Page 15: Canadian Immunization Guide: Part 1 - Key Immunization Information

Contents of Immunizing Agents Available for Use in Canada

Last partial content update (see Table of Updates): April 2017

• Introduction
• Contents of Immunizing Agents
• Table 1: Types and Contents of Vaccines Available for Use in Canada
• Table 2: Types and Contents of Passive Immunizing Agents Available for Use in Canada

Introduction

The following tables provide a comprehensive list of contents of immunizing agents available in Canada. Table 1 lists contents of active vaccines and Table 2 lists contents of passive immunizing agents. Vaccine providers should consult the product label, product leaflet, or product monograph for current product information. Manufacturers provide evidence of vaccine safety and efficacy and receive authorization for the immunizing agent only when it is used in accordance with the product monograph available through Health Canada's Drug Product Database. Information about the vaccine manufacturer/distributor is available in vaccine-specific chapters in Part 4.

Contents of Immunizing Agents

In addition to the active component (antigen in case of vaccines or antibody in case of immune globulins), immunizing agents may contain additional ingredients such as adjuvants, preservatives, additives, and traces of other substances.

Adjuvants

An adjuvant is a substance that is added to a vaccine to enhance the resulting immune response and to extend the duration of B and T cell activation. An adjuvant allows a reduction in the amount of antigen per dose or the total number of doses needed to achieve immunity, and helps to improve the immune response in individuals with some degree of immune suppression (for example, the elderly). The adjuvants used in vaccines currently marketed in Canada are:

• aluminum salts (aluminum hydroxide, aluminum phosphate, or aluminum hydroxyphosphate sulfate)
• AS04 (3-O-desacyl-4'-monophosphoryl lipid A adsorbed onto aluminum [as hydroxide salt])
• MF59 (oil-in-water emulsion composed of squalene as the oil phase, stabilized with the surfactants polysorbate 80 and sorbitan trioleate, in citrate buffer).

Preservatives

Chemicals (for example, thimerosal, phenol, 2-phenoxyethanol) may be added to vaccines to prevent serious infections which may result from bacterial or fungal contamination of the vaccine. Most vaccines available for use in Canada do not contain thimerosal.

Other contents of immunizing agents

Other substances that may be found in immunizing agents include:

• Minute amounts of chemicals that are used during the production process, such as for the growth or purification of specific antigens or the inactivation of toxins. For example, antibiotics that prevent contamination during viral cell culture; egg or yeast proteins glycerol, serum, amino acids and enzymes that are needed for the growth of bacteria and viruses; and formaldehyde that is used to inactivate viruses and protein toxins.
• Small amounts of chemicals that support product stability. For example, additives such as potassium or sodium salts, lactose, and polysorbate help control product acidity (pH) and maintain the quality of vaccine antigens.

Abbreviations

Abbreviations:

Selected References

• Keith LS, Jones DE, Chou C. Aluminum toxicokinetics regarding infant diet and vaccinations. Vaccine 2002;20:S13-17.
• Offit PA, Jew RK. Addressing parents' concerns: Do vaccines contain harmful preservatives, adjuvants, additives, or residuals? Pediatrics 2003;112:1394-97.