Additional GSK quadrivalent flu vaccine approved by FDA

GlaxoSmithKline plc, a research-based pharmaceutical company, recently announced the U.S. Food and Drug Administration's approval of GSK's FluLaval Quadrivalent influenza virus vaccine for individuals three years of age and older.

The vaccine is the second GSK intramuscular quadrivalent influenza vaccine approved by the FDA, following the approval in December of GSK's Fluarix Quadrivalent. FluLaval Quadrivalent protects against two influenza A strains and two influenza B strains. Previous vaccines only included three strains to protect against two A virus strains and one B strain.

"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," Leonard Friedland, the vice president and director of scientific affairs and public health at 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."

Seasonal influenza causes between three and five million cases of severe illness worldwide and as many as 500,000 deaths annually. Vaccination against influenza is considered one of the most effective ways to prevent influenza complications, hospitalizations and mortality.

GSK said quadrivalent vaccines could decrease influenza-related morbidity across all age groups: the elderly, children and adults.

"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 said.

GSK plans to make a limited amount of FluLaval Quadrivalent available this flu season. Starting in 2014, GSK will have the capacity to supply substantial quantities of quadrivalent vaccine shots to the U.S. from its facilities in Quebec, Canada, Dresden, Germany, and Marietta, Pa.