SPIKEVAX BIVALENT ORIGINAL/OMICRON (Moderna Australia Pty Ltd)
Product name
SPIKEVAX BIVALENT ORIGINAL/OMICRON
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
60 (255 working days)
Active ingredients
elasomeran, davesomeran
Registration type
NCE/NBE
Indication
SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 (elasomeran/davesomeran) COVID-19 Vaccine has provisional approval for the indication below:
As a booster dose for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 12 years of age and older who have previously received at least a primary vaccination course against COVID-19.
The use of this vaccine should be in accordance with official recommendations.
The decision has been made on the basis of immunogenicity and short-term safety data. Continued approval depends on the evidence of longer term benefits 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