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November 1, 2002

U.S. IMMUNIZATION NEWS

"Government Considers When Smallpox Vaccine Study Should Begin for Children" Associated Press (www.ap.org) (11/01/02); Neergaard, Lauran

The Food and Drug Administration (FDA) is asking for public input on a proposal to allow a few toddlers and preschoolers to be vaccinated against smallpox in a study to test the best vaccine dose for children--an idea that raises safety and ethical questions, given that the vaccine can have severe side effects and that newly vaccinated people can transmit smallpox to others. The FDA does not often ask for public comment, but the government fears that terrorists may possess samples of the smallpox virus and could possibly use it in a bioterrorist attack on the United States.  According to federal regulations, special oversight is needed for studies that pose more than a slight risk to children who will not see a significant benefit; however, most experts say the research should take place because of the possible benefit to society.  The study would be sponsored by the National Institutes of Health and would test diluted doses of the smallpox vaccine in children.

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