Medigen Vaccine Biologics Corporation (MVC), a biopharmaceutical company focusing on the development and production of vaccines and biologics based in Taiwan, and Dynavax Technologies Corporation, a US based biopharmaceutical company focused on developing and commercializing vaccines, have announced that the first participant has been dosed in the Phase 2 clinical trial evaluating MVC's COVID-19 vaccine candidate, MVC-COV1901.  

MVC-COV1901 is a subunit vaccine with recombinant S-2P antigen adjuvanted with CpG 1018 supplied by Dynavax.

MVC's Phase 2 clinical trial is a randomized, double-blinded, multi-center clinical trial, expecting to enroll 3,700 healthy subjects, 20 years of age and above. The trial will evaluate MVC-COV1901 safety and endurance of immunogenicity. The proposed dosing regimen is two doses administered intramuscularly one month apart.

Based on MVC's Phase 1 interim data, MVC-COV1901 has demonstrated a good safety profile and encouraging immunogenicity performance.

"MVC is delighted to receive the Phase 2 clinical trial IND approval by Taiwan FDA for MVC-COV1901 vaccine" said Charles Chen, Chief Executive Officer at Medigen. "We would like to express our deepest gratitude to all the volunteers, partners and Dynavax for the continued support.  MVC will continue with our best efforts to bring MVC-COV1901 vaccine to market to meet our commitment to help the global community in the fight against COVID-19."