GlaxoSmithKline (plc) today announced that a supply contract has been signed by the Swiss Federal Office of Public Health and GlaxoSmithKline for 8 million doses of GSK?s H5N1 antigen influenza vaccine and its proprietary adjuvant for pre-pandemic use. The order provides enough doses, one per head of the entire Swiss population, to help prepare the immune system against the threat of a human influenza pandemic and is the first national programme to do so. Supply and stockpiling of the pre-pandemic vaccine is expected in early 2007 once the Swiss regulatory agency, Swissmedic, has reviewed and approved GSK?s regulatory file.
Andrew Witty, President Pharmaceuticals Europe said: ?This is the first major contract that GSK has signed for its candidate H5N1 vaccine. The Swiss Government have adopted a comprehensive strategy to help protect their population. Our vaccine, which has already demonstrated strong immunogenicity at the lowest dose seen with a split cell vaccine, provides an attractive option for Governments currently considering how best to combat the threat of a flu pandemic. We continue to work with Governments across Europeon their pandemic plans and are on track to file our adjuvanted H5N1 vaccine with the European regulators by the end of 2006.?
In the event of an influenza pandemic further immunisation with a vaccine appropriate to the actual pandemic would be needed for full protection. To this end the supply contract also provides for an advance purchase agreement for 7.5 million doses of a GSK pandemic vaccine which will be manufactured once a pandemic strain is identified by the WHO.
In July GSK announced that its candidate H5N1 vaccine enabled over 80% of subjects who received 3.75?g of antigen (the lowest dose tested in the study) to demonstrate a strong immune response. Oncea pandemic has been declared by WHO and the final pandemic strain identified, it is hoped that the immunity developed in response to H5N1 vaccine will prepare the immune system against the threat of an actual pandemic virus.
The GSK H5N1 and pandemic vaccines are administered with a proprietary adjuvant, an extra ingredient in the vaccine formulation which is designed to increase the immunogenicity of the vaccine as well as potentially offering protection against variant virus strains (commonly called drift strains).
About GSK
GSK continues to be committed to doing all it can to support governments and health authorities around the world in planning to respond to a global influenza pandemic prior to its outbreak and in the event one is officially declared. GSK has made substantial progress in its vaccine development programme and continues to investigate ways to further improve our pre-pandemic and pandemic vaccine strategies. To this end more than $2 billion has already been invested in developing a vaccine to combat avian flu, increasing the production capacity for influenza vaccines and GSK?s anti-viral flu treatment Relenza, in addition to ensuring the continuity of critical business operations and processes?
GlaxoSmithKline ? one of the world?s leading research-based pharmaceutical and healthcare companies ? is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
Issued ? Wednesday 18 October 2006, Bern, Switzerland, London, UK and Rixensart, Belgium