July 26, 2006

GlaxoSmithKline makes advances in bird flu vaccine

GlaxoSmithKline Wednesday (Jul 26) released data indicating that its H5N1 bird flu vaccine has achieved a high immune response at a low dose of antigen.

The company said that the vaccine, which uses a proprietary adjuvant, enabled over 80 percent of subjects who received 3.8 grammes of antigen to demonstrate a strong seroprotective immune response.

It said, "This level of seroprotection meets or exceeds target criteria set by regulatory agencies for registration of influenza vaccines.

GlaxoSmithKline added that 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.

JP Garnier, 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." he said, adding, "There is still a lot more work to be done with this programme, 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.

The company expects to make regulatory filings for the vaccine in the coming months.