The controversial US-backed hepatitis B vaccine trial involving newborns in Guinea-Bissau has been stopped, the study's lead investigator announced on Wednesday. Frederik Schaltz-Buchholzer, a Danish researcher, said on LinkedIn that it is "now clear" the project "will not move forward in Guinea-Bissau" because the necessary governmental approval was not granted.
The trial, which had attracted global criticism, was due to be funded by the US Centers for Disease Control and Prevention (CDC). Organisers faced scrutiny from international observers and civil society groups after details of the planned study became public, prompting debate over the ethics of foreign-funded clinical research in low-income countries.
Schaltz-Buchholzer's statement did not elaborate on the specific reasons the Guinean authorities withheld approval or on whether any of the scientific partners would seek to revise the protocol to address concerns. The announcement makes clear, however, that the planned enrolment of newborn infants in the study will not proceed in its current form in Guinea-Bissau.
Clinical trials typically require multiple layers of regulatory and government sign-off before they can begin, and the absence of such approvals can halt studies regardless of external funding or scientific intent. It remains unclear whether the research team will pursue alternative arrangements, modify their proposal to satisfy local authorities, or abandon the project entirely.
Health officials and outside observers have said in recent weeks that questions raised about the project highlighted broader tensions around how international research is planned and communicated in resource-limited settings. The halted trial is likely to deepen discussions about oversight, community engagement and consent in cross-border vaccine research, though the immediate practical outcome is that the Guinea-Bissau study will not go ahead as proposed.