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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
GlaxoSmithKline (London, England) has developed a vaccine against the H5N1 bird flu strain that, the company says, shows better immune response than other vaccines in development.
GlaxoSmithKline (GSK, London, www.gsk.com) has developed a vaccine against the H5N1 bird flu strain that, the company says, shows better immune response than other vaccines in development. “All being well, we expect to make regulatory filings for the vaccine in the coming months,” said JP Garnier, GlaxoSmithKline’s CEO in a company release.
GSK says 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, says GSK. The company says efficacy at these levels of antigen dosage has not been reported for any other H5N1 vaccine in development to date, including those using other adjuvants such as alum.
GSK will continue the development of its vaccine, including assessing the ability of the vaccine to offer cross-protection to variants of the H51N strain.