GlaxoSmithKline has submitted a Biologics License Application (BLA) for FluLaval (Influenza Virus Vaccine) to the US FDA. If licensed, FluLaval will be used for the active immunization of adults 18 years of age and older against influenza disease caused by influenza virus types A and B, which are contained in the vaccine.
"GSK is committed to increasing the supply of seasonal flu vaccine to help keep Americans healthy during the flu season," Christopher Viehbacher, President, US Pharmaceuticals, GSK said adding, "Influenza is a serious threat to public health and the US has faced recent shortages of vaccine to prevent it. Following last year's approval of Fluarix, today's announcement is another important step toward ensuring adequate availability of a critical weapon to fight the flu."
Fluarix (Influenza Virus Vaccine) was approved by the US FDA on August 31, 2005. GSK added FluLaval to its portfolio of flu products when it acquired the Canadian vaccine manufacturer ID Biomedical Corporation in December 2005. FluLaval was granted fast track status by the US FDA in July 2005 and is marketed in Canadaunder the name Fluviral. If granted US marketing approval for FluLaval, GlaxoSmithKline expects to provide up to 30 million doses of seasonal influenza vaccine (FluLaval and Fluarix) to the US market for the 2006/2007 flu season, stated a release.
Influenza is a highly contagious and potentially fatal virus that affects five to 20 percent of the total US population during each influenza season. Between 1990 and 1999, approximately 36,000 people died in the United States each year from complications of influenza infection; more than 90 percent of these deaths occurred in persons 65 years of age and older. Influenza can reach epidemic levels and poses a significant threat to public health, particularly among the nation's oldest and youngest citizens.