US health agency reportedly ready to fund contested hepatitis B vaccine trial on newborns in Guinea-Bissau
The US Centers for Disease Control and Prevention has reportedly moved to set aside $1.6 million for a trial in Guinea-Bissau in which half of newborns would not receive the hepatitis B vaccine. Health experts say the design is unethical.
The US Centers for Disease Control and Prevention (CDC), the country's main public health agency, is reportedly still eager to fund a study in the West African country of Guinea-Bissau that would leave newborns exposed to hepatitis B. The plan has prompted outrage among health experts. The trial was suspended in January after its design drew international criticism.
The funding
According to a Rolling Stone report, staff in the CDC director's office told the agency's budget office in late September to set aside $1.6 million. The money was to come from the CDC's global health security programs, which could otherwise support efforts such as responding to the Ebola outbreak in the Democratic Republic of the Congo. The Department of Health and Human Services, which oversees the CDC, did not respond to Ars Technica's request for comment.
In December, the CDC announced an unsolicited $1.6 million grant to a research group at the University of Southern Denmark, led by married couple Christine Stabell Benn and Peter Aaby. Their studies have been promoted by anti-vaccine advocates, and Danish authorities are investigating them over allegations of falsification and scientific misconduct in earlier vaccine research.
The design and the criticism
The trial would enroll 14,000 newborns: half would receive a birth dose of hepatitis B vaccine and half would not. The aim is to look for alleged harms from the birth dose, even though decades of global use have shown it to be safe and effective. Unvaccinated newborns risk a lifelong infection that can lead to cirrhosis, liver cancer and premature death. In February, the World Health Organization said resource constraints cannot justify withholding proven care in research.
Rolling Stone reports the design has been revised so that mothers are asked about hepatitis B infection and a small share are tested. Critics say this does not remove the ethical problem of an unvaccinated group. The University of Southern Denmark and an ethics committee in Guinea-Bissau have approved the revised plan, but national authorization is still required. The advocacy group Stand Up for Science has vowed to block the trial.
