CDC seeks $1.6 million for suspended Guinea-Bissau vaccine trial
The Centers for Disease Control and Prevention is reportedly pursuing $1.6 million in funding for a hepatitis B vaccine trial in Guinea-Bissau that would expose newborns to the virus without vaccination, despite the trial being suspended in January following international outcry over its ethical design. The CDC director's office instructed the agency's budget office in late September to allocate the money, which would be diverted from global health security programmes that might otherwise fund efforts to combat the current Ebola outbreak in the Democratic Republic of the Congo.
The trial would enrol 14,000 newborns in Guinea-Bissau, with half receiving a birth dose of hepatitis B vaccine and half remaining unvaccinated, despite decades of evidence showing the vaccine is safe and effective. The trial is being conducted by Danish researchers Christine Stabell Benn and Peter Aaby, who are currently under investigation by Danish authorities for alleged scientific misconduct and falsification in previous vaccine research. International health bodies, including the World Health Organisation, have condemned the trial as unethical, arguing that ethical guidelines require providing the "best proven intervention"—a birth dose of the vaccine—regardless of the country's current standard of care, and that withholding it puts infants at risk of chronic, potentially life-threatening infection.
- CDC allocates $1.6 million for trial leaving 14,000 newborns unvaccinated against hepatitis B
- Trial suspended in January over ethics concerns but funding still being pursued
- WHO and others condemn trial for withholding proven vaccine without valid justification
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A hepatitis B vaccine trial in Guinea-Bissau has sparked international concern over research ethics. The trial would give one group of 14,000 newborns a hepatitis B vaccine at birth, whilst leaving a second group unvaccinated to study the effects. Hepatitis B is a serious liver infection that can cause lifelong health complications in people infected as infants.
The trial is being conducted by Danish researchers Christine Stabell Benn and Peter Aaby, who are currently under investigation by Danish authorities for alleged scientific misconduct in previous vaccine research. The United States Centers for Disease Control and Prevention is now seeking $1.6 million to fund the trial, despite it being suspended in January following international criticism. The funding would be taken from global health security budgets otherwise allocated to initiatives such as the response to the current Ebola outbreak in the Democratic Republic of the Congo.
International health organisations, including the World Health Organisation, have raised ethical objections to the trial's design. They argue that research ethics require providing all study participants with the best available treatment—in this case, the vaccine—rather than withholding it from a control group. They contend that this approach puts infants in the unvaccinated group at risk of serious infection.
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Originally published by Ars Technica as “Outrage grows as CDC reportedly poised to fund “unethical” vaccine trial”.