A U.S.-funded medical research trial in Guinea-Bissau has sparked heated debate over ethics, necessity, and scientific validity. Public health experts have criticized the study as unethical, drawing comparisons to the infamous Tuskegee Experiment, while the U.S. government and the researchers involved have promoted it as a rare opportunity to examine broader health effects of the hepatitis B vaccine at birth. The trial is partially funded with $1.6 million from the U.S. Centers for Disease Control and Prevention (CDC) and aims to study newborns in Guinea-Bissau, a country with a high prevalence of hepatitis B.
The randomized controlled trial would involve 14,500 newborns, with half receiving the hepatitis B vaccine at birth and the other half vaccinated later, as per routine immunization schedules. Researchers are not testing whether the vaccine prevents hepatitis B—its efficacy is well-established—but instead intend to study other potential health effects, including severe illnesses, eczema, and neurological differences in early childhood.
Ethical concerns quickly emerged after the study was announced. Critics argue that withholding the vaccine for six weeks from some newborns exposes them to unnecessary risk, especially given the high local rate of hepatitis B transmission from mother to child. Experts, including Dr. Paul Offit and Dr. Boghuma Titanji, warned that the study could erode trust in vaccines and public health interventions for generations. The researchers defend the trial, noting that newborns in Guinea-Bissau do not currently receive the vaccine at birth and asserting that the study will increase timely vaccination coverage.
The trial has also been clouded by political and procedural controversy. Guinea-Bissau’s Ministry of Public Health temporarily suspended the study, citing inadequate local ethics oversight, weak coordination, and communication gaps. Africa CDC is assisting the country in reviewing the trial, emphasizing that the decision ultimately rests with Guinea-Bissau authorities. Meanwhile, U.S. health officials have issued contradictory statements, claiming the study is proceeding as planned.
Additional criticism focuses on the researchers and selection process. The study is led by Danish scientists affiliated with the Bandim Health Project, whose past research has faced questions about statistical rigor and over-interpretation of results. Concerns have also been raised over the non-competitive process by which CDC funding was awarded, prompting accusations of cronyism and political influence, particularly from figures aligned with vaccine skepticism.
Despite these controversies, U.S. officials maintain that the study offers a unique scientific opportunity to examine the broader health effects of the hepatitis B vaccine at birth. They argue the findings could inform global vaccine policies, though many experts continue to question whether the research justifies the ethical and public trust risks involved.
