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MedImmune Announces FDA Approval of First Four-strain Flu Vaccine, FluMist® Quadrivalent (Influenza Vaccine Live, Intranasal)
Date:2/29/2012

GAITHERSBURG, Md., Feb. 29, 2012 /PRNewswire/ -- MedImmune today announced that the U.S. Food and Drug Administration (FDA) has approved FluMist® Quadrivalent (Influenza Vaccine Live, Intranasal) for prevention of influenza. The company submitted the sBLA early in the second quarter of last year.  FluMist Quadrivalent is the first quadrivalent influenza vaccine approved by the FDA.

All other currently available licensed seasonal influenza vaccines are trivalent, containing three strains [two strains of type A influenza (A/H1N1 and A/H3N2) and one B lineage strain].  FluMist Quadrivalent contains four strains (two type A strains and two type B lineages) to help provide broad protection against circulating influenza A and B.

In recent years, influenza B strains from two different lineages (B/Yamagata and B/Victoria) have circulated.  The quadrivalent vaccine includes strains from both lineages, helping provide protection against both B lineages.  The first of its kind approval for FluMist Quadrivalent reinforces MedImmune's commitment to innovation within the infectious disease area.

"According to the Centers for Disease Control and Prevention (CDC), since the 2001-2002 season, influenza B viruses from both lineages have co-circulated in the USA," said Stan Block, MD, FAAP, Professor of Clinical Pediatrics at the University of Kentucky College of Medicine in Lexington and at the University of Louisville School of Medicine. "In the United States, in 5-of-the-10 influenza seasons between 2001 and 2011, the predominant circulating influenza B lineage was different from the one selected for inclusion in the trivalent vaccines. The CDC has estimated that between 2001 and 2009, 2.7 million fewer Americans would have gotten the flu if all influenza vaccines had been quadrivalent.[1]"

In pivotal clinical studies conducted in children and adults 2-49 years of age, FluMist Quadrivalent was compared to two trivalent f
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SOURCE MedImmune
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