A controversial hepatitis B vaccine trial approved by a Danish ethics committee will now proceed in Guinea‑Bissau, involving 14,000 newborns. The study, championed by Robert F. Kennedy Jr., the U.S. Department of Health and Human Services secretary and a long‑time vaccine critic, will give half of the infants a birth dose while withholding it from the other half for six weeks.
The trial raises significant ethical questions. Several members of the University of Southern Denmark’s research ethics committee resigned in protest, citing the risk that children left unvaccinated could contract hepatitis B during a period when the virus can be transmitted casually. Experts such as Paul Offit and Henrik Støvring argue that the study places children in a “lottery” that contravenes standard care recommendations.
Funding for the project includes $1.6 million from the U.S. Centers for Disease Control and Prevention and matching private contributions from the Pershing Square Foundation and the Bluebell Foundation. The protocol has been updated to test mothers for hepatitis B before birth; infants of positive mothers will receive the vaccine and be excluded from the trial, while those of negative mothers may be enrolled. Guinea‑Bissau, which has an adult hepatitis B prevalence of about 18 %, plans to begin universal newborn vaccination in 2028.
Reactions from public health officials have been mixed. The African CDC has expressed opposition, and U.S. officials say discussions are ongoing. Critics, including Offit, describe the delay in standard care as “unethical and cruel,” noting that the study’s focus on speculative outcomes conflicts with WHO guidance that newborns receive the vaccine at birth.
