Quinhin Nantote told a press briefing on Tuesday that the ministry did not authorise the study “under the terms presented in the publications currently in circulation”, and that officials in Guinea-Bissau were “surprised” by media reports that the country had approved it.
The denial comes after members of a Danish research ethics committee were told that officials in Guinea-Bissau had approved an updated design of the study, which influenced some committee members' votes to proceed with the trial last week.
Nantote spoke after convening an emergency meeting with the Bandim Health Project, the local ethics committee, the National Institute of Public Health (Inasa) and the Expanded Vaccination Program. “Any scientific research initiative involving human beings, particularly children, must strictly comply with applicable national legislation, international ethical principles, competent evaluation and approval mechanisms,” he said.
The study, funded by the US government and private partners, would not investigate the safety or effectiveness of vaccines. Instead it would track “nonspecific” health outcomes such as overall mortality and neurodevelopmental conditions.
The Bandim Health Project is run by Danish researchers Peter Aaby and Christine Stabell Benn, whose decades of research have been called into question in the past year. Kennedy, a longtime anti-vaccine activist who now leads the US Department of Health and Human Services, has repeatedly praised their work, saying it shows that after vaccination “you can have mass injuries, and catastrophic injuries, and they're hiding in plain sight.”
Aaby, Stabell Benn and Frederik Schaltz-Buchholzer did not respond to questions about why the Danish ethics committee was told the trial had been approved locally, and why it could not be held in Denmark, where infants born to hepatitis B-negative parents do not receive the shot and the virus is rare. Experts have described the African experiment as “horribly unethical and cruel”, “neo-colonialist” and “damaging”.