Trial called off after approval was withheld
A US-backed trial of the hepatitis B vaccine in newborns in Guinea-Bissau has been halted, the study's lead researcher said on Wednesday. Frederik Schaltz-Buchholzer, a Danish researcher, wrote on LinkedIn that it was "now clear" the study "will not move forward in Guinea-Bissau." He added, "we were not given the necessary governmental approval."
The Guardian reported that Guinea-Bissau's health minister, Quinhin Nantote, had previously denied that the project would proceed. "This is not even remotely true," Nantote told the paper in Portuguese last week.
The government now has control of the researchers' vaccines. According to the Guardian, they were taken when authorities searched the offices of the Bandim Health Project on Monday.
What the study proposed
The trial was to be funded with $1.6m from the US Centers for Disease Control and Prevention, which was appropriated through the agency's global health work. Another $1.6m was to come from private partners, including the Pershing Square Foundation, which is backed by Bill Ackman, and the Bluebell Foundation.
The Danish team is led by Schaltz-Buchholzer, Christine Stabell Benn and Peter Aaby. They hypothesized that live vaccines such as Bacillus Calmette-Guérin (BCG) may reduce overall mortality beyond preventing illnesses like tuberculosis. Giving a hepatitis B vaccine alongside BCG, they suggested, could dampen that effect.
Besides mortality, the study would have examined side effects such as skin conditions and neurodevelopmental conditions. The Guardian noted that dozens of studies have found no link between vaccination and autism.
Experts question the science and the ethics
Paul Offit, a vaccines expert at the Children's Hospital of Philadelphia, sharply criticized the proposal as unethical. He called the underlying hypothesis "fanciful" because the hepatitis B vaccine is a single protein among billions the immune system encounters each day. "There's no evidence for that, and it doesn't make biological sense," he said.
Offit also pointed to the vaccine's long record. Hundreds of millions of children, he argued, have received it as a birth dose or have not, and any problem would be known by now. He noted that hepatitis B was virtually eliminated in US children within years of the program starting. He stressed that Guinea-Bissau has a high incidence of chronic hepatitis B, with a risk of lifelong illness and death from infection.
Consent was another concern. Experts told the Guardian that families who declined to take part would not have received the vaccine, which made true informed consent impossible. Henrik Støvring, a Danish researcher who has co-published work questioning earlier Bandim project research, laid out the dilemma. Participating parents would have a 50% chance of their child getting the vaccine, he said, while those who stayed out would have none. "So how can you say that's a non-coercive informed consent?" he asked.
Responses and what comes next
Schaltz-Buchholzer said the proposed trial fueled distrust among Bissau-Guineans, some of whom wondered whether the vaccine was being tested on Africans because it was dangerous. He wrote that it "should be clear" neither birth vaccination schedule, with or without hepatitis B, is "dangerous to anyone." He also said he believes the study was canceled because it challenges "prevailing medical assumptions, such as that HBV0 does not have non-specific effects." The Danish researchers did not respond to the Guardian's questions by press time.
The World Health Organization recommends that all infants receive a first dose of the hepatitis B vaccine as soon as possible after birth, preferably within 24 hours, followed by at least two more doses. WHO spokesperson Tarik Jašarević said the agency remains committed to working with national authorities, researchers and partners so all newborns receive timely, evidence-based protection.
The CDC did not respond to questions about whether the funding would now go toward rolling out the vaccine to all newborns in Guinea-Bissau. Offit said supporting the country in doing so as soon as possible was vital. Guinea-Bissau currently plans to offer the universal birth dose in 2028.
