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FDA Approves Shipping of Fluarix Quadrivalent Vaccine
GlaxoSmithKline vaccine is first quadrivalent flu vaccine; 10 million doses expected to be provided

TUESDAY, Aug. 6 (HealthDay News) -- The U.S. Food and Drug Administration has approved shipping of the GlaxoSmithKline (GSK) 2013 to 2014 Fluarix Quadrivalent influenza virus vaccine to U.S. Centers for Disease Control and Prevention's distribution centers and U.S. health care providers.

The Fluarix Quadrivalent influenza vaccine received FDA approval on Dec. 14, 2012, for immunization of children (aged 3 and older) and adults. The vaccine contains two A virus strains and two B virus strains, and is the first quadrivalent vaccine.

The Fluarix Quadrivalent influenza vaccine will soon be supplied to U.S. health care providers who placed orders late last year, after FDA approval. The largest order will go to the CDC, and these more than four million doses will be allocated to U.S. state and local health care providers. GSK estimates that it will provide up to 10 million doses of quadrivalent vaccines in the United States, and will supplement with trivalent seasonal influenza vaccines.

"Trivalent (three-strain) influenza vaccines offer important protection against influenza. But since the late 1980s, scientists noted that two B virus lineage strains circulate to varying degrees each year, and it's difficult to predict which one will cause the most illness in a particular influenza season," Leonard Friedland, M.D., vice president of Scientific Affairs and Public Policy, GSK North America, said in a statement. "Fluarix Quadrivalent addresses this by protecting against both B strains."

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April 18, 2014

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