Raxtozinameran
Prevention of COVID-19 disease caused by SARS-CoV-2 in adults aged ≥18 years at increased risk of severe COVID-19 disease, as booster vaccination (annual or biannual depending on age and risk status).
Decisions on record
- Meeting Dec 2025 Recommended Prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 no PSD
- Meeting May 2025 Deferred Prevention of COVID-19 in adults at increased risk
Access path
- Dec 2025Recommended
vs no (booster) vaccine
- PBS listing · Restricted
From the public summary
7.1 The PBAC deferred making a recommendation for raxtozinameran in relation to the requested National Immunisation Program (NIP) listing for the prevention of COVID-19 66 OFFICIALPSD · May 2025
OFFICIAL Public Summary Document – May 2025 PBAC Meeting with December 2025 Addendum disease caused by the SARS-CoV-2 virus in adults aged ≥ 18 years at increased risk of severe COVID-19 disease. The PBAC advised that further information was required to support appropriate consideration of this submission, including further input from the sponsor, the Australian Technical Advisory Group on Immunisation (ATAGI) and the Department.PSD · May 2025
6.45 On the grounds of a claim of therapeutic superiority of raxtozinameran versus no (booster) immunisation, the submission presented a modelled cost-utility analysis comparing raxtozinameran with no immunisation.PSD · May 2025
6.46 The submission proposed that the modelled economic evaluation reflected the incremental costs and outcomes associated with implementing a COVID-19 national immunisation program for Australian adults using Comirnaty® (raxtozinameran or subsequent).PSD · May 2025
6.41 The submission described raxtozinameran as superior in terms of effectiveness compared with no booster vaccination and inferior in terms of safety compared with no booster vaccination. 42 OFFICIALPSD · May 2025
OFFICIAL Public Summary Document – May 2025 PBAC Meeting with December 2025 AddendumPSD · May 2025
6.3 The input from the individual did not support the vaccine. The input stated that vaccination was neither necessary nor effective to prevent COVID-19.PSD · May 2025
6.4 The comments from organisations were supportive of the proposed NIP listing of raxtozinameran. Some of the main themes of the input were:PSD · May 2025
Cost-effectiveness
ICER value not stated in public text; cost-effectiveness analysis was conducted but specific numeric ICER not published in PSD.
Decision context
PopulationAdults aged ≥18 years at increased risk of severe COVID-19 disease (including those aged 18–64 years at standard or high risk, aged 65–74 years at any risk, and aged ≥75 years at any risk), with severe immunocompromise receiving annual or biannual booster doses.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Dec 2025 | Recommended | no (booster) vaccine | — | RCT · Other |
Consumer voice
One individual submitted input opposing the vaccine, stating vaccination was neither necessary nor effective for COVID-19 prevention. Two organisations (Lung Foundation Australia and NACCHO) supported the NIP listing, highlighting increased COVID-19 risks for people with lung disease and Aboriginal/Torres Strait Islander communities, and noting advantages of the pre-filled syringe formulation for
Lung Foundation Australia highlighted additional risks of COVID-19 for Australians living with lung diseases including increased risk of symptom exacerbation, lung function deterioration, hospitalisation and even death. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to adults ≥18 years at increased risk of severe COVID-19; TGA label includes all individuals ≥6 months regardless of risk status.