TGA commences evaluation of Pfizer's COVID-19 vaccine (COMIRNATY) for children aged 6 months to less than 5 years

The Therapeutic Goods Administration (TGA) has commenced evaluation of an application from Pfizer Australia Pty Ltd to extend the use of its COVID-19 vaccine, COMIRNATY, to use in a three-dose course in children aged 6 months to less than 5 years old.

Currently this vaccine is provisionally approved for immunisation to prevent COVID-19 in individuals aged 5 years and older as a primary course and as a booster dose for those aged 12 years and older. A lower dose (3 micrograms in 0.2 mL) of the vaccine will be assessed for younger children. This contrasts with a 10 microgram dose for 5-11 year olds and 30 micrograms for 12 years and over.

On 19 July 2022, the TGA provisionally approved a paediatric dose of the Moderna COVID-19 vaccine, SPIKEVAX, for use in children aged 6 months to less than 6 years.

The TGA's decision to provisionally approve a vaccine indicates that it has met high safety, quality and efficacy standards, however this is the first step in consideration of the use of the vaccine in Australia.

The Australian Technical Advisory Group on Immunisation (ATAGI) will provide advice to the Government on the potential use of this vaccine, should it receive provisional approval from the TGA.

Further information on the vaccines that have been approved by the TGA for COVID-19 is available at COVID-19 vaccines regulatory status. Information about Australia's vaccine rollout can be found on the Department of Health and Aged Care's webpage.

Contact for members of the media:

• Email: news@health.gov.au
• Phone: 02 6289 7400