US-Funded Hepatitis B Vaccine Trial for Babies Suspended in Guinea-Bissau Over Ethics Concerns
February 7, 2026
Researchers at the University of Southern Denmark planned a US-funded hepatitis B vaccine trial on 14,000 babies in Guinea-Bissau. Half of the infants were to receive the vaccine at birth, while the other half would get it six weeks later. The study aimed to track health outcomes over five years. However, the Guinea-Bissau government suspended the trial on January 22 due to public and expert backlash.
Magda Robalo, former health minister of Guinea-Bissau, said, “I was disappointed, to say the least, that my country could have approved a study of that kind.” She criticized the researchers for bypassing the national public health institute and taking advantage of Guinea-Bissau's limited research capacity.
Babies are at high risk of hepatitis B virus (HBV), which can cause serious liver damage and cancer. WHO recommends giving hepatitis B vaccines at birth and boosters later. Guinea-Bissau usually vaccinates babies six weeks after birth due to vaccine shortages but plans to switch to at-birth vaccination in 2028.
The Danish researchers argue the trial is timely. They said half of the babies would get the vaccine at birth for the first time in the country. Critics, including Robalo, called the study unethical for delaying vaccines for 7,000 infants.
The trial is led by the Bandim Health Project, with scientists Christine Stabell Benn and Peter Aaby. Their past studies have questioned vaccine effects, stirring controversy. Critics say they lack solid proof and have ignored key findings.
The trial’s design, an open-label study, raises further concerns about bias. The US Centers for Disease Control and Prevention (CDC) funded the $1.6 million trial under Health Secretary Robert F Kennedy Jr, known for vaccine skepticism.
Despite criticism, the Bandim scientists said, “We will not withhold the vaccination from any children who would otherwise have received it.” However, Guinea-Bissau's new government was not consulted before the trial was approved.
The controversy echoes past unethical medical trials in Africa and America. Critics demand better respect for Guinea-Bissau and call for immediate provision of vaccines rather than testing new schedules.
Robalo emphasized, “We are not second-level citizens. We are not a population to be used for anything that you cannot do in the Global North.”
Read More at Aljazeera →
Tags:
Guinea-Bissau
Hepatitis B Vaccine
Vaccine Trial
Us funding
Ethics Controversy
Bandim Health Project
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