Guinea-Bissau Denies Approving U.S.-Backed Hepatitis B Study in Newborns
Guinea-Bissau has not approved a proposed U.S.-backed study of hepatitis B vaccination in newborns, Health Minister Quinhin Nantote said Tuesday. The Guardian
The denial was categorical. Nantote said the health ministry did not authorize the tests under the terms presented in publications in circulation. Officials in Bissau were surprised to see media reports that the country had approved the study.
Nantote spoke after an emergency meeting with the institutions that would handle any such protocol. Those present included the Bandim Health Project, the local ethics committee — the body that reviews research for safety and consent — the National Institute of Public Health, known as Inasa, and the Expanded Vaccination Program, known as PAV.
His statement directly contradicts information given to regulators in Europe. Members of a Danish research ethics committee had been told that Guinea-Bissau officials approved an updated design of the hepatitis B study. That assurance influenced some members' votes to proceed last week.
The proposal would not test vaccine safety or effectiveness in the usual way. Instead, it would track broader, nonspecific health outcomes among newborns, such as overall mortality or neurodevelopmental conditions. Think of it as looking beyond the target disease. Such nonspecific effects trials study effects beyond the target germ and require different endpoints, consent steps, and follow-up monitoring.
The proposed study is linked to two overlapping networks. The Bandim Health Project, run by Danish researchers Peter Aaby and Christine Stabell Benn, would implement the work locally. Funding would come from the U.S. government and private partners. U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. has championed the proposal.
Earlier, in February, Guinea-Bissau blocked a U.S.-funded hepatitis B vaccine trial, according to Reuters reporting at the time. Reuters The World Health Organization had called that trial unethical and warned of irreversible harm. In January, the same U.S.-funded newborn study had been referred for ethical review involving Africa CDC officials. Reuters
The broader context here is jurisdictional, or who has the authority to approve. Research on newborns across countries typically requires dual clearance, with host-country authorization and sponsor-country ethics approval operating together. When one committee is told the other has signed off, momentum builds. A denial from the host ministry interrupts that sequence and forces reassessment of what was voted upon.
Looking at what this means for oversight, the next questions are documentary. Which version of the protocol was circulated in Bissau, what was communicated to Copenhagen, and when. The answers will determine whether this was miscommunication about an evolving design or a more consequential breakdown in reciprocal notification between national regulators, local ethics committees and external funders. That paper trail is now the central evidence.
