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TGA Australia grants provisional approval to COVID-19 Vaccine Moderna to prevent COVID 19 – Moderna Inc
Moderna, Inc. announced that the Therapeutic Goods Administration (TGA) has granted provisional registration to the COVID-19 Vaccine Moderna in Australia for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older. Delivery of Moderna’s COVID-19 vaccine to Australia is expected to commence in the second half of September.
The Australian government has previously secured 10 million doses of COVID-19 Vaccine Moderna for delivery in 2021, through a supply agreement announced on May 12, 2021, as well as an option to procure 15 million doses in 2022. Moderna has also received emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine from health agencies in more than 50 countries and an Emergency Use Listing (EUL) from the World Health Organization (WHO).
The TGA continues to evaluate an application for provisional registration of Moderna’s COVID-19 vaccine for use in adolescents aged 12 to 18 years.