Plans for a controversial U.S.-funded hepatitis B vaccine study in Guinea-Bissau have been paused for further evaluation by national authorities. The future of the trial remains uncertain, although some African officials indicated that it may still proceed. During a press briefing, Quinhin Nantote, Guinea-Bissau’s public health minister, stated, “There has been no sufficient coordination in order to make a final decision regarding that study.” The briefing was conducted by the Africa Centres for Disease Control and Prevention (Africa CDC), which is involved in the regulatory processes for such clinical studies.
Jean Kaseya, the director general of Africa CDC, emphasized the importance of the sovereignty of each nation in deciding whether to authorize clinical trials. He noted that any approval for such studies must come from the host country itself. Kaseya mentioned that officials from Africa CDC would provide technical support in Guinea-Bissau to facilitate the necessary regulatory and ethical review. “Africa CDC is respecting and supporting the sovereignty of the country,” Kaseya said. “It’s not Africa CDC that will say, this clinical trial will take place or not.”
Despite these assurances, the trial’s future appears unclear. U.S. health officials have stated that they view the study as proceeding as planned. 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 last month. The study aims to evaluate the effects of administering the hepatitis B vaccine at birth versus the standard care regimen, which occurs at six weeks of age for some newborns in Guinea-Bissau.
The study has faced criticism from various experts who argue that its design may not yield results that are relevant to vaccine policy in the United States. Concerns were raised particularly as the previous U.S. administration had recently overturned a recommendation for all infants to receive the hepatitis B vaccine at birth. Additionally, stakeholders in Guinea-Bissau had planned to implement a universal birth dose policy in line with recommendations from the World Health Organization (WHO) in the coming year.
During the press briefing, Nantote noted that following a coup in November 2023, the country is now unlikely to provide the hepatitis B vaccine to all newborns until 2028. The design of the trial, which aims to compare “overall health outcomes” between the two groups of infants, has also come under scrutiny.
Confusion surrounding the trial intensified this month. Reports suggested that it had been canceled, citing the Africa CDC briefing. However, U.S. officials maintained that the study would continue as planned. The briefing served as an opportunity for Africa CDC to defend its mission and work across the continent. Kaseya addressed criticisms, referencing an email from an unnamed U.S. health official that labeled Africa CDC as “a powerless, fake organization.” He asserted the agency’s commitment to supporting health initiatives in Africa and highlighted its collaborations with global health organizations.
“Our vision is not coming from Western countries,” Kaseya stated. “Our vision is coming from Africa, shaped by African leadership, based on African realities.” He also mentioned that senior U.S. health officials had engaged with Africa CDC leaders recently, expressing unawareness of any critiques directed at the agency. “I trust them, I’ve closed the chapter,” Kaseya concluded.
As the situation develops, Guinea-Bissau’s public health authorities will need to undertake a thorough review of the proposed vaccine study to address ethical concerns and ensure that any clinical trial aligns with national health policies and objectives.
