Regulatory Decision Summary for Flucelvax Quad
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
The purpose of this Supplement to a New Drug Submission (SNDS) is to seek an extension of the indication of Flucelvax Quad to children 6 months to < 4 years of age.
After evaluation of the submitted data package, Health Canada authorized the indication: Active immunization of adults and children aged 6 months or older for the prevention of influenza disease caused by influenza virus subtypes A and B contained in the vaccine.
The safety and efficacy of Flucelvax Quad in children less than 6 months of age have not been established.
Why was the decision issued?
Influenza typically causes annual seasonal epidemics and can sometimes cause pandemics. Morbidity/mortality highest among the very young, the elderly, and those with underlying medical conditions. Flucelvax Quad is the first cell-derived influenza vaccine to be available in Canada. Inclusion of both B lineages as part of a quadrivalent vaccine is projected to provide additional benefit in most seasons.
The submitted data from study V130_10 demonstrate that vaccination with Flucelvax Quad elicits an immune response that is not inferior to that of a United States-licensed comparator quadrivalent influenza vaccine (QIV) containing the same virus strains as, Flucelvax Quad in a pediatric population 6 through 47 months. Other immunogenicity analyses performed in this study confirmed this observation.
No new safety signal has been identified in the submitted clinical trial data following Flucelvax Quad vaccination in subjects 6 through 47 months of age, for whom the present indication is being extended.
Taking into consideration all the above, the overall benefit/risk of Flucelvax Quad in children > 6 months to < 4 years is considered favorable and thus supports the extension of the approval of this vaccine for prevention of influenza in children 6 through 47 months of age. A notice of Compliance has been granted.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations