TGA commences evaluation of Moderna COVID 19 vaccine (SPIKEVAX) for children aged 6 months to 5 years old

The Therapeutic Goods Administration (TGA) has received, and immediately commenced evaluation of, an application from Moderna Australia Pty Ltd to extend the use of its COVID-19 vaccine, SPIKEVAX, to children aged 6 months to 5 years old.

Currently this mRNA vaccine is provisionally approved for immunisation to prevent COVID-19 in individuals aged 6 years and older (primary series of 2 doses administered at least 28 days apart) and as a booster dose for adults aged 18 years and older. A lower dose of the vaccine (25 micrograms in 0.25 mL) is being assessed for 6 months to 5 year old children compared to that used for children 6 to 11 years (50 micrograms in 0.25 mL) and adolescents and adults over 12 years (100 micrograms in 0.5 mL).

SPIKEVAX is an mRNA vaccine. mRNA vaccines use a genetic code to enable the production of the coronavirus spike protein. Immune cells then recognise the spike protein as foreign and begin building an immune response against it. The RNA from the vaccine does not change or interact with our DNA in any way.

Further information on the vaccines that have been approved by the TGA for COVID-19 is available at COVID-19 vaccine: Provisional registrations.

Information about Australia's vaccine rollout can be found on the Department of Health's webpage.

Contact for members of the media:

• Email: news@health.gov.au
• Phone: 02 6289 740