On November 14, 2005, the Chinese Ministry of Science and Technology and the Ministry of Health jointly evaluate the progress of a project to produce human bird flu vaccines. Thanks to more than a year?痵 painstaking efforts, Chinese researchers have completed the development of manufacturing techniques for human bird flu vaccines, and established a virus bank. In the meantime, researchers worked out detailed techniques, quality standards, and testing modalities, along with a line of production workflows and technical documents. Tests of the vaccine in animals have shown reliable security performance and immunogenicity.
The research team, made up of scientists from SINOVAC BIOTECH CO., LTD. and China CDC, produces human bird flu vaccines using the NIBRG-14 viral strains provided by WHO. Under a prototype vaccine based technical line, the project has not only developed a capacity preparing human bird flu vaccines to fight a pandemic caused by avian flu H5N1 virus, but also a potential capability to produce new vaccines based on mutated strains. By creating a technology platform for producing human bird flu vaccines, researchers have made technical reserves ready for China to fight the possible pandemic. At present, the vaccine has entered the pilot production, in an attempt to make the vaccines available for clinical trials. The research team and CDC have jointly filed up an application for clinical trials before the State Food and Drug Administration.
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