1 / 11

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.

norman-baird
Download Presentation

Pandemic Influenza Vaccine Manufacture Preparedness

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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!

More Related