A controversial US-funded study on hepatitis B vaccination in newborns in Guinea-Bissau has been cancelled following widespread criticism over its ethical design. The decision was confirmed by Yap Boum, a senior official at the Africa Centres for Disease Control and Prevention, who said the trial raised serious concerns about withholding a proven, life-saving vaccine from thousands of infants in a country with a high burden of hepatitis B.
The $1.6m study, funded under the oversight of Robert F Kennedy Jr at the US Department of Health and Human Services, proposed vaccinating only half of participating newborns, prompting outrage from scientists and ethicists. Africa CDC said it would only support any future research if it were redesigned to meet international ethical standards, with African oversight.
Confusion briefly surrounded the project’s status, with some officials suggesting revisions were under discussion. However, a senior Guinean official later confirmed the trial had been cancelled outright due to ethical concerns, and the country will maintain its existing vaccination schedule until a universal birth-dose rollout begins in 2027.
Public health experts welcomed the decision. Paul Offit of the Children’s Hospital of Philadelphia called the cancellation “extremely heartening,” comparing the proposed study to the Tuskegee experiment because it would knowingly deny effective treatment. Researchers and advocates said the outcome marked a significant stand against exploitative research practices in Africa and underscored the need for trials to be ethically sound, locally led and focused on improving access to proven interventions.
