GlaxoSmithKline has received approval from the Food and Drug Administration for FluLaval Quadrivalent, a seasonal flu vaccine to help prevent influenza virus subtypes A and B in people ages 3 and older.


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GSK gets OK for another four-strain flu vaccine

August 19th, 2013

PHILADELPHIA – GlaxoSmithKline has received approval from the Food and Drug Administration for FluLaval Quadrivalent, a seasonal flu vaccine to help prevent influenza virus subtypes A and B in people ages 3 and older.

GSK said Friday that FluLaval Quadrivalent is its second intramuscular quadrivalent flue vaccine approved by the FDA. Earlier this month, GSK received FDA clearance to ship its 2013-14 Fluarix Quadrivalent flu vaccine to U.S. health care providers.

Influenza strains that cause seasonal flu are classified as A or B strains. Most recently, flu vaccines have been offered in the trivalent (three-strain) form to help protect against the two A virus strains most common in humans and the B strain expected to be predominant in a given year. But two B virus strains (Victoria and Yamagata) co-circulate to varying degrees each flue season.

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

"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 30 years only covered against three strains," stated Dr. Leonard Friedland, vice president and director of scientific affairs and public health for GSK Vaccines North America. "With this limitation, global influenza experts have had to make a difficult determination around the strains each season to cover, and in six of the past 11 influenza seasons (2001-2012), one of the predominant strains was not included in the season's influenza vaccines. 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."

GSK said that starting in 2014, it will have the capacity to supply the United States with substantial quantities of quadrivalent flu vaccine shots made in Quebec, Canada (FluLaval Quadrivalent); and Dresden, Germany/Marietta, Pa. (Fluarix Quadrivalent).

The company also noted that the approval of FluLaval Quadrivalent marks the first time that all GSK flu shots are approved for use by the FDA for children ages 3 and older, as well as for adults. FluLaval Trivalent vaccine was previously limited to people 18 and older.

GSK added that the availability of FluLaval Quadrivalent enables the company meet the needs of health care providers who prefer to stock multidose vials of flu vaccines. FluLaval Quadrivalent will be available in multidose vials, while Fluarix Quadrivalent is available in prefilled syringes.

The company said it expects to make a limited amount of FluLaval Quadrivalent available this influenza season.

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