Page 7: Canadian Immunization Guide: Part 1 - Key Immunization Information

Principles of Vaccine Interchangeability

Introduction

Similar vaccines from different manufacturers are routinely authorized for use in Canada. Circumstances such as vaccine shortages, contraindication to a specific vaccine, changes in product availability, or migration across jurisdictions may necessitate giving vaccines from different manufacturers to the same individual over time. Because immunization schedules and specific products used vary across provinces and territories and among countries, questions about vaccine interchangeability may arise when evaluating the immunization status of persons new to Canada or people who have moved between jurisdictions.

General Principles of Vaccine Interchangeability

  • In general, the same manufacturer's product should be used for all doses in a vaccine series. However, routine immunization should not be deferred because of the lack of availability of a specific product.
  • To be considered interchangeable, the vaccines should:
    • be authorized with the same indications and with equally acceptable schedules, and
    • be authorized for the same population, and
    • contain comparable type and quantity of antigen, and
    • be similar in terms of safety, reactogenicity, immunogenicity and efficacy.
  • Even when vaccines from different manufacturers are authorized for the same indications, the manufacturers may use differing production methods, antigens or antigen concentrations, adjuvants, conjugating proteins, stabilizers and preservatives. Each of these factors can affect the vaccine's potential for interchangeability.
  • In general, vaccine diluents are not interchangeable. Lyophilized vaccines should be reconstituted only with the diluent provided by the manufacturer for that purpose, unless otherwise permitted by the manufacturer.

Vaccine Interchangeability Recommendations

The following recommendations for vaccine interchangeability are applicable only to vaccines with the same indications and authorization for use in the same populations.

Evidence-base for Vaccine Interchangeability Recommendations

Ideally, as new vaccines become available, clinical trials should be conducted evaluating interchangeability with existing products. To date, most of the available information regarding vaccine interchangeability has been gathered as a result of vaccine shortages or new product purchases resulting from negotiation of new contracts. Given the importance of this issue and the limited data available regarding the interchangeability of vaccines, further research in this area should be encouraged.

Selected References

  • Abarca K, Ibanez I, Perret C et al. Immunogenicity, safety, and interchangeability of two inactivated hepatitis A vaccines in Chilean children. Int J Infect Dis 2008;12(3):270-77.
  • Centers for Disease Control and Prevention. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep 2011;60(02):1-61.
  • Halperin SA, Tapiero B, Law B et al. Interchangeability of two diphtheria and tetanus toxoids, acellular pertussis, inactivated poliovirus. Haemophilus influenzae type b conjugate vaccines as a fourth dose in 15-20-month-old toddlers. Vaccine 2006;24(18):4017-23.
  • Kwak GY, Kwon HJ, Kim JH et al. The immunogenicity and safety of DTaP interchangeable immunization among Korean children. Vaccine 2012;30(31):4644-7.
  • National Advisory Committee on Immunization. Interchangeability of diphtheria, tetanus, acellular pertussis, polio, Haemophilus influenzae type b combination vaccines presently approved for use in Canada for children <7 years of age. Can Commun Dis Rep 2005;31(ACAS-1):1-10.
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