Guinea-Bissau hepatitis B vaccine trial faces ethics backlash

The plan

A high-stakes, controversial research trial in Guinea-Bissau has been greenlit to proceed after receiving approval from an ethics committee at the University of Southern Denmark. The study aims to enroll 14,000 infants, randomly assigning them to either receive a hepatitis B vaccine at birth or have it withheld for their first six weeks of life.

This project is a key piece of the "vaccine vision" championed by Robert F. Kennedy Jr., the Secretary of the US Department of Health and Human Services. Kennedy, a vocal vaccine skeptic, has praised the Danish researchers behind the study and advocated for policies that would reduce the reliance on birth-dose vaccinations in the U.S.

Ethical alarm bells

Critics are highkey stressing over the design of this trial. The study creates a "lottery" where infants who lose out on the vaccine face potential exposure to hepatitis B, a virus that can cause irreversible, lifelong damage. Stig Børsen Hansen, who resigned from the review committee in protest, noted that infants who contract the virus during the study do so "by design."

Despite the pushback, the project is backed by $1.6 million from the U.S. Centers for Disease Control and Prevention (CDC) and private funding from the Pershing Square Foundation and the Bluebell Foundation. Several members of the Danish ethics committee have resigned in protest, arguing that such a study would never be permitted under U.S. or European ethical standards.

The context

Guinea-Bissau currently has some of the world's highest rates of hepatitis B. While the research team adjusted their protocol to screen mothers for the virus, experts like Dr. Paul Offit point out that community transmission is a major factor. The virus can live on surfaces for up to a week and be spread through everyday items like washcloths or fingernail clippers. Offit and other professionals have called the trial "cruel" and an exploitation of a developing nation’s healthcare landscape. The WHO and other health bodies strongly recommend birth doses of the vaccine to protect against severe outcomes like chronic infection and liver cancer.

Why it matters

This isn't just about one trial—it’s giving a masterclass in how global health policy is currently being weaponized by political agendas. By testing speculative theories in a region where standard care is delayed, the trial has become a flashpoint for a larger battle over scientific ethics and the future of public health mandates.