A controversial research trial that will withhold hepatitis B vaccines from some African newborns was granted approval to move forward this week, according to the Guardian.
The study forms a central part of the vaccine vision of Robert F Kennedy Jr, the US health and human services secretary and a longtime opponent of vaccines.
Speaking at an anti-vaccine conference last month, Kennedy praised the Danish researchers behind the trial and held up US-supported research into hepatitis B in newborns as an example of the Trump administration’s vaccine agenda, which has included cutting vaccine recommendations and casting doubt on the safety and effectiveness of shots.
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.”
Offit added that Kennedy could never run the trial in the US because of its significant ethical concerns. “He’s taking advantage of a developing country … Is it because children in Africa are more expendable than children here?”
Under the plan, Danish researchers intend to enroll 14,000 infants in Guinea-Bissau, giving the hepatitis B vaccine to half the babies at birth and withholding it from the remainder for the first six weeks of life.
An ethics committee at the researchers’ home institution, the University of Southern Denmark, voted this week to proceed, and officials in Guinea-Bissau have also greenlit the project. The country’s health minister, Quinhin Nantote, had initially said the trial was suspended following international uproar earlier this year.
Stig Børsen Hansen, a founding member of the committee and one of two reviewers who presented the study to it, resigned from the group in protest on Friday, citing major ethical issues.
“You are now enrolling newborns in a lottery to test a hypothesis,” Hansen said. Children randomly selected not to receive the birth dose — those who “lost the lottery” — face the risk of contracting hepatitis B in their earliest days, an infection that can cause irreversible lifelong damage. Hansen said they contract the virus as part of a research project, which made the infection happen, in effect, “by design”.
Three other committee members have also resigned in protest.
The US Centers for Disease Control and Prevention has reportedly set aside $1.6m in this year’s budget for the project, to be matched by private funding from 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 the Guardian’s questions about the trial.
News that the Danish ethics committee approved the study was first reported on Thursday by CIDRAP News. The disclosure of the updated protocol details is the first of its kind.
According to details shared with the Guardian, the Guinea-Bissau study protocol has changed since it was posted in January. Researchers will now test mothers for hepatitis B before they give birth. Babies of mothers who test positive will receive the vaccine and will be excluded from the trial, while babies of mothers who test negative may be enrolled. The new protocol has not been released publicly.
In earlier research, half of the children who contracted hepatitis B did so after birth through community exposures. “This virus can be transmitted casually,” Offit said. It can survive on surfaces for up to seven days and can be acquired by sharing washcloths, toothbrushes and fingernail clippers. The hepatitis B test also has a 5% false negative rate, which could give false assurance that a birthing parent does not carry the virus.
Decades of research make clear the vaccine would be beneficial, meaning it would be unfair to place some children in the vaccinated group and others in the unvaccinated group, said Henrik Støvring, a professor of statistics and pharmacometrics at Aarhus University in Denmark.
Under 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 in order to vote on this one. Committee members with expertise argued against approving it, but the majority ruled to move forward.
“It’s very unusual to bring this into a committee like that,” Støvring said. Denmark’s national ethics committee oversees medical research, but the study fell outside its purview because it will not take place in Denmark.
Yet “I don’t see why you couldn’t do it in Denmark,” Støvring said of the trial, noting that several conditions make it a better location. The hepatitis B vaccine is not usually given to newborns in Denmark unless the mother is positive for the virus, for which all pregnant people there are tested.
Guinea-Bissau has some of the highest rates of hepatitis B in the world, with roughly 18% of adults carrying the virus. While it may be passed from mother to child during birth, it can also be transmitted by another parent, relatives, siblings or caregivers. Children infected with hepatitis B in their first year of life are significantly more likely to develop severe outcomes, including chronic infection and liver cancer.
The Bandim Health Project, run by the 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. At least one top official, the current director of public health, held a dual appointment with Bandim as recently as December.
Kennedy praised the Danish researchers at a recent anti-vaccine conference, calling them “the deities of vaccine research”. He claimed a prior study they conducted indicated that after vaccination “you can have mass injuries, and catastrophic injuries, and they’re hiding in plain sight”. He did not mention that another follow-up study by the same researchers found no effects at all.
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.”
Asked about the study at a Thursday briefing, an official with the Africa CDC, which has opposed the trial, said 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 pushed the campaign back to 2028.
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.”
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