SPIKEVAX (Moderna Australia Pty Ltd)
Product name
SPIKEVAX
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
47 (255 working days)
Active ingredients
elasomeran
Registration type
EOI
Indication
The provisionally approved new indication for the New SPIKEVAX Medicine is:
SPIKEVAX (elasomeran) COVID-19 Vaccine has provisional approval for the indication below:
- Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 6 months of age and older.
The use of this vaccine should be in accordance with official recommendations.
The decision has been made on the basis of short-term efficacy and safety data. Continued approval depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration