Guinea-Bissau Suspends Trump-Backed Hepatitis B Vaccine Study Amid Ethical Concerns
Key Insights
Guinea-Bissau has suspended a $1.6 million Trump administration-funded hepatitis B vaccine study on newborns pending an ethical review after a six-person ethics committee failed to meet during the initial confirmation process.
The controversial randomized controlled trial would withhold proven hepatitis B (search) vaccines from some newborns at significant infection risk, raising ethical alarms among public health experts.
The study was awarded to University of Southern Denmark researchers who have been cited by anti-vaccine activists and whose work has been questioned by leading public health experts.
Guinea-Bissau has suspended a Trump administration-backed hepatitis B vaccine study on newborns, pending an ethical review, Health Minister Quinhi Nantot announced during a news conference held by the Africa Centers for Disease Control and Prevention (search). The suspension comes after a six-person ethics committee failed to meet during the initial confirmation process to review the controversial research.
The study represents a $1.6 million, no-bid contract awarded by the Trump administration to scientists at the University of Southern Denmark. The research team has been cited by anti-vaccine activists and their work has been questioned by leading public health experts, adding to concerns about the study's scientific merit and ethical framework.
Study Design Raises Ethical Alarms
The research is designed as a randomized controlled trial that would withhold hepatitis B (search) vaccines from some infants while giving them to others. Children participating in the study would be tracked for death, illness and long-term developmental outcomes. Some experts have suggested that the research plan is unethical because it will withhold vaccines that work from newborns at significant risk of infection.
Research and widespread medical consensus holds that the hepatitis B vaccine protects newborns, making the decision to withhold it from some babies particularly concerning to public health experts. The study was set to begin early this year in Guinea-Bissau, an impoverished West African nation where hepatitis B (search) infection is common.
Research Scope and Timeline
The researchers are funded for five years to study 14,000 newborns in total. Most of the children will be followed for less than two years to look for side effects, but the first 500 enrolled will be followed for five years to look for behavior and brain development problems. As initially designed, there was no placebo involved in the study protocol.
The U.S. Centers for Disease Control and Prevention (search) awarded the grant to a research team led in part by Christine Stabell Benn, a consultant for a Kennedy-appointed committee that recently voted to stop recommending a dose of hepatitis B vaccine for all American newborns. The team has been lauded by U.S. Health Secretary Robert F. Kennedy Jr.
Conflicting Statements on Study Status
Despite Guinea-Bissau's suspension announcement, U.S. health officials maintained that the study would proceed as planned. "The study is proceeding as planned, and we continue to work with our partners to finalize the study's protocols," Andrew Nixon, spokesman for the U.S. Department of Health and Human Services (search), said in a statement on Wednesday.
Africa CDC Director-General Jean Kaseya expressed full support for the ethical review while emphasizing the agency's relationship with the U.S. government. "We are led by the interests of our people in Africa," Kaseya said. "We are not led by the small interests of individual people." He highlighted the agency's "excellent relationship" with the U.S. government despite the current disagreement over study protocols.
Nixon did not release additional details about the current version of the study design, leaving questions about potential modifications to address the ethical concerns that prompted Guinea-Bissau's suspension of the research.