ARTG Entry
COMIRNATY
ARTG entry for COMIRNATY (SARS-CoV-2 spike protein (mRNA) LP.8.1), ARTG 506534 — Product Information, dosage form, registration history. Compiled by…
- Sponsor: Pfizer
- Active ingredient: SARS-CoV-2 spike protein (mRNA) LP.8.1
- Therapeutic area: Infectious Disease
What it is
COMIRNATY is a single-stranded, 5'-capped messenger RNA (mRNA) encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Each dose contains COVID-19 mRNA vaccine embedded in lipid nanoparticles.
Approved indications
— Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, in individuals 6 months of age and older.
Dosing overview
COMIRNATY JN.1 is available in three strengths: 30 micrograms for ages 12 years and older, 10 micrograms for ages 5 to less than 12 years, and 3 micrograms for ages 6 months to less than 5 years.
Regulatory history
COMIRNATY JN.1 (bretovameran) was first listed on the ARTG on 2024-10-11 across multiple formulations and presentations. An AusPAR (Australian Public Assessment Report) was approved on 2023-12-21 for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. In May 2025, a PBAC outcome was deferred for prevention of COVID-19 in adults with medical risk conditions, immunocompromised patients aged 18 and older, or adults aged 60 years and over. In December 2025, PBAC recommended listing on the National Immunisation Program (NIP) for prevention of COVID-19 caused by SARS-CoV-2 in specific adult populations at increased risk of severe COVID-19 disease, though a lower price was advised to ensure cost-effectiveness.