Pcv15

The PBAC recommended that 15-valent pneumococcal conjugate vaccine (PCV15, Vaxneuvance) be a designated vaccine for the purposes of the National Health Act 1953, for the prevention of pneumococcal disease in non-Indigenous adults aged ≥70 years, Indigenous adults aged ≥50 years, and individuals at increased risk of pneumococcal disease aged ≥18 years.PSD · Nov 2021

The PBAC considered that nomination of Prevenar 13 as the main comparator was appropriate, noting that Prevenar 13 was TGA-approved and NIP-funded for certain 23PSD · Nov 2021

The submission presented a cost-minimisation approach between PCV15 and PCV13.PSD · Nov 2021

A summary of this approach is presented in Table 7. The submission claimed that PCV15 was noninferior in terms of efficacy and safety compared to PCV13. The submission’s superiority claim for serotypes 3, 22F and 33F was not considered in the 18PSD · Nov 2021

PCV13 for serotype 3. PCV15 is superior to PCV13 in terms of immunogenicity for 22F and 33F. PCV15 is noninferior to PCV13 in terms of safety.PSD · Nov 2021

The submission claimed that PCV15 was noninferior in terms of efficacy compared with PCV13 for 12 of the 13 shared serotypes and superior for serotype 3 and for the unique additional serotypes 22F and 33F. Noninferiority was demonstrated in terms of OPA GMT for all shared serotypes however, the evaluation raised concerns it may not have been demonstrated for all the requested populations.PSD · Nov 2021