On 9 August 2021, the Therapeutic Goods Administration (TGA), part of the Department of Health, granted provisional approval to Moderna Australia Pty Ltd for its COVID-19 vaccine-Spikevax (elasomeran)-making it the fourth COVID-19 vaccine to receive regulatory approval in Australia.
This messenger RNA (mRNA) vaccine is provisionally approved and included in the Australian Register of Therapeutic Goods (ARTG) 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.
The Moderna COVID-19 vaccine has shown strong efficacy preventing symptomatic COVID-19 and severe COVID-19 in clinical trials. The vaccine has also received regulatory approval or emergency authorisation in several countries and is being widely used in the United Kingdom, Canada, the European Union, the United States, Switzerland and Singapore.
Provisional approval of this vaccine in Australia is subject to certain strict conditions, such as the requirement for Moderna Australia Pty Ltd to continue providing information to the TGA on longer-term efficacy and safety from ongoing clinical trials and post-market assessment.
Data to support the use of Moderna's COVID-19 vaccine in adolescents aged 12 to 17 years are currently under evaluation and no specific concerns have been identified to date. The TGA's decision on use in this age group will be announced separately.
