Guinea-Bissau Reviews U.S.-Funded Hepatitis B Vaccine Study Plans

Plans for a controversial U.S.-funded hepatitis B vaccine study in Guinea-Bissau are currently on hold as national authorities conduct a further review. This announcement comes from Quinhin Nantote, Guinea-Bissau’s public health minister, who expressed concerns over the lack of sufficient coordination necessary for a final decision. The review process could still result in the trial moving forward, according to statements made during a press briefing held by the Africa Centres for Disease Control and Prevention (Africa CDC) on Thursday.

During the briefing, Africa CDC’s director general, Jean Kaseya, emphasized that any authorization for clinical studies must come from the countries hosting them. “Africa CDC is respecting and supporting the sovereignty of the country,” Kaseya stated. He reiterated that it is the responsibility of Guinea-Bissau, not any international body, to determine whether the clinical trial will proceed. To assist in this process, the Africa CDC is dispatching officials to provide technical support for the necessary regulatory and ethical review.

Despite this pause, the future of the trial remains uncertain. U.S. health officials indicated that they plan to proceed as originally intended. The U.S. Centers for Disease Control and Prevention (CDC) awarded a grant of $1.6 million to researchers at the University of Southern Denmark to conduct this trial. The study proposes that a portion of newborns in Guinea-Bissau would receive a dose of the hepatitis B vaccine at birth, while others would adhere to the country’s current practice of vaccination at six weeks.

Critics have raised ethical concerns regarding the trial, particularly given Guinea-Bissau’s plans to implement a universal birth dose policy next year, as recommended by the World Health Organization. During the briefing, Nantote indicated that, following a coup in November 2023, the country is now unlikely to provide the vaccine to all newborns until 2028.

The design of the trial has also attracted scrutiny, with experts questioning its potential to generate results relevant to vaccine policy in the U.S. This skepticism escalated recently when conflicting reports emerged regarding the status of the trial. A report from The Guardian suggested the trial had been canceled, but U.S. officials countered that it would continue as planned.

In a defense of its operations, Kaseya addressed criticisms directed at the Africa CDC, including an email from an unnamed U.S. health official who described the agency as “a powerless, fake organization.” Kaseya defended the agency’s track record across the continent, highlighting its role in providing technical support and responding to health emergencies. “Our vision is not coming from Western countries. Our vision is coming from Africa, shaped by African leadership, based on African realities,” he asserted.

Kaseya also noted that senior U.S. health officials communicated with Africa CDC leaders on Wednesday, reassuring them that they were unaware of any negative statements concerning the organization. “I trust them, I’ve closed the chapter,” Kaseya concluded.

As this situation unfolds, the implications for both Guinea-Bissau’s health policy and international vaccine research ethics remain significant. The outcome of this review could influence future collaborations in health initiatives across Africa and beyond.