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《TAIPEI TIMES》 Medigen to apply to Australian agency for provisional approval of its vaccine - 焦點

By 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. ....

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Medigen to apply to Australian agency for provisional approval of its vaccine

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.
The TGA has provisionally approved the COVID-19 vaccines ....

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