Medigen 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.
Medigen would provide the regulator with all required data, including those from its phase 2 clinical trials conducted in Taiwan and from its clinical trials conducted in other countries, such as Paraguay, spokesperson Leo Lee (李思賢) told the Taipei Times.
Photo: Billy H.C. Kwok, Bloomberg
The TGA has provisionally approved the COVID-19 vaccines made by Moderna Inc, Pfizer Inc, Johnson & Johnson and AstraZeneca PLC. 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.
The protein-based subunit vaccine would be considered for active immunization to prevent COVID-19 caused by SARS-CoV-2 in people aged 18 or older, the TGA said in a statement.
If the vaccine is approved, a complete course of MVC-COV1901 is likely to be two doses given as an injection four weeks apart, the TGA said.
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.
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