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Guinea-Bissau has halted a controversial United States-funded hepatitis B virus vaccine trial involving thousands of infants following global scrutiny and safety investigations. A researcher confirmed the project failed to secure the necessary government approval, dealing a significant setback to African science.
The Vaccine Trial and Its Funding
The project aimed to evaluate World Health Organization-recommended hepatitis B vaccines across two groups of approximately 14,000 infants, with one group receiving the shot at birth and the other receiving it six weeks later, tracking their health over a five-year period. The US Centers for Disease Control and Prevention provided $1.6 million in funding for the research under Health Secretary Robert F Kennedy. Following widespread anger over withholding the vaccine from one group of babies, the Guinea-Bissau government paused the study in January to launch a review. In mid-October, the nation’s judicial police raided the Bissau facilities of the lead research group, the Bandim Health Project, and seized vaccine batches to determine if safety standards were met.
Leadership and Controversy
The University of Southern Denmark-affiliated Bandim Health Project, chaired by scientists Christine Stabell Benn and Peter Aaby, planned the trial. The married couple has operated out of Bissau since 1978 and focuses on the unintended impacts of vaccines, having previously theorized that inactivated virus vaccines can cause death. Critics and counterparts in Denmark have previously accused them of downplaying results or withholding evidence, citing a past study on diphtheria, tetanus, and pertussis vaccines. Health experts strongly condemned the new hepatitis B trial, calling it unethical to withhold a proven lifesaving vaccine from infants at high risk of chronic infection, which can lead to liver damage and cancer.
Magda Robalo, a former Guinea-Bissau health minister, told Al Jazeera that the researchers exploited the country’s limited research capacity. Critics also questioned the open-label design of the trial, where researchers knew who received the vaccines, and compared the study to the historical Tuskegee syphilis trial in the United States. In their defense, Benn and Aaby stated they were testing whether disease prevention comes at a prohibitive price such as death, while Benn denied any wrongdoing in an email to Al Jazeera in February.
Government Response and Cancellation
Guinea-Bissau launched an inquiry into the project in January alongside the Africa Centres for Disease Control and Prevention and the WHO, stating that the transitional government following a November coup had not approved it. Although a Danish ethics committee reportedly received information that an updated proposal had been approved, Health Minister Quinhin Nantote denied that claim in mid-October. Following police raids on October 19, Bandim researcher Frederik Schaltz-Buchholzer stated on LinkedIn that the trial will not move forward because the government denied approval.
