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UPDATE: GlaxoSmithKline Receives FDA Approval To Ship Four-Strain (Quadrivalent) Influenza Vaccine To Healthcare Providers

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GlaxoSmithKline (NYSE: GSK) announced today it has received U.S. Food and Drug Administration (FDA) approval to start shipping 2013-2014 FLUARIX® QUADRIVALENT (Influenza Virus Vaccine) to CDC distribution centers and U.S. healthcare providers. This is the first season that vaccines protecting against more than three strains of influenza (flu) will be commercially available.

Fluarix Quadrivalent was the first intramuscular quadrivalent influenza vaccine approved by the FDA [on December 14, 2012] for the immunization of children (three years and older) and adults to help prevent disease caused by seasonal influenza virus subtypes A and B contained in the vaccine. Before vaccine manufacturers can begin shipping influenza vaccines each season, the FDA first must certify that the supplies to be provided to healthcare providers meet the agency's quality and safety standards.

Scientists classify the influenza strains that cause seasonal influenza as A or B strains. Most current influenza vaccines provide trivalent (three-strain) influenza protection. Trivalent influenza vaccines protect against the two A virus strains most common in humans and the B strain expected to be predominant in a given year.

"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," said Dr. Leonard Friedland, VP, Scientific Affairs and Public Policy, GSK Vaccines, North America. "Fluarix Quadrivalent addresses this by protecting against both B strains."

With today's FDA lot release, GSK's Fluarix Quadrivalent influenza vaccine soon will be supplied to U.S. healthcare providers who placed orders for the new vaccine after it was approved late last year. The CDC (U.S. Centers for Disease Control and Prevention) placed the largest order for Fluarix Quadrivalent - for more than four million doses - and will allocate those doses to U.S. state and local healthcare providers. The CDC annually purchases large quantities of influenza vaccines from multiple influenza manufacturers.

For this influenza season, GSK will supplement the supply of Fluarix Quadrivalent with its trivalent seasonal influenza vaccines. In the U.S., GSK estimates it will provide up to 10 million doses of quadrivalent influenza vaccines, and 22 to 24 million doses of influenza vaccines overall. GSK believes the healthcare community will steadily transition in coming years to quadrivalent influenza vaccines, and the company is in the process of increasing its capability to provide substantially more quadrivalent influenza vaccine doses for coming influenza seasons.

Fluarix Quadrivalent also is approved in Germany (marketed as INFLUSPLIT™Tetra®) and the UK (as FLUARIX™ TETRA). The full U.S. Prescribing Information is available on http://www.gsk.com/products/index.htm.

For a link to the GSK Fluarix Quadrivalent electronic press kit, U.S. journalists can click here.

About Seasonal Influenza Seasonal influenza may cause three to five million cases of severe illness and up to 500,000 deaths per year worldwide. Vaccination against influenza is considered one of the most effective ways of preventing mortality, complications and hospitalizations. The U.S. Centers for Disease Control and Prevention (CDC) recommends that children six months of age and older and adults receive an influenza vaccine annually. More information about seasonal influenza can be found at http://flu.gov and http://www.cdc.gov/flu/about/season/index.htm.

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