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Pandemic Influenza Vaccine Manufacture Preparedness

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.

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Pandemic Influenza Vaccine Manufacture Preparedness

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

  2. 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

  3. 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

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

  5. Pandemic Vaccine Clinical Results (1) 1st dose 2nd dose • 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

  6. 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%

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

  8. Epidemic vs. Capacity

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

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

  11. Thank You!

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