https://www.tga.gov.au/covid-19-vaccines-undergoing-evaluationBefore any COVID-19 vaccine is approved for use in Australia, it will be subject to the well-established and rigorous assessment and approval processes of the Therapeutic Goods Administration (TGA), part of the Department of Health.
The TGA has received applications and is assessing preliminary data for the following COVID-19 vaccines using the provisional pathway and rolling review procedures.
Sponsor Name Type Further information Regulatory status 1 Moderna Australia Pty Ltd SPIKEVAX (elasomeran) mRNA Provisional Determination Notice
- Provisionally approved on 9 August 2021 for adults aged 18 years and over.
- Provisionally approved on 3 September 2021 for individuals aged 12-17 years.
- Booster dose provisionally approved on 7 December 2021 for individuals aged 18 years and over.
- Application for use in individuals <12 years of age under evaluation.
2 Biocelect Pty Ltd on behalf of Novavax Inc NVX-CoV2373 Protein vaccine Provisional determination notice Under evaluation
