Guinea-Bissau halts hepatitis B vaccine study on newborns pending ethics review, AP reports

Guinea-Bissau has suspended a hepatitis B vaccine study involving newborns while the project undergoes an ethical review, according to reporting by the Associated Press. Health Minister Quinhi Nantot said an ethics committee did not initially review the study, prompting the government to pause it pending further assessment of the protocols and safeguards. ([apnews.com](https://apnews.com/article/9d172d68afb36c62a85d1236f639ddcf?utm_source=openai))

The study is a randomized controlled trial that would vaccinate some newborns while withholding the vaccine from others—an approach that has triggered criticism because the hepatitis B shot is widely viewed as established protection. Critics argue that designing a trial in which some infants do not receive an effective vaccine raises profound ethical questions, particularly when the participants are newborns who cannot consent and whose risk window begins immediately after birth. ([apnews.com](https://apnews.com/article/9d172d68afb36c62a85d1236f639ddcf?utm_source=openai))

The AP reported that Africa CDC supported the decision to review the study’s ethics, emphasizing that research in African countries should prioritize the welfare of local communities and meet internationally recognized standards. That backing adds institutional weight to concerns that trials must be designed in a way that does not deny participants proven care unless there is a compelling, clearly justified reason and appropriate protections. ([apnews.com](https://apnews.com/article/9d172d68afb36c62a85d1236f639ddcf?utm_source=openai))

U.S. officials disputed the characterization of the pause, saying the study was proceeding while awaiting final protocol approvals. The project’s funding and contracting also drew attention: the AP said the work involved a $1.6 million no-bid contract awarded to Denmark’s University of Southern Denmark, and that the research plan included tracking about 14,000 infants, with a smaller group followed for years to monitor longer-term effects. ([apnews.com](https://apnews.com/article/9d172d68afb36c62a85d1236f639ddcf?utm_source=openai))

Ethicists often focus on a basic test in such situations: whether participants in the control arm are being denied the current standard of care. With vaccine-preventable diseases, the ethical bar is typically high because the potential harms of non-vaccination are well known and can be severe, while the benefits of established immunizations are widely documented. The controversy in Guinea-Bissau reflects that tension between research goals and immediate public-health obligations. ([apnews.com](https://apnews.com/article/9d172d68afb36c62a85d1236f639ddcf?utm_source=openai))

The outcome of the ethics review could influence not just this particular study but also how future vaccine research is structured across the region. Health officials and researchers will be watching whether the review results in protocol changes—such as ensuring all infants receive protection, adjusting comparison groups, or strengthening oversight—so that scientific questions can be pursued without compromising core ethical principles. ([apnews.com](https://apnews.com/article/9d172d68afb36c62a85d1236f639ddcf?utm_source=openai))