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Spikevax
Published
Product name
Spikevax
Active ingredient
Elasomeran
Submission type
New biological entity
Decision
Approved for provisional registration
Decision date
Registration date
What this medicine was approved for
Spikevax (elasomeran) was approved for the following therapeutic use:
Spikevax (elasomeran) COVID-19 vaccine 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.
How this medicine works
Spikevax contains messenger ribonucleic acid (mRNA) encapsulated in lipid nanoparticles. The mRNA encodes for the full-length severe acute respiratory syndrome coronavirus (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 (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 was considered favourable for the therapeutic use approved.
Sponsor