Danish panel clears hepatitis B trial in Guinea-Bissau despite resignations

CDC allocates $1.6 million to trial championed by Kennedy

The University of Southern Denmark’s ethics committee voted this week to approve a research trial in Guinea-Bissau that will enroll 14,000 infants and withhold the hepatitis B vaccine from half of them for the first six weeks of their lives. The trial is central to the vaccine vision of Health and Human Services Secretary Robert F. Kennedy Jr., a longtime vaccine opponent who has praised the Danish researchers behind the work at an anti-vaccine conference and touted US-supported research on hepatitis B in newborns as exemplifying the Trump administration’s vaccine agenda.

Kennedy “wants to make it so we don’t use a birth dose here in this country,” said Paul Offit, an infectious disease physician at Children’s Hospital of Philadelphia. “That’s the goal.” Kennedy would never be able to do the trial in the US because of its significant ethical concerns, Offit added. “He’s taking advantage of a developing country … Is it because children in Africa are more expendable than children here?”

Danish researchers plan to enroll 14,000 infants in Guinea-Bissau, giving the vaccine to half the babies at birth and withholding it from the others for six weeks. According to details shared with the Guardian, the study protocol has changed since it was first posted in January. Under the revised protocol, researchers will test mothers for hepatitis B before they give birth. Babies whose mothers test positive will receive the vaccine and be excluded from the trial. Only babies whose mothers test negative may be enrolled. The new protocol has not been made public.

The hepatitis B test has a 5 percent false negative rate, which could provide false assurance that a birthing parent does not have the virus, according to Offit. “This virus can be transmitted casually,” Offit said. Hepatitis B can live on surfaces for up to seven days and can be acquired through shared washcloths, toothbrushes and fingernail clippers. In previous research, half of children who contracted hepatitis B did so after birth, through community exposures.

Four members of the University of Southern Denmark ethics committee resigned in protest over the study, including Stig Børsen Hansen, a founding member who was one of two reviewers to present the study to the panel. Hansen resigned Friday citing major ethical issues. “You are now enrolling newborns in a lottery to test a hypothesis,” Hansen said. The children who are randomly selected not to receive the birth dose of the vaccine, those who “lost the lottery,” face in their earliest days the risk of contracting hepatitis B, which can cause irreversible lifelong damage. “They contract hepatitis B in the context of being part of a research project,” Hansen said, which made their infection happen, in effect, “by design.”

Guinea-Bissau’s health minister, Quinhin Nantote, initially said the trial was suspended after international controversy earlier this year. Officials have since approved the project. Africa CDC, which has opposed the trial, said in a Thursday briefing that there were “ongoing discussions” between the US and Guinea-Bissau and that more details would be shared shortly. Guinea-Bissau had planned to begin vaccinating all newborns against hepatitis B in 2027 but has pushed the campaign back to 2028.

The US Centers for Disease Control and Prevention has reportedly set aside $1.6 million in this year’s budget for the project, with private funding to be matched by the Pershing Square Foundation, co-founded by the billionaire activist Bill Ackman, and the Bluebell Foundation. The CDC, the Danish researchers, Pershing Square and Nantote did not respond to questions from the Guardian about the trial.

The Bandim Health Project, run by Danish researchers Peter Aaby and Christine Stabell Benn, has operated in Guinea-Bissau for decades and is closely enmeshed in the country’s health system. Guinea-Bissau’s current director of public health held a dual appointment with Bandim as recently as December.

At an anti-vaccine conference last month, Kennedy praised the Danish researchers, calling them “the deities of vaccine research.” Kennedy claimed that a prior study they conducted indicated that after vaccination “you can have mass injuries, and catastrophic injuries, and they’re hiding in plain sight.” Kennedy did not mention that another follow-up study from the same researchers found no effects at all.

According to the Helsinki declaration, international medical research must be approved by ethics committees in both the host and sponsor countries. The Danish research ethics committee at the University of Southern Denmark had never considered medical studies before but changed its rules to vote on this one. While committee members with expertise argued against approving it, the majority ruled to move forward. “It’s very unusual to bring this into a committee like that,” said Henrik Støvring, a professor of statistics and pharmacometrics at Aarhus University in Denmark. The national ethics committee in Denmark oversees medical research, but this study was outside of their purview because it won’t take place in Denmark.

Støvring said decades of research make it clear that the vaccine would be beneficial, which means it would be unfair to place some children in the vaccinated group and some children in the unvaccinated group. “I don’t see why you couldn’t do it in Denmark,” Støvring said. In Denmark, the hepatitis B vaccine is not usually given to newborns unless the mother tests positive, and all pregnant people are tested.

Guinea-Bissau has some of the highest rates of hepatitis B in the world, with about 18 percent of adults carrying the virus. Children infected with hepatitis B in the first year of life are significantly more likely to develop severe outcomes, including chronic infection and liver cancer.

The study will focus on vaccination and mortality, as well as outcomes such as skin conditions and neurodevelopmental conditions. “The main problem of this trial is that you have some very well-known bad diseases that you can protect with this vaccine,” Støvring said. “And what they then want to study is something highly speculative — in a situation where WHO and others are saying that you should give this vaccine at birth, period.”

Kennedy and the Danish researchers were “taking advantage of that delay in practicing standard care to put these children at risk unnecessarily,” Offit said. “What a terrible thing to do. What a horribly unethical and cruel thing to do.”

The news that the trial was approved by the Denmark ethics committee was first reported on Thursday by CIDRAP News.