Guinea-Bissau Denies Approving Hepatitis B Trial on Newborns

Guinea-Bissau’s government has denied authorizing a controversial hepatitis B study involving 14,000 newborns, half of whom would initially be denied vaccination. Health Minister Quinhin Nantote said officials were surprised by reports that the country had approved the research, which is associated with Danish researchers and backed by US government funding and private foundations. The proposed study would examine broader health outcomes rather than directly assess vaccine safety or effectiveness. Critics have raised serious ethical concerns about withholding an established vaccine from infants in a country where hepatitis B is widespread. Danish ethics committee members had reportedly been told local authorities approved a revised design, influencing last week’s vote. At least four members later resigned.