities plan to officially recommend it by 2028. However, infectious disease and clinical trial experts have strongly condemned the protocol, noting that hepatitis B is widespread in Guinea-Bissau, where roughly one in five adults carry the virus. Critics argue that withholding the vaccine from newborns in a resource-constrained setting exposes vulnerable infants to serious lifelong infection risks.
“It’s completely unethical that this trial is even proposed,” said BK Titanji, a researcher at Emory University, emphasizing that safe and effective vaccines have been available for decades. Titanji praised Guinea-Bissau’s pushback, noting that collaborative research applications typically require extensive documentation and institutional review board approval. Critics and non-profit leaders, including Colette Delawalla of Stand Up for Science, have pointed out that immunizing every newborn in Guinea-Bissau annually would cost approximately $13,200 using UNICEF and Gavi pricing, contrasting the low cost of prevention with the high stakes of the trial.
US Funding Allocation and International Scrutiny
Despite the local opposition and previous suspensions, internal agency actions indicate the US government continues to move forward with financial backing. According to reports by Rolling Stone, a staff member within the director’s office at the US Centers for Disease Control and Prevention (CDC) instructed the agency’s budget office in late September to set aside $1.6 million to help fund the trial. The allocation is being drawn from congressional funds originally directed for global health security programs, a decision that has drawn internal criticism from agency employees who point to competing global health crises, such as an Ebola outbreak in the Democratic Republic of Congo.
The CDC funding is slated to be matched by private contributions from the Pershing Square Foundation and the Bluebell Foundation. Meanwhile, the lead researchers face separate accusations of scientific misconduct currently under review by the Danish Committee on Research Misconduct, though those inquiries are unrelated to the hepatitis B trial. Guinea-Bissau, which is currently governed by a transitional military government following a November coup, requested assistance from the Africa Centres for Disease Control and Prevention (Africa CDC) in January to evaluate the study. The World Health Organization (WHO) has also offered support to accelerate the rollout of the routine hepatitis B birth dose nationwide, leaving the future status of the US-backed trial uncertain.