TAIPEI, TAIWAN --June 10th, 2021. MVC released COVID-19 Vaccine Phase 2 interim analysis results. The results demonstrated a good safety profile in participants. There were no vaccine related Severe Adverse Events (SAE) in all participants in the interim analysis. Safety data will continue to be accrued and monitored. For immunogenicity results, on the 28th day after second dose, seroconversion rate of 99.8% was achieved in all participants across all age, and the geometric mean titer (GMT) was 662, with GMT ratio as 163 for all participants in the study. For subjects from 20 to 65 years of age, the seroconversion rate was 99.9% with GMT of 733 and GMT ratio at 180. The interim analysis results met MVCs expectations.
MVC's main Phase 2 clinical trial was conducted in Taiwan's 11 hospitals with over 4,000 volunteers enrolled, with 3,800 final participants remaining after screening. The first dose was administrated to participants on January 22nd, 2021. On April 28th , all participants had received second dose. According to the EUA requirement, on May 28th all subjects have achieved at least one month follow-up after the second dose, and median follow-up period was 2 months.
The subject's serum was sent to the P3 Laboratory of the Academia Sinica to analyze the neutralizing antibodies against wild-type viruses. And all raw data collected and analyzed during the period from clinical trial center, Academia Sinica and other CRO were uploaded to the third-party clinical trial CRO company, Clinipace, in a blind state for data collection and analysis. An Independent Data Monitoring Committee (IDMC) was gathered on June 10th to conduct data unblinding and announced interim analysis results.
The results of the interim analysis demonstrated a good safety profile and the immunogenicity data fulfilled MVC's expectations. MVC will submit the interim analysis report to the Taiwan FDA for the application of Emergency Use Authorization (EUA), and MVC will keep communicating with other global regulatory authorities for Phase III clinical trials.
About MVC-COV1901
MVC-COV1901 is a subunit vaccine with recombinant S-2P antigen adjuvanted with CpG 1018 supplied by Dynavax plus 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). Building upon the S-2P platform, MVC conducted large-scale screenings of various adjuvants and finalized the compositions of MVC-COV1901 vaccine to optimize safety and desired immunogenicity properties. MVC established the production platform of MVC-COV1901 and based on MVC's preclinical, Phase 1 and Phase 2 clinical study data, MVC-COV1901 has shown robust safety and promising immunogenicity responses and as a result plans to apply for EUA application in Taiwan and continue to discuss with other global regulatory agencies for Phase 3 clinical trial development.
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, MVC also aims to provide vaccines and biopharmaceuticals to meet regional needs and with a desire to help globally against the threats of infectious diseases. MVC's pipeline includes enterovirus EV71 vaccine, dengue vaccine, influenza quadrivalent 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.