A controversial research trial that will withhold hepatitis B vaccines from some African newborns was given approval to move forward this week. It is a central part of the vaccine vision for Robert F Kennedy Jr, the secretary of the US Department of Health and Human Services (HHS) and a longtime vaccine opponent. At an anti-vaccine conference last month, Kennedy praised the Danish researchers behind the trial and touted US-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. An ethics committee at the researchers’ home institution of the University of Southern Denmark voted this week to proceed with the trial, and officials in Guinea-Bissau have also greenlit the project, which the health minister, Quinhin Nantote, initially said was suspended after international uproar earlier this year. Stig Børsen Hansen, a founding member who was one of two reviewers who presented the study to the Danish committee, resigned from the group in protest on Friday, citing major ethical issues with the study.
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. Three other members of the committee have also resigned in protest. The US Centers for Disease Control and Prevention (CDC) has reportedly set aside $1.6m in this year’s budget for the project, and it will be matched with private funding from the Pershing Square Foundation, which was co-founded by the 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 this trial. The news that the trial was approved by the Denmark ethics committee was first reported on Thursday by CIDRAP News. This is the first time details of the updated protocol have been disclosed.
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.
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