Excerpt
Medigen Vaccine Biologics Corp (高端疫苗) has applied to the Australian medicines regulator for provisional approval of its COVID-19 vaccine.
Article Summary
Medigen Vaccine Biologics Corp applied to Australian medicines regulator for provisional approval of the COVID-19 vaccine and has delivered the necessary documents to the Australian Therapeutic Goods Administration (TGA), but did not say when the regulator would complete its review, the filing showed.
The corporate data showed that TGA in November last year gave the Medigen vaccine a provisional determination, the first step to provisional approval. The step allows for provisional registration of medicines on the basis of preliminary clinical data.
The TGA is one of the world’s most credible regulatory authorities as defined by the WHO, Medigen said in the filing. The COVID-19 vaccines from AstraZeneca PLC, Moderna Inc, Pfizer Inc and BioNTech SE, Johnson & Johnson, and Novavax Inc have obtained provisional approvals from the TGA.
Medigen’s COVID-19 vaccine has been given emergency use authorization in Taiwan and Paraguay, and the company is waiting for a review to be completed in the Kingdom of Eswatini, while New Zealand, Palau, Indonesia, Belize and Thailand exempt travelers who have received the vaccine without requiring strict quarantine measures.
Medigen’s VP of International Affairs, Dr. Allen Lien, will be presenting the Progress Updates of MVC Covid-19 Vaccine at the 10th Biologics World Taiwan 2022 which will be held on 30 August – 1st September at Grand Victoria Hotel Taipei, Taiwan. More than 300 attendees from Taiwan and International Biopharma will attend the event in-person to exchange views, debate on the best practices in clinical trials and manufacturing of biologics and network after 2 years of virtual event. Registration is still open, visit https://imapac.com/biologics-world-taiwan/ to view the full programme and register your slot.
About Medigen Vaccine Biologics Corp.
MVC is a biopharmaceutical company focusing on the development and mass production of vaccines and biologics. MVC has PIC/S GMP certified cell culture commercial mass production capabilities, and targets global and regional infectious diseases to develop novel vaccines and affordable biosimilar drugs via international alliances.
