TAIPEI, TAIWAN --July 20th, 2021. Medigen Vaccine Biologics Corp. (MVC) filed a Phase 3 Clinical Trial IND application with Paraguay's regulatory authority, Dirección Nacional de Vigilancia Sanitaria (DINAVISA), on July 6th for MVC-COV1901 Vaccine. DINAVISA has, as of today, approved MVC's application and have given authorization to initiate subject recruitment.
The Phase 3 clinical trial is a collaboration between MVC and Asunción University of Paraguay School of Medicine. The Phase III immune-bridging trial compares the performance of MVC's COVID-19 vaccine with AstraZeneca (AZ) COVID-19 vaccine. MVC expects to complete the recruitment of about 1,000 participants by the 3rd quarter of 2021, and aims to obtain interim analysis data in the 4th quarter. The trial will allow MVC to collect comparative safety and immunogenicity data and accelerate MVC's COVID-19 vaccine to be rolled out in Central and South American markets.
About MVC-COV1901
MVC-COV1901 is a subunit vaccine with recombinant S-2P antigen adjuvanted with CpG 1018 supplied by Dynavax and aluminum hydroxide. The S-2P antigen is a trimeric and prefusion-stable recombinant spike protein developed by the U.S. NIH. MVC has obtained a global technology license for S-2P from the U.S. Vaccine Research Center at National Institutes of Health (NIH). MVC-COV1901 vaccine's Phase 1 and Phase 2 clinical study data has shown robust safety and promising immunogenicity responses and as a result obtained Taiwan's EUA approval on July 19th, 2021. MVC will continue to collaborate with international partners for phase 3 clinical trial development, and assist the global community in its fight against the COVID-19 pandemic.
About Medigen Vaccine Biologics Corp. (MVC)
MVC is a biopharmaceutical company using cell-based technologies to develop novel vaccines and biosimilars. MVC's pipeline includes EV71 vaccine, dengue vaccine, quadrivalent influenza vaccine and COVID-19 vaccine 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
Contact
Paul Torkehagen
Director, International Business Development
paul@medigenvac.com