The United States has announced funding of a $1.6 million, five-year study to evaluate the effects of administering the hepatitis B vaccine at birth in Guinea-Bissau, a West African country where recent surveys show a high prevalence of hepatitis B markers among adults. The decision has provoked sharp criticism from global health experts, ethicists and clinicians who call the trial unethical, risky and potentially harmful to public trust in vaccines.
What the Trial Proposes
According to the CDC award announcement, the Bandim Health Project—led by Peter Aaby and Christine Stabell Benn and affiliated with the University of Southern Denmark—will run a randomized, single-blinded trial in which newborns are assigned either to receive or to forgo a hepatitis B vaccine at birth. Investigators plan to compare early-life mortality, illness and developmental outcomes between the groups over several years. The study is scheduled to begin in early 2026.
Why Experts Are Alarmed
Critics raise several ethical and scientific objections:
- Withholding a Proven Intervention: The World Health Organization recommends a universal birth dose of hepatitis B vaccine to prevent vertical and early-life transmission. Many experts say it is unethical to withhold a vaccine with well-documented benefits and safety records.
- High-Prevalence Setting: Guinea-Bissau has reported roughly 18% prevalence of hepatitis B markers in some adult samples and high infection rates among young children in prior studies. In such settings, the birth dose is especially important to prevent chronic infection and later liver disease.
- Study Design Concerns: The trial is single-blinded (researchers, not participants, are aware of assignment) and will examine broad "overall health effects" rather than specific, pre-specified clinical endpoints like infection rates—features that critics say invite bias and ambiguous interpretation.
- Investigator Controversies: The Bandim team’s prior research has been criticized for inconsistent findings and methodological questions. Some experts worry donor-driven selection of investigators may create conflicts of interest.
- Informed Consent and Equity: Observers question whether truly informed consent can be obtained in the proposed context and whether conducting the trial in a low-resource, high-prevalence population—rather than a low-prevalence setting—risks a neocolonial dynamic or fuels mistrust.
Context: US Policy Shifts and Global Impact
Controversy surrounding the trial intensifies against the backdrop of policy changes by the US Centers for Disease Control and Prevention, which recently described newborn hepatitis B vaccination as an "individual" decision, and broader shifts in US global health funding under Health Secretary Robert F. Kennedy Jr. Critics say those changes, combined with new research funding, could undermine longstanding efforts to increase vaccine coverage worldwide.
Expert Voices
"It’s highly unethical to choose to give a vaccine to some children but not others," said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
"Conducting this trial in a population where nearly one in five adults show markers of infection seems extremely risky," added Martin McKee of the London School of Hygiene and Tropical Medicine.
Alternatives and Recommendations
Many public-health authorities argue the priority should be operational: increasing access to and coverage of the WHO-recommended birth dose across sub-Saharan Africa, where coverage remains low. They also suggest that if additional data are needed on safety or non-specific effects, such research should use rigorous, double-blinded designs, pre-specified endpoints, and settings where the ethical balance is clearer.
The debate remains active: proponents of the study argue it could clarify potential broader health effects, while opponents emphasize the established benefits of the birth dose and the ethical problems of withholding it in a high-risk population.
