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

First and Only Nasal Spray Influenza Vaccine for Young Children in U.S.

Available for 2007-2008 Flu Season

GAITHERSBURG, Md., Sept. 19 /PRNewswire/ -- MedImmune, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the expanded use of FluMist(R) (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. Only one manufacturer had previously been licensed in the United States to produce influenza vaccine for children under four years of age.

(Photo: http://www.newscom.com/cgi-bin/prnh/20070919/NEW078-a )

(Photo: http://www.newscom.com/cgi-bin/prnh/20070919/NEW078-b )

MedImmune anticipates shipping FluMist with the expanded label to health care providers in the coming days so that vaccinations may be offered to eligible individuals ahead of and throughout the upcoming influenza season.

"As a company dedicated to innovative advancements in pediatric medicine, MedImmune is delighted to be able to offer FluMist as an option for children as young as two years old to help protect them from influenza," said James F. Young, Ph.D., president, research and development. "With the new, refrigerated formulation approved in January, the results from our head-to- head study published in the February issue of The New England Journal of Medicine, and the expanded age indication now within the label, it is an exciting time for FluMist."

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 co
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SOURCE MedImmune, Inc.
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