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Anflu
Split Influenza Vaccine
Sinovac has been working on split influenza vaccine development since 2001. The pre-clinical research was completed in 2004. The result of clinical trial on Anflu shows it is well tolerated to children, adults and elder people. In June, 2006, Sinovac submitted the New Drug application to State Food and Drug Administration (“SFDA”). The “New Drug Certification” for Split Influenza Vaccine was obtained from SFDA on Feb. 25, 2005. The production license was then issued on July 27, 2005. The GMP Certificate was issued by SFDA on October 19, 2005. It is expected to launched Anflu™ into the Chinese market in second half of 2006.
Research result for safety and immunogenicity on Anflu
Safety:
No preservative contained.
The clinical trial result shows the local adverse event is the swelling on inoculated area and the frequency of reported side effect rate is lower than 2%.
Immunogenicity:
The clinical trial result shows the immunogenicity met the criteria European regulatory requirements for the licensing of an influenza vaccine after the vaccination on adults and elder.
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