A planned U.S.-funded hepatitis B vaccine trial in Guinea-Bissau has drawn sharp criticism from global health experts, raising concerns over ethics, informed consent, and the safety of vulnerable infants.
The five-year study, supported by the U.S. Centers for Disease Control and Prevention (CDC) and sponsored by the U.S. National Institutes of Health (NIH), would randomly assign newborns to receive or not receive the hepatitis B vaccine at birth. This approach comes despite the World Health Organization’s (WHO) recommendation that all babies receive the vaccine immediately after birth.
Guinea-Bissau has one of the world’s highest hepatitis B rates, with roughly 18 percent of adults infected. Critics argue that withholding a proven vaccine in such a setting puts infants at serious risk. Some participants reportedly received limited information before consenting, raising concerns about whether participation was fully voluntary.
Dr. Samba Sow, a bioethicist and former health minister of Mali, warned, “There are serious ethical questions here. Many participants were not fully informed about the risks and the nature of the trial.” Activist Fatimata Seidi emphasized the need to protect vulnerable populations, stating that “our people should not be exploited as test subjects.”
The trial will be conducted by the Bandim Health Project, led by Danish researchers whose previous work questioning vaccine safety has drawn scrutiny. Experts note that the study’s focus on “overall health effects” rather than vaccine effectiveness is unclear, suggesting that the priority should be expanding access to the birth-dose vaccine rather than re-testing it.
U.S. officials defend the trial, stressing adherence to international ethical standards. Dr. Mark Thompson of the NIH said, “Our trial follows all international ethical standards. We are committed to safeguarding the participants’ health.”