Approval of the Covid-19 Vaccine in Australia

covid vaccine

The Therapeutic Goods Administration (TGA) is responsible for assessing all COVID-19 vaccines before they can be used in Australia.

The Australian Government has secured three COVID-19 vaccines that are currently subject to approval from the TGA.  On 25 January, the TGA granted provisional approval to Pfizer Australia Pty Ltd for its COVID-19 vaccine, COMIRNATY, making it the first COVID-19 vaccine to receive regulatory approval in Australia.

The TGA rigorously assesses vaccines for safety, quality and efficacy before they can be used in Australia and is working with international counterparts, monitoring information on vaccine clinical trials, manufacturing and safety. 

The TGA will continue to monitor COVID-19 vaccines for safety, after they are supplied in Australia, through ongoing safety monitoring. The TGA will receive adverse event reporting and if it suspected there is an issue with a vaccine an investigation will be undertaken which may include suspending the use of the vaccine under investigation.



Department of Health


Therapeutic Goods Administration