Key facts
- Guinea-Bissau's health minister denied approving a controversial hepatitis B study in newborns.
- The study would track general health outcomes like mortality and neurodevelopment, not vaccine efficacy.
- Robert F. Kennedy Jr. champions the study, linking it to his anti-vaccine activism.
- Danish ethics committee members were told the study had local approval, leading to some members voting to proceed.
- The US Centers for Disease Control and Prevention reportedly set aside $1.6 million for the trial's funding.
- The World Health Organization offered support for rolling out the hepatitis B vaccine to all newborns in Guinea-Bissau.
Guinea-Bissau's minister of health, Quinhin Nantote, denied on Tuesday that the country had approved a controversial study involving hepatitis B vaccinations for newborns, a project championed by Robert F. Kennedy Jr. The study, which would track general health outcomes like mortality and neurodevelopment rather than vaccine efficacy, has drawn sharp criticism from experts who have labeled it "horribly unethical and cruel" and "neo-colonialist."
Members of a Danish research ethics committee had been informed that Guinea-Bissau officials had approved an updated design of the study, influencing some committee members' votes to proceed. However, Nantote stated at a press briefing that the health ministry never agreed to or authorized the trial under the presented terms, expressing surprise at media reports of approval.
Nantote emphasized that any scientific research involving humans, especially children, must strictly comply with national legislation and international ethical principles. He convened an emergency meeting with local health officials and the Bandim Health Project, run by Danish researchers Peter Aaby and Christine Stabell Benn, whose work Kennedy has praised.
Experts have decried the proposed African experiment, with Colette Delawalla, founder of Stand Up for Science, commending Guinea-Bissau's government for resisting potential exploitation. Delawalla also pointed out the relatively low cost of vaccinating all newborns in Guinea-Bissau annually.
Despite the denial, reports indicated that the US Centers for Disease Control and Prevention had set aside $1.6 million for the trial's funding this year, to be matched by private foundations. The US Department of Health and Human Services confirmed to Reuters that the study has not been approved. At least four members of the Danish committee resigned after the trial's approval process was fast-tracked, and requests for more information about the Guinea-Bissau approval were not met.