Guinea-Bissau Denies Approving Controversial Hepatitis B Study in Newborns
Guinea-Bissau has denied approving a controversial hepatitis B study in newborns that would be funded by the US government and private partners, the country's health minister, Quinhin Nantote, said on Tuesday. The Danish-led trial, championed by Robert F Kennedy Jr, the US health secretary and a longtime anti-vaccine activist, would not investigate vaccine safety or effectiveness but would instead track "nonspecific" outcomes such as overall mortality and neurodevelopmental conditions. Nantote said the ministry "did not authorize" the study and that officials were surprised by media reports of approval, insisting any research involving children must comply with national legislation and ethical standards.
The dispute follows a decision by a Danish research ethics committee to proceed with the trial last week after members were informed that Guinea-Bissau had approved an updated design. The study, run by the Bandim Health Project under researchers Peter Aaby and Christine Stabell Benn, would enroll 14,000 newborns, half of whom would be denied the hepatitis B vaccine for the first six weeks of life in a country where the virus is widespread and childhood infection can cause lifelong harm. At least four committee members resigned after approval was fast-tracked and the committee's rules were changed to accommodate a trial outside its usual purview.
Experts have condemned the study as "horribly unethical and cruel" and "neo-colonialist," questioning why it could not be conducted in Denmark, where infants of hepatitis B-negative parents do not receive the shot. The US Centers for Disease Control and Prevention has again set aside $1.6m for the trial this year, to be matched by private foundations, though the health department said "the study has not been approved." The World Health Organization has offered to help Guinea-Bissau introduce the birth-dose vaccine for all newborns, while researcher Colette Delawalla noted it would cost roughly $13,200 a year to immunize every newborn in the country through Unicef and Gavi.
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