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Spikevax bivalent Original/Omicron BA.4-5
Published
Product name
Spikevax bivalent Original/Omicron BA.4-5
Active ingredient
Elasomeran and davesomeran
Submission type
New biological entity
Decision
Approved for provisional registration
Decision date
Registration date
What this medicine was approved for
Spikevax bivalent Original/Omicron BA.4-5 (elasomeran and davesomeran) was approved for the following therapeutic use:
The provisionally approved new indication(s) for the medicine(s) are:
Spikevax bivalent Original/Omicron BA.4-5 (elasomeran and 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.
How this medicine works
Spikevax (original) (elasomeran) and Spikevax bivalent Original/Omicron (BA.1) (elasomeran/imelasomeran) both contain messenger ribonucleic acid (mRNA) encapsulated in lipid nanoparticles. The 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 coronavirus disease 2019 (COVID-19).
The nucleoside-modified mRNA in Spikevax bivalent Original/Omicron BA.4-5 (elasomeran/davesomeran) is formulated in lipid particles, which enable delivery of the nucleoside-modified mRNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits an immune response to the S antigen, which protects 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 BA.4-5 COVID-19 vaccine was considered favourable for the therapeutic use approved.
Sponsor