The concept of a Taiwan Vaccine Center for Research and Development was proposed in 1992 and the Center for Diseases Control of Taiwan was appointed by Executive Yuan to conduct the feasibility study on “human vaccine self-manufacturing plans” in 1997. The anthrax attacked in Washington in late 2001, the out-break of SARS in Asia and Canada in early 2003 and the threat of avian flu pandemic in the world in 2004 had enormous impact on each national security, global economy and health care systems. As predicted, out-breaks of new emerging diseases will continue around the world. It could happen that Taiwan cannot find the vaccines and/or drug against the disease. Therefore, to facilitate the “Strategies for Biotechnology Development in Taiwan”, the Executive Yuan in 2001 made the decision and appointed National Health Research Institute (NHRI) to take over the “human vaccine self-manufacturing plans” and integrate the current Vaccine and Serum section of Taiwan CDC into a new NHRI Vaccine Research and Development Center (VRDC). After numerous advisory meetings with academic Professors, industry advisors to the Department of Health (DoH) and DoH internal scientific officials, in November/2004 the DoH finally agreed to and budgeted for establishing the Vaccine Research and Development Center.
Following the government’s mandate of establishing a NHRI Vaccine Center, five major missions are established after the recommendation from Steering Committee and Advisory Board Committee:
- To establish the infra-structure and facility for developing novel vaccines and immunotherapeutic candidates to fulfill Asian health care needs such as BCG vaccine and anti-venin which are currently manufacturing at Kun-Yan of Taiwan CDC.
- To develop the capability to respond to Taiwan government emergency requests for vaccines against pandemic diseases and bioterrorism.
- To develop novel vaccines or adjuvants as Taiwan biotechnology or business model.
- To facilitate the academics or local industry to perform pre-clinical studies and to develop products for phase 1 and 2 clinical trials.
- To establish and run forums for training and educating young scientists in vaccine-related biotechnology.
Major Platform Technologies
At present, biological correlates of efficacy for many vaccines are unknown or at best poorly understood. Such correlates will be established only through a comprehensive and systematic in-depth immune monitoring of natural disease and efficacy trials. In order to be competitive and the best vaccine center in Asia, the current VRDC research programs have been aimed at the “Establishment of Innovative Vaccinology Research and Technology Development Programs”. In addition, to secure and ensure long-term financial supports, VRDC has considered using the current product development programs to establish the cGMP Facility as a “Technology Transfer” unit. With the completion of the infra-structure and facility, VRDC cGMP Facility are now playing important roles and leadership in Taiwan vaccine industry. The Vaccine Center has formed strategic alliance with a local Biotech company and provided contract-service for production of GMP-grade clinical trials materials for H1N1 flu vaccine. The strategies for product development in the cGMP Facility are fully described in the section of “Vaccine Center Global Strategic Plans”. This strategic plan is divided into three sections and outlined in the following diagram: (a) innovative vaccinology research and technology development programs; (b) product development programs in cGMP Facility; and (c) strategic alliance and business development plan.