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In June 2003, the FDA approved the use of a live attenuated influenza virus vaccine (LAIV, FluMist) for the prevention of influenza among healthy individuals aged 5 to 49 years. Now, the expanded approval extends its use to healthy children aged 2 to 5 years. Three studies submitted to the FDA supported the vaccine’s safety. The studies evaluated approximately 6400 children. In the single study comparing LAIV with inactivated influenza vaccine (TIV), significantly fewer children in the LAIV group than in the TIV group acquired influenza (1.4% vs. 2.4%).
Comment
The new studies submitted to the FDA, as well as previous studies of LAIV, have shown LAIV to be equivalent or superior to TIV, particularly when the vaccine a…