CDC director’s office ordered $1.6 million reserved for Guinea-Bissau trial — Ars Technica
Staff at the office of the director of the US Centers for Disease Control and Prevention (CDC) instructed the agency’s budget office in late September to reserve $1.6 million for a suspended trial of hepatitis B vaccination for newborns in Guinea-Bissau. Ars Technica reports, citing Rolling Stone. The funds were planned to be taken from CDC funding for global health security programs.
The trial involves 14,000 newborns: half were to receive a dose of hepatitis B vaccine at birth, while the other half were not. Its purpose is to test claims of possible harm from this vaccination, although the birth dose has been used worldwide for decades and, according to the publication, is safe and effective.
The study was suspended in January
Guinea-Bissau’s authorities suspended the study in January following international criticism of its design. The country’s health minister, Kvinin Nantote, said at the time that there had not been sufficient coordination for a final decision on the project, while ethical and technical assessments were still ongoing.
Guinea-Bissau has a high prevalence of hepatitis B. Infants who are not vaccinated immediately after birth may develop a chronic infection that can lead to cirrhosis, liver cancer, and premature death. The country’s authorities plan to begin universal use of the birth dose in 2028, but currently lack the necessary resources and infrastructure.
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Criticism of the trial’s ethics
The study is to be conducted by a group from the University of Southern Denmark led by Christine Stabell Benn and Peter Aaby. They argued that the trial is not unethical because newborns in the country do not yet receive this vaccination routinely. At the same time, outside experts cited the Declaration of Helsinki, which requires research participants to be provided with the best proven medical intervention.
In February, the World Health Organization said that withholding vaccination as part of such a study is unethical. WHO stressed that limited resources cannot be grounds for denying proven medical care to research participants.
After the study design was revised, researchers plan to ask mothers whether they have hepatitis B and test a small portion of them for the infection. However, the trial still cannot begin without final government approval from Guinea-Bissau. According to Ars Technica, Danish authorities are investigating allegations of data falsification and scientific misconduct related to previous vaccine studies by Stabell Benn and Aaby.
