An ethics committee at the University of Southern Denmark approved a research trial this week that will enroll 14,000 infants in Guinea-Bissau, administering hepatitis B vaccines to half of the newborns at birth while withholding the vaccine from the other half for the first six weeks of life. The trial has drawn significant controversy and ethical concerns from medical professionals and researchers.
Several members of the Danish ethics committee resigned in protest following the approval. One founding member cited major ethical issues with the study design, noting that infants randomly selected not to receive the vaccine face risk of contracting hepatitis B in their earliest days. The committee member stated that children who contracted the virus would do so “by design” as part of the research project. Three additional committee members also resigned in protest after the approval.
The trial is supported by HHS Secretary Robert F. Kennedy Jr., who has long opposed vaccines. Kennedy has cited the research as exemplifying the Trump administration’s vaccine agenda, which includes reducing vaccine recommendations. Medical experts have raised concerns that Kennedy could not conduct such a trial in the United States due to ethical constraints, and have questioned whether the trial is proceeding in Guinea-Bissau because children there may be viewed differently than those in the United States.
The trial protocol has been modified since its initial posting in January. Researchers will now test mothers for hepatitis B before birth, with infants born to mothers testing positive receiving the vaccine and remaining outside the trial. However, the updated protocol has not been made publicly available. Guinea-Bissau has among the highest hepatitis B rates globally, with approximately 18% of adults carrying the virus. Medical professionals have noted that hepatitis B can be transmitted through casual contact and that children infected during infancy face significantly increased risks of severe outcomes, including chronic infection and liver cancer.
Funding for the trial includes $1.6 million from the US Centers for Disease Control and Prevention budget, matched with private funding from the Pershing Square Foundation and the Bluebell Foundation. The CDC, Danish researchers, funding organizations, and Guinea-Bissau officials have not responded to inquiries about the trial.
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