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April 09, 2003

U.S. IMMUNIZATION NEWS

"Vaccine Testing on Kids Blocked"

Los Angeles Times (www.latimes.com) (04/08/03) P. 3; Ornstein, Charles

A controversial study to test the effects of the smallpox vaccine on children has been sidelined by opponents who say the trial is fraught with risks.  In a joint statement issued Jan. 24, the U.S. Department of Health and Human Services and the Food and Drug Administration wrote that "there is no justification for this particular clinical investigation to proceed."  The board that reviews research proposals at the UCLA Center for Vaccine Research at Harbor-UCLA had been divided over whether the benefits of the study outweighed the risks, and eventually requested that the federal government get involved in the decision-making process.  The study--which would have used 40 two- to five-year-olds to see whether diluted doses of the vaccine would retain its potency--had been endorsed by the National Institute of Allergy and Infectious Diseases; but, in their letter, the federal officials said that because bioterrorism preparedness plans do not call for children to receive diluted vaccine, such research was not necessary.

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