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FDA Approves Expanded Label for FluMist(R) to Include Children Two to Five Years of Age
Date:9/19/2007

mpared with those who received the traditional flu shot (4.5 percent vs. 9.8 percent, respectively).(1) 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.

In 48 completed clinical trials, more than 48,000 subjects ranging in age from six weeks to more than 90 years of age received FluMist. In addition to the clinical trial experience, approximately 60,000 doses of FluMist have been administered in two post-marketing studies, and approximately seven million doses of FluMist have been distributed for use in individuals five to 49 years of age following licensure of the product in 2003 through the 2006-2007 influenza season. 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 body's natural response to an influenza infection.

"The FDA approval of FluMist for young children is important because these young kids have very high attack rates for influenza, often require medical evaluation for their influenza illness, and can spread influenza easily to others," said Pedro Piedra, M.D., professor, Department of Molecular Virology and Microbiology, and Pediatrics, Baylor College of Medicine. "Also, the live attenuated influenza vaccine is quite effective in helping prevent influenza and is generally very acceptable to children and their parents since it is administered by nasal spray rather than a shot."

Influenza's Impact on Young Children

The flu is most prevalent in school-age children, as the virus travels easily from person to person and because children in this age group spend a large part of their day in close contact with other children. Children two to 17 years of age are twice as likely to get influenza than adults, including the elderly.(2) During a widespread outbreak, the rate of fl
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SOURCE MedImmune, Inc.
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