PHILADELPHIA — Following regulatory approval by the Food and Drug Administration's Center for Biologics Evaluation and Research, GlaxoSmithKline confirmed it has begun shipping the first lots of its 2012-2013 seasonal influenza vaccines to healthcare providers and Centers for Disease Control and Prevention distribution centers.
GSK said FluLaval is approved for use in adults ages 18 years and older to help protect against influenza disease caused by the virus subtypes A and B contained in the vaccine. GSK said its other vaccine, Fluarix, is approved for use in adults, as well as children ages 3 years and older.
"The three strains of influenza virus in the seasonal influenza vaccine can change from year-to-year based on estimates of the strains that will circulate in the upcoming season," said Leonard Friedland, VP and head of clinical/medical affairs for GSK North America Vaccine Development. "This is a key reason why the CDC recommends everyone six months of age and older gets an influenza vaccination every year. For the 2012-2013 influenza season, two of the three strains have been changed compared to last year's formulation."