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 mixed signals 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 suspension was announced 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 core issue revolves around the perceived lack of coordination and transparency in the study's planning and execution. Some African scientists have voiced concerns about the ethical implications of research funded and led by foreign entities, particularly regarding the level of local involvement in decision-making processes. The specific details of the U.S.-funded hepatitis B vaccine study, including the vaccine product details and the study's protocol, have not been fully disclosed in public statements, contributing to the controversy.
Hepatitis B is a viral infection that attacks the liver and can cause both acute and chronic disease. The World Health Organization (WHO) estimates that in 2019, 296 million people were living with chronic hepatitis B infection, with 1.5 million new infections occurring each year. A key preventative measure is vaccination, typically administered shortly after birth. Guinea-Bissau plans to implement a universal birth-dose policy for the Hepatitis B vaccine in 2027.
The suspension of the trial raises broader questions about the conduct of clinical research in Africa and the need for greater collaboration and equity in global health initiatives. The Africa CDC is working to strengthen the capacity of African countries to conduct and oversee clinical trials, ensuring that research is aligned with local priorities and ethical standards.
The technical and ethical review by Guinea-Bissau's national public health institute will determine the future of the study. The review is expected to assess the study's scientific merit, ethical considerations, and alignment with national health priorities. The outcome of the review will likely influence future collaborations between Guinea-Bissau and international research partners.
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Guinea-Bissau has suspended a US-funded hepatitis B vaccine trial following concerns from African scientists regarding its ethical oversight and coordination. The suspension allows for a technical and ethical review by Guinea-Bissau's public health institute, highlighting the increasing scrutiny of international research collaborations in Africa and potentially impacting future vaccine development initiatives. The trial's future remains uncertain despite conflicting statements from involved parties.
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