Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated, Cell-Based)
Prevention of seasonal influenza in Aboriginal and Torres Strait Islander people aged ≥5 to <65 years, persons aged ≥5 to <65 years with chronic medical conditions increasing risk of influenza complications, and pregnant women. Children older than 5 years but less than 9 years require 2 doses at least 1 month apart for initial vaccination.
Decision on record
- Meeting Sep 2022 Recommended Prevention of influenza in Aboriginal and Torres Strait Islander peoples aged ≥5 to <65 years, people at increased risk of complications aged ≥5 to <65 years, and pregnant women
Access path
- Sep 2022Recommended · restricted
vs egg-based quadrivalent influenza vaccine (QIVe)
- PBS listing · Restricted
From the public summary
The PBAC recommended that quadrivalent influenza virus vaccine, surface antigen, inactivated, cell-based (QIVc, Flucelvax® Quad) be a designated vaccine for the purposes of the National Health Act 1953, for the vaccination against influenza in Aboriginal and Torres Strait Islander people aged ≥5 to <65 years, people at increased risk of influenza disease complications aged ≥5 to <65 years and pregnant women.PSD · Sep 2022
The PBAC acknowledged there were advantages of cell-based vaccine production technology over the egg-based technology and in diversifying vaccine production platforms. The PBAC noted that cell-based technology may allow faster start-up of vaccine production when needed (for example in the event of a pandemic) and production would not be dependent on egg supply.PSD · Sep 2022
The submission presented a stepped economic evaluation implementing a modelled economic evaluation based on retrospective (observational) cohort studies. The stepped economic evaluation included cost-effectiveness analyses (cost per influenza case avoided and cost per life year gained; CEA) and cost-utility analysis (cost per quality adjusted life year (QALY) gained; CUA) comparing a QIVc vaccination program versus the current QIVe vaccination program for …PSD · Sep 2022
• A dynamic transmission model that estimated the direct and indirect (herd immunity) impact of the alternative influenza vaccination programs.PSD · Sep 2022
The submission claimed QIVc was superior to QIVe in effectiveness against clinically relevant influenza-related outcomes, and “comparable” in terms of safety compared to QIVe. The ESC noted that the effectiveness claim was based on non-randomised studies that used administrative data.PSD · Sep 2022
The ESC considered that while superior effectiveness of QIVc compared to QIVe was biologically plausible, this would depend on egg-adaptation which can vary from year to year. The pre-PBAC Response maintained that the superior effectiveness of QIVc compared to QIVc was well supported by the studies presented in the submission and emphasised that the variability in rVE, based on season-specific characteristics of the circulating virus and its match to …PSD · Sep 2022
Lung Foundation Australia noted that availability of Flucelvax® Quad through the NIP would provide Australians with an alternate supply of influenza vaccine, ensuring access when needed. Lung Foundation Australia noted the benefits of reducing the risk of disease associated with influenza outbreaks and minimising the economic and social burden associated with illness. Lung foundation Australia emphasised the 6PSD · Sep 2022
Cost-effectiveness
The document indicates the sponsor used price and cost-effectiveness claims but does not explicitly state a numeric ICER in the public text. The submission is described as being based on a cost-effectiveness analysis, but the specific ICER value is not disclosed in this PSD.
Decision context
PopulationAboriginal and Torres Strait Islander people aged ≥5 to <65 years, persons aged ≥5 to <65 years with chronic cardiac, respiratory, neurological or other chronic illnesses, and pregnant women aged 5 to <65 years
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Sep 2022 | Recommended · restricted | egg-based quadrivalent influenza vaccine (QIVe) | — | RCT | Registry · Surrogate |
Consumer voice
Lung Foundation Australia welcomed the availability of Flucelvax® Quad through the NIP as an alternate influenza vaccine supply, noting benefits in reducing disease risk, economic and social burden, and the wider benefits to children, families, and working Australians.
Lung Foundation Australia noted that availability of Flucelvax® Quad through the NIP would provide Australians with an alternate supply of influenza vaccine, ensuring access when needed. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to Aboriginal/Torres Strait Islander people, those with chronic conditions, and pregnant women aged 5–<65 years; TGA label permits all ages ≥2 years.