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 that the study would undergo a technical and ethical review by the country's national public health institute.
The announcement followed weeks of conflicting statements regarding 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 meeting where the decision was formalized was convened by the Africa Centres for Disease Control and Prevention (Africa CDC). Last week, an official with the organization signaled that the trial would not proceed.
The study in question involved a birth-dose policy for the Hepatitis B vaccine. The proposed policy aimed to administer the first dose of the vaccine to newborns shortly after birth, a strategy designed to prevent mother-to-child transmission of the virus and provide early protection. Guinea-Bissau is slated to implement a universal birth-dose policy for the Hepatitis B vaccine in 2027.
The suspension highlights a growing concern among African scientists and public health officials about the ethical oversight and control of clinical trials conducted on the continent. Questions have been raised about the extent to which African researchers and institutions are involved in the design, implementation, and analysis of studies funded by foreign entities. The lack of coordination cited by Minister Nantote underscores the need for greater collaboration and communication between international funders and local health authorities.
The review by Guinea-Bissau's national public health institute will likely examine the study's protocol, informed consent procedures, and potential benefits and risks to the local population. It will also address the broader issue of research governance and the role of African institutions in shaping the research agenda. The outcome of this review could have significant implications for future clinical trials in Guinea-Bissau and other African countries, potentially leading to stricter regulations and greater local control over research activities.
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