CDC reportedly moves to fund contested hepatitis B trial as Denmark panel approves it

The Danish researchers plan to enroll 14,000 infants in Guinea-Bissau, giving the hepatitis B vaccine to half of the babies at birth and withholding it from the others for the first six weeks of life, The Guardian reported. The project is a central part of the vaccine vision of Robert F. Kennedy Jr., the secretary of the U.S. Department of Health and Human Services and a longtime vaccine opponent. At an anti-vaccine conference last month, Kennedy praised the Danish researchers behind the trial and touted U.S.-supported research on hepatitis B in newborns as exemplifying the Trump administration’s agenda for vaccines, which has included slashing 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 would never be able to do the trial in the United States 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?” Offit said.

An ethics committee at the researchers’ home institution, the University of Southern Denmark, voted this week to proceed with the trial, and officials in Guinea-Bissau have also greenlit the project, according to The Guardian. The health minister, Quinhin Nantote, initially said the trial was suspended after international uproar earlier this year. Stig Børsen Hansen, a founding member of the committee and one of two reviewers who presented the study to the Danish committee, 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 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.” Three other members of the committee have also resigned in protest.

Ars Technica reported that the CDC’s director’s office told the agency’s budget office in late September to set aside $1.6 million to fund the trial, according to a report by Rolling Stone. The money was to be pulled from funding for the CDC’s global health security programs, which might otherwise go toward efforts like combating the Ebola outbreak currently raging in the Democratic Republic of the Congo. The Department of Health and Human Services, which oversees the CDC, did not respond to a request for comment from Ars Technica. The Guardian reported that the CDC has set aside $1.6 million in this year’s budget for the project, to be matched with private funding from the Pershing Square Foundation, co-founded by billionaire activist Bill Ackman, and the Bluebell Foundation. The CDC, the Danish researchers, Pershing Square and Nantote have not responded to the Guardian’s questions about the trial. CIDRAP News first reported on Thursday that the trial was approved by the Denmark ethics committee.

The Guinea-Bissau study protocol has changed since it was posted in January, according to details shared with The Guardian. The researchers will now test mothers for hepatitis B before they give birth. The babies of mothers who test positive will be given the vaccine and will not be included in the trial. But the babies of mothers whose tests are negative may be enrolled. The new protocol has not been shared publicly.

In previous research, half of children who contracted hepatitis B did so after birth, through community exposures. Offit said the virus can be transmitted casually, can live on surfaces for up to seven days, and can be acquired by sharing washcloths, toothbrushes and fingernail clippers. In addition, 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.

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 in the unvaccinated group, said Henrik Støvring, a professor of statistics and pharmacometrics at Aarhus University in Denmark. 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 it changed the rules in order 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,” Støvring said. The national ethics committee in Denmark oversees medical research, but this study was 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, adding that several conditions make it a better location.