A controversial US-funded study on hepatitis B vaccines for newborns in Guinea-Bissau has been cancelled after 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.
The $1.6m study, overseen by the US Department of Health and Human Services under secretary Robert F Kennedy Jr, planned to randomise newborns so that only half would receive the hepatitis B birth dose in a country with one of the world’s highest infection rates. Critics argued the design knowingly deprived children of essential protection. Boum said Africa CDC supported research in Africa but only when it meets accepted ethical standards.
While some US officials indicated the trial could be redesigned, a senior official in Guinea-Bissau confirmed it had been halted and that the country would continue its existing vaccination schedule until universal birth-dose coverage is introduced in 2027. The cancellation was welcomed by public health experts, including Paul Offit, who called it a victory for ethics and advocacy.
The episode has reignited debate about research practices in low-income countries, with African and international scientists stressing that trials must not exploit vaccine scarcity and should be led by local priorities and expertise.
