Guinea-Bissau's health minister says the government never signed off on a Danish-led hepatitis B trial in newborns backed by RFK Jr.
Guinea-Bissau is drawing a hard line on who gets to decide health policy on its own soil. On Tuesday, the country's health minister said the government has not approved a hepatitis B study in newborns, a project tied to US government funding and private partners, and that it "did not authorize" the trial.
The study is led out of Denmark and has been championed by Robert F Kennedy Jr, the US Health and Human Services secretary and a longtime anti-vaccine activist. That backing is a big reason it has drawn scrutiny. The minister's statement makes clear that, as far as Bissau is concerned, the green light was never given.
The design of the study is also raising eyebrows. It would not test the safety or effectiveness of vaccines. Instead, it would track "nonspecific" outcomes in babies, such as overall mortality and neurodevelopmental conditions. That is a very different brief from a standard vaccine trial, and it puts the focus on how newborns are monitored and what questions are being asked of them.
For African health systems, the message is bigger than one trial. Decisions about research involving the continent's youngest citizens belong with African governments, and Guinea-Bissau just reminded everyone of that publicly. Expect more questions about who is funding, who is approving, and who is accountable when studies like this are proposed in West Africa.
