GlaxoSmithKline (GSK) Reports Significant Advance In H5N1 Pandemic Flu Vaccine Program

PHILADELPHIA, July 26, 2006 /PRNewswire-FirstCall/ -- GlaxoSmithKline plc today announced headline data showing that its H5N1 pandemic flu vaccine achieved a high immune response at a low dose of antigen. The vaccine, which uses a proprietary adjuvant, enabled over 80% of subjects who received 3.8 micrograms of antigen to demonstrate a strong seroprotective immune response. This level of seroprotection meets or exceeds target criteria set by regulatory agencies for registration of influenza vaccines. Efficacy results at these levels of antigen dosage have also not been reported for any other H5N1 vaccine in development to date, including those using other adjuvants such as alum.

Commenting on the data, JP Garnier, GlaxoSmithKline's Chief Executive Officer, said: "These excellent clinical trial results represent a significant breakthrough in the development of our pandemic flu vaccine. This is the first time such a low dose of H5N1 antigen has been able to stimulate this level of strong immune response.

"There is still a lot more work to be done with this program, but this validation of our approach provides us with the confidence to continue developing the vaccine, including assessment of its ability to offer cross-protection to variants of the H5N1 strain. All being well, we expect to make regulatory filings for the vaccine in the coming months."

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