Contents of immunizing agents authorized for use in Canada: Canadian Immunization Guide
For health professionals
Last partial content update (see Table of Updates): February 2023
This chapter was updated to align with changes made to:
- Canadian Immunization Guide Chapter on Influenza and Statement on Seasonal Influenza Vaccine for 2022-2023
- COVID-19 Vaccine chapter in Part 4
- Pneumococcal Vaccine chapter in Part 4
- The section on "Adjuvants" was updated to include two additional adjuvants: AS03 and Matrix M adjuvant used in COVIFENZ® AND NUVAXOVIDTM COVID-19 vaccines, respectively
Last complete chapter revision (see Table of Updates): April 2017
On this page
- Introduction
- Contents of immunizing agents
- Table 1: Types and contents of vaccines authorized for use in Canada
- Table 2: Types and contents of passive immunizing agents authorized for use in Canada
Introduction
The following tables provide a comprehensive list of contents of immunizing agents authorized 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. For more information about immunoglobulins, refer to Basic Immunology and Vaccinology in Part 1.
Contents of immunizing agents
In addition to the active component (antigen or instructions for the antigen in case of vaccines or antibody in case of immunoglobulins), 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 [Al(OH)₃], aluminum phosphate [AlPO4], or amorphous aluminum hydroxyphosphate sulfate [AAHS])
- AS01B (3-O-desacyl-4'-monophosphoryl lipid A [MPL], Quillaja saponaria Molina, fraction 21 [QS-21], cholesterol, dioleoyl phosphatidylcholine [DOPC], disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, water for injection)
- AS03 (DL-alpha-tocopherol, squalene, polysorbate 80, phosphate buffered saline)
- AS04 (3-O-desacyl-4'-monophosphoryl lipid A adsorbed onto aluminum [as hydroxide salt])
- Matrix-M adjuvant (cholesterol, disodium hydrogen phosphate dihydrate, phosphatidylcholine, potassium chloride, potassium dihydrogen phosphate, sodium chloride)
- 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 authorized 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.
Brand name | Route | Vaccine type (live; non-live) |
Immunogen | Adjuvant | Preservative | Potential allergens Footnote 1 | Other materials | Abbreviation |
---|---|---|---|---|---|---|---|---|
A dash [ - ] indicates that there are no materials under that category in the product. |
||||||||
Act-HIB® | IM | non-live |
|
- | - |
|
|
Hib |
ADACEL® | IM | non-live |
|
AlPO4 | PE | - |
|
Tdap |
ADACEL® -POLIO | IM | non-live |
|
AlPO4 | PE |
|
|
Tdap-IPV |
AFLURIA® TETRA | IM | non-live |
|
- | TmFootnote 3 |
|
|
IIV4-SD |
AVAXIM® | IM |
non-live |
HA |
Al(OH)3 |
|
|
|
HA |
BEXSERO® | IM | non-live | Men B | Al(OH)3 | - |
|
|
4CMenB |
BOOSTRIX® | IM | non-live |
|
Al(OH)3 | - |
|
|
Tdap |
BOOSTRIX® -POLIO | IM | non-live |
|
Al(OH)3, AlPO4 | - |
|
|
Tdap-IPV |
CERVARIX® | IM | non-live | HPV | AS04 | - |
|
|
HPV2 |
COMIRNATY ® (Original) - Gray Vial Cap and Label Border | IM |
non-live |
SARS-CoV-2 |
- |
- |
|
|
COVID-19 |
COMIRNATY ® (Original) - Orange Vial Cap and Label Border | ||||||||
COMIRNATY ® (Original) –Maroon Vial Cap and Label Border | ||||||||
COMIRNATY ® (Original) & Omicron BA.4/BA.5 – Gray Vial Cap and Label Border | ||||||||
COMIRNATY ® (Original) & Omicron BA.4/BA.5 – Orange Vial Cap and Label Border | ||||||||
COMIRNATY ® (Original) & Omicron BA.1 | ||||||||
COMIRNATY ® (Original) - Purple Vial Cap and Label Border | IM | non-live | SARS-CoV-2 | - | - |
|
|
COVID-19 |
COVIFENZ® COVID-19 Vaccine | IM | non-live | SARS-CoV-2 | AS03 | - |
|
|
COVID-19 |
DUKORAL® | Oral | non-live |
|
- | - | - |
|
Chol-Ecol-O |
ENGERIX® -B | IM |
non-live |
HB |
Al(OH)3 |
- |
|
|
HB |
ENGERIX® -B Pediatric dose | ||||||||
ERVEBO® | IM | live | ZEBOV | - | - |
|
|
EZV |
FLUAD® |
IM |
non-live |
Inf |
MF59 |
- |
|
|
IIV3-Adj |
FLUAD® Pediatric |
||||||||
FLUCELVAX® QUAD | IM | non-live | Inf | - | Tm Footnote 3 |
|
|
IIV4-cc |
FLULAVAL TETRA | IM | non-live | Inf | - | Tm Footnote 3 |
|
|
IIV4-SD |
FLUMIST® QUADRIVALENT | IN | live | Inf | - | - |
|
|
LAIV4 |
FLUVIRAL® | IM | non-live | Inf | - | Tm Footnote 3 |
|
|
IIV3-SD |
FLUZONE® Quadrivalent | IM | non-live | Inf | - | Tm Footnote 3 |
|
|
IIV4-SD |
GARDASIL® 9 | IM | non-live | HPV | AAHS | - |
|
|
HPV9 |
HAVRIX® | IM |
non-live |
HA |
Al(OH)3 |
- |
|
|
HA |
HAVRIX® 720 JUNIOR | ||||||||
HIBERIX® | IM | non-live | Hib | - | - |
|
|
Hib |
IMOVAX® Polio | SC | non-live | IPV | - | PE |
|
|
IPV |
IMOVAX® Rabies | IM | non-live | Rab | - | - |
|
|
HDCV |
SC | live | Vaccinia | - | - |
|
|
SMV |
|
INFANRIX hexa® | IM | non-live |
|
Al(OH)3, AlPO4 | - |
|
|
DTaP-HB-IPV-Hib |
INFANRIX® -IPV/Hib | IM | non-live |
|
Al(OH)3 | - |
|
|
DTaP-IPV-Hib |
INFLUVAC® TETRA | SC/IM | non-live | Inf | - | - |
|
|
IIV4-SD |
IXIARO® | IM | non-live | JE | Al(OH)3 | - | - |
|
JE |
JCOVDENTM COVID-19 VACCINE |
IM | non-live | SARS-CoV-2 | - | - |
|
|
COVID-19 |
Menactra® | IM | non-live | Men | - | - |
|
|
Men-C-ACYW-DT |
MENJUGATE Liquid | IM | non-live | Men | Al(OH)3 | - |
|
|
Men-C-C-CRM |
MenQuadfiTM | IM | non-live | Men | - | - |
|
|
Men-C-ACYW-TT |
MenveoTM | IM | non-live | Men | - | - |
|
|
Men-C-ACYW-CRM |
M-M-R® II | SC | live |
|
- | - |
|
|
MMR |
NeisVac-C® Vaccine | IM | non-live | Men | Al(OH)3 | - |
|
|
Men-C-C-TT |
NIMENRIX® | IM | non-live | Men | - | - |
|
|
Men-C-ACYW-TT |
COVID-19 Vaccine |
IM | non-live | SARS-CoV-2 | Matrix-M | - |
|
|
COVID-19 |
PEDIACEL® | IM | non-live |
|
AlPO4 | PE |
|
|
DTaP-IPV-Hib |
PNEUMOVAX® 23 | SC/IM | non-live | Pneu | - | P | - |
|
Pneu-P-23 |
PREHEVBRIOTM | IM | non-live | HB | Al(OH)3 | - | - |
|
HB |
Prevnar® 13 | IM | non-live | Pneu | AlPO4 | - |
|
|
Pneu-C-13 |
IM | non-live | Pneu | AlPO4 | - |
|
|
Pneu-C-20 |
|
PRIORIX® | SC/IM | live |
|
- | - |
|
|
MMR |
PRIORIX-TETRA | SC/IM | live |
|
- | - |
|
|
MMRV |
PROQUADTM | SC | live |
|
- | - |
|
|
MMRV |
QUADRACEL® | IM | non-live |
|
AlPO4 | PE |
|
|
DTaP-IPV |
RabAvert® | IM | non-live | Rab | - | - |
|
|
PCECV |
RECOMBIVAX HB® | IM | non-live | HB | AAHS | - |
|
|
HB |
ROTARIX® | Oral | live | Rot | - | - | - |
|
Rot-1 |
RotaTeq® | Oral | live | Rot | - | - |
|
|
Rot-5 |
SHINGRIX | IM | non-live | VZVgE | AS01B | - |
|
|
RZV |
SPIKEVAXTM Elasomeran mRNA vaccine – Red plastic cap (0.20 mg/mL) |
IM |
non-live |
SARS-CoV-2 |
- |
- |
|
|
COVID-19 |
SPIKEVAXTM Elasomeran mRNA vaccine – Royal blue plastic cap (0.10 mg/mL) |
||||||||
SPIKEVAXTM Bivalent (Original / Omicron BA.1) |
||||||||
SPIKEVAX Bivalent (Original / Omicron BA.4/5) |
||||||||
SupemtekTM |
IM | non-live | Inf | - | - |
|
|
RIV4 |
SYNFLORIX® | IM | non-live | Pneu | AlPO4 | - |
|
|
Pneu-C-10 |
Td ADSORBED | IM | non-live |
|
AlPO4 | PE | - |
|
Td |
TRUMENBA® | IM | non-live | Men B | AlPO4 | - |
|
|
MenBf-HBP |
TWINRIX® | IM |
non-live |
|
Al(OH)3, AlPO4 |
- |
|
|
HAHB |
TWINRIX® Junior | ||||||||
TYPHIM Vi® | IM | non-live | Typh | - | P | - |
|
Typh-I |
VAQTA® | IM | non-live | HA | AAHS | - |
|
|
HA |
VARILRIX® | SC | live | Var | - | - |
|
|
Var |
VARIVAX® III | SC | live | Var | - | - |
|
|
Var |
IM | non-live | Pneu | AlPO4 | - |
|
|
Pneu-C-15 |
|
VAXZEVRIATM |
IM | non-live | SARS-CoV-2 | - | - |
|
|
COVID-19 |
Vivotif® | Oral | live | Typh | - | - |
|
|
Typh-O |
YF-VAX® | SC | live | YF | - | - |
|
|
YF |
|
Abbreviations
Route-
- ID
- intradermal
- IM
- intramuscular
- IN
- intranasal
- SC
- subcutaneous
Immunogen-
- aP
- acellular pertussis
- ap
- acellular pertussis (reduced)
- BCG
- Bacillus Calmette-Guérin
- Chol
- cholera
- D
- diphtheria
- d
- diphtheria (reduced)
- Ecol
- enterotoxigenic Escherichia coli
- Hib
- Haemophilus influenzae type b
- HA
- hepatitis A
- HB
- hepatitis B
- HPV
- human papillomavirus
- Inf
- influenza
- IPV
- inactivated poliomyelitis
- JE
- Japanese encephalitis
- Men
- meningococcus
- Men B
- Neisseria meningitidis Serogroup B protein
- Meas
- measles
- Mumps
- mumps
- Pneu
- pneumococcus
- Rab
- rabies
- Rot
- rotavirus
- Rub
- rubella
- T
- tetanus
- Typh
- typhoid
- Var
- varicella
- YF
- yellow fever
- ZEBOV
- Zaire ebolavirus
- Zos
- herpes zoster
Adjuvant-
- AAHS
- amorphous aluminum hydroxyphosphate sulfate
- Al(OH)3
- Aluminum hydroxide
- AlPO4
- Aluminum phosphate
- AS01B
- 3-O-desacyl-4'-monophosphoryl lipid A [MPL], Quillaja saponaria Molina, fraction 21 [QS-21], cholesterol, dioleoyl phosphatidylcholine [DOPC], disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, water for injection
- AS04
- 3-O-desacyl-4'-monophosphoryl lipid A adsorbed onto aluminum (as hydroxide salt)
- MF59
- squalene, polysorbate 80, sorbitan trioleate, sodium citrate, citric acid, water for injection
Preservative-
- P
- phenol
- PE
- 2-phenoxyethanol
- Tm
- thimerosal
Brand name | Route | Passive immunizing agent type | Origin of antibodies | Protects against or treats | Preservative | Potential allergens | Other materials | Abbreviation |
---|---|---|---|---|---|---|---|---|
A dash [ - ] indicates that there are no materials under that category in the product. |
||||||||
Antidiphtheria serumFootnote 1 |
IV | Antitoxin | Horse serum or Horse plasma | D | Type varies with supplier |
|
|
DAT |
BAT® Footnote 2 |
IV | Antitoxin | Horse plasma | B | - |
|
|
BAT |
Baby BIG® Footnote 1Footnote 2 |
IV | Immunoglobulin | Human plasma | B | - | - |
|
BIG-IV |
BEYFORTUSTM (nirsevimab) |
IM | Human monoclonal antibody | Recombinant DNA technology | RSV | - |
|
|
RSVAb |
Cytogam® Footnote 4 |
IV | Immunoglobulin | Human plasma | CMV | - | - |
|
CMVIg |
CNJ-016TM | IV | Immunoglobulin | Human plasma | Vac | - |
|
|
VIG |
EVUSHELDTM |
IM | Anti-SARS-CoV-2 monoclonal antibodies | Recombinant DNA technology | SARS-CoV-2 | - |
|
|
- |
GamaSTAN® S/D | IM | Immunoglobulin | Human plasma | HA Meas |
- | - |
|
Ig |
HepaGam B® | IM/IV | Immunoglobulin | Human plasma | HB | - |
|
|
HBIg |
HyperHEP B® S/D | IM | Immunoglobulin | Human plasma | HB | - | - |
|
HBIg |
HYPERRAB® | IM/ Local | Immunoglobulin | Human plasma | Rab | - | - |
|
RabIg |
HYPERTET® S/D | IM | Immunoglobulin | Human plasma | Tet | - | - |
|
TIg |
KamRABTM | IM/ Local | Immunoglobulin | Human plasma | Rab | - | - |
|
RabIg |
SYNAGIS® (palivizumab) | IM | Humanized monoclonal antibody | Recombinant DNA technology | RSV | - | - |
|
RSVAb |
VariZIG® TM | IV/ IM | Immunoglobulin | Human plasma | Var | - |
|
|
VarIg |
|
Abbreviations:
Route-
- IM
- intramuscular
- IV
- intravenous
- Local
- local wound infiltration
Protects against or treats-
- B
- botulism
- CMV
- cytomegalovirus
- D
- diphtheria
- HA
- hepatitis A
- HB
- hepatitis B
- Meas
- measles
- Rub
- rubella
- Rab
- rabies
- RSV
- respiratory syncytial virus
- T
- tetanus
- Vac
- vaccinia
- Var
- varicella
- N/A
- Not applicable
Preservative-
- P
- phenol
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.
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