A controversial US-funded study on hepatitis B vaccines for newborns in Guinea-Bissau has been cancelled following widespread ethical concerns, according to the Africa Centres for Disease Control and Prevention. The $1.6m trial, overseen by the US Department of Health and Human Services under Secretary Robert F Kennedy Jr, drew criticism for potentially withholding a proven vaccine from thousands of infants in a country with high hepatitis B prevalence.
Africa CDC official Yap Boum said the study’s design raised serious ethical challenges and could only proceed if fully redesigned. Although some US officials suggested the trial might continue in a revised form, a senior Guinea-Bissau official confirmed in a letter that it had been cancelled, with the country maintaining its current vaccination schedule until universal birth-dose coverage begins in 2027.
Public health experts welcomed the decision. Paul Offit of the Children’s Hospital of Philadelphia called the cancellation “extremely heartening”, while Boghuma Titanji said it marked a win for research ethics in Africa. Critics argued the trial risked repeating past abuses by denying life-saving vaccines, comparing it to the Tuskegee syphilis experiment.
Guinea-Bissau has one of the highest hepatitis B burdens globally, with about 18% of adults affected. Health advocates stressed that limited vaccine supply should be addressed through expanded access, not trials that leave children unprotected.
