Quadrivalent Influenza Vaccine (Split Virion, Inactivated)
Prevention of seasonal influenza in infants and children aged 6 to 35 months of age who have medical conditions associated with an increased risk of influenza disease complications or who are Aboriginal and/or Torres Strait Islander, eligible under the National Immunisation Program.
Decision on record
- Meeting Jul 2020 Recommended Prevention of seasonal influenza no PSD
Access path
- Mar 2019Recommended
vs FluQuadri Junior
- PBS listing · Restricted
From the public summary
6.1 The PBAC recommended an extension to the listing of Fluarix Tetra® (quadrivalent influenza vaccine (split virion, inactivated)), on the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No.1) (the Determination), for the prevention of seasonal influenza to include high risk and Aboriginal and/or Torres Strait Islander infants and children aged 6 to 35 months of age.PSD · Mar 2019
6.2 The PBAC noted that the NIP currently provides free seasonal influenza vaccines each year to infants, children, and adults who meet the criteria outlined in Table 2, and that this cohort is covered by a single vaccine, FluQuadri Junior, in a dose specific to the 6- 7PSD · Mar 2019
5.19 As a minor submission, there was no economic comparison presented/ an economic comparison was not relevant.PSD · Mar 2019
5.20 The submission claimed cost-minimisation based on the equi-effective dose of one 0.5 mL dose of Fluarix Tetra (containing 60 mcg hemagglutinin) to one 0.25 mL dose of FluQuadri Junior (containing 30 mcg hemagglutinin). The submission noted there were no differences in costs of Fluarix Tetra and FluQuadri Junior with respect to administration, monitoring or safety.PSD · Mar 2019
5.13 The submission claimed that Fluarix Tetra was non-inferior with respect to efficacy and safety to FluQuadri Junior in the prevention of seasonal influenza disease caused by the influenza virus types A and B contained in the vaccine for infants and young children aged 6 - 35 months.PSD · Mar 2019
5.14 In its December 2018 Pre-PBAC Submission Advice , ATAGI considered Fluarix Tetra suitable to be listed on the National Health (Immunisation Program – Designated Vaccines) Determination for the prevention of seasonal influenza in infants and children aged 6 - 35 months who have medical conditions associated with an increased risk of influenza disease complications and who are eligible for influenza vaccines under the National Immunisation Program …PSD · Mar 2019
Cost-effectiveness
This was a minor submission with no economic comparison; cost-minimisation analysis based on price parity with comparator.
The PBAC considered that Fluarix Tetra was cost-effective on a cost-minimisation basis to the comparator FluQuadri® Junior on the basis of an equi-effective dose of one 0.5 mL dose of Fluarix Tetra to one 0.25 mL dose of the currently NIP listed comparator FluQuadri Junior. PBAC · 2019
Decision context
PopulationInfants and children aged 6 to 35 months of age who have medical conditions associated with an increased risk of influenza disease complications (such as cardiac disease, chronic respiratory conditions, chronic neurological conditions, immunocompromising conditions, diabetes, renal disease, haematological disorders, or long-term aspirin therapy) or who are Aboriginal and/or Torres Strait Islander, eligible for free vaccination under the National Immunisation Program.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2019 | Recommended | FluQuadri Junior | — | RCT · Surrogate |
Consumer voice
One individual submitted a consumer comment highlighting the importance of making influenza vaccines affordable and accessible for immunocompromised people.
The comment referred to the benefit of making influenza vaccines affordable to immunocompromised individuals. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to ages 6–35 months with specific medical conditions or Aboriginal/Torres Strait Islander status; TGA label includes all ages from 6 months.