Pandemic Influenza Vaccine Manufacture Preparedness Lin Su Sinovac Biotech Co., Ltd

Vaccine R&D Supported by Government Pandemic influenza vaccine R&D program –National Key Technologic R&D Program, supported by China MOST, MOH, SFDA –Financially supported by National and local government

Collaboration with China CDC Pandemic influenza vaccine development was taken as an important part in Chinese National Pandemic Preparedness Plan –Sinovac signed a collaboration agreement with China CDC collaborate on vaccine development, in 2004 China CDC provided supports on basic R&D –Surveillance –Virus isolation –Constructing rg prototype strain using Chinese strain

Antigen sparing strategy –Antigen: whole virion –Adjuvant ： Al –Lower dose The fast the better The more the better Technology –Reverse genetics Pre-registration vaccine –Clinical evaluation Safety/immunogenicity –Production process –China SFDA fast track approval procedure Strategy for Pandemic Vaccine

1st dose 2nd dose Pandemic Vaccine Clinical Results (1) Safety results –No SAE reported –Most reported local and systemic reactions were graded as mild and transient –The frequencies of local and systemic reactions after the second dose are significant lower than after the first dose

Pandemic Vaccine Clinical Results (2) ％ HI Seropositive ( ％ ) Day Immunogenicity results –Antibody responses were detected in 1.25/2.5/5/10 ug groups 14 days after 1st dose –Antibody responses showed a clear dose-related effect –Highest antibody responses after 2 doses were recorded in the 10 ug group: 78%

Manufacturing Capacity Expansion Plan Expand to 20 million doses per year Supported by national government Well established process Finished by the end of 2007

Epidemic vs. Capacity

Situation in China 22 cases, 14 death Numbers of outbreaks in poultry 16 billion population 20 million doses

Things need to do Enhance R&D Expand capacity Government supports Encourage public use of seasonal influenza vaccines produced in China

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