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July 12, 2002

U.S. IMMUNIZATION NEWS

"Approval Delayed on Inhaled Vaccine"

Los Angeles Times (www.latimes.com) (07/12/02) P. 3; Gellene, Denise

Efforts to get government approval for the first inhaled flu vaccine were stymied after the Food and Drug Administration (FDA) called for more information about the vaccine from its manufacturer.  MedImmune CEO David M. Mott said the FDA had nearly 70 questions about the manufacturing and clinical data that had been turned in about FluMist, but the majority of the questions were considered minor.  The FDA was particularly concerned about the safety of using the drug in children under the age of three, especially those with asthma; the agency expressed concern about an elevated incidence of asthma and wheezing in asthmatic toddlers who received the vaccine, according to Mott.  Mott said his company should be able to answer the FDA's questions within the next 30 to 45 days.

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