Wyeth RotaShield fever-related hospitalization rate needs further study -- FDA advisory committee.
Executive Summary
WYETH ROTASHIELD HOSPITALIZATION RATE SHOULD BE STUDIED, FDA's Vaccines and Related Biological Products Advisory Committee agreed at a Dec. 12 meeting to review the live oral tetravalent vaccine for the prevention of rotavirus gastroenteritis in infants. The committee voted unanimously that Wyeth-Ayerst's RotaShield is moderately effective in overall rotavirus gastroenteritis prevention and shows greater efficacy in the prevention of severe disease.
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