Regulatory Decision Summary for AREPANRIX H5N1
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?
Arepanrix H5N1 is an adjuvanted monovalent Influenza A (H5N1) vaccine, currently approved in Canada for active immunization of adults ≥ 18 years of age against influenza caused by the H5N1 subtype virus from which the vaccine is derived. The intent of this SNDS is to expand the indication to include children 6 months to 17 years old for Arepanrix H5N1.
Why was the decision issued?
Two clinical studies (Study 021 and Study 035) were submitted to support the pediatric indication.
Study 021 showed that Arepanrix H5N1 produced a robust immune response in children 6 months through 17 years of age. The immune response led to a statistically significant rise in hemagglutination inhibition antibody titer, a surrogate endpoint for influenza vaccine efficacy. In addition, vaccine efficacy is supported by the clinical efficacy/effectiveness data from other GSKs influenza vaccines, with similar manufacturing process and formulation (for example, from Study 035).
Studies 021 and 035 showed increased local adverse events (AEs) with the adjuvanted vaccines (Arepanrix H5N1 and Arepanrix H1N1) compared to the controls, and there was a trend of higher numbers of solicited general AEs reported with the adjuvanted vaccines. However, the incidence of unsolicited AEs, medically attended AEs, potential immune mediated diseases and serious adverse events was generally similar across groups. No special safety concerns were identified in the studies.
If human to human transmission were to occur, there would be a high degree of morbidity and mortality associated with H5N1 influenza virus illness in children. In view of the submitted data to support the safety and effectiveness, the clinical benefits of Arepanrix H5N1 would outweigh its risks in children with respect to the intended indication and usage.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations