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Sinovac Biotech Ltd First Company To Gain Approval For Clinical Trials On SARS Vaccine
January 23, 2004 |
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Sinovac Biotech Ltd (Sinovac) has announced that it has been approved to in China to commence clinical trials of a vaccine for SARS by SFDA (Chinese FDA).
Animal tests on safety, efficacy and immunogenicity have been completed successfully. Immune response was invoked by the vaccine in all animal models. No immune enhancement was observed in any of the pre-clinical testing.
Clinical protocols have been developed with the cooperation of the World Health Organization, Chinese FDA, China CDC and the China Medical Academic College. Phase I human clinical trials, testing for safety, are expected to start soon on 30 volunteers. The ultimate aim of the vaccine will be to provoke the body's immune system into action, so that it can destroy the SARS virus if infected.
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