9 August 2021 - Today, the Therapeutic Goods Administration, granted provisional approval to Moderna Australia for its COVID-19 vaccine—Spikevax (elasomeran)—making it the fourth COVID-19 vaccine to receive regulatory approval in Australia.
This messenger RNA vaccine is provisionally approved and included in the Australian Register of Therapeutic Goods for active immunisation to prevent coronavirus disease-2019 (COVID-19) caused by SARS-CoV-2 in individuals 18 years of age and older.
It is recommended that the vaccine is given in two doses that are administered 28 days apart.