An ethics committee at the University of Southern Denmark voted this week to proceed with a research trial in Guinea-Bissau that will enroll approximately 14,000 infants. Under the study protocol, half of the newborns will receive the hepatitis B vaccine at birth while the other half will have the vaccine withheld for the first six weeks of life. The trial has received approval from health officials in Guinea-Bissau, though initial international criticism led the health minister to previously state the project was suspended.
The research has drawn significant opposition from medical ethics professionals. Four members of the Danish ethics committee have resigned in protest, with one founding member citing concerns that randomly selected infants face risk of contracting hepatitis B during their earliest days of life. Critics argue the trial raises ethical concerns that would prevent its approval in the United States. The updated study protocol includes maternal hepatitis B testing before birth, with infants born to mothers who test positive excluded from the trial and vaccinated. However, the new protocol has not been publicly shared.
The project has financial backing from the US Centers for Disease Control and Prevention, which has reportedly allocated $1.6 million in this year’s budget, matched with private funding from the Pershing Square Foundation and the Bluebell Foundation. The trial is associated with Danish researchers who have operated the Bandim Health Project in Guinea-Bissau for decades. Secretary Kennedy has publicly praised the Danish research team at an anti-vaccine conference, describing them as central to the Trump administration’s vaccine agenda, which has included reducing vaccine recommendations.
Medical experts have raised technical concerns about the study design. Guinea-Bissau has among the world’s highest hepatitis B rates, with approximately 18% of adults carrying the virus. Hepatitis B can be transmitted through casual contact via surfaces, contaminated items, or other household members, and the hepatitis B test carries a 5% false negative rate. Children infected with hepatitis B in their first year of life face significantly elevated risk of chronic infection and liver cancer.
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