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FDA Approves Shipping of GSK Four-Strain Flu Vaccine

Influenza ultrastructure illustration (Dan Higgins, CDC)

Influenza ultrastructure illustration (Dan Higgins, CDC)

The global pharmaceutical company GlaxoSmithKline says the U.S. Food and Drug Administration gave its approval to ship the company’s vaccine covering four potential virus strains for the 2013-2014 influenza season. GSK says this year will be the first that vaccines will be available to protect against more than three strains of flu.

FDA approved GlaxoSmithKline’s Fluarix Quadrivalent vaccine in December 2012 for immunizations of adults and children age three years and older. However, FDA also must certify that vaccine supplies meet the agency’s quality and safety standards before a company can begin shipments.

Most influenza vaccines cover three strains, in two of the three subtypes — A and B — associated with seasonal flu, two strains from subtype A most commonly affecting humans and one from subtype B expected to appear in the next flu season. Since the 1980s, however, two strains from subtype B have appeared each year, making it difficult to select only one strain for the annual seasonal vaccine formulation.

GlaxoSmithKline says with the FDA approval, shipments of Fluarix Quadrivalent are expected to begin soon and number some 10 million doses by the end of the flu season. The Centers for Disease Control and Prevention (CDC), says GSK, placed the largest order — more than 4 million doses — which it will distribute to health care providers in the U.S. The agency purchases large quantities of seasonal flu vaccines each year from multiple vendors.

The CDC lists 12 vaccine products available for the 2013-2014 season, including other quadrivalent vaccines by Sanofi Pasteur and MedImmune.

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