Plans for a controversial U.S.-funded hepatitis B vaccine study in Guinea-Bissau have hit a roadblock as national authorities have paused the project for further review. However, African officials have indicated that the trial could still potentially move forward pending additional assessments.
Quinhin Nantote, Guinea-Bissau’s public health minister, expressed that there has been a lack of coordination to reach a final decision regarding the study. Speaking at a press briefing held by the Africa Centres for Disease Control and Prevention, Nantote emphasized the need for thorough consideration before proceeding with the trial.
Jean Kaseya, the director general of Africa CDC, reiterated the importance of obtaining authorization for clinical studies from the hosting countries. While Africa CDC is providing technical support to facilitate the regulatory and ethical review process in Guinea-Bissau, Kaseya emphasized that the ultimate decision lies with the country itself.
Despite the ongoing discussions, the future of the trial remains uncertain. U.S. health officials have maintained their stance that the study is progressing as planned, although they did not provide immediate responses to inquiries on Thursday.
The U.S. Centers for Disease Control and Prevention recently granted a $1.6 million grant to researchers at the University of Southern Denmark to conduct the trial in Guinea-Bissau. The study involves administering the hepatitis B vaccine to newborns at birth, with some infants receiving the vaccine at 6 weeks old as per the country’s standard of care.
Criticism surrounding the study has been widespread, with experts questioning its relevance to U.S. vaccine policy and raising ethical concerns. Guinea-Bissau had been preparing to implement a universal birth dose policy recommended by the World Health Organization, making the trial design contentious.
Confusion surrounding the fate of the trial escalated when reports emerged suggesting its cancellation, although U.S. officials maintained that it was still progressing. The Africa CDC used a recent briefing to defend its work and emphasize its commitment to supporting health initiatives across the continent.
In response to criticisms, Kaseya highlighted the agency’s contributions to technical support and outbreak response in various African countries. He underscored Africa CDC’s vision as being driven by African leadership and realities, distancing it from Western influence.
Despite challenges, Kaseya revealed that senior U.S. health officials had engaged in discussions with Africa CDC leaders, clarifying any misunderstandings and reaffirming their trust in the agency. Moving forward, the fate of the controversial hepatitis B vaccine study in Guinea-Bissau remains uncertain as national authorities continue to review the project.
