Medigen to apply to Australian agency for provisional approval of its vaccineBy Kao Shih-ching / Staff reporterMedigen Vaccine Biologics Corp (高端疫苗) yesterday said it would apply to the Australian Therapeutic Goods Administration (TGA) for provisional approval of its COVID-19 vaccine in the near term, after obtaining a provisional determination from the agency. A provisional approval in Australia is similar to emergency use authorization in other countries, Medigen said in a statement. Signage for Medigen Vaccine Biologics Corp is pictured at the entrance to the company’s facility in Hsinchu on Aug. 31. It has also given a provisional determination to Novavax Inc.Medigen said it yesterday became the sixth firm to gain a provisional determination, after the agency granted a provisional determination to Grand Pacific CRO, the Australian sponsor acting on behalf of Medigen for its MVC-COV1901 vaccine. Provisional determination is the first step in the provisional registration process and means that Grand Pacific CRO is eligible to apply for provisional registration, the agency said.

Source: Taipei Times November 22, 2021 19:01 UTC