Meningococcal Polysaccharide Conjugate Vaccine Serogroups A, C, W-135 And Y

7.1 The PBAC recommended that meningococcal polysaccharide serogroups A, C, W135 and Y conjugate vaccine (MenACWY-TT) vaccine be a designated vaccine for the purposes of the National Health Act 1953 for the prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W135, and Y (MenA, MenC, MenW135 and MenY, respectively) in infants.PSD · Mar 2018

7.2 In line with the ATAGI advice, the PBAC recommended that the administration of the MenACWY-TT vaccine occur at around 12 months of age and further that administration of the Hib containing vaccine be moved to around 18 months of age.PSD · Mar 2018

6.42 The submission presented a cost-minimisation analysis of the MenACWY-TT vaccine compared to the Hib-MenC vaccine. 6.43 The equi-effective doses were estimated as:PSD · Mar 2018

• 5 μg of meningococcal serogroup C component from the MenACWY-TT (Nimenrix) conjugate vaccine, andPSD · Mar 2018

6.38 The submission described the MenACWY-TT vaccine as non-inferior in terms of effectiveness (based on rSBA-MenC ≥ 1:8 at one month) and non-inferior in terms of safety compared to the Hib-MenC vaccine (p126 of the submission).PSD · Mar 2018

6.39 This claim should be considered with caution.  The indirect comparison found that the MenACWY-TT vaccine elicited an immune response to serogroup C (rSBA-MenC ≥ 1:8) that was comparable with the Hib-Men C vaccine. However, the trials included in the submission were all non-inferiority trials.PSD · Mar 2018

6.2 The PBAC noted and welcomed the input from individuals (2) and organisations (1) via the Consumer Comments facility on the PBS website. The comments described the complications that can arise out of infant onset of meningococcal disease and were supportive of the requested listing.PSD · Mar 2018