SPIKEVAX BIVALENT ORIGINAL/OMICRON (elasomeran and imelasomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial (Moderna Australia Pty Ltd)
Product name
SPIKEVAX BIVALENT ORIGINAL/OMICRON (elasomeran and imelasomeran) COVID-19 VACCINE 0.1 mg/mL suspension for injection vial
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
49 (255 working days)
Active ingredients
elasomeran, imelasomeran
Registration type
NCE/NBE
Indication
SPIKEVAX BIVALENT ORIGINAL/OMICRON (elasomeran/imelasomeran) 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 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 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.