FDAnews
www.fdanews.com/articles/62083-chinese-biotech-announces-pandemic-flu-vaccine-trial-results

CHINESE BIOTECH ANNOUNCES PANDEMIC FLU VACCINE TRIAL RESULTS

August 29, 2006

China-based Sinovac Biotech has announced preliminary results of a Phase I clinical trial of its pandemic influenza vaccine, which was supported by China's Ministry of Science and Technology and co-developed by the company and the Chinese Centers For Disease Control and Prevention.

The results show that vaccines with four different levels of antigen induce an immune response and that the 10-microgram dose had the best immunogenicity with a zero positive rate of 78.3 percent, which exceeds the European Union's criteria for seasonal influenza vaccines. The randomized, double-blind trial began in December 2005. There were no serious adverse events reported in any of the 120 volunteers, and the vaccine was well-tolerated.

The pandemic flu virus strain used in the vaccine was NIBRG-14, which is recommended by World Health Organization. The strain was a reassortant strain prepared using reverse genetics and was non-pathogenic.

Sinovac plans to upgrade its vaccine plant to expand the production capability to 20 million doses per year, allowing the company to stockpile vaccines for a potential influenza pandemic. The company expects construction to be completed in 2007.