CDC Faces Backlash Over Funding Controversial Hepatitis B Vaccine Study in Guinea-Bissau

The US Centers for Disease Control and Prevention has earmarked $1.6 million to resume a suspended hepatitis B vaccine trial in Guinea-Bissau that international bioethicists have condemned as a breach of the Declaration of Helsinki, according to reports from Ars Technica and CIDRAP. The funding decision, communicated by the CDC director's office to the agency's budget office in late September, would divert resources from programs currently supporting the Ebola response in the Democratic Republic of Congo.

Trial design and the Helsinki question

The proposed study, led by Christine Stabell Benn and Peter Aaby of the University of Southern Denmark's Bandim Health Project, would enroll 14,000 newborns in Guinea-Bissau. Half would receive a birth dose of hepatitis B vaccine; the other half would not. Birth-dose hepatitis B vaccination has been the global standard of care for decades. CIDRAP reports that nearly one in five people in Guinea-Bissau carries the virus, with 15% to 25% of chronic cases resulting in liver cancer or failure.

The ethical objection rests on a specific provision of the Declaration of Helsinki: trial arms must receive the "best proven intervention," defined independently of whatever routine the host country currently practices. Guinea-Bissau does not yet administer birth doses, and authorities plan to begin universal birth-dose vaccination in 2028, but Aaby and Stabell Benn maintain that withholding the vaccine from one arm is defensible because it does not fall below existing national policy. Outside researchers, including Stand Up for Science, argue the position cannot be reconciled with the Helsinki standard.

Status of approvals and unresolved variables

The trial was suspended in January 2026 by Guinea-Bissau's public health minister at the time, Quinhin Nantote, who cited insufficient ethical and technical review. CIDRAP now reports that University of Southern Denmark dean Jakob Grauslund approved the revised protocol on the basis of an independent ethics committee assessment, and that Guinea-Bissau's national ethics committee cleared it over the summer. Final governmental authorization in Guinea-Bissau is still pending.

Two procedural questions remain open. First, the Danish researchers face an ongoing investigation by Danish authorities into allegations of "falsification" and "scientific misconduct" in prior vaccine work, a status that has not, on the public record, been adjudicated. Second, the post-coup government in Guinea-Bissau (since November 2025) has not indicated whether it will lift its earlier suspension. The Department of Health and Human Services, which oversees the CDC, declined to comment to either outlet, and the $1.6 million sits allocated but not yet disbursed.