An ethics committee at the University of Southern Denmark voted this week to authorize a research study that will enroll approximately 14,000 infants in Guinea-Bissau. The trial design calls for administering the hepatitis B vaccine to half of the newborns at birth while delaying vaccination in the other half for the first six weeks of life.
The trial has generated significant controversy among medical professionals and ethics experts. Several members of the Danish ethics committee have resigned in protest, citing major ethical concerns with the study design. One committee member stated that children randomly assigned to the unvaccinated group face risk of contracting hepatitis B in their earliest days of life and that infection would occur “by design” as part of the research project. Another expert noted that decades of research demonstrate the vaccine’s benefits, making it unfair to withhold it from some participants.
The study has connections to Robert F. Kennedy Jr., the current secretary of the US Department of Health and Human Services. Kennedy has promoted the research and praised the Danish scientists leading the trial at an anti-vaccine conference. The CDC has reportedly allocated $1.6 million toward the project, matched with private funding from the Pershing Square Foundation and the Bluebell Foundation.
The trial protocol was modified since it was initially posted in January. Researchers will now test mothers for hepatitis B before delivery, vaccinating infants born to mothers who test positive and excluding them from the trial. However, the updated protocol has not been publicly shared. Medical experts have raised additional concerns, noting that hepatitis B can be transmitted through casual contact after birth and that the hepatitis B test carries a 5% false negative rate.
Guinea-Bissau has among the world’s highest rates of hepatitis B infection, with approximately 18% of adults carrying the virus. The country’s health system has longstanding ties to Danish researchers who have operated health programs there for decades.
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