To further enhance the domestic influenza vaccine research and development (R & D) ability and manufacturing capabilities, and to provide better protection for our people, Taiwan Centers for Disease Control (Taiwan CDC) has collaborated with domestic scholars and experts in influenza from the Academia Sinica, National Yang-Ming University, National Taiwan University, National Chiao Tung University, Chuang Hsing University, Chang Gung University, National Cheng Kung University, National Health Research Institutes (NHRI), Taipei Veterans General Hospital, Zhongshan Medical College, Center for Drug Evaluation, Development Center for Biotechnology, Council of Agriculture, Animal Health Research Institute, etc. to conduct the "Influenza Vaccine Research and Development Project" since 2006.The purposes of the project are to sustain emergency flu vaccine supply before the completion of the BOO Projects for self-manufacturing flu vaccine, to select virus strain for future industry needs, and to establish vaccine policies, regulations and clinical trials. It has been 3 years since the initiation of the project, and a number of major breakthroughs have been made in the project. The successful results and progress of the project were made available to the public on April 3, 2009..

For surveillance and prediction of influenza activity, the project includes integrating data generated by the national influenza virus surveillance system, the notification system, and various laboratory analyses to produce comprehensive disease information from those results. In addition, through the implementation of this project, new type of influenza virus and viral antigen shift can be monitored, and serological surveillance can be conducted to select the reference vaccine strain. Antibodies of Taiwan local strain from ferrets have been prepared to facilitate diagnosis and virus subtyping. The platform for surveillance and prediction of influenza activity has been established, outlining the Standard Operating Procedure (SOP) and planning the timeline of the process for selecting the virus strain.

For effectiveness of influenza vaccination and community antibody prevalence, an influenza vaccine clinical trials research team has been successfully set up to analyze pre-and post-vaccination immune response.The results show a significant increase in antibody titer, which means the immune response is improved with vaccination.Moreover, antibody titer against the local circulating strains has been monitored in order to establish a serum bank and to evaluate the efficacy of seasonal flu vaccine.

For production of emergency vaccine, NHRI has set up a production line of emergency stocks of influenza vaccine, and is expected to receive approval for the clinical trials of its H5N1 vaccine through the Investigational New Drug (IND) program during the second quarter of 2009 and to start the first phase of clinical trails during the third quarter. Another major breakthrough is that the Genomic R&D team led by the president of the Academia Sinica, Dr. Chi-Huey Wong, has developed a DNA vaccine which could be used against both human and bird influenza viruses.The research provides a platform to produce the DNA vaccine for emergency use in just six months’ time if an outbreak were to occur.Further, the research results have been published in the well-known scientific journal, “Proceedings of the National Academy of Sciences of the United States of America”.

The “Influenza Vaccine Research and Development Project” is the first large project that integrated all the available resources and expertise from different fields to provide basic setup and capability in influenza vaccine technology in Taiwan. This project can effectively strengthen our influenza prevention efforts and to set up an emergency response mechanism. Two drill exercises were conducted during the flu seasons of 2007 and 2008 to evaluate and confirm the effectiveness of the entire project.The project brings us one big step closer to self-sufficiency in influenza vaccine production.