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Quadrivalent Influenza Vaccine

Withdrawn VaccinesRestrictedNot applicable line 💬 consumer voice

Prevention of seasonal influenza in children aged 6 months to <5 years not currently eligible through the NIP, and in at-risk individuals currently eligible for NIP-funded influenza vaccination (adults ≥65 years, Aboriginal and Torres Strait Islanders ≥6 months, persons ≥6 months at increased risk of complications, and pregnant women).

4
Submissions
1 resub
2015–19
On the record
—
ICER range
Not modelled
Cost basis

Decisions on record

4 decisions
  • Meeting Mar 2022 Withdrawn Prevention of influenza no PSD
  • Meeting Mar 2019 Recommended Influenza
  • Meeting Aug 2016 Recommended Prevention of seasonal Influenza
  • Meeting Jul 2015 Recommended Prevention of seasonal influenza

Access path

4 submissions · public record
  1. Mar 2015
    Recommended

    vs Fluarix trivalent influenza vaccine

  2. Jul 2015
    Recommended

    Comparator changed: Fluarix trivalent influenza vaccine → Fluarix Tetra (children ≥3…

  3. Nov 2018
    Recommended

    Evidence: Meta-analysis → Registry

  4. Jul 2019
    Recommended · restricted

    Evidence: Registry → RCT

  5. PBS listing · Restricted
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
7.1 The PBAC recommended the listing of quadrivalent influenza vaccine (QIV, Vaxigrip Tetra) on the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1) (the Determination), for the prevention of seasonal influenza in children aged 6 months to <5 years as well as in at-risk individuals who are currently eligible for vaccination through the NIP, under the same provisions (see section 8).PSD · Jul 2019
0.5 mL Vaxigrip Tetra and one dose of an alternative QIV, such as 0.5 mL FluQuadri or 0.25 mL FluQuadri Junior.PSD · Jul 2019
Economic analysis
Children aged 6 months to <5 years not currently eligible under the NIPPSD · Jul 2019
6.46 The submission presented a cost-utility analysis for children aged 6 months to <5 years based on GQM05. Table 9 presents the key components of the economic evaluation. 17PSD · Jul 2019
Clinical claim
Children aged 6 months to <5 years not currently eligible under the NIPPSD · Jul 2019
6.36 The submission described QIV (Vaxigrip Tetra) as superior in terms of vaccine efficacy compared with placebo (no vaccination) and had an acceptable safety profile.PSD · Jul 2019
Consumer comments
6.2 The PBAC noted and welcomed the input from individuals (1), and organisations (5) via the Consumer Comments facility on the PBS website:  Diabetes NSW & ACT and Diabetes Queensland both noted the higher risk of hospitalisation due to influenza for people living with diabetes and expressed support for all Australians with diabetes and their families, all children under 5 years of age, and older Australians to be vaccinated against influenza.PSD · Jul 2019
This organisation claimed that NIP funding of an influenza vaccine for young children would improve awareness and uptake of the vaccine in childhood, compared with under the current state funded programs. 4PSD · Jul 2019

Cost-effectiveness

Economic evaluation section not provided in the PSD excerpt. Cost-utility analysis mentioned for children aged 6-35 months; cost-minimisation analysis mentioned for at-risk populations, but no numeric ICER values are stated in the available text.

The ESC considered it was not appropriate to estimate cost savings for a vaccine with claimed non-inferior efficacy. PSD · 2015
Economic model disputedSurrogate endpointIndirect comparisonCost-effectiveness accepted ×2

Decision context

PopulationChildren aged 6 months to <5 years not currently eligible through the NIP, and at-risk individuals aged ≥6 months currently eligible for NIP-funded influenza vaccination (including adults ≥65 years, ATSI people, persons with chronic diseases/conditions, and pregnant women).

Submission history

4 entries
DecidedOutcomeComparatorICEREvidence
Jul 2019 Recommended · restricted Placebo (no vaccination) for children aged 6 months to <5 years; QIVs (FluQuadri and FluQuadri Junior) for at-risk indiv — RCT · Laboratory-confirmed influenza (children aged 6-35 months); Immunogenicity measured by seroconversion rates and GMT (at-risk populations)
Nov 2018 Recommended — — Registry · Cost-minimisation
Jul 2015 Recommended Fluarix Tetra (children ≥3 years and adults); trivalent influenza vaccines (TIVs) (infants 6-<36 months) — Meta-analysis · Surrogate
Mar 2015 Recommended Fluarix trivalent influenza vaccine — RCT · Surrogate

Consumer voice

Jul 2019

Six organisations and one individual supported listing of influenza vaccine for children under 5 years, highlighting increased hospitalisation risks for this age group, benefits of herd immunity, and improved vaccine uptake through NIP funding.

infants and children younger than 5 years of age, and especially those under 3 years of age, have an increased risk of hospitalisation due to influenza that decreases with increasing age. Consumer comments · PSD
unmet needaccess barriersherd immunityvulnerable populationsvaccine uptake

Similar precedents

By decision profile
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Regulatory · TGA

Label narrower than PBS population — PBAC restricts to specific age groups (6 months to <5 years not on NIP) and at-risk individuals, excluding healthy adults under 65.