""There has been no sufficient coordination in order to take a final decision regarding the study," said Quinhin Nantote, the minister of public health for Guinea-Bissau. "Faced with this situation, we decided to suspend it.""
""The study is proceeding as planned and we continue to work with our partners to finalize the study's protocols," wrote Emily Hilliard, a spokesperson for the HHS."
"The continuing row shines a spotlight on long-standing tensions for clinical research trials in Africa. African scientists say that the Guinea-Bissau study shows how political pressure, funding interests and fragmented oversight can push local health priorities aside."
Guinea-Bissau suspended a US-funded hepatitis B vaccine trial pending a technical and ethical review by the national public health institute. The suspension followed weeks of conflicting statements about the trial's status and a meeting convened by the Africa CDC. US Department of Health and Human Services officials indicated the study remained on track, while Guinea-Bissau health officials cited insufficient coordination. The trial was designed by the Bandim Health Project at the University of Southern Denmark and received part of its funding via a US$1.6 million grant from the US Centers for Disease Control and Prevention. The study planned to randomize newborns in Guinea-Bissau.
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