TAIPEI, TAIWAN --June 20th, 2021. Medigen Vaccine Biologics (MVC) released Enterovirus 71 (EV71) Vaccine Multi-regional and Multi-central Phase 3 clinical trial results. The results demonstrated MVC's EV71 vaccine has robust safety profile with 100% vaccine efficacy.
This multi-regional, multi-central phase 3 clinical trial is a randomized, double-blind, placebo-controlled trial, with total 3,049 effective samples from Taiwan and Vietnam randomly assigned with 1:1 ratio to receive vaccine or placebo. The subjects are divided into three age groups: 2~6 months, 6 months~2 years old, and 2 years~6 years old, at ratio of 1:2:1. This trial involved 5 hospitals in Taiwan and 2 local hospitals coordinated by the Pasteur Institute in Ho Chi Minh City.
MVC EV71 Vaccine Phase 3 data demonstrated:
1. Good Safety profile
Subjects age ranges from 2 months to 6 years old. Infants of 2~6 months old constituted approximately 25% of total study populations. The data indicated that the vaccine has a favorable safety profile with no significant differences between placebo and vaccine groups.
2. Robust Immunogenicity performance
Immunogenicity data was unblinded on April 10, 2021. For EV71 vaccine group after receiving second dose,
- The seroprotection rate (defined as serum NT Ab titer≥ 1:32) at 28 days achieved 99.5% (TFDA recommendation for accelerated approval was ≥ 90%).
- The seroprotection rate (defined as serum NT Ab titer≥ 1:32) at 6 months achieved 97.9% (The immunogenicity endpoint should be ≥ 70% per TFDA recommendation for accelerated approval).
- The seroprotection rate at 1 year remained 97.9%. (No target set by regulatory authority but must continue with follow-up)
3. High Efficacy and Cross-Protection
This phase 3 study randomly assigned subjects to vaccine and placebo group at 1:1 ratio. In two years and one month follow-up period, there were 22 cases of EV71 incidence in placebo group, and none was observed in EV71 vaccine group. According to the TFDA's guideline, MVC's EV71 vaccine efficacy is 100%. After analysis with Poisson regression statistic model, the estimated VE is 96.8% with P-value < 0.0001, demonstrating MVC's VE result was statistically significant.
MVC EV71 vaccine antigen is B4 subgenotype. After analyzing the virus strains observed in all infected cases in placebo groups, the virus strains were EV71 subgenotype B5 and C4. The data demonstrated that MVC EV71 vaccine offer cross-protection against various prevalent EV71 subgenotypes circulating in Taiwan and South-East Asia.
As the efficacy and safety results of MVC's Phase 3 clinical trial fulfills the regulatory requirement, MVC is compiling document to apply for Taiwan FDA Biologics License Application and will share the results with regulatory agencies in target markets
About EV71
Enteroviruses are members of the Picornaviridae family. Among all enteroviruses other than polio, EV71 is frequently associated with severe neurological complications, leading to severe medical and socioeconomical losses. As of now, the EV71 outbreak continue to occur every 3~4 years in Taiwan. In China and Southeast Asia, the high incidence rate even leads to seasonal outbreaks in these areas.
About Medigen Vaccine Biologics Corp. (MVC)
MVC is a biopharmaceutical company using cell-based technologies to develop novel vaccines and biosimilars. With a goal of national self-sufficiency and a desire to help globally against the threats of infectious diseases, MVC also aims to provide vaccines and biopharmaceuticals to meet regional needs. MVC's pipeline includes enterovirus EV71 vaccine, COVID-19 vaccine, dengue vaccine and influenza quadrivalent vaccine, all of which all have entered late clinical stage. MVC's large-scale production facility is state-of-the-art and adherent to international PIC/s GMP requirements. For more information, visit www.medigenvac.com.
MVC's Forward Looking Statements
This press release contains certain forward-looking statements relating to the business of Medigen Vaccine Biologics Corporation (MVC, TPEx: 65470.TWO) including with respect to the progress, timing and completion of research, development and clinical trials for MVC's EV71 vaccine candidate, and the ability to manufacture, market, commercialize and achieve market acceptance thereof. These forward-looking statements are based largely on the current expectations of MVC as applicable, as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In light of these risks and uncertainties, there can be no assurance that such forward-looking statements will in fact be realized. MVC and is providing the information in this press release as the date hereof, and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Contact
Leo Lee, Spokesperson
ir@medigenvac.com