The Therapeutic Goods Administration (TGA) has granted provisional determination to Moderna Australia Pty Ltd for their COVID-19 vaccine candidate, Elasomeran. It is being considered for use in those aged 12 years or older for active immunisation to prevent COVID-19 disease. It is an mRNA vaccine requiring two doses, given 28 days apart.
Granting provisional determination means that Moderna Australia Pty Ltd is now eligible to apply for provisional registration. Following the provisional pathway provides a formal and transparent mechanism for speeding up the registration of promising new medicines with preliminary clinical data.
Provisional determination is only granted once the TGA has considered all eligibility criteria, including evidence of a plan to submit comprehensive clinical data.
You can read the press release from the TGA below:
TGA grants provisional determination for the Moderna COVID-19 vaccine, Elasomeran
For more information on the process of COVID-19 vaccine provisional approval please refer to our reference page:
MVEC: Provisional registration of COVID-19 vaccine(s) in Australia