Public health authorities in Guinea-Bissau suspended a U.S.-funded hepatitis B vaccine study amid questions regarding the authority over clinical research conducted in Africa. Officials from Guinea-Bissau's Ministry of Health announced the suspension at a press conference, stating the study would undergo a technical and ethical review by the country's national public health institute.
The announcement followed weeks of uncertainty surrounding the trial's continuation. "There has been no sufficient coordination in order to take a final decision regarding the study," said Quinhin Nantote, the minister of public health for Guinea-Bissau. "Faced with this situation, we decided to suspend it."
The decision was made after a meeting convened by the Africa Centres for Disease Control and Prevention (Africa CDC). An official with the Africa CDC had previously indicated the trial would not proceed.
The study aimed to evaluate the efficacy of a novel hepatitis B vaccine administered at birth. Hepatitis B is a viral infection that attacks the liver and can cause both acute and chronic disease. According to the World Health Organization, the hepatitis B virus is most commonly spread from mother to child during birth and delivery, as well as through contact with blood or other body fluids. The current standard of care involves a birth dose of the hepatitis B vaccine within 24 hours of birth, followed by subsequent doses. The suspended trial sought to explore alternative vaccination schedules and potentially improve vaccine coverage.
The suspension raises broader questions about the oversight and ethical considerations surrounding clinical trials conducted in Africa, particularly those funded by foreign entities. Some African scientists have voiced concerns about the extent to which local researchers and communities are involved in the design and implementation of such studies. These concerns include ensuring that research aligns with local health priorities and that data generated benefits the African population.
Guinea-Bissau is scheduled to implement a universal birth-dose policy for the Hepatitis B vaccine in 2027. The review by the national public health institute will assess the study's scientific merit, ethical implications, and alignment with Guinea-Bissau's national health priorities. The outcome of the review will determine whether the trial will be allowed to resume or be terminated permanently.
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