Guinea-Bissau Halts Controversial US Vaccine Study Amid Sovereignty and Ethics Dispute
A heated international controversy has erupted over a US-funded hepatitis B vaccine study in Guinea-Bissau, with the west African nation asserting its sovereignty by suspending the trial amid serious ethical concerns. The dispute pits US health officials against African health leaders, highlighting tensions in global medical research practices.
Conflicting Statements on Study Status
While US Department of Health and Human Services (HHS) officials insist the trial will proceed as planned, Guinea-Bissau's recently appointed Health Minister Quinhin Nantote has confirmed to journalists that the study has been "cancelled or suspended." The minister cited inadequate scientific review as the primary reason for halting the research, which was to be led by Danish researchers in one of the world's poorest nations.
Jean Kaseya, director-general of the Africa Centres for Disease Control and Prevention, emphasized that the decision rests solely with Guinea-Bissau. "It's the sovereignty of the country," Kaseya stated during a press meeting. "I don't know what will be this decision, but I will support the decision that the minister will make."
Ethical Concerns and Study Design
The proposed study design has drawn significant criticism from medical professionals. Researchers planned to administer hepatitis B vaccines to 7,000 infants at birth while withholding vaccines from another 7,000 infants until six weeks of age to study overall health effects. This approach contradicts World Health Organization recommendations that all newborns receive the hepatitis B vaccine within 24 hours of birth.
Dr. Abdulhammad Babatunde, a Nigerian medical doctor and global health researcher, condemned the study's methodology. "This is not acceptable," Babatunde said. "To prevent things like the Tuskegee study and others, the control group has to get the standard of care, and the intervention group should get [potentially] better care."
Babatunde further emphasized that funding should focus on promoting vaccine coverage rather than using children as research subjects. "The current reason why the vaccine is not achieving coverage in Guinea-Bissau is because there's no funding, and the funding should try to promote the vaccine, not use children as lab rats," he stated.
US-Africa CDC Tensions Escalate
The controversy has sparked unusually direct criticism between US and African health authorities. An HHS spokesperson dismissed the Africa CDC as "a powerless, fake organization attempting to manufacture credibility by repeating its claims publicly," while Kaseya highlighted his organization's crucial role in responding to global health outbreaks.
Gavin Yamey, professor of global health at the Duke Global Health Institute, stressed that Guinea-Bissau's ministry of health holds the most important voice in this matter. "The most important voice is that of Guinea-Bissau's ministry of health, which is responsible for protecting the health of all Bissau-Guineans," Yamey noted.
Ethics Committee Approval Questions
Further complicating the situation are questions about how the study received initial approval. According to Danish researchers, an early version was approved by Guinea-Bissau's six-person ethics committee on November 5th. However, subsequent updates to the study design were not approved by the committee.
An individual identifying himself as the interim director of Guinea-Bissau's ethics committee told the Guardian that the approved study did not mention that infants would go unvaccinated. The ethical concern centers on withholding vaccines from some newborns at birth when protection is most crucial.
Broader Health Context in Guinea-Bissau
The vaccine study controversy unfolds against a challenging health backdrop in Guinea-Bissau. Less than a quarter of the population has access to basic services like water and sanitation, while poverty and food insecurity remain persistent problems. With limited healthcare access, maternal mortality rates are high, and malaria represents a leading cause of death.
Kaseya acknowledged these challenges while defending Guinea-Bissau's right to determine its own health policies. "The authorities of Guinea-Bissau, they know that," he said. "They are doing their best to address that."
International Response and Next Steps
At Nantote's request, a team of research experts from the Africa CDC will travel to Guinea-Bissau to help officials review the study. Officials from Denmark and the United States have also been invited to participate in the review process.
Babatunde called for solidarity among African nations, stating, "At this moment, it's [time] for other African member states to come support Guinea-Bissau, to maintain their sovereignty and protect the children of Guinea-Bissau."
The HHS, Danish researchers, and the University of Southern Denmark have not responded to inquiries about whether US or Danish ethical committees were consulted, nor have they addressed specific ethical concerns raised about the trial's design.
