A controversial clinical trial that withholds hepatitis B vaccines from some African newborns received approval to proceed this week, marking a research project central to vaccine skepticism championed by Robert F. Kennedy Jr., the US secretary of the Department of Health and Human Services.
The University of Southern Denmark's ethics committee voted to allow Danish researchers to enroll 14,000 infants in Guinea-Bissau in the study. Half will receive the hepatitis B vaccine at birth; the other half will have it withheld for the first six weeks of life. Guinea-Bissau officials have also greenlit the project, according to Health Minister Quinhin Nantote.
Kennedy, a longtime vaccine opponent, praised the Danish researchers at an anti-vaccine conference last month. He has advocated for eliminating the birth dose of hepatitis B vaccine in the US, according to Paul Offit, an infectious disease physician at Children's Hospital of Philadelphia.
Four members of the Danish ethics committee have resigned in protest over the trial's design. Stig Børsen Hansen, a founding committee member who presented the study, resigned Friday. He stated that children randomly assigned not to receive the vaccine "face in their earliest days the risk of contracting hepatitis B, which can cause irreversible lifelong damage."
The updated protocol, disclosed for the first time, now includes testing mothers for hepatitis B before birth. Babies of mothers who test positive will receive the vaccine and be excluded from the trial. Babies of mothers who test negative may be enrolled. The new protocol has not been made public, according to the reporting.
Henrik Støvring, a professor of statistics at Aarhus University in Denmark, argued that decades of research showing the vaccine's effectiveness make randomization unethical. He noted the trial could be conducted in Denmark, where the vaccine is not routinely given to newborns unless the mother tests positive. The hepatitis B test carries a 5% false negative rate.
Guinea-Bissau has among the world's highest hepatitis B prevalence rates, with approximately 18% of adults carrying the virus. Children infected in their first year face significantly higher risk of chronic infection and liver cancer.
The CDC has reportedly allocated $1.6 million for the project in its current budget, to be matched by private funding from the Pershing Square Foundation, co-founded by billionaire activist Bill Ackman, and the Bluebell Foundation. The CDC, Danish researchers, foundations and Nantote have not responded to requests for comment.