Regulatory Decision Summary for Vaxneuvance

Seven studies were submitted to support the safety and immunogenicity of Vaxneuvance (V114):

Four studies (P019V114, P020V114, P016V114, and P017V114) enrolled participants ≥18 years without prior history of pneumococcal vaccination at over 180 sites in 14 countries.

Study P019V114 was the main study evaluating the effectiveness of Vaxneuvance in adults ≥50 years of age without prior history of pneumococcal conjugate vaccination (pneumococcal vaccine-naïve).The study success criteria for immunogenicity were met: Vaxneuvance was non inferior to Prevnar 13 for the 13 shared serotypes and superior to Prevnar 13 for the 2 unique serotypes in Vaxneuvance.

Studies P016V114 and P020V114 were submitted to support the indication in adults 50 years of age or older. In study P016V114 Vaxneuvance demonstrated comparable immune response between subjects administered Vaxneuvance or Prevnar 13, one year  prior to receipt of Pneumovax 23 for all 15 serotypes in Vaxneuvance. While, study P020V114 provided lot-to-lot consistency data showing that all 3 lots of Vaxneuvance met equivalence criteria.

Study P017V114 which enrolled participants 18 to 49 years each evaluated sequential administration of Pneumovax 23, 12 months and 6 months after Vaxneuvance administration, respectively. The study success criteria for immunogenicity were met as well.

Two additional Phase 3 studies (P021V114 and P018V114) evaluated Vaxneuvance when administered concomitantly with a quadrivalent influenza vaccine (Fluarix, QIV) and Vaxneuvance when administered to HIV-infected adults ≥18 years of age.

One supportive Phase 2 study (P007V114) evaluated the impact of prior administration of Pneumovax 23 on the immunogenicity of a single dose of Vaxneuvance compared to Prevnar 13 in adults ≥65 years of age.

In all studies, Vaxneuvance elicited an immune response, thus meeting the pre-specified primary objective for non-inferiority.

Safety data from the seven clinical studies demonstrates an acceptable safety profile for Vaxneuvance.

There were no serious adverse events (SAE) considered causally related to Vaxneuvance.

Vaxneuvance showed a similar safety profile with that observed in immunocompetent, pneumococcal vaccine-naïve adults, in the following populations:

• Adults 18 to 49 years of age with risk factors for pneumococcal disease;
• Adults ≥18 years of age considered immunocompromised due to HIV infection;
• Adults ≥65 years of age with prior pneumococcal vaccination.

Vaxneuvance administered sequentially with Pneumovax 23 or concomitantly with quadrivalent influenza vaccine (Fluarix, QIV) showed a similar safety profile with that of Vaxneuvance in immunocompetent, pneumococcal vaccine-naïve adults.

To conclude, Vaxneuvance was moderately more reactogenic following a single dose when compared to a single dose of Prevnar 13, however overall safety profiles were comparable across groups.

In the submitted clinical studies, no data were available in special populations (e.g. pregnant and breast feeding women). Such limitations are not unique to Vaxneuvance, and recommendations on the use of Vaxneuvance in special populations have been clearly labelled in the Product Monograph for Vaxneuvance.

In conclusion, the benefit risk assessment for Vaxneuvance is favorable and supports the use of Vaxneuvance in subjects aged 18 years and older.