Guinea-Bissau's health minister said on Tuesday that the government "did not authorize" a controversial hepatitis B vaccine trial in newborns, contradicting reports that the West African nation had approved the study.
The trial would be funded by the US government and private partners. It would not measure the safety or effectiveness of the hepatitis B vaccine itself. Instead, researchers would track what the source describes as "nonspecific" health outcomes, including overall mortality and neurodevelopmental conditions.
Robert F Kennedy Jr, now secretary of the US Department of Health and Human Services, has championed the study. The source identifies Kennedy as "a longtime anti-vaccine activist."
The denial from Guinea-Bissau's health minister suggests a dispute over whether formal approval was ever granted for the research to proceed in the country. The Guardian's reporting does not specify who had claimed the government had authorized the trial, nor does it provide details on the trial's design, timeline, sample size, or sponsoring institutions beyond naming US government and private partners.
The source does not elaborate on Kennedy's specific role in advancing the study or what the stated rationale is for tracking mortality and neurodevelopmental outcomes rather than vaccine safety metrics. It also does not include reaction from the trial's organizers to the government's denial, or clarification on what stage the approval process has reached.