Public health authorities in Guinea-Bissau announced the suspension of a controversial US-funded hepatitis B vaccine study, intensifying a broader debate over control and oversight of clinical research conducted in Africa. During a press conference held today, officials from Guinea-Bissau’s Ministry of Health said the trial would be paused pending a technical and ethical review by the country’s national public health institute. The announcement came after weeks of conflicting signals about whether the study would move forward, exposing deep tensions over authority, funding influence, and scientific ethics in global health research.
Quinhin Nantote, Guinea-Bissau’s minister of public health, said the decision was driven by insufficient coordination among stakeholders. “There has been no sufficient coordination in order to take a final decision regarding the study,” Nantote said. “Faced with this situation, we decided to suspend it.” The meeting, convened by the Africa Centres for Disease Control and Prevention (Africa CDC), followed a series of mixed messages about the trial’s status. An official with Africa CDC indicated last week that the trial would not proceed, while the US Department of Health and Human Services (HHS)—a major funder of the research—maintained that the study was still on track.
The conflicting statements highlight a persistent fault line in global health research: who ultimately holds decision-making power when foreign funding meets local public health priorities. In an email to Nature, HHS spokesperson Emily Hilliard insisted that the trial was continuing as planned and that the agency was working with partners to finalize the study’s protocols. Yet the suspension announcement in Guinea-Bissau suggests that local authorities are asserting their authority and demanding more thorough ethical oversight, particularly in light of criticism from African scientists who argue that the study prioritizes external research goals over local needs.
The trial was designed by researchers at the Bandim Health Project at the University of Southern Denmark and funded in part by a $1.6 million grant from the US Centers for Disease Control and Prevention, part of HHS. It aims to randomize 14,000 newborns in Guinea-Bissau starting in early 2026 to either receive the hepatitis B vaccine at birth or not, before the country’s planned universal birth-dose vaccine policy begins in 2027. Bandim researchers have argued that the study offers a rare opportunity to investigate whether the vaccine has broader effects on infant health outcomes beyond hepatitis B prevention.
However, critics say the study’s design is ethically troubling because it intentionally withholds a safe, life-saving vaccine from a portion of newborns in a country where hepatitis B prevalence is around 19%. Experts note that newborns’ immune systems are underdeveloped, and about 90% of infants infected at birth go on to develop chronic, lifelong hepatitis B infections, which can lead to severe liver disease and early death. Opponents argue that the trial is structured to increase the likelihood of detecting harm from the birth dose, even if such harm is not real or clinically meaningful.
Some scientists have framed the trial as a case of global health exploitation, arguing that it uses African children to answer questions driven by interests in the Global North. “They’re trying to use African children to prove a case for reducing vaccines in the US,” said Seye Abimbola, a professor of health systems at the University of Sydney who researches decolonizing global health. His criticism reflects broader concerns that research priorities in Africa are too often shaped by external funding and political agendas rather than by local public health needs. The debate is further complicated by the fact that the United States removed its own recommendations for a birth dose of the hepatitis B vaccine earlier this year, raising questions about the motives behind the study and the ethics of testing a policy in Africa that the US has abandoned.
The suspension of the trial in Guinea-Bissau has renewed urgent questions about oversight, consent, and power in international research. As the country prepares to conduct a formal review, the controversy is likely to deepen scrutiny of how vaccine studies are designed, funded, and regulated, particularly when they involve vulnerable populations and high-stakes public health decisions.
