Inactivated Trivalent Influenza Vaccine (Surface Antigen), Adjuvanted

7.1 The PBAC recommended that inactivated trivalent influenza vaccine (surface antigen), adjuvanted (aTIV) vaccine be a designated vaccine for the purposes of the National Health Act 1953 for active immunisation against influenza in adults aged ≥65 years of age.PSD · Mar 2018

7.2 The PBAC considered the aTIV vaccine would be acceptably cost-effective if subsidised on a cost-minimisation basis with the currently NIP listed quadrivalent inactivated vaccines (QIV) for those aged ≥65.PSD · Mar 2018

Influenza vaccine July 2009 NIP listing for Recommended CMA to current NIP (Intanza) patients aged 65 funded vaccines for and older via this age group eg intradermal route Vaxigrip Trivalent influenza July 2014 Extend NIP Recommended Compared to vaccine schedule to Fluarix trivalent include vaccination for Indigenous children aged 6 months to 5 years of age Quadrivalent influenza March 2015 People 3 to 9 Recommended (did not CMA to Fluarix vaccine …PSD · Mar 2018

3.5 The submission was prepared in response to liaison with the company from the Chief Medical Officer following the outcomes of the 2017 influenza season in Australia.PSD · Mar 2018

6.20 The submission presented a clinical claim of non-inferiority to QIV for comparative effectiveness in immunogenicity measures and effectiveness, noting a superiority of effectiveness compared to non-adjuvanted TIV (Submission, P154). The submission presented a claim of non-inferior comparative safety overall, noting inferiority for injection site reactions within the first three days (Submission, P154). 6PSD · Mar 2018

6.21 ATAGI considered that aTIV was suitable for listing based on non-inferiority overall against currently used standard dose QIVs (Pre-Submission PBAC Advice, P1).PSD · Mar 2018