Chinese biotech company Sinovac announced this week that it has completed the preliminary appraisal of the clinical trials for its influenza A/H1N1 (swine flu) vaccine, which has demonstrated positive efficacy and safety. The company noted that the vaccine is the first in the world to complete preliminary appraisal of the clinical studies.

The single-centre, randomised, double-blind clinical trial started in July with 1,614 volunteers involved. The company is to file for the regulatory approval of the vaccine to the Chinese drug watchdog State Food and Drug Administration (SFDA) following the completion of the full appraisal.

Significance: The preliminary results of the clinical studies are encouraging to Sinovac, which was designated by the SFDA to produce vaccines against the H1N1 virus together with 10 other compatriot biotech firms. The final SFDA nod, if successfully secured, will significantly bolster Sinovac's profile as a vaccine maker and the sales of the vaccine before other producers' swine flu vaccines hit the market. The SFDA and the country's Ministry of Health have been paying close attention to Sinovac's development of the vaccine including conducting on-site inspections. It istherefore likely that the regulatory review process can be completed with fast-track status as the government is making efforts to make the vaccine available soon.


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