4 September 2021 - On 3 September 2021, the TGA granted provisional approval to Moderna Australia for the use of its COVID-19 vaccine—Spikevax (elasomeran)—in individuals aged 12 years and older.
This decision follows the provisional approval granted by the TGA to Spikevax (elasomeran) on 9 August 2021 for use in individuals aged 18 years and older.
As for previous COVID-19 vaccine applications, this assessment was expedited by the TGA through the provisional approval pathway.