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Spikevax Bivalent Original/Omicron
Published
Product name
Spikevax Bivalent Original/Omicron
Active ingredient
Elasomeran and imelasomeran
Submission type
New biological entity
Decision
Approved for provisional registration
Decision date
Registration date
What this medicine was approved for
Spikevax Bivalent Original/Omicron (elasomeran and imelasomeran) was approved for the following therapeutic use:
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.
How this medicine works
Elasomeran and imelasomeran contain mRNA encapsulated in lipid nanoparticles.
The messenger ribonucleic acid (mRNA) encodes for the full-length severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein modified with 2 proline substitutions within the heptad repeat 1 domain (S-2P) to stabilise the spike protein into a prefusion conformation. After intramuscular injection, cells at the injection site and the draining lymph nodes take up the lipid nanoparticle, effectively delivering the mRNA sequence into cells for translation into viral spike protein. The delivered mRNA does not enter the cellular nucleus or interact with the genome, is nonreplicating, and is expressed transiently mainly by dendritic cells and subcapsular sinus macrophages. The expressed, membrane-bound spike protein of SARS-CoV-2 is then recognised by immune cells as a foreign antigen. This elicits both T-cell and B-cell responses to generate neutralising antibodies, which may contribute to protection against COVID-19.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Spikevax bivalent original/Omicron was considered favourable for the therapeutic use approved.
Sponsor
ARTG details
- 389513