FDA Seeks Public Comment on Clinical Trial of Smallpox Vaccine in Children
In a "highly unusual" move, the FDA is seeking public comment on a proposed clinical trial of the smallpox vaccine in children, the AP/Nando Times reports. The agency's research oversight boards had "mixed reaction" to the proposed trial, which would take place at the University of California-Los Angeles and Cincinnati Children's Hospital. Under the trial protocol, researchers would vaccinate 40 two- to five-year-olds; children with compromised immune systems or skin diseases, such as eczema, or children with a family member who has those conditions, which can increase the risk of vaccine side effects, would be excluded from the study. In addition, children who live with a pregnant woman or an infant would not be eligible for the study because children younger than age one are at "significantly higher risk of a vaccine-caused brain infection," the AP/Times reports. The study protocol also calls for "inoculation sites" to be covered with a bandage that "proved very effective at preventing spread of the vaccine's virus" during adult studies. Dr. Karen Midthun, head of vaccine research at the FDA, said that although children are likely to remove their bandage, this one is "extra sticky" and "very, very hard to get off." Still, some are concerned that the vaccine, which is made of live virus and could result in to death for 15 of every one million people who receive it, could put the participants -- and their families -- at undue risk (Neergaard, AP/Nando Times, 11/1). Vera Sharav, president of the Alliance for Human Research Protection, said, "I think putting children at risk as subjects in a clinical trial with such a controversial vaccine is unconscionable" (Ricks, Long Island Newsday, 11/1). Joel Ward, lead researcher in the UCLA study, said, "This is an unusual time, it's an unusual need and I think the risks are not totally insignificant. So I think this extra care is appropriate" (AP/Nando Times, 11/1).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.