Government officials in Guinea-Bissau have formally rejected a clinical trial run by Danish researchers and funded by the US that would examine alleged nonspecific harms from the newborn dose of the hepatitis B vaccine. The vaccine is currently recommended globally for all newborns and has been used safely and effectively for decades. Christine Stabell Benn of Bandim Health Project and the University of Southern Denmark said in an email to Ars Technica that the Council of Ministers "formally reaffirmed its non-acceptance of the study on 16 October." She added: "We regret the decision because we considered the study scientifically and ethically justified, but we respect the government's authority to decide whether research may proceed in the country." The rejection followed a police raid on Bandim Health's offices, where judicial police seized vaccines.
The World Health Organization and many outside experts have widely decried the trial as unethical because it would withhold the newborn dose from half of the participants. Given the country's high rates of chronic hepatitis B infection, this could put thousands of babies at risk of lifelong infection, liver cirrhosis, cancer and premature death. The WHO wrote in February that the trial "posits hypothetical safety outcomes without sufficient credible evidence." Outrage intensified after the US Centers for Disease Control and Prevention awarded a $1.6 million unsolicited grant to Bandim Health, which Stabell Benn runs with her husband Peter Aaby. Their work has been praised by anti-vaccine advocates, including US Health Secretary Robert F. Kennedy, but their scientific peers have criticized its quality, and Danish authorities are investigating them for alleged scientific misconduct.
The researchers argue the study is ethical because Guinea-Bissau does not currently offer routine birth doses, so trial participants would not otherwise have received them. Critics, including the WHO, cite the Declaration of Helsinki, which requires trials to provide the "best proven intervention." The WHO stated that "Resource constraints cannot be used to justify withholding proven care in a research study."
Source: Ars Technica · Summarized by HeadlinesBriefing