Guinea-Bissau's Minister of Health, Quinhin Nantote, announced on Tuesday that the country has not approved a controversial hepatitis B study in newborns. This statement contradicts information provided to a Danish research ethics committee, which had been informed of Guinea-Bissau's approval for an updated study design.
Mr Nantote, speaking at a press briefing in Portuguese, stated that the health ministry "did not authorize the tests under the terms presented in the publications currently in circulation." He added that officials were "surprised" by media reports indicating the country had given its approval.
The study, which would be funded by the US government and private partners, would not assess vaccine safety or effectiveness. Instead, it aims to track "nonspecific" health outcomes such as overall mortality or neurodevelopmental conditions. Robert F Kennedy Jr, Secretary of the US Department of Health and Human Services (HHS), has championed the study.
The US Centers for Disease Control and Prevention (CDC) has reportedly set aside $1.6 million for funding for the trial this year, to be matched by private funding. However, the HHS stated to Reuters that "The study has not been approved."
The proposed study would enrol 14,000 newborns in Guinea-Bissau, with half receiving vaccination at birth and the other half denied immunisation for the first six weeks. Hepatitis B is prevalent in Guinea-Bissau, and infection in children can lead to serious lifelong effects.