Guinea-Bissau has announced the suspension of a U.S.-backed hepatitis B vaccine study involving newborns, pending a full ethical review, raising fresh concerns about research standards and child protection in global health trials.

The country’s Health Minister, Quinhi Nantot, disclosed the decision on Thursday during a press conference organised by the Africa Centres for Disease Control and Prevention (Africa CDC). According to Nantot, the suspension follows revelations that the national ethics committee responsible for reviewing the study did not convene during the initial approval process.

The six-member committee, which is required to assess the ethical implications of medical research, failed to meet before the study was cleared, prompting authorities to pause the project until proper oversight is completed.

The study, backed by the administration of former U.S. President Donald Trump, is structured as a randomised controlled trial. Under its design, some newborns receive the hepatitis B vaccine at birth, while others do not. Researchers intend to monitor the children over time, tracking outcomes such as mortality, illness, and long-term development.

The trial has drawn criticism from several public health experts, who argue that the research design is ethically problematic. Critics say withholding a proven and effective vaccine from newborns in a region where hepatitis B infection is a significant risk exposes infants to avoidable harm.

Africa CDC Director-General Jean Kaseya voiced strong support for the ethical review, stressing that the health and welfare of African populations must come first. While acknowledging the organisation’s “excellent relationship” with the United States government, Kaseya emphasised that Africa CDC’s priorities are firmly rooted in public interest.

“We are led by the interests of our people in Africa,” Kaseya said. “We are not led by the small interests of individual people.”

Despite Guinea-Bissau’s move to suspend the trial, U.S. health officials said on Wednesday that the study remains scheduled to proceed, suggesting potential tensions between local health authorities and international partners.

The situation has renewed debate around medical research in low-income countries, particularly concerns over informed consent, ethical oversight, and the balance between scientific inquiry and the protection of vulnerable populations.