Guinea-Bissau Says It Never Authorized the Trial

Guinea-Bissau’s health minister, Quinhin Nantote, said Tuesday that his ministry had not authorized the Danish-led newborn hepatitis B study championed by US Health and Human Services Secretary Robert F. Kennedy Jr. The Guardian reported the denial on October 14. Our earlier coverage described the trial as approved. That framing now requires a public correction, not a quiet retreat into the word “controversial.”

The contradiction concerns who granted permission and what that permission covered. The Guardian’s October 9 report said an ethics committee at the University of Southern Denmark had voted to proceed. It also reported that officials in Guinea-Bissau had greenlit the project. The October 14 report says Danish committee members had been told that Guinea-Bissau officials approved an updated design. That account influenced some members’ votes. A claim about one institution’s permission helped another institution decide.

Nantote disputed that account. “The ministry did not authorize the tests under the terms presented in the publications currently in circulation,” he said. He spoke after an emergency meeting with the Bandim Health Project, the local ethics committee, the National Institute of Public Health, and the Expanded Vaccination Program. His statement establishes the ministry’s denial. It does not establish that every form of ethics review was absent. Nor do these reports establish that recruitment began.

The proposed protocol makes those distinctions material. Danish researchers planned to enroll 14,000 infants in Guinea-Bissau. Half would receive hepatitis B vaccination at birth. The other half would not receive it for the first six weeks. The study would therefore withhold a recommended birth dose from thousands of newborns. The later Guardian report describes its purpose as tracking “nonspecific” outcomes, including overall mortality and neurodevelopmental conditions, rather than testing vaccine safety or effectiveness.

That research question does not dissolve the duty to justify the comparison. The October 9 report documented resignations from the Danish committee over ethical concerns. A committee vote establishes that a decision occurred; it does not settle whether the design adequately protects infants. Kennedy’s political support is another separate fact. His endorsement cannot supply Guinea-Bissau’s permission, establish ethical adequacy, or demonstrate that proposed US and private funding has reached the study.

Permission cannot be assembled from institutions pointing at one another. The decisive records would identify the approving authority, the protocol version, the decision date, and any conditions. Researchers should also explain who told the Danish committee that Guinea-Bissau had approved the revised design. The present record does not resolve whether that assurance reflected a misunderstanding, a narrower authorization, or an inaccurate claim.

The University of Southern Denmark and the Bandim Health Project can publish the decisions and communications on which they relied. Guinea-Bissau’s health ministry can specify the authorization status and the national requirements that remain applicable. Our publication owes readers a visible correction distinguishing the documented Danish ethics vote from the disputed government permission. Each institution can supply its own record. None needs another reassuring headline.