Guinea-Bissau has reportedly ended a hepatitis B virus vaccine trial that generated international controversy over its design and ethical implications. The project, which received $1.6 million in funding from the U.S. Centers for Disease Control and Prevention, involved withholding the vaccine from a control group of approximately 7,000 babies out of 14,000 expected participants. Judicial police in the West African nation raided the research facilities in mid-October and confiscated vaccine batches while conducting inquiries into whether the trial met national safety standards. A researcher involved acknowledged the trial had not obtained necessary government approval, characterizing its termination as a significant setback for African scientific research.
The trial was designed by Denmark-based Bandim Health Project, led by prominent researchers Christine Stabell Benn and Peter Aaby. The study aimed to compare health outcomes over five years between babies vaccinated at birth against those vaccinated at six weeks, a timeline that researchers argued provided a unique research window before Guinea-Bissau planned to implement universal birth-dose vaccination from 2028. Given the nation’s high hepatitis B prevalence, affecting approximately one-fifth of its 2.2 million population, the delayed administration drew significant criticism from global health authorities and observers.
The World Health Organization characterized the trial design as unethical, citing concerns that the research would deny infants access to a highly effective vaccine known to prevent chronic infection and long-term liver complications. Critics questioned the open-label methodology, which allowed researchers to know participant assignment, rather than employing standard blind randomization. Former Guinean health officials and experts argued the trial exploited limited research infrastructure and capacity in the country. Comparisons were drawn to historical unethical medical studies, including the Tuskegee syphilis experiments.
Benn and Aaby maintained their research aimed to assess whether vaccine benefits came with unintended consequences rather than testing vaccine efficacy. The trial announcement in December last year prompted the Guinean government to pause the project in January and launch a formal review in coordination with the Africa Centres for Disease Control and Prevention and the WHO. Officials also noted that Guinea-Bissau’s transitional government, which assumed power following a November coup, had not participated in the original approval process.
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