Regulatory Decision Summary for MenQuadfi
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 the new drug submission (NDS) was to seek marketing authorization of MenQuadfi for prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroup A, C, Y, and W-135 in individuals 12 months of age and older. After evaluation of the submitted data package, Health Canada has authorized MenQuadfi for prevention of IMD caused by Neisseria meningitidis serogroup A, C, Y, and W-135 in individuals 12 months of age and older.
Why was the decision issued?
Authorization was based on 9 clinical studies, including 3 Phase II studies (MET44, MET50, and MET54) and 6 Phase III studies (MET35, MET43, MET49, MET51, MET56, and MET57), in toddlers, children, adolescents, and adults (including those 56 years of age and older). A total of 6398 subjects received a single dose of MenQuadfi alone (5417 subjects) or MenQuadfi with at least one concomitant vaccine (981 subjects) in the 9 studies.
The efficacy of MenQuadfi was inferred from immunogenicity, as measured by human complement serum bactericidal assay (hSBA), and rabbit complement serum bactericidal assay (rSBA, most of studies). MenQuadfi was compared with several approved quadrivalent meningococcal groups A, C, W and Y vaccines in Canada (Menveo, Menactra, Nimenrix or Menomune). The immune response (seroresponse rate or seroprotection rate) for MenQuadfi was not inferior to that of comparator vaccines for all 4 serogroups in individuals 2 years of age and older who received a primary vaccination, and in individuals 15 years of age and older who received a booster vaccination at least 4 years following a previous dose of a meningococcal (Groups A, C, W, Y) conjugate vaccine.
MenQuadfi was well tolerated when given as a single dose in study participants 12 months of age and older. The safety profile was comparable to the currently licensed quadrivalent meningococcal groups A, C, W and Y conjugate vaccines. The important potential risks include anaphylaxis, Guillain-Barré syndrome, Bells palsy. No cases of these important potential risks in the pivotal Phase III studies within 42 days of vaccination.
Uncertainties included the long-term persistence of the immune response after vaccination with MenQuadfi, immunogenicity and safety of a booster in individuals primed with MenQuadfi, immunogenicity and safety in children less than 12 months of age and immunogenicity and safety in special populations, including pregnant and breastfeeding woman, and immunocompromised and immunosuppressed persons.
Overall, the benefits of MenQuadfi overweigh the risks for active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in individuals 12 months of age and older.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.