The Therapeutic Goods Administration (TGA) has provisionally approved the use of the Moderna Australia Pty Ltd COVID-19 vaccine SPIKEVAX (elasomeran) in individuals 12 years and older. This decision follows the provisional approval granted by the TGA to Spikevax on 9 August 2021 for use in individuals aged 18 years and older.
The recommended dose and dose interval is the same as that for the adult population - two full doses given 28 days apart. Further information is available in the Product Information (PI)
Provisional approval for use in the 12-17 years age group has been made following careful evaluation of the available data supporting safety and efficacy. The vaccine has also received regulatory approval or authorisation in this age group in several jurisdictions, including the United Kingdom, Canada, the European Union and Switzerland.
