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FDA Okays Glaxo's Second Four-strain Seasonal Influenza Vaccine For Use In U.S.

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British drug giant GlaxoSmithKline Plc (GSK: Quote, GSK.L) announced Friday that the U.S. Food and Drug Administration or FDA has approved Flulaval Quadrivalent (Influenza Virus Vaccine) for the immunization of children (three years and older) and adults to help prevent disease caused by seasonal influenza (flu) virus subtypes A and type B contained in the vaccine.

FluLaval Quadrivalent helps protect against the two A strains and B strains, decreasing influenza-related morbidity across all age groups - children, adults and the elderly.

"Since the late 1980s, public-health authorities have known that four primary influenza strains circulate each year causing the majority of influenza illness, but the influenza vaccines used for the past thirty years only covered against three strains," said Dr. Leonard Friedland, V.P., Director, Scientific Affairs and Public Health, GSK Vaccines North America.

FluLaval Quadrivalent is the second similar vaccine from GlaxoSmithKline that has been approved for the same indications after the FDA approval for its Fluarix Quadrivalent vaccine in mid-December 2012, which was the first-ever intramuscular influenza vaccine approved by the FDA that protects against four influenza strains.

Both the vaccines, Flulaval Quadrivalent and Fluarix Quadrivalent, are also the first to be approved for use by the FDA for children three years of age and older as well as for adults. Previously, GSK's FluLaval Trivalent vaccine (cover against three influenza strains) was limited for administration to individuals 18 and older.

"Trivalent vaccines do reduce influenza risk even in years when a vaccine strain-mismatch occurs, though quadrivalent influenza vaccines are the important next step in broadening strain coverage," Friedland added.

Seasonal influenza may cause three to five million cases of severe illness and up to 500,000 deaths per year globally. Vaccination against influenza is considered one of the most effective ways of preventing mortality, complications and hospitalizations.

Fluarix Quadrivalent is expected to be available in time for the 2013-14 flu season as healthcare providers traditionally order flu vaccines months in advance of each flu season. Meanwhile, GSK expects to making only a limited amount of FluLaval Quadrivalent available this influenza season.

GSK noted that it will have the capacity to supply substantial quantities of both the quadrivalent influenza vaccine shots to the U.S. from the beginning of 2014. FluLaval Quadrivalent will be available in multi-dose vials, while Fluarix Quadrivalent is available in pre-filled syringes.

FluLaval Quadrivalent and Fluarix Quadrivalent are not currently approved or licensed in any country outside of the U.S.

In Friday's regular trading session, GSK is currently trading at $51.56, up $0.03 or 0.06% on a volume of 0.66 million shares. Meanwhile, GSK.L is trading on the LSE at 1,651.00 pence, down 6.50 pence or 0.39% on a volume of 4.32 million shares.

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by RTT Staff Writer

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