Guinea-Bissau has suspended a US-funded hepatitis B vaccine study slated to begin among newborns in the West African nation, citing serious ethical and procedural concerns over the trial’s design and oversight. Health officials say the decision reflects the country’s sovereign authority over clinical research after questions were raised about whether proper ethical review and approvals were in place.
The study, backed by a US$1.6 million grant from the United States Department of Health and Human Services and awarded to a Danish research team, was designed as a randomised controlled trial in which some infants would receive the hepatitis B vaccine at birth while others would follow the country’s standard vaccination schedule, which currently begins at six weeks. Critics argue that withholding a well-established preventive intervention from some participants, even temporarily, raises major ethical concerns, especially in a setting where hepatitis B infection rates are relatively high and early immunisation is recommended by the World Health Organization.
Guinea-Bissau’s health minister, Quinhin Nantote, told a press briefing that the national medical ethics committee did not have sufficient technical resources when the trial was initially approved and that key bodies had not fully reviewed the proposal. The trial has therefore been paused pending further ethical and technical review, with Africa CDC officials dispatched to assist local authorities with the evaluation. Nantote emphasised that the review process is central to ensuring that research protocols respect national standards and protect participants.
The Africa Centres for Disease Control and Prevention (Africa CDC) has supported Guinea-Bissau’s move, underscoring that clinical studies in African countries must be overseen according to national ethical frameworks and that external partners cannot override local authority in research decisions. However, US health officials have maintained that the study is still intended to go ahead once final protocols are complete, reflecting differing interpretations of the trial’s status.
The controversy has drawn attention from public health experts and rights advocates, who contend that randomising vaccine timing in an environment with limited access to timely immunisation and high disease prevalence poses ethical dilemmas. They stress that transparent, locally led ethical review is essential to maintaining trust in health research and protecting vulnerable populations during clinical investigations.
