Regulatory Update: GSK announces submissions for two influenza vaccines

GlaxoSmithKline [GSK] announced today that it has submitted regulatory files for two of its influenza vaccines currently in development.

Quadrivalent influenza vaccine

GSK has submitted US and EU regulatory applications seeking approval of a quadrivalent influenza vaccine for the “active immunisation of adults and children from 3 years of age for the prevention of influenza disease caused by influenza virus types A and B contained in the vaccine”.

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.

H5N1 influenza vaccine

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.