Regulatory Decision Summary for Flucelvax Quad

Fourteen clinical studies were submitted to support the safety, immunogenicity and efficacy of Flucelvax Quad (QIVc): two with QIVc and 12 with Flucelvax (Trivalent - TIVc). The TIVc studies are supportive of the QIVc product as both vaccines are manufactured using the same process and have overlapping compositions. Overall, there is substantial evidence of immunogenicity/efficacy to support the use of QIVc in subjects aged 9 years and older.

Three studies provided most relevant clinical data in adults. In Study V58P13, the vaccine efficacy of TIVc was demonstrated in subjects aged 18-49 years. In addition data from Study V58P4 showed non-inferiority of TIVc to a similar product Agriflu (licensed in Canada), and Study V130_01 showed non-inferiority of QIVc to TIVc in adults. Health Canada considers this evidence sufficient to support the immunogenicity and efficacy of QIVc in adults.

Study V58P12 showed that the criteria established by the United States Food and Drug Administration-Center for Biologics Evaluation and Research (FDA-CBER) (seroconversion and seroprotection rates) for TIVc were achieved for all three strains by cell-based HI assay in the 9 to <18 year age group. Immune responses following vaccination with TIVc in subjects 9 to <18 years in Study V58P12 were comparable to those observed in the adult population in the efficacy Study (V58P13). Although there are known limitations to cross study comparisons, they were partially mitigated by the fact that both studies were performed during the same influenza season and the HI assays were done in the same lab. In addition, Study V130_03 showed similar immune response between QIVc and TIVc. Therefore, the evidence submitted was sufficient to support the immunogenicity and efficacy in subjects 9 to <18 years of age.

No newly identified safety concerns were seen in the submitted data with TIVc and QIVc. Across all age groups, injection site pain was the most common local solicited adverse event (AE) reported and headache the most common systemic solicited AE. The clinical data suggested that the QIVc safety profile is generally comparable to that of the TIVc and egg-derived influenza vaccines. There are some limitations in the submitted clinical studies, e.g. no data available in special populations (e.g. immunocompromised individuals, and pregnant and breast feeding women). These are addressed in the Product Monograph as well as through post-market activities.

In conclusion, the benefit risk assessment for the QIVc is favorable and supports licensure of this vaccine for prevention of influenza in individuals ≥ 9 years of age.