Controversial Infant Hepatitis B Vaccine Trial Approved in Guinea-Bissau

A controversial clinical trial that involves withholding the hepatitis B vaccine from thousands of newborns has received approval to proceed in Guinea-Bissau. Conducted by Danish researchers associated with the Bandim Health Project, the trial plans to enroll 14,000 infants. Half of the enrolled newborns will receive the recommended hepatitis B vaccine at birth, while the other half will have the dose withheld for their first six weeks of life.

The study has drawn praise from Robert F. Kennedy Jr., Secretary of the U.S. Department of Health and Human Services (HHS), who highlighted the research at a recent conference as aligned with administrative goals regarding vaccine policies. U.S. medical experts, including infectious disease physician Dr. Paul Offit, have expressed strong ethical concerns, noting that such a study could not be conducted in the United States due to the risks posed to infants in the control group.

ETHICAL DISPUTES AND COMMITTEE RESIGNATIONS

The institutional ethics committee at the University of Southern Denmark approved the project after altering its internal rules to review international medical studies. Following the vote, four committee members resigned in protest, including reviewer Stig Børsen Hansen. Opponents argue that withholding the vaccine exposes infants to significant risks of acquiring hepatitis B through casual contact, environment, or false-negative maternal tests.

Under an updated, unreleased protocol, researchers plan to test pregnant mothers for hepatitis B prior to delivery. Infants of mothers who test positive will receive the birth dose and be excluded from the trial, while babies of mothers who test negative may be randomized. However, health experts point out that hepatitis B can survive on surfaces for up to seven days and spread through casual household exposures, making early protection critical in high-prevalence areas. Guinea-Bissau has an adult hepatitis B prevalence rate of approximately 18%.

FUNDING AND LOCAL GOVERNANCE

Officials in Guinea-Bissau have approved the research, despite earlier statements from Health Minister Quinhin Nantote indicating the project had been suspended following international backlash. The trial is scheduled to receive $1.6 million from the U.S. Centers for Disease Control and Prevention (CDC) budget, alongside matching private funds from the Bluebell Foundation and the Pershing Square Foundation, co-founded by Bill Ackman. The trial will focus on evaluating mortality rates alongside neurodevelopmental and skin conditions.