Respiratory Syncytial Virus Vaccine, Recombinant, Pre-Fusion F Protein 3, Older Adult
Prevention of RSV-confirmed lower respiratory tract disease (LRTD) in adults aged ≥75 years, First Nations adults aged 60-74 years, and adults aged 60-74 years with medical conditions associated with increased risk of severe RSV disease.
Access path
- Mar 2026Recommended
vs no vaccine
- PBS listing · Restricted
From the public summary
7.1 The PBAC recommended a change to the previously recommended National Immunisation Program (NIP) listing for respiratory syncytial virus vaccine (RSVPreF3 OA, Arexvy®). The submission requested NIP listing for adults aged 60-74 years with at least one condition associated with increased risk of severe RSV disease as described in the Australian Immunisation Handbook (AIH).PSD · Mar 2026
7.2 The PBAC acknowledged comments in the pre-PBAC response that suggested the sponsor may be unwilling to proceed with a recommendation for the eligible population to include all people aged 60-74 years, and its proposal to further restrict eligibility to people aged 65-74 years at increased risk of severe RSV.PSD · Mar 2026
6.53 The resubmission presented a modelled economic evaluation comparing a single dose of RSVPreF3 OA with no vaccine based on data from AReSVi-006 for the following groups: • adults ≥75 YOA • adults 60-74 YOA at increased risk of severe RSV disease.PSD · Mar 2026
6.54 For the 60-74 YOA at increased risk of severe RSV disease population, the resubmission presented two models: one for individuals with at least one at-risk medical condition associated with increased risk of severe RSV disease, as per the AIH list, and another based on each AIH-defined risk category separately.PSD · Mar 2026
RSVPreF3 OA versus placebo in adults aged 60–74 years with medical conditions that increase the risk of severe RSV diseasePSD · Mar 2026
6.46 The resubmission described RSVPreF3 OA as superior in terms of VE compared with no vaccine for the prevention of RSV-confirmed LRTD among adults 60-74 YOA with a comorbidity of interest associated with increased risk of severe RSV disease, and with an acceptable safety profile, despite being more reactogenic than placebo (no vaccination).PSD · Mar 2026
Cost-effectiveness
ICER values are redacted (commercially sensitive). The PBAC considered revised cost inputs reasonable at the December 2025 intracycle meeting for the two previously recommended populations; however, no specific ICER figures are stated in the public text.
The PBAC considered that the revised cost inputs for the economic evaluation were reasonable, and that the vaccine was cost effective at the price proposed for adults aged at least 75 YOA and First Nations adults 60-74 YOA. PBAC · 2026
Decision context
PopulationThree populations: (1) adults aged ≥75 years; (2) First Nations adults aged 60-74 years; (3) adults aged 60-74 years with at least one medical condition associated with increased risk of severe RSV disease (as defined in the Australian Immunisation Handbook).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Recommended | no vaccine | $25k–35k | RCT |