SPIKEVAX COVID-19 VACCINE (Moderna Australia Pty Ltd)
Product name
SPIKEVAX COVID-19 VACCINE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
23 (255 working days)
Active ingredients
elasomeran
Registration type
NCE/NBE
Indication
SPIKEVAX COVID-19 VACCINE (suspension for injection) has provisional approval for the indication below:
Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 18 years 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