In brief
Guinea‑Bissau halted a U.S.‑funded hepatitis B vaccine trial led by a Danish research team that planned to compare birth‑dose and six‑week‑dose schedules for 14,000 babies. The trial faced ethical backlash and never received government approval, prompting a pause in January and a police raid on the team’s facilities in mid‑October. Officials have not commented, while authorities continue investigations into safety compliance.
Guinea‑Bissau has stopped a United States‑funded hepatitis B virus vaccine trial that would have withheld a life‑saving shot from half of the babies enrolled.
The study, led by a Danish research group from the Bandim Health Project, sought to compare birth‑dose versus six‑week‑dose schedules for approximately 14,000 infants, tracking outcomes over five years.
White‑paper critics said the trial represented an ethical breach by denying timely vaccination to one randomly selected half of the cohort, and the World Health Organization’s recommended schedule would have protected all babies.
In January, the Guinea‑Bissau government paused the project and launched a review after the announcement in December of a $1.6 million CDC grant under Health Secretary Robert F. Kennedy.
A researcher involved in the project stated that the trial’s cessation was a “significant setback” for African science, noting that the study had not secured the necessary approval from the national authorities.
Officials have not commented further, but the West African nation’s judicial police reported in mid‑October that they had raided the Bandim Health Project’s facilities in Bissau and seized vaccine batches.
Authorities say inquiries are continuing to determine whether the trial complied with Guinea‑Bissau’s safety standards, while the research team maintains that their protocols met international norms.
