21-Valent Pneumococcal Conjugate Vaccine
Prevention of pneumococcal disease in non-Indigenous adults aged ≥70 years (or ≥65 years per ATAGI recommendation), Aboriginal and Torres Strait Islander adults aged ≥25 years, and adults aged ≥18 years with specified medical risk conditions.
Decision on record
- Meeting Nov 2025 Recommended Prevention of pneumococcal disease in at-risk adults, non-Indigenous adults aged ≥65 years, Aboriginal and Torres Strait Islander adults aged ≥25 years
Access path
- Nov 2025Recommended · restricted
vs 13-valent pneumococcal conjugate vaccine (13vPCV)…
- PBS listing · Restricted
From the public summary
7.1 The PBAC recommended that 21-valent pneumococcal conjugate vaccine (21vPCV, Capvaxive) be a designated vaccine for the purposes of the National Health Act 1953, for the prevention of pneumococcal disease in individuals with an at-risk condition aged ≥ 18 years, non-Indigenous adults aged ≥ 65 years and Aboriginal and Torres Strait Islander adults aged ≥ 25 years.PSD · Nov 2025
7.2 The PBAC considered there is a clinical need for alternative pneumococcal vaccines as there remains a substantial burden of disease in the proposed NIP populations, despite NIP listing of 13vPCV and 23vPPV. The PBAC noted the proposed listing of 21vPCV was supported by the consumer comments received for this submission.PSD · Nov 2025
6.43 The submission presented results from a separate CUA with results expressed as the cost per quality-adjusted life year (QALY) gained ($/QALY) for the current NIP populations for 13vPCV ± 23vPPV and the near-market comparator 20vPCV. The PBAC considered that 13vPCV ± 23vPPV was the appropriate main comparator for the current NIP populations (paragraph 5.1). The submission presented a CMA for the Indigenous population aged 25 to 49.PSD · Nov 2025
OFFICIAL Public Summary Document - November 2025 PBAC Meeting Cost-utility analysisPSD · Nov 2025
6.31 The submission claimed that in adults ≥ 18 years, 21vPCV has superior effectiveness against pneumococcal disease compared to 13vPCV and 20vPCV in current NIP populations and non-inferior effectiveness in Aboriginal and Torres Strait Islander adults aged 25-49 years. The claims for superiority should be interpreted with caution as they were not supported by evidence demonstrating clinical effectiveness.PSD · Nov 2025
6.32 The specific efficacy claims (based on immunogenicity outcomes) were: Non-Indigenous 70+:PSD · Nov 2025
Cost-effectiveness
Cost-utility analysis (CUA) and cost-minimisation analysis (CMA) performed; numeric ICER values not stated in public document. For Aboriginal and Torres Strait Islander adults aged 25-49 years, cost-minimisation approach used versus 20vPCV.
Decision context
PopulationNon-Indigenous adults aged ≥70 years; Aboriginal and Torres Strait Islander adults aged ≥25 years; adults aged ≥18 years with specified medical risk conditions (asplenia, immunocompromising conditions, chronic respiratory disease, chronic renal disease, CSF leak, cochlear implants, intracranial shunts, or prior invasive pneumococcal disease).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2025 | Recommended · restricted | 13-valent pneumococcal conjugate vaccine (13vPCV); near-market comparators: 15vPCV and 20vPCV | — | RCT · Immunogenicity (serotype-specific opsonophagocytic responses and IgG responses) |
Consumer voice
Six organisations and health care professionals provided input supporting 21vPCV listing on the NIP. The input highlighted benefits including broader serotype coverage, alignment with influenza vaccination age ranges, and the significant burden of pneumococcal disease in older people and First Nations populations.
The PBAC noted and welcomed the input from health care professionals (2) and organisations (4) via the Office of Health Technology Assessment Consultation Hub. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to specific age groups (≥70 or ≥65 non-Indigenous; ≥25 Aboriginal/Torres Strait Islander) and medical risk conditions, versus TGA's broad ≥18 years.