A supplemental Biologics License Application has been submitted to the U.S. Food and Drug Administration (FDA) and a new application has been submitted to European regulatory authorities. The quadrivalent influenza vaccine is currently not approved or licensed anywhere in the world for the prevention of influenza.
A regulatory application has also been submitted to the U.S. 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.
GSK's H5N1 pandemic influenza vaccine, manufactured in Quebec, is currently approved in Europe under the brand name, Pumarix™. For more information about the currently licensed indication of Pumarix™ in Europe, please visit the EMA website.
The H5N1 influenza vaccine programme was supported by a development contract (HHSO100200700029C) with the Biomedical Advanced Development and Research Authority (BARDA) of the US Department of Health and Human Services.
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