PBAC's latest decision on Mrna-1345: Not recommended (2025). Considered for 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.
PBAC outcome
Not recommended
Not applicable
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2025
Submissions
1
2025 → 2025
Eligible population
Adults aged ≥75 years and Aboriginal and Torres Strait Islander people aged 60-74 years for prevention of RSV lower respiratory tract disease.
Therapy area
Vaccines
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
Vaccine efficacy to prevent RSV-LRTD with ≥2 or ≥3 symptoms
Key trials
mRNA-1345-P301, mRNA-1345-P302
Comparator
RSVPreF (Abrysvo)
Economic model
CUA
ICER note
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.
Why PBAC said no
Reasons cited in the latest PSD: 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