Every year, the number of outpatients with enterovirus infection in Taiwan reaches its peak around mid-June and enterovirus 71 often causes severe complications and even fatalities in children. Since 2001, the Taiwan Centers for Disease Control (Taiwan CDC) has begun devoting to the research and development of enterovirus vaccine. As of now, Taiwan CDC has established the technology for large scale production and is expected to enter the clinical trial for the vaccine in 3 years. Our research results and data are at the leading edge of global research. Once the vaccine is successfully developed, it can protect our children from the threat of enterovirus and significantly decrease the fatality rate.
Thus far, Taiwan CDC has established the technology for a 20 liter scale production of Vero cell-derived inactivated enterovirus 71 vaccine and transferred this technology to the National Health Research Institutes (NHRI) in 2008 for production of clinical trial lots. On the other hand, in September, 2008, Taiwan CDC collaborated with National Tsing Hua University, the Development Center of Biotechnology, and National Taiwan University Hospital on “Development of Enterovirus 71 virus-like particle (VLP) Vaccine Project”. VLP preserves the native conformation of antigens and contains no viral nucleic acids; therefore, the infection risk of VLP is low. Moreover, since VLPs resemble the structure of authentic viruses, they can induce a high immunogenic response compared to inactivated virus. An example of a VLP-based vaccine available in the market now is the Human Papillomavirus Vaccine (HPV).
Vaccine development usually takes 12-15 years from research to licensed product. Due to the presence of the many genotypes of enterovirus, the time is further lengthened. As a result, it takes longer to screen for a high titer vaccine strain with extensive cross neutralization. Taiwan CDC has formed a management advisory board comprising an oversight committee and a consultative committee dedicated to plan the strategy for the development of enterovirus vaccine, focusing on domestic development of enteroviral diagnostic reagent, vaccine, pharmaceutical medicine, and other related biomedical agents. The strategy is divided into 2 stages. The first stage is to domestically develop the vaccine, and the second stage is to produce the vaccine in large quantity by way of guarantee purchase. The purposes of this two-stage strategy include combining and integrating all the resources and experts for vaccine development, and encouraging and inspiring the local biotechnology industry though conducting successful future clinical trial, and presenting our accomplishment in vaccine technology research and development to the world.