Key facts
- CDC is reportedly still eager to fund a controversial vaccine trial in Guinea-Bissau.
- The trial aims to expose newborns to hepatitis B without vaccination to find alleged harms.
- The trial was suspended in January but the CDC is seeking to allocate $1.6 million for it.
- The lead researchers, Christine Stabell Benn and Peter Aaby, are under investigation for scientific misconduct.
- The World Health Organization has stated that withholding the vaccine in the trial is unethical.
The Centers for Disease Control and Prevention (CDC) is reportedly still seeking to fund a controversial vaccine trial that would expose newborns in Guinea-Bissau to hepatitis B without vaccination, despite international outcry and ongoing investigations into the lead researchers. The trial, suspended in January, aims to find alleged harms from the hepatitis B vaccine, a practice deemed unethical by global health experts.
According to a report by Rolling Stone, CDC staff informed the agency's budget office in late September to set aside $1.6 million for the trial, to be pulled from global health security programs. The Department of Health and Human Services, which oversees the CDC, did not respond to a request for comment.
If the trial proceeds, it would be funded by the US but run by Danish researchers Christine Stabell Benn and Peter Aaby, who are currently under investigation by Danish authorities for alleged "falsification" and "scientific misconduct" related to previous vaccine research. In December, the CDC had announced an unsolicited grant of $1.6 million to their research group at the University of Southern Denmark.
Guinea-Bissau officials suspended the research in January, stating that ethical and technical reviews were ongoing. Quinhin Nantote, the minister of public health for Guinea-Bissau, said at the time that a final decision had not been made.
The trial intends to enroll 14,000 newborns, with half receiving a hepatitis B vaccine dose at birth and the other half not. This design has drawn criticism because the newborn dose of the hepatitis B vaccine is considered safe and effective after decades of global use. Experts, including the World Health Organization, argue that withholding a proven intervention is unethical, especially when the trial's premise is based on hypothetical safety outcomes without sufficient credible evidence. The WHO also stated that resource constraints cannot justify withholding proven care and that ethical obligations require minimizing risk and ensuring a prospect of benefit for participants.
While the trial's design has been revised to ask mothers about their hepatitis B infection status and test a fraction of them, concerns about the unvaccinated group remain. Researchers at the University of Southern Denmark have approved the revised design, and a relevant ethics committee in Guinea-Bissau has reportedly signed off. However, final government authorization from Guinea-Bissau is still required for the trial to begin. Nonprofit advocacy group Stand Up for Science has vowed to block the study, calling it a "gross violation of human rights."