Danish University Approves Newborn Trial; Guinea-Bissau Denies Authorization

A revised U.S.-funded hepatitis B vaccine trial involving 14,000 newborns in Guinea-Bissau has received approval from the University of Southern Denmark and reportedly cleared an ethics committee in Guinea-Bissau, but the country’s government says it has not granted the final authorization needed for the study to begin. Under the plan, infants whose mothers test positive for hepatitis B would be vaccinated at birth and excluded; other participants would either receive a birth dose or follow the current schedule, which starts vaccination at six weeks. The $1.6 million CDC-funded study has drawn international criticism because it would delay a proven protective vaccine for some newborns in a country with high hepatitis B prevalence. The World Health Organization criticized the earlier study design, and public health experts have raised ethical concerns about withholding the birth dose, which helps prevent transmission from mother to child.