AUS-funded study examining the effects of hepatitis B vaccines on newborns in Guinea Bissau has been brought under renewed ethical review, contradicting earlier reports of its cancellation. The clarification comes from a senior official at the Africa Centres for Disease Control and Prevention, amid a backdrop of global concern and contested narratives around vaccine research ethics in low-income settings.
The study, backed by a 1.6 million US dollar grant from the United States Centers for Disease Control and Prevention, is led by researchers from the Bandim Health Project, affiliated with the University of Southern Denmark. While some reports indicated that the Africa CDC had previously declared the study cancelled, officials now confirm that the trial remains under discussion following a request by authorities in Guinea Bissau for additional ethical and technical evaluation. An announcement detailing the next steps is expected to be made public shortly.
The US Department of Health and Human Services maintains that the study is proceeding as originally planned, with officials insisting that all protocols are being finalised in line with global ethical standards. However, this assurance has not quietened criticism from leading global health experts, some of whom argue that the study fails to meet the ethical threshold for research involving vulnerable populations.
At the heart of the criticism is the design of the trial, which includes newborns who will not receive a birth dose of the hepatitis B vaccine despite the World Health Organization’s recommendation that all infants be given the vaccine within 24 hours of birth. The vaccine has long been recognised for its efficacy in preventing mother-to-child transmission of the virus, which is known to lead to chronic infection, liver failure and cancer in a significant proportion of cases.
In Guinea Bissau, the first hepatitis B dose is currently administered at six weeks of age due to logistical and structural constraints in the healthcare system. Researchers argue that the children enrolled in the trial would not otherwise have received the birth dose, and therefore are not being denied access to any services that are standard in the country at present. All infants in the study are expected to receive the six-week dose in accordance with national policy, and mothers known to be hepatitis B positive will be offered immediate immunisation for their infants.
Dr Christine Stabell Benn, Chair of the Bandim Health Project, has emphasised that no participating child is receiving fewer vaccines than they would have received outside the study. Lead investigator Frederik Schaltz-Buchholzer added that while provisions are being made for children of mothers with confirmed hepatitis B, the broader issue remains the lack of widespread screening in Guinea Bissau, which prevents effective implementation of targeted early immunisation.
Guinea Bissau’s hepatitis B prevalence is among the highest in the world, with the Africa CDC estimating that nearly one in five individuals carry the virus. In such a context, the stakes of early prevention are especially high. Data from Johns Hopkins University indicate that around 90 percent of infants exposed to hepatitis B in their first year of life go on to develop chronic infections, with up to a quarter of them dying prematurely from related complications.
Critics of the study, including prominent vaccine expert Dr Paul Offit, argue that even in resource-limited settings, trials that include an arm without the birth dose place newborns at unnecessary risk. Dr Offit, speaking to Reuters, expressed scepticism over the possibility of redesigning the study in a way that would address these ethical concerns, and welcomed the current pause for further ethical evaluation.
Further controversy surrounds the broader context of the trial, particularly its associations with Robert F Kennedy Jr, the current US Secretary of Health and a prominent vaccine sceptic. Kennedy has previously cited Bandim Health Project’s research in his advocacy for cuts to funding for Gavi, the Vaccine Alliance, a global organisation that supports vaccination in low-income countries. His appointment by President Donald Trump has reignited tensions between political ideology and scientific consensus in global health policy.
In December, the US health department reversed its long-standing universal recommendation for hepatitis B vaccination of newborns, shifting the decision-making to individual families and healthcare providers. Leading medical institutions in the United States have condemned the move, warning that it increases risk to children and undermines decades of public health progress.
While the researchers behind the Guinea Bissau trial defend their study as an attempt to build a nuanced understanding of vaccine impacts in real-world conditions, others caution that research in African settings must be grounded in ethical frameworks that prioritise the rights and wellbeing of participants, particularly when interventions involve infants.
In some European countries such as Denmark and the United Kingdom, a birth dose of hepatitis B is only administered when the mother is known to be infected. However, the significantly lower prevalence of the virus and better healthcare infrastructure in those contexts make such policies less risky than in countries like Guinea Bissau, where maternal status is often unknown and access to care is fragmented.
The unfolding situation in Guinea Bissau highlights the broader challenge of conducting ethically sound and contextually sensitive research in African countries where public health needs are immense but infrastructure is limited. It also underscores the importance of African institutions, such as the Africa CDC, playing a central role in guiding and overseeing such research, ensuring it serves local populations and is aligned with pan African public health priorities.
The case calls for a reframing of global health research narratives, moving away from linear interpretations of African vulnerability or Western benevolence, towards approaches that are collaborative, transparent and rooted in equitable partnerships. The ethical review underway is not simply a procedural step but an opportunity to centre African voices in determining how research is conducted on the continent and to challenge legacies of external control in health policy design.The
