The controversial clinical study planned to evaluate potential broader health outcomes of the hepatitis B vaccine across 14,000 infants, but experts condemned the control group design as unethical and neocolonial. Guinea-Bissau's health ministry maintained a strict prohibition against child trials for the shot, denying foreign claims that a revised protocol had secured local ethical clearance. Police took action by seizing an imported batch of vaccines directly from the research centre to halt operations. In response to the crisis, national authorities are now looking to advance routine infant birth vaccinations to early next year.
Key points
Ethicists and global health agencies condemned the project because withholding standard i…: Ethicists and global health agencies condemned the project because withholding standard immunization exposed thousands of infants to severe risks like liver cancer and chronic infection.
Health Minister Quinhin Nantote rejected claims of local protocol approval and reaffirmed…: Health Minister Quinhin Nantote rejected claims of local protocol approval and reaffirmed the government's official ban on child trials.
The trial intended to study wider health impacts, but international authorities stressed…: The trial intended to study wider health impacts, but international authorities stressed that the vaccine has over 30 years of established safety in more than 115 countries.
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A proposed trial of a hepatitis B vaccine on newborn babies in Guinea-Bissau has been cancelled following accusations that the trial was "unethical" and "neocolonial".
The trial was funded by the US, under Health Secretary Robert F Kennedy Jr, who has a long record of expressing scepticism about vaccines.
Police have seized a batch of vaccines from the research centre at the heart of the controversy.
The proposed trial drew international criticism because it planned to withhold a vaccine recommended by the World Health Organization (WHO) from half of the participating newborns.
Some public health experts argued that the proposed trial raised broader questions about whether vulnerable populations in African countries were being asked to take risks that researchers would not accept in wealthier countries.
The BBC has asked the US department of health and human services for comment.
Here is what you need to know.
What was the trial?
The study was planned at the Bandim Health Project, a research centre that has operated in Guinea-Bissau since 1978.
It was designed to involve 14,000 newborns, with half…
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