Sinovac commenced the development of its split influenza vaccine in 2001. The pre-clinical research was completed in 2004. The result of clinical trial for Anflu showed that it is well tolerated in children, adults and the elderly. In June 2006, Sinovac submitted the New Drug application to China State Food and Drug Administration (China SFDA). The “New Drug Certification” for Split Influenza Vaccine was obtained from SFDA in February 2005. The production license was then issued in July 2005. The GMP Certificate was issued by SFDA in October 2005. Sinovac began marketing Anflu in September 2006.
Market Opportunity in China
The market penetration of the seasonal flu vaccine in China is significantly below that in the developed markets. Based on NICPBP lot release records, the market penetration in China
in 2009 was only 2.5%, compared to 45% in the U .S. in the flu season of 2008 to 2009.
International Quality Standards and Preservative Free
Sinovac is the only Influenza Vaccine Supply (IVS) task force member from a developing country that collaborates with world-class partners in influenza vaccine research. The Anflu vaccine is an inactivated split viron influenza vaccine formulated from three split inactivated viron solutions. Anflu is produced with the virus strains recommended by the WHO each year and is likely the only flu vaccine, among all produced by other domestic manufacturers within China, that does not contain preservatives. The primary influenza vaccine used worldwide is the split viron vaccine, which contains virus particles disrupted by detergent treatment.
Research result for safety and immunogenicity on Anflu
The clinical trial result showed the local adverse event is the swelling on inoculated area and the frequency of reported side effect rate is lower than 2%.
The clinical trial result showed the immunogenicity met the European regulatory standards for the licensing of an influenza vaccine for the vaccination in adult and elderly populations.