A controversial, US-backed hepatitis b vaccine trial involving newborns in Guinea-Bissau has received approval to move forward, reigniting intense debate among international health experts and scientists over medical ethics and trial design.
The $1.6 million research project, funded by the United States Department of Health and the US Centers for Disease Control and Prevention (CDC), plans to enroll 14,000 babies in the West African nation. Under the revised study protocol approved by the University of Southern Denmark, researchers from the Bandim Health Project plan to administer the hepatitis B vaccine to only half of the participating newborns at birth, alongside the BCG and oral polio vaccines. The remaining infants will have the vaccine withheld for the first six weeks of life, receiving their jab at age six weeks instead.
Ethical Concerns and International Pushback
The study faced significant scrutiny earlier this year, leading to a temporary pause in January following widespread outrage from international scientific communities. Organizations including the Africa Centres for Disease Control and Prevention and the World Health Organization (WHO) previously raised objections or concerns regarding the study. The WHO criticized the project, stating it had insufficient scientific justification and exploited scarcity in a developing nation.
Critics point out that roughly 90 percent of infants infected with hepatitis B at birth develop chronic infections, significantly increasing their lifetime risk of severe conditions such as liver cancer and cirrhosis. Opponents argue that withholding standard preventative care places vulnerable infants at unnecessary risk.
Researchers and Sponsors Defend the Project
Despite the backlash, the Danish researchers leading the study—Dr. Peter Aaby and Dr. Christine Stabell Benn—along with their supporters, have defended the research design. In a statement published on the Bandim Health Project website, researchers emphasized that no child enrolled in the study will receive fewer vaccines than what is currently mandated under national policy in Guinea-Bissau.
Currently, Guinea-Bissau does not routinely vaccinate newborns against hepatitis B at birth, though the developing nation has scheduled plans to begin universal newborn vaccinations starting in 2028. Proponents of the clinical trial argue the research aims to observe health differences and evaluate potential long-term effects of the immunization schedule. Meanwhile, the project unfolds against a backdrop of shifting vaccine policies in the United States, where health leadership under the U.S. Department of Health has frequently expressed vaccine skepticism and adjusted domestic infant immunization recommendations.
