GSK files at FDA for H5N1 subtype Influenza vaccine - 07-Mar-2012

GSK has submitted a regulatory application to the FDA seeking approval for an H5N1 influenza vaccine. The Biologics License Application seeks approval for the “active immunisation for the prevention of disease in persons 18 years of age and older at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine” for use as directed by the U.S. Government. H5N1 pandemic influenza vaccine, manufactured in Quebec, was approved in Europe on 4 March 2011 under the brand name, Pumarix.