Summary of updates in the Canadian Immunization Guide as of March 31, 2025: Updated guidance on quadrivalent conjugate meningococcal vaccines available in Canada
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Overview
On March 31, 2025, the Public Health Agency of Canada (PHAC) released revised guidance from the National Advisory Committee on Immunization (NACI) in the Canadian Immunization Guide (CIG) on the use of quadrivalent conjugate meningococcal vaccines available in Canada. Based on current evidence and NACI's expert opinion, NACI recommends that for individuals 2 years of age and older:
- Any of the currently authorized Men-C-ACYW vaccines, including MenQuadfi™, can be used for the prevention of IMD, as indicated in the Canadian Immunization Guide, Meningococcal Vaccines chapter.
- Any of the currently authorized Men-C-ACYW vaccines, including MenQuadfi™, may be used for booster doses and re-vaccination, regardless of which meningococcal vaccine was used for initial vaccination.
Supporting information
In 2020, Health Canada approved the use of MenQuadfi™, a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (Men-C-ACYW-TT) for the prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W and Y in individuals 12 months of age and older. With this latest authorization, there are now four quadrivalent conjugate meningococcal vaccines (Men-C-ACYW) authorized for use in Canada: Menactra® (Men-C-ACYW-DT), MENVEO (Men-C-ACYW-CRM), NIMENRIX® (Men-C-ACYW-TT), and MenQuadfi™ (Men-C-ACYW-TT).
Immunogenicity of MenQuadfi™ in individuals 2 years of age and older was assessed in five clinical trials. In children 2 to less than 18 years of age, immune responses following vaccination with MenQuadfi™ were found to be non-inferior compared to vaccination with Men-C-ACYW-CRM or Men-C-ACYW-DT. Non-inferior immune responses were also observed in participants 18 to 55 years of age when comparing MenQuadfi™ to Men-C-ACYW-DT.
In all clinical trials, MenQuadfi™ demonstrated an acceptable safety profile, with most adverse events being mild to moderate. Injection site pain was the most reported local adverse event, and myalgia, headache, and malaise were the most reported systemic adverse events across age groups. MenQuadfi™ had a similar safety profile as other quadrivalent conjugate meningococcal vaccines that are authorized for use in Canada. MenQuadfi™ should not be administered to subjects with known hypersensitivity to any component of the vaccine. No clinically relevant concerns about concurrent administration of MenQuadfi™ with human papillomavirus (HPV) or tetanus, diphtheria, acellular pertussis (Tdap) vaccines among adolescents have been identified.
NACI recommends that any of the currently authorized Men-C-ACYW vaccines, including MenQuadfi™, can be used for the prevention of IMD in individuals 2 years of age and older, as indicated in the Canadian Immunization Guide, Meningococcal Vaccines chapter:
- For routine vaccination in healthy adolescents and young adults 12 to 24 years of age, even if they have previously been vaccinated as an infant or toddler. Either a monovalent meningococcal C conjugate or a Men-C-ACYW vaccine, depending on local epidemiology and programmatic considerations, is recommended. The vaccine in this age group is routinely provided at 12 years of age.
- For individuals at high risk of IMD including those with underlying medical conditions and those who are at increased risk of exposure.
- In some circumstances, for contacts of a case of IMD or during a community outbreak.
NACI reiterates that periodic booster doses with Men-C-ACYW vaccine are recommended for individuals at high risk for meningococcal disease due to underlying medical conditions or who have ongoing increased risk of exposure.
NACI also recommends that for individuals 2 years of age and older, any currently authorized Men-C-ACYW vaccine, including MenQuadfi™, may be used for booster doses and re-vaccination, regardless of which meningococcal vaccine was used for initial vaccination.
As with other Men-C-ACYW vaccines, MenQuadfi™ may be administered concurrently with adolescent and adult age-appropriate vaccines.
NACI has had a long-standing recommendation to prefer MENVEO (Men-C-ACYW-CRM) over other products in children who are less than 2 years of age and at high risk of IMD due to underlying medical conditions or increased risk of exposure. This was because the CRM conjugate was expected to provide better protection for high risk populations than the diphtheria toxoid (DT) conjugate vaccine. In recent years, additional vaccine options have become authorized in the younger age range with conjugation to tetanus toxoid (TT) and these have not yet been reviewed by NACI for possible equivalency and use in populations at high risk of IMD under 2 years of age. Therefore, considering that MenQuadfi™ and Nimenrix® (Men-C-ACYW-TT) are now authorized by Health Canada in individuals 12 months of age and older and 6 weeks to 55 years of age respectively for the prevention of IMD, NACI will prioritize a review of the product options for individuals under 2 years of age. For current product monographs please refer to Health Canada's Drug Product Database.
Details regarding current recommendations for use, schedules, booster doses and re-immunization, post-exposure management, outbreak control, vaccination of specific populations, and administration practices (including interchangeability and concurrent administration of vaccines) are provided in the Meningococcal vaccines chapter in Part 4 of the Canadian Immunization Guide. Refer to the 2024 to 2026 NACI workplan for additional information on the current policy questions for meningococcal vaccines.
Provided is a list of selected references that informed this guidance:
- Áñez G, Hedrick J, Simon MW, et al. Immunogenicity and safety of a booster dose of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adolescents and adults: a Phase III randomized study. Hum Vaccin Immunother. 2020 Jun 2;16(6):1292-1298. https://doi.org/10.1080/21645515.2020.1733867
- Baccarini CI, Simon MW, Brandon D, et al. Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine in Healthy Meningococcal-Naïve Children 2-9 Years of Age: A Phase III, Randomized Study. Pediatr Infect Dis J. 2020 Oct;39(10):955-960. https://doi.org/10.1097/inf.0000000000002832
- Chang LJ, Gedrick J, Christensen S, et al. A Phase II, randomized, immunogenicity and safety study of a quadrivalent meningococcal conjugate vaccine, MenACYW-TT, in healthy adolescents in the United States. 2020 Apr 23;38(19):3560-3569. https://doi.org/10.1016/j.vaccine.2020.03.017
- Esteves-Jaramillo A, Koehler T, Jeanfreau R, et al. Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in ≥56-year-olds: A Phase III randomized study. Vaccine. 2020 Jun 9;38(28):4405-4411. https://doi.org/10.1016/j.vaccine.2020.04.067
- National Library of Medicine. Immune Lot Consistency, Immunogenicity, and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adolescents and Adults Aged 10 to 55 Years. Data cut-off date 2017 Feb 28 [Internet]. United States: U.S. Department of Health and Human Services; 2022 Apr 05 [cited 2024 Jun 25]. Available from: https://clinicaltrials.gov/study/NCT02842853#contacts-and-locations
- Product Monograph Including Patient Medication Information: MenQuadfi™ [Internet]. Toronto (ON): Sanofi Pasteur Limited; 2024 Oct 30 [cited 2025 Feb 25]. Available from: https://pdf.hres.ca/dpd_pm/00077618.PDF
For more information on NACI's recommendations on the use of quadrivalent conjugate meningococcal vaccines authorized for use in Canada, refer to the Canadian Immunization Guide, Part 4, Meningococcal vaccines chapter, as well as the NACI statements and publications web page.
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