The proposed enrollment of thousands of newborns in a hepatitis B trial is “not going to happen,” Guinea Bissau’s foreign minister has said
Guinea-Bissau has stopped a controversial hepatitis B vaccine study funded by the administration of US President Donald Trump after the World Health Organization (WHO) raised ethical concerns about its design.
On Tuesday, the West African country’s foreign minister, Joao Bernardo Vieira, said the government has shut down the trial in response to the concerns.
“It’s not going to happen, period,” he said in an interview, according to Reuters.
The country’s former health minister, Magda Robalo, was a vocal critic of the project. She told the science journal Nature last month that the trial is “not acceptable and it should not go on.”
The study, backed by a $1.6 million grant from the US Centers for Disease Control and Prevention, was designed to enroll about 14,000 newborns in Guinea-Bissau, where hepatitis B rates are among the highest in the world.
Under the trial, infants would have been randomly allocated the vaccine at birth or at six weeks, a schedule change supported by some researchers but controversial because it would have meant withholding the inoculation from half of the babies at birth.
In a statement last Friday, the WHO denounced the proposed trial as “unethical,” warning that withholding the vaccine could cause “irreversible harm.”
The global health body described the birth-dose vaccine as “an effective and essential public health intervention, with a proven record,” preventing 70–95% of cases of mother-to-child transmission for over three decades.
Researchers from the Guinea-Bissau-based Bandim Health Project, run by the University of Southern Denmark, defended the study’s scientific goals, with Frederik Schaltz-Buchholzer, the lead investigator, saying the debate had shifted toward politics rather than scientific discussion.
The trial had previously been suspended in January pending an ethics review, after the national committee responsible for such research failed to review the protocol in full, according to health officials. Africa Centers for Disease Control and Prevention Director-General Jean Kaseya said African health authorities must retain control over research conducted on the continent.
Guinea-Bissau, one of West Africa’s poorest countries, had planned to introduce a birth dose of the hepatitis B vaccine as part of its national schedule by 2028.
