The Therapeutic Goods Administration (TGA) has provisionally approved the Moderna COVID-19 vaccine, SPIKEVAX, for use in individuals aged 6 years and older. This follows provisional approvals granted by the TGA to Moderna for the use of SPIKEVAX in individuals aged 12 years and older on 3 September 2021, and on 7 December 2021 the SPIKEVAX booster dose for use in adults 18 years and older.

The TGA carefully assessed the data following the KidCOVE clinical trial which included up to 4,000 participants aged 6 to 11 years across the US and Canada, demonstrating that the immune response to the vaccine in children was similar to that seen in older age groups. 

In addition to this, clinical data showed that the safety profile in children is similar to that seen in adults. The most frequent side effects in this age cohort were short term and non-severe. These included injection site pain, redness and/or swelling, axillary (groin) swelling or tenderness, fatigue, headache, fever and muscle pain. 

Further advice on the rollout of SPIKEVAX to this age group will be provided to the Government by the Australian Technical Advisory Group on Immunisation (ATAGI). 

To read the statement in full, please click on the link below:

TGA statement: Moderna’s COVID-19 vaccine (SPIKEVAX) provisionally approved for use in individuals 6 years and older