TAIPEI, TAIWAN --July 19th, 2021. Medigen Vaccine Biologics Corp (MVC) obtains Taiwan EUA approval due to MVC's COVID-19 vaccine has fulfilled following EUA standards set by Taiwan's regulatory agencies:
1.For the GMT of MVC-COV1901, the lower bound of 95% confidence interval (CI) is 3.4 times the GMT of AstraZeneca. (Set criteria: 0.67 times the GMT of AstraZeneca.)
2.For the sero-response rate of MVC-COV1901, the lower bound of 95% CI achieved 95.5%, which far exceeded the set threshold of 50%.
MVC COVID-19 vaccine is indicated for adults over 20 years old and vaccinated in two doses 28 days apart for prevention of COVID-19. The Advisory Committee recommended that MVC should submit safety monitoring report monthly during the declared EUA period and should submit a vaccine effectiveness report within one year after obtaining EUA approval.