A planned U.S.-funded clinical study on hepatitis B vaccination in Guinea-Bissau, West Africa, has been cancelled or suspended after widespread ethical concerns and public criticism from scientists, health officials and research watchdogs. The decision comes amid confusion over the trial’s future, as different stakeholders provide contrasting accounts of its status.

Senior officials from the Africa Centres for Disease Control and Prevention (Africa CDC) announced the cancellation during a press briefing in early January 2026, saying the planned trial raised “serious challenges” in its design and would only be reconsidered once it met accepted ethical standards. Africa CDC’s Dr. Yap Boum stated that the study’s design posed significant ethical questions, prompting the halt and ongoing discussions between Guinea-Bissau authorities and U.S. researchers about how to proceed in a manner consistent with international norms. 

The proposed study had been backed by a $1.6 million grant from the U.S. Department of Health and Human Services (HHS) and involved researchers from the Bandim Health Project at the University of Southern Denmark. It aimed to investigate the effects of administering the hepatitis B vaccine at birth compared with later vaccination, in a country where the virus remains highly endemic, infecting roughly 18 percent of adults and about 11 percent of children under age one. 

Critics raised ethical alarms because the trial would have randomly assigned about half the newborns to receive the hepatitis B vaccine at birth, while the other half would follow Guinea-Bissau’s current practice of receiving the vaccine at six weeks of age. Opponents argued that this design effectively withholds timely access to a vaccine already proven to prevent a serious, life-threatening disease. Health experts said such an approach is unacceptable where birth-dose vaccination is recommended by the World Health Organization and considered a critical intervention to prevent chronic infection and liver disease later in life. 

The controversy intensified after ethical concerns were highlighted by prominent global health voices, who compared the proposed trial to historical abuses in research ethics, noting the risks of undertaking a study that denies proven interventions to vulnerable infants. Questions were also raised about the transparency of the study protocol and the involvement of researchers whose earlier work had been criticized for selective data reporting. 

Despite the Africa CDC’s announcement of cancellation, officials from the U.S. Department of Health and Human Services have suggested the trial remains under development, with the protocol still being refined and not definitively halted. This contradiction underscores ongoing uncertainty about the study’s future, though there is broad agreement among African public health leaders that any future research must adhere strictly to global ethical standards.

Guinea-Bissau’s Ministry of Health has indicated that while the trial has been paused, discussions are continuing to determine how to design ethically robust research that both respects participants’ rights and contributes valuable scientific knowledge. Africa CDC has advised that any future hepatitis B vaccine studies in the country should be redesigned with input from local researchers and ethical review bodies to ensure protection of the community’s health interests. 

The suspension of this trial highlights the tension between advancing research and upholding ethical standards, reinforcing calls from African and global health experts for locally led, ethically sound research that prioritizes the wellbeing of populations most affected by disease.

Photo courtesy / Cancer Centre

Article Courtesy of Guardian News & Media Ltd

 https://www.theguardian.com/us-news/2026/jan/15/hepatitis-b-vaccines-study-africa-cancel