Guinea-Bissau is suspending a Trump administration-backed hepatitis B vaccine study on newborns, pending an ethical review, Health Minister Quinhi Nantot announced Thursday. The decision comes amid concerns that the research was designed to withhold a protective vaccine from some infants, raising fundamental questions about research ethics in developing nations.
The suspension marks an escalation of questions about vaccine research being conducted overseas by the Trump administration, particularly involving researchers linked to Health Secretary Robert F. Kennedy Jr. The study’s design—withholding an effective vaccine from control-group infants—conflicts with established medical consensus on the vaccine’s protective benefits.
The Study Design
The hepatitis B vaccine study was designed as a randomized controlled trial. Some newborns would receive the vaccine at birth while others would not. Children were to be tracked for death, illness, and long-term developmental outcomes, including behavioral and brain development problems.
The study was set to begin early this year in Guinea-Bissau, with researchers funded for five years to study 14,000 newborns. Most of the children would be followed for less than two years to look for side effects, but the first 500 enrolled would be followed for five years to assess behavioral and brain development problems.
“A six-person ethics committee didn’t meet to review the study during the initial confirmation process,” Health Minister Quinhi Nantot said during a news conference held by the Africa Centers for Disease Control and Prevention.
Why the Study Raised Alarms
Medical consensus holds that the hepatitis B vaccine protects newborns. Experts have suggested that withholding an effective vaccine from some infants constitutes an ethical violation. Guinea-Bissau is an impoverished West African nation where hepatitis B infection is common, making vaccination particularly important for newborn health.
“Some experts have suggested that the research plan is unethical, because it will withhold vaccines that work from newborns at significant risk of infection,” according to reporting on the study.
The Research Team and Funding
The Trump administration awarded a $1.6 million no-bid contract to the University of Southern Denmark to conduct the study. One of the research team’s leaders is Christine Stabell Benn, who serves as a consultant for a Kennedy-appointed federal committee that recently voted to stop recommending a hepatitis B vaccine dose for all American newborns.
The researchers have been cited by anti-vaccine activists, and their work has been questioned by leading public health experts.
International Response
Africa CDC Director-General Jean Kaseya said he fully supports the ethical review. “We are led by the interests of our people in Africa,” Kaseya said. “We are not led by the small interests of individual people.”
U.S. health officials said the study remains set to proceed. “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, said in a statement.