Full Breakdown
CDC-Funded Hepatitis B Birth-Dose Trial Stalls Amid Ethical and Political Pushback
By Drooid · · How we work
Core Event
The U.S. Centers for Disease Control and Prevention (CDC) awarded a $1.6 million grant to Danish researchers to conduct a hepatitis B birth-dose trial in Guinea-Bissau, a West African nation where roughly one-in-five people carry the virus. The study planned to enroll 14,000 newborns, randomly assigning half to receive the hepatitis B vaccine at birth and the other half to forego it. The trial is not proceeding because Guinea-Bissau’s health ministry has not granted the required governmental approval.
Background and Context
Guinea-Bissau does not currently give a hepatitis B birth dose but intends to adopt universal newborn vaccination by 2028. The World Health Organization (WHO) has long advised a birth dose, and the CDC previously recommended it until a federal advisory panel, appointed by Health and Human Services Secretary Robert F. Kennedy Jr., voted earlier this year to halt the universal recommendation—a decision later stayed by a Boston judge. Critics note that the vaccine’s safety record spans decades and that the proposed trial’s design—denying half of the participants a proven preventive measure—has been described as “highly unethical and colonialist.”
Official Statements & Responses
The lawmakers requested a staff briefing by early November. CDC officials have not publicly detailed the grant’s approval process.
Criticism and Opposition
The WHO publicly denounced the trial. Dr. Robert Gish, director of the Hepatitis B Foundation, said, “Maternal screening alone cannot prevent transmission.” Dr. Arthur Caplan, founding head of the medical ethics division at NYU Grossman School of Medicine, argued that the $1.6 million would be better spent vaccinating all children in Guinea-Bissau. A University of Southern Denmark ethics committee member warned that “working and reasoning under the pressure of knowing that people might lose their funding short-circuited the process. We reached a bad decision in a bad way.”
Verbatim Quotes
- “Maternal screening alone cannot prevent transmission,” — Dr. Robert Gish, director of the Hepatitis B Foundation
- “Working and reasoning under the pressure of knowing that people might lose their funding short-circuited the process. We reached a bad decision in a bad way,” — committee