Medigen Vaccine Biologics Corporation Withdraws Covid-19 Vaccine Provisional Application and Update with Three-Dose Data for Further Review
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.