Diphtheria And Tetanus Toxoids Combined With Pertussis Vaccine-Acellular

7.1 The PBAC recommended a change to the circumstances under which dTpa, Adacel, is made available as a designated vaccine for the NIP to include vaccination of 12PSD · Mar 2017

7.2 The PBAC accepted that dTpa, Boostrix, is the appropriate comparator, and that the equi-effective doses are Adacel 1 x 0.5 mL dose and Boostrix 1 x 0.5 mL dose.PSD · Mar 2017

6.17 The submission presented a cost minimisation analysis of Adacel compared to Boostrix.PSD · Mar 2017

6.18 The equi-effective doses were estimated as Adacel 1 x 0.5 mL dose and Boostrix 1 xPSD · Mar 2017

6.13 The submission described Adacel as non-inferior in terms of comparative efficacy and non-inferior in terms of comparative safety to Boostrix. The claim regarding comparative safety was adequately supported. The ESC noted: o There were no head-to-head RCTs measuring the vaccine efficacy of Adacel versus Boostrix in the target population of pregnant women. 10PSD · Mar 2017

6.14 In the PSCR, the sponsor argued that o The submission provides a large body of evidence to support the clinical claim. o Amirthalingam (2014) has previously been considered by the PBAC and the PBAC previously considered Adacel (or Repevax) and Boostrix equivalent on the basis of this evidence (Boostrix PSD, July 2016). o Amirthalingam (2016) reaffirm the results of Amirthalingam (2014).PSD · Mar 2017