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Guinea-Bissau police seize vaccines amid hepatitis B trial dispute
Guinea-Bissau’s Judicial Police have seized a batch of hepatitis B vaccines from the Bandim Health Project in Bissau as part of an investigation into a controversial clinical trial involving newborns. While the seizure is part of an inquiry to establish the circumstances surrounding the vaccine batch, authorities noted that the action does not inherently prove irregularities regarding the quality or safety of the vaccines.
The investigation follows international scrutiny of a proposed $1.6 million clinical trial involving 14,000 newborns. Funded by the U.S. Centers for Disease Control and Prevention (CDC), the study proposed delaying hepatitis B vaccinations for half of the participants until six weeks of age to compare health outcomes against a control group. The protocol has faced criticism from medical experts and the World Health Organization (WHO) over ethical concerns regarding newborn safety and parental consent.
Although the University of Southern Denmark has approved the trial to proceed, Guinea-Bissau’s Minister of Public Health, Quinhin Nantote, has denied that national authorities authorized the study. The trial cannot begin until formal national authorization is granted, and the government has rejected claims that it had previously approved the research project.
Entities
Bandim Health Project · Centers for Disease Control and Prevention · University of Southern Denmark