A US-funded vaccine study planned in Guinea-Bissau will be subjected to a fresh ethical review before proceeding, African health officials said, following concerns raised over the trial’s design. The study, backed in part by the US Centers for Disease Control and Prevention (CDC), focuses on the timing of a hepatitis B vaccine for newborns and has attracted scrutiny from global health experts, as reported by Reuters.
Guinea-Bissau’s health ministry said the project has not been cancelled but will undergo additional assessment after procedural issues emerged with the local ethics approval process. Africa Centres for Disease Control and Prevention Director-General Jean Kaseya said African health authorities are providing technical support while emphasising that final approval rests with Guinea-Bissau’s regulators, reinforcing national oversight of medical research, according to comments cited by Reuters.
The proposed study compares health outcomes of infants who receive the hepatitis B vaccine at birth with those vaccinated later, reflecting current practice in Guinea-Bissau, where the first dose is typically administered at six weeks. Critics argue that delaying a vaccine widely regarded as safe and effective raises ethical concerns, particularly in regions with high hepatitis B prevalence, while supporters say the trial aligns with existing national immunisation schedules.
Officials said the ethical review is intended to ensure the study meets international research standards and addresses public concerns before any implementation. The case has renewed debate around consent, trial design and safeguards in global health research conducted in low-income countries, as highlighted in broader commentary referenced by GhanaMMA.
