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FDA approves expanded label for FluMist (influenza virus vaccine live, intranasal) to include childr

The U.S. Food and Drug Administration (FDA) has approved the expanded use of FluMist (influenza virus vaccine live, intranasal) in children two to five years of age. FluMist is now approved for active immunization for the prevention of disease caused by influenza A and B viruses in individuals two to 49 years of age.1 Only one manufacturer had previously been licensed in the United States to produce influenza vaccine for children under four years of age.

In a pivotal study that included more than 4,000 children between the ages of two and five years of age during the 2004-2005 influenza season, there was a 54 percent reduction in cases of flu in children who received FluMist compared with those who received the traditional flu shot (4.5 percent vs. 9.8 percent, respectively).2 In the study, FluMist demonstrated a reduction in influenza rates compared to the inactivated vaccine against strains that were both matched and mismatched to the vaccine. FluMist is different from the flu shot in that it uses live, attenuated or weakened viruses within the vaccine to help stimulate an immune response that is designed to closely resemble the bodys natural response to an infection.3

FluMist will be available for the 2007-2008 influenza season. For more information about FluMist visit or call 1-877-FLUMIST (1-877-358-6478).


Contact: Maria Dottori
Fleishman-Hillard, Inc.

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