Guinea-Bissau's minister of health told reporters on Tuesday that the government has not authorized a proposed hepatitis B study in newborn infants, contradicting reports that the West African country had approved the trial.
Study description
According to descriptions of the project, the study would not test the safety or efficacy of vaccines but would instead monitor so-called "nonspecific" health outcomes such as overall mortality and neurodevelopmental conditions among newborns. The research is led by investigators from Denmark and would be funded by the US government alongside private partners.
Political and public profile
The trial has attracted attention because it has been championed by Robert F. Kennedy Jr., identified in reports as the US secretary of the Department of Health and Human Services and known previously as a long-time critic of vaccines. Organizers and proponents have argued the study aims to measure broader health effects, while its profile has prompted public scrutiny.
Government response
Guinea-Bissau's health minister was clear in saying the government "did not authorize" the study. No further details were provided about how the proposal was reviewed or whether the investigators plan to reapply for permission under national regulatory procedures.
Given the attention the proposal has received, observers will be watching for any formal submissions to Guinea-Bissau's health authorities or statements from the study coordinators clarifying the trial's purpose and oversight arrangements.