TGA commences evaluation of Moderna COVID-19 vaccine (SPIKEVAX) for potential transition to full registration

The Therapeutic Goods Administration (TGA) has commenced evaluation of an application from Moderna Australia Pty Ltd to transition its COVID-19 vaccine, SPIKEVAX, to full registration for the immunisation of individuals 6 years and over, and as a booster dose for individuals aged 12 years and older.

This is the first application received by the TGA to transition a provisionally-approved COVID-19 vaccine to full registration. However, a number of COVID-19 vaccines, including SPIKEVAX already have the equivalent of full registration (market authorisation) in major overseas countries.

Currently in Australia this mRNA vaccine is provisionally approved for immunisation to prevent COVID-19 in individuals aged 6 months and older, and as a booster dose for individuals aged 12 years and older.

As part of the provisional approval, sponsors are required to continue to submit longer-term evidence of safety and efficacy to the TGA. Data from these ongoing trials can support a sponsor’s application to transition their COVID-19 vaccine to full registration status. The TGA will undertake a rigorous assessment of the safety, efficacy and quality of this vaccine for use in individuals 6 years of age and older.

Further information on the transition from provisional to full registration is available at: Provisional registration extension and transition to full registration.

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