Guinea-Bissau formally rejects US-funded hepatitis B vaccine trial

Christine Stabell Benn, one of the trial's leads, told Ars Technica that Guinea-Bissau's Council of Ministers "formally reaffirmed its non-acceptance of the study on 16 October." She said she regretted the decision but respected the government's authority to decide whether research may proceed.

Three days after that decision, police searched the Bandim Health Project's offices on Monday 19 October and seized hepatitis B vaccine doses, Ars Technica reported. The government now controls the researchers' vaccines. Health Minister Quinhin Nantote had already denied authorising the research, telling The Guardian that reports the project would proceed were "not even remotely true." In a LinkedIn post on 21 October, Frederik Schaltz-Buchholzer said it was "now clear" the study "will not move forward in Guinea-Bissau" and that "we were not given the necessary governmental approval."

The trial design

The protocol planned to enrol 14,000 infants and withhold the hepatitis B vaccine from 7,000 for the first six weeks of life, Streamline Feed reported. That delay mirrors current practice in Guinea-Bissau, where the vaccine is recommended at six weeks because of access problems. The country plans a universal birth dose in 2028.

WHO recommends a first dose as soon as possible after birth, preferably within 24 hours, followed by at least two additional doses. In a February statement, the agency said the trial was "inconsistent with established ethical and scientific principles" and that neither condition allowing a no-treatment arm appeared to be met. WHO said the birth dose prevents 70 to 95 percent of mother-to-child transmission and that more than 115 countries include it in national schedules.

Paul Offit, a vaccine expert at the Children's Hospital of Philadelphia, called the hypothesis "fanciful." He said "there's no evidence for that, and it doesn't make biological sense" and argued the money should instead go to vaccinating children. Henrik Støvring, a Danish researcher who has co-published work questioning earlier Bandim findings, questioned consent: "If they decide to participate in the trial, they have a 50% chance of getting the vaccine for their children. But if they stay out, they have a 0% chance of getting the vaccine. So how can you say that's a non-coercive informed consent?"

Funding and the December grant

The study was to receive $1.6m from the CDC and another $1.6m from private partners including the Pershing Square Foundation and the Bluebell Foundation, making it a $3.2m project. The CDC announced the award in December: an unsolicited $1.6m grant to a research group at the University of Southern Denmark. Outrage flared again in October after a Rolling Stone report, cited by Ars Technica, said CDC staff had told the agency's budget office in late September to set aside $1.6m for the trial. The money was to be pulled from global health security programmes. The Department of Health and Human Services, which oversees the CDC, did not respond to Ars Technica's request for comment. The CDC did not answer The Guardian's questions about whether its funding would now be used to roll out the vaccine to all newborns.

The trial was suspended in January after its design came to light and drew international outcry. Africa CDC's Yap Boum told journalists then that "the study has been cancelled," while an HHS official told The Guardian it "is going to proceed as planned." Guinea-Bissau said in January it would keep its current vaccination schedule until the birth dose is implemented for all newborns, according to a letter The Guardian obtained.

The researchers

Bandim Health Project researchers designed the study: Schaltz-Buchholzer, Stabell Benn and Peter Aaby. They hypothesised that live vaccines such as BCG, given against tuberculosis, may carry an overall mortality benefit, and that giving a non-live hepatitis B vaccine alongside it could dampen that effect. Stabell Benn and Aaby are under investigation by Danish authorities over allegations of "falsification" and "scientific misconduct" related to previous vaccine research. Their studies have been promoted by anti-vaccine advocates, and Robert F. Kennedy Jr., the US health secretary, has repeatedly praised them.

What happens next

WHO said it stands ready to help Guinea-Bissau with birth-dose delivery within 24 hours, antenatal screening for hepatitis B surface antigen, cold-chain logistics and health worker training.