Regulatory Decision Summary for Prevnar 13

The Sponsor submitted one clinical trial in support of coadministration with Nimenrix, one clinical trial in support of coadministration with QIV, and three published studies of AMR in pneumococcal isolates for inclusion in the PM.

Coadministration of Prevnar 13 with Nimenrix in children aged 12-23 months who have previously received the infant series of Prevnar 13 is expected to be safe and effective based on the following evidence:

• Immune responses to all 13 vaccine-type pneumococcus following coadministration was non-inferior to immune responses following administration of Prevnar 13 alone.
• Immune responses to all 4 meningococcal serogroups following coadministration was non-inferior to immune responses following administration of Nimenrix.
• This study showed a mild increase in local and systemic reactions during the first 4 days in the coadministration group, but without any increase in related or severe adverse events. The safety profile with coadministration is considered acceptable.

Coadministration of Prevnar 13 with QIV in adults aged ≥50 years who are not immune suppressed or chronically ill, and who have previously received PPSV23 is expected to be safe and immunologically non-inferior based on the following evidence:

• Immune response to all 13 vaccine-type pneumococcus following coadministration was non-inferior to immune response following administration of Prevnar 13 alone.
• Immune response for all 4 influenza strains in the QIV (Fluzone) following coadministration was non-inferior to immune response following administration of QIV (Fluzone) alone.
• The safety profile with coadministration generally reflects known and expected adverse events with these vaccines, and the results do not suggest any new or unexpected safety issues, and is acceptable.

There is uncertainty regarding efficacy of Prevnar 13 with coadministration with QIV in individuals who have previously received PPSV23 in individuals with immune suppression or chronic illness, due to several factors:

• The immune response to the pneumococcal serotypes was lower in the coadministration group than in the group that received Prevnar 13 alone for 11 of the serotypes, and statistically-significantly lower for 4 of the 13.
• The study population excluded individuals with severe chronic disease, immune deficiency and immune suppression who are often recipients of PPSV23. Since these individuals are known to have poorer immune responses to immunization, it is unclear if vaccine effectiveness following coadministration would be sufficient in these individuals.

Antimicrobial resistance is multifactorial and variable by geographic region and season. The published studies regarding antimicrobial resistance that were submitted were not sufficiently robust to support inclusion of these data in the Product Monograph.

Based on the current evidence, the reviewer concluded that the benefit-risk balance is favourable with respect to:

• coadministration with Nimenrix, in children 12-23 months who have previously received the infant series of Prevnar 13.

Provision of information regarding immune response and safety with coadministration of Prevnar 13 with QIV in a population of adults ≥50 who had previously received PPSV23.