A controversial US-funded hepatitis B vaccine study involving newborns in Guinea-Bissau has been cancelled, according to Africa health officials. Yap Boum of the Africa Centres for Disease Control and Prevention confirmed the decision, citing serious ethical concerns over the trial’s design.
The $1.6m study, funded under the authority of Robert F Kennedy Jr at the US Department of Health and Human Services, drew criticism for potentially withholding a proven hepatitis B vaccine from thousands of newborns. Critics argued the design would deny half the infants access to a life-saving vaccine by random allocation.
Although some officials in Guinea-Bissau initially suggested the trial could proceed after redesign, senior authorities later confirmed its cancellation due to ethical risks. Guinea-Bissau will maintain its current vaccination schedule until universal birth-dose coverage begins in 2027.
Medical ethicists welcomed the decision, calling it a victory for research ethics and African oversight. Paul Offit of the Children’s Hospital of Philadelphia compared the trial to historic unethical experiments and urged vaccine funds be used directly to protect children. Experts said the case highlights growing resistance in Africa to studies seen as exploitative or misaligned with local health priorities.
