Guinea-Bissau Stops Trump-Backed Hepatitis B Vaccine Study
Foreign Minister Joao Bernardo Vieira confirmed the West African nation's decision on Tuesday, announcing the government had shut down the trial in direct response to the international health body's objections.
"It's not going to happen, period," he said, according to media.
The trial, funded by a $1.6 million grant from the U.S. Centers for Disease Control and Prevention (CDC), had been designed to enroll approximately 14,000 newborns across Guinea-Bissau — a country where hepatitis B infection rates rank among the world's highest. Under its framework, infants would have been randomly assigned to receive the vaccine either at birth or at six weeks of age. Critics immediately flagged the design as deeply problematic, arguing it would effectively deny half of all enrolled babies the birth-dose inoculation.
In a statement issued last Friday, the WHO condemned the proposed study as "unethical," cautioning that delaying vaccination could inflict "irreversible harm" on participating children. The agency described the birth-dose vaccine as "an effective and essential public health intervention, with a proven record," noting it has prevented between 70 and 95 percent of mother-to-child hepatitis B transmissions over more than three decades.
Opposition to the trial had been building for weeks. Guinea-Bissau's former health minister, Magda Robalo, had emerged as one of its most prominent critics, telling the science journal Nature last month that the trial is "not acceptable and it should not go on."
Researchers from the Bandim Health Project — a Guinea-Bissau-based institute operated by the University of Southern Denmark — pushed back against the mounting criticism. Lead investigator Frederik Schaltz-Buchholzer argued the controversy had veered away from scientific merit, saying the debate had shifted toward politics rather than scientific discussion.
The trial had already been placed on hold in January pending a formal ethics review, after the national committee tasked with evaluating such research failed to conduct a full assessment of the study's protocol, according to health officials.
Africa Centers for Disease Control and Prevention Director-General Jean Kaseya used the episode to issue a broader warning, asserting that African health authorities must retain control over research conducted on the continent.
Guinea-Bissau, one of West Africa's most economically vulnerable nations, had been on track to incorporate a birth-dose hepatitis B vaccine into its national immunization schedule by 2028. Whether the collapse of the trial will delay that timeline remains to be seen.
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