HHS Decision Blocks Trial To Test Smallpox Vaccine in Children
Officials from HHS and the FDA have blocked a study that would have tested the effectiveness of diluted doses of the smallpox vaccine in children ages two to five, the Los Angeles Times reports. In a Jan. 24 letter to Torrance, Calif.-based Harbor-UCLA Medical Center, which proposed the study, federal officials wrote that "there is no justification for this particular clinical investigation to proceed." A Harbor-UCLA board that reviews human research could not reach agreement on whether to conduct the study and asked the federal government to make a decision, the Times reports (Ornstein, Los Angeles Times, 4/8). The FDA last November sought public comment on the study, which would have taken place at Harbor-UCLA and Cincinnati Children's Hospital. Researchers would have vaccinated 40 two- to five-year-olds; the study would not have included 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. In addition, children who live with a pregnant woman or an infant would not have qualified for the study because children younger than age one have a higher risk of a brain infection from the vaccine (California Healthline, 11/1/02). The FDA received hundreds of comments that criticized the study. "The vaccine has tremendous life-threatening risks attached to it. There's no justification for exposing healthy little children to that kind of risk," Vera Sharav, president and founder of the Alliance for Human Research Protection, said. Dr. Joel Ward, director of the Center for Vaccine Research at Harbor-UCLA, said that the study was "too controversial" to conduct and that the public "was profoundly against giving the vaccine to children" (Los Angeles Times, 4/8).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.