Guinea-Bissau Delays Controversial U.S.-Funded Vaccine Trial

Plans for a contentious U.S.-funded study on hepatitis B vaccination in **Guinea-Bissau** have been paused pending further review by national authorities. The **Africa Centres for Disease Control and Prevention** (Africa CDC) indicated on Thursday that the trial might still proceed, pending additional evaluation.

During a press briefing in which **Quinhin Nantote**, Guinea-Bissau’s Minister of Public Health, addressed the media, he noted a lack of sufficient coordination that has delayed a final decision on the study. “There has been no sufficient coordination in order to make a final decision regarding that study,” Nantote stated through an interpreter.

Regulatory Oversight and Ethical Concerns

**Jean Kaseya**, the Director General of Africa CDC, emphasized that any authorization for clinical studies must come from the host countries. He announced that the agency would send officials to provide technical support for the necessary regulatory and ethical reviews. “Africa CDC is respecting and supporting the sovereignty of the country,” Kaseya affirmed.

Kaseya clarified that it is not up to Africa CDC or any foreign entity to decide the fate of the clinical trial. “It’s the sovereignty of the country,” he reiterated. Despite this, uncertainty looms over the trial’s future. U.S. health officials maintain that the study is proceeding as planned, but they did not provide immediate answers to media inquiries on Thursday.

The **U.S. Centers for Disease Control and Prevention** awarded a grant of **$1.6 million** to researchers at the **University of Southern Denmark** for this trial. The study aims to administer hepatitis B vaccinations to some newborns at birth, while others would receive the vaccine at the standard age of six weeks.

Critics have raised significant ethical concerns regarding the trial, arguing it would not yield results beneficial for vaccine policy in the U.S. Notably, the **Trump administration** recently overturned a longstanding recommendation for administering the hepatitis B vaccine at birth, further complicating the context of this study.

Timeline and Future Implications

Many health experts have expressed apprehension about the trial’s design, which seeks to analyze differences in overall health outcomes between the two groups of infants. Amidst this scrutiny, Guinea-Bissau officials had previously planned to implement a universal birth dose policy for the hepatitis B vaccine in 2024, following recommendations from the **World Health Organization**. However, Nantote indicated that this initiative may now be postponed until **2028** due to the recent political coup in November.

Recent media reports, including one from **The Guardian**, suggested that the trial had been canceled, which prompted confusion about its status. U.S. officials countered that the study was still on track, highlighting the conflicting narratives between international and local perspectives.

In defense of its role, Africa CDC showcased its extensive work across the continent, noting its commitment to providing technical assistance to countries and responding to health crises. Kaseya pointed out that the agency’s vision is rooted in African leadership and realities, distancing it from perceptions of external influence.

He also mentioned that interactions between senior U.S. health officials and Africa CDC leaders took place on Wednesday, where they expressed unawareness of any statements criticizing the agency. “I trust them, I’ve closed the chapter,” Kaseya concluded, signaling a desire to move forward collaboratively.

As Guinea-Bissau navigates this complex situation, the future of the hepatitis B vaccine trial remains uncertain, with both ethical considerations and national sovereignty at the forefront of discussions.