MVC announced today (4/28) that all 3,700 subjects in MVC COVID19 Vaccine Phase II clinical trial have completed second dose vaccination, fulfilling requirement regulated by TFDA and clinical trial protocols. Since vaccine safety and immunogenicity will be evaluated on the 28th day after the second dose in accordance with regulatory recommendations, MVC is expecting the analysis results by the end of May. And if the safety and immunogenicity results meets regulatory requirement, MVC will submit EUA applications in accordance with regulations in June this year.
MVC initiated COVID-19 vaccine phase II clinical trial in 11 medical centers in Taiwan, and the regulatory agency recommended 3,500 subjects shall be recruited, including 700 elderly people over 65 years old. Due to active participations from the public, at the end of March, more than 4,000 subjects joined this trial, including 850 elderlies have been admitted. The enrollment far exceeded the subject number recommended by Taiwan's Ministry of Health and Welfare for EUA application.