Medigen Vaccine Biologics Corporation filed provisional approval of MVC COVID-19 Vaccine to Therapeutic Goods Administration (TGA) in June 2022, and is undergoing the GMP inspection by TGA. According to the recommendations from the Australian regulatory authority (TGA) and
regulatory consultants, MVC withdraw the MVC COVID-19 Vaccine provisional application which claimed suitability for a two-dose regimen now. Following the regulatory advice, the data for a three-dose regimen (primary and booster doses) and corresponding claims will be compiled into the Common Technical Dossier for further review. The Good Manufacturing Practice (GMP) inspections of vaccine manufacturers (including Contract Manufacturing Organization, CMO) by TGA are unaffected and continue as scheduled.