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Comirnaty original/Omicron BA.1 COVID-19 Vaccine
Published
Product name
Comirnaty original/Omicron BA.1 COVID-19 Vaccine
Active ingredient
Tozinameran and riltozinameran
Submission type
New biological entity/new combination of active ingredients
Decision
Approved for provisional registration
Decision date
Registration date
What this medicine was approved for
Comirnaty original/Omicron BA.1 COVID-19 Vaccine (tozinameran and riltozinameran) was approved for the following therapeutic use:
Comirnaty original/Omicron BA.1 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 short term immunogenicity 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
The nucleoside-modified messenger RNA (ribonucleic acid) in the vaccine is formulated in lipid nanoparticles, which enable delivery of the non-replicating RNA into host cells to direct transient expression of the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) spike (S) antigen. The mRNA (messenger ribonucleic acid) codes for membrane-anchored, full-length S with two point mutations within the central helix. Mutation of these two amino acids to proline locks S in an antigenically preferred prefusion conformation. The vaccine elicits both neutralising antibody and cellular immune responses to the antigen, 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 Comirnaty original/Omicron BA.1 COVID-19 Vaccine was considered favourable for the therapeutic use approved.
Sponsor
ARTG details
N/A