Mrna-1345
Deferred VaccinesNot applicableNot applicable line
Prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals aged ≥75 years and Aboriginal and Torres Strait Islander people aged 60-74 years.
1
Submissions
2025–25
On the record
—
ICER range
Cost-min
Cost basis
From the public summary
PBAC outcome
90.9 87.5 Primary analysis 11/2,815 1/2,809 8/2,904 1/2,892 NR NR NR (29.3, 98.8) (6.8, 99.7)PSD · Nov 2025
83.3 85.7 52.5 Primary analysis 6/2,815 1/2,809 7/2,904 1/2,892 6/2,646 3/2,671 (-38.9, 98.0) (-11.2, 99.7) (-122.5, 92.3)PSD · Nov 2025
Economic analysis
6.65 As summarised in Table 16, the submission presented a CMA comparing mRNA-1345 with RSVPreF as the primary economic evaluation, based on the ITC of mRNA-1345 against RSVPreF. The submission analysis included only the acquisition cost of a single dose of the respective vaccines (based on the publicly available price in the private market for RSVPreF) and assumed the same costs of administration and management of adverse events.PSD · Nov 2025
6.66 The submission proposed equi-effective doses of mRNA-1345 50 mcg/0.5 mL and RSVPreF 120 mcg/0.5 mL for the basis of the CMA. The submission noted that marginally different adverse event profiles were observed in the two pivotal trials for mRNA-1345 and RSVPreF, which is not expected to significantly impact their therapeutic comparability.PSD · Nov 2025
Clinical claim
6.47 The submission claimed that for adults aged ≥ 75 years and Aboriginal and Torres Strait Islander people > 60 years of age, mRNA-1345 is superior in terms of effectiveness compared to placebo.PSD · Nov 2025
6.48 The ESC agreed with the evaluation that this claim was adequately supported for adults ≥ 60 YOA for up to 16 months. Beyond 16 months, the proportion of participants remaining at risk is too small (2% at 24 months) to allow for meaningful conclusions about long-term effectiveness (paragraph 6.20).PSD · Nov 2025
Cost-effectiveness
Cost-minimisation analysis was presented comparing mRNA-1345 with RSVPreF; no numeric ICER stated in public text. A cost-utility analysis comparing mRNA-1345 with no vaccine was also presented but no ICER value is disclosed in the PSD.
Decision context
PopulationAdults aged ≥75 years and Aboriginal and Torres Strait Islander people aged 60-74 years for prevention of RSV lower respiratory tract disease.
Why it was knocked back
- Insufficient evidence for non-inferiority claim versus RSVPreF and RSVPreF3 OA; faster waning of vaccine efficacy than comparators suggesting need for more frequent revaccination; revaccination strategy not established or evaluated; cold chain requirements incompatible with rural/remote Aboriginal and Torres Strait Islander communities; uncertainty regarding long-term protection and need for booster doses
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2025 | Deferred | RSVPreF (Abrysvo) | — | RCT · Vaccine efficacy to prevent RSV-LRTD with ≥2 or ≥3 symptoms |
Similar precedents
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