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COMIRNATY
Published
Product name
COMIRNATY
Active ingredient
BNT162b2 (mRNA)
Submission type
New biological entity
Decision
Approved for provisional registration
Decision date
Registration date
What this medicine was approved for
COMIRNATY (BNT162b2 mRNA) was provisionally approved for the following therapeutic use:
COMIRNATY (BNT162b2 (mRNA)) 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 16 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
The nucleoside-modified messenger RNA in COMIRNATY 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 spike (S) antigen. The mRNA 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. COMIRNATY 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 was considered favourable for the therapeutic use approved.
Sponsor
ARTG details
N/A