MVC EV71 Vaccine has obtained the BLA approval from the Ministry of Health and Welfare and is expected to be available for supply starting from the third quarter of this year.
•MVC EV71 Vaccine has obtained the conventional drug registration approval through the comprehensive Phase 3 clinical vaccine efficacy data, making it the first enterovirus vaccine in Taiwan to be approved without relying on the accelerated approval mechanism.
•The outstanding vaccine efficacy data of MVC EV71 Vaccine, with a vaccine efficacy of 100%, has been published in "The Lancet".
•After obtaining domestic drug registration of MVC EV71 Vaccine in Taiwan, MVC will apply for drug registration in target markets, including Southeast Asia where EV71 epidemic is prevalent.
•The estimated supply time is expected to start in the third quarter of this year.
On April 12th, MVC EV71 Vaccine obtained the BLA approval letter from the Taiwan Food and Drug Administration. It is the first enterovirus vaccine in Taiwan to receive drug registration approval without relying on the accelerated approval mechanism (based on neutralizing antibodies). In the multinational and multicenter Phase 3 clinical trial, the real-world vaccine efficacy of MVC EV71 Vaccine is 100% (all confirmed cases occurred in the placebo group, with no infections among the vaccinated subjects during the follow-up period). This data has been published in the globally authoritative journal "The Lancet." MVC is currently the only domestic developer with in-house production capacity for enterovirus vaccines. MVC will soon launch the vaccine in the domestic market and apply for drug registration in target markets, including Southeast Asia.
MVC EV71 Vaccine was technology transferred from the National Health Research Institutes (NHRI) in Taiwan. After acquiring the research results, including the Phase 1 clinical trial data in adults from NHRI, the MVC team conducting Phase 2 clinical trial in infants and children to assess safety, dose exploration, and cross-protection against genotypes. MVC selected the optimized dose of 2.5µg and the appropriate vaccination interval. Simultaneously, MVC integrated the entire vertical process from bulk to finished product formulation and successfully developed commercial-scale production capacity in the facility in Zhubei. Their manufacturing process quality has also obtained the Taiwan Food and Drug Administration's PIC/S GMP certification, making MVC the first domestic vaccine manufacturer capable of full-scale production in their own facility. This achievement demonstrates their commitment to local research, production, international clinical validation, and marketing of the enterovirus vaccine.
Infants and young children are the group with the highest risk of severe illness and death from enterovirus. After completing Phase 2 clinical trial in Taiwan, MVC evaluated the global prevalence of enterovirus, market potential, and the quality of clinical trial. Ultimately, MVC collaborated with the Pasteur Institute in Vietnam to conduct a multinational and multicenter Phase 3 clinical trial. MVC EV71 Vaccine is currently the only EV71 vaccine development project in the world that has obtained clinical efficacy data for infants aged 2 to 6 months. In the Phase 3 multinational and multicenter clinical trial of MVC EV71 Vaccine, clinical data from three age groups (2-6 months, 6 months to 2 years, 2 years to under 6 years) demonstrated the "vaccine efficacy" of 100% (all confirmed cases occurred in the placebo group, with no infections among the vaccinated infants during the follow-up period). The statistical Poisson regression analysis showed an efficacy is 96.8%. Furthermore, during the Phase 3 clinical trial of MVC EV71 Vaccine, confirmed cases covered regional epidemic genotypes B5 and C4 of EV71. In the real world, the vaccine has been proven to provide 100% cross-protection against local epidemic genotypes of EV71.
The results of the Phase 3 clinical trial of MVC EV71 Vaccine have also been reviewed and published in "The Lancet" one of the highest-impact medical journals in the world (Impact Factor: 202.731). It has received a special invitation from "The Lancet" journal to external experts for their commentary and recommendation. The recommended citation by "The Lancet" also emphasizes the importance of MVC EV71 Vaccine in preventing infants aged 2 to 6 months and the long-term immunological benefits of administering the EV71 vaccine as a booster dose.
EV71 is prevalent in hot and humid regions, and besides Taiwan, it is an endemic disease that has been circulating in Southeast Asia and China for many years. In terms of vaccine development, currently, only three vaccine manufacturers in China have products on the market, and two vaccine manufacturers in Taiwan are preparing to launch their products. In Taiwan, the evaluation of the enterovirus vaccine registration involves two approaches. One approach is to apply for accelerated drug registration with the Taiwan Food and Drug Administration based on neutralizing antibody titers as an efficacy indicator (which still requires confirmatory study to demonstrate the clinical efficacy). The other approach is adopted by MVC EV71 Vaccine, which is to submit complete Phase 3 clinical vaccine efficacy data for domestic registration.
After obtaining the official domestic drug license for the enterovirus vaccine based on comprehensive data, MVC will continue to expand into international markets. With the excellent Phase 3 clinical efficacy data and the approval in Taiwan, MVC will submit the drug license application in the countries in Southeast Asia which EV71 epidemic is prevalent, such as Vietnam, Thailand, Malaysia, and other targeted markets.