Flumist advisory committee
Executive Summary
MedImmune says Dec. 17 is a "tentative date" for FDA's Vaccines & Related Biological Products Committee to review Flumist. "Based on our dialogue with FDA, we expect a discussion at the meeting to focus around age range of children and adults for which we have adequate data of FluMist. We expect the discussion to be around the risks of elevated wheezing episodes in the subpopulation of children less than 5 years of age," MedImmune says. FDA's advisory committee agreed in July 2001 that MedImmune and partner Wyeth did not provide adequate safety data to recommend approval of the intranasal flu vaccine (1"The Pink Sheet" July 30, 2001, p. 4)...