CDC, JUDY SCHMIDTIf the risks are low, researchers could be permitted to study the anthrax vaccine in children, according to a 146-page report released today (March 19) by the Presidential Commission for the Study of Bioethical Issues. The commission was tasked with investigating the issue in the fall of 2011 after the National Biodefense Science Board (NBSB) recommended trial of the anthrax vaccine in children.
“This was one of the most difficult ethical reviews that any bioethics commission has ever conducted,” the commission's chair, Amy Gutmann, president of the University of Pennsylvania, told ScienceInsider. On one hand, understanding appropriate usage and dosage of such a vaccine in children is critical for an effective response in the face of a bioterrorist threat. On the other hand, the study would likely expose children to certain risks and may offer no benefit to trial participants.
In weighing these considerations, the commission emphasized that the risks, such as soreness around an injection site, should be “minimal.” Such risks could be demonstrated in a study of young adults, such as those in the US military who have already received the vaccine—made from an inactivated protein from the anthrax bacterium—and teenagers, before testing it in younger age groups. Under “extraordinary circumstances,” a trial of children could take place under slightly greater, though still minor, risks, such as low fever. In this case, the study would need to be reviewed and approved by a national ethics panel, as dictated by existing rules.
“Many steps would have to be taken” before launching a trial of children, Gutmann told ScienceInsider, but added that “it is not our intent to determine whether or not the government goes ahead.” The report simply provides an ethical “framework” for considering such a trial.