Contents of immunizing agents authorized for use in Canada: Canadian Immunization Guide
Introduction
The following tables provide a comprehensive list of contents of immunizing agents authorized in Canada.  lists contents of active vaccines and  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 . Information about the vaccine manufacturer/distributor is available in  in Part 4. For more information about immunoglobulins, refer to  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 , aluminum phosphate , or amorphous aluminum hydroxyphosphate sulfate )
- AS01B (3-O-desacyl-4'-monophosphoryl lipid A , *Quillaja saponaria- Molina, fraction 21 , cholesterol, dioleoyl phosphatidylcholine , 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 )
- 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.
- Sucrose
- Trometamol
- d
- ap
- Glutaraldehyde
- d
- ap
- IPV
- Polymyxin B
- Streptomycin
- Polysorbate 80 
- Formaldehyde
- Glutaraldehyde
- Water for injection
- Neomycin sulfate
- Polymixin B sulfate
- Thimerosal 
- Calcium chloride
- Dibasic sodium phosphate (anhydrous)
- Hydrocortisone
- Monobasic potassium phosphate
- Monobasic sodium phosphate
- Potassium chloride
- Sodium chloride
- Sodium taurodeoxycholate
- Sucrose
- Water for injection
- Polysorbate 80 
- Medium 199 Hanks
- Water for injection
- Formaldehyde
- Kanamycin (Residue)
- Sodium chloride
- Sucrose
- Water for injections
- d
- ap
- Glycine
- Sodium chloride
- Water for injection
- d
- ap
- IPV
- Polymyxin B
- Medium 199
- Sodium chloride
- Water for injection
- Sodium dihydrogen phosphate dihydrate
- Water for injection
- Tromethamine
- Tromethamine (hydrochloride)
- ALC-0159 = 2-[(polyethylene
 glycol)-2000]-N,N-ditetradecylacetamide
- ALC-0315 = ((4-hydroxybutyl) azanediyl)bis
 (hexane-6,1-diyl)bis(2-hexyldecanoate)
- Cholesterol
- Sodium chloride 
- Sucrose
- Water for injection
- ALC-0159 = 2-[(polyethylene
 glycol)-2000]-N,N-ditetradecylacetamide
- ALC-0315 = ((4-hydroxybutyl) azanediyl)bis
 (hexane-6,1-diyl)bis(2-hexyldecanoate)
- Cholesterol
- Dibasic sodium phosphate dihydrate
- Monobasic potassium phosphate
- Potassium chloride
- Sodium chloride
- Sucrose
- Water for injection
- Kanamycin
- Polyethylene Glycol (PEG) 
- Polysorbate 80 
- Phosphate buffered saline
- Potassium phosphate monobasic anhydrous
- Sodium chloride
- Sodium phosphate dibasic anhydrous
- Squalene
- Water for injection
- Ecol
- Disodium hydrogen phosphate
- Raspberry flavor
- Saccharin sodium
- Sodium carbonate
- Sodium citrate
- Sodium chloride
- Sodium dihydrogen phosphate
- Sodium hydrogen carbonate
- Water for injection
- Sodium chloride
- Sodium dihydrogen phosphate dihydrate
- Water for injection
- Recombinant human serum albumin
- Sodium hydroxide
- Trace amounts of rice protein
- Trometamol buffer
- Water for injection
- Kanamycin
- Neomycin
- Polysorbate 80 
- Cetyltrimethylammonium bromide
- Citric acid
- Disodium phosphate dihydrate
- Formaldehyde
- Hydrocortisone
- Magnesium chloride hexahydrate
- Potassium chloride
- Potassium dihydrogen phosphate
- Sodium chloride
- Sodium citrate
- Sorbitan trioleate
- Squalene
- Water for injection
- Thimerosal 
- Cetyltrimethylammonium bromide
- Disodium phosphate dihydrate
- Magnesium chloride hexahydrate
- Potassium chloride
- Potassium dihydrogen phosphate
- Sodium chloride
- Water for injections
- Thimerosal 
- Polysorbate 80 
- Disodium hydrogen phosphate heptahydrate
- Ethanol
- Formaldehyde
- Potasium chloride
- Potassium dihydrogen phosphate
- Sodium chloride
- Sodium deoxycholate
- Sucrose
- Water for injection
- Egg protein
- Gelatin hydrolysate
- Gentamicin
- Monosodium glutamate
- Monobasic potassium phosphate
- Sucrose
- Thimerosal 
- Polysorbate 80 
- Disodium hydrogen phosphate heptahydrate
- Ethanol
- Formaldehyde
- Potassium chloride
- Potassium dihydrogen phosphate
- Sodium chloride
- Sodium deoxycholate
- Sucrose
- Water for injection
- Sodium phosphate-buffered isotonic sodium chloride solution
- Triton X-100
- Thimerosal 
- Sodium phosphate-buffered isotonic sodium chloride solution
- Triton X-100
- Polysorbate 80 
- Sodium borate
- Sodium chloride
- Disodium phosphate
- Formaldehyde
- Monopotassium phosphate
- Polysorbate 20
- Potassium chloride
- Sodium chloride
- Water for injection
- Polymyxin B
- Streptomycin
- Polysorbate 80 
- Formaldehyde
- Medium 199 Hanks
- Phenol red
- Water for injection
- Bromobutyl rubber stopper
- Ciprofloxacin
- Gentamicin
- Residual host (egg) cell DNA and protein
- Trometamol
- Sodium chloride
- Tris-hydroxymethyl-amino methane
- Water for injection
- T
- aP
- HB
- IPV
- Hib
- Neomycin
- Polymyxin B
- M199
- Sodium chloride
- Water for injection
- T
- aP
- IPV
- Hib
- Polymixin sulphate
- Polysorbate 80 
- Sodium chloride
- M199
- Water for injection
- Residual formaldehyde
- Potassium chloride
- Disodium phosphate
- Monopotassium phosphate
- Glycine
- Egg Material
- Gentamicin sulphate
- Neomycin sulphate 
- Polymyxin B sulphate 
- Polysorbate 80 
- Cetyltrimethyl ammonium bromide
- Disodium phosphate dihydrate
- Formaldehyde
- Hydrocortisone
- Magnesium chloride hexahydrate
- Potassium chloride
- Potassium dihydrogen phosphate
- Sodium chloride
- Sodium citrate
- Sucrose
- Tylosine tartrate
- Water for injection
- Potassium dihydrogen phosphate
- Sodium chloride
- Water for injection
- Citric acid monohydrate
- Ethanol
- Hydrochloric acid
- Sodium chloride
- Sodium hydroxide
- Trisodium citrate dihydrate
- Water for injection
- Sodium phosphate dibasic (anhydrous)
- Sodium phosphate monobasic
- Water for injection
- Bromobutyl rubber stopper
- Sodium chloride
- Water for injection
- Sodium chloride
- Sterile water for injection
- Potassium dihydrogen phosphate
- Sodium chloride
- Sodium dihydrogen phosphate monohydrate
- Sucrose
- Water for injection
- Mumps
- Rub
- Phenol red
- Porcine gelatin
- Residual components of chick embryo cell cultures
- Medium 199 with Hank's salts
- Minimum essential medium (Eagle)
- Monosodium L-glutamate monohydrate
- Potassium phosphate dibasic (anhydrous)
- Potassium phosphate monobasic
- Recombinant human albumin
- Sodium bicarbonate
- Sodium phosphate dibasic (anhydrous)
- Sodium phosphate monobasic
- Sorbitol
- Sucrose
- Water for injection
- Trometamol
- Sodium chloride
- Water for injection
- Disodium hydrogen phosphate dihydrate
- Disodium hydrogen phosphate heptahydrate
- Hydrochloric acid
- Phosphatidylcholine
- Potassium chloride
- Potassium dihydrogen phosphate
- Sodium chloride
- Sodium dihydrogen phosphate monohydrate
- Sodium hydroxide
- Water for Injection
- T
- aP
- IPV
- Hib
- Polymyxin B
- Streptomycin
- Polysorbate 80 
- Formaldehyde
- Glutaraldehyde
- Water for injection
- Hydrochloric acid
- Potassium chloride
- Potassium dihydrogen phosphate
- Sodium chloride
- Sodium hydroxide
- Water for injection
- Polysorbate 80 
- Succinic acid
- Water for injection
- Succinic acid
- Water for injection
- Mumps
- Rub
- Neomycin
- Lactose
- Mannitol
- Sorbitol
- Water for injection
- Mumps
- Rub
- Var
- Neomycin
- Lactose
- Mannitol
- Sorbitol
- Water for injection
- Mumps
- Rub
- Var
- Neomycin
- Chicken protein
- Urea
- Sodium chloride
- Sorbitol
- Monosodium L-glutamate
- Sodium phosphate
- Human albumin
- T
- aP
- IPV
- Polymyxin B
- Polysorbate 80 
- Formaldehyde
- Glutaraldehyde
- Chicken protein
- Chlortetracycline
- Neomycin
- Polygeline (gelatin)
- Egg protein
- Yeast protein
- Sodium borate
- Sodium chloride
- Water for injection
- DNA fragments from porcine circovirus 1
- Dulbecco's Modified Eagle Medium
- Sterile water
- Sucrose
- Fetal bovine serum
- Residual protein from cell culture
- Sodium citrate dihydrate
- Sodium hydroxide
- Sodium phosphate monobasic monohydrate
- Sucrose
- Sodium dihydrogen phosphate dihydrate
- Sucrose
- Water for injection
- Trometamol
- Trometamol (hydrochloride)
- Cholesterol
- DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine)
- Lipid SM-102
- PEG2000-DMG (1,2-dimyristoyl-racglycerol,
 methoxy-polyethyleneglycol)
- Sodium acetate trihydrate
- Sucrose
- Water for injection
- Baculovirus and Spodoptera frugiperda cell proteins
- Dibasic sodium phosphate
- Monobasic sodium phosphate
- Sodium chloride
- Triton X-100
- Diphtheria toxoid carrier protein
- Tetanus toxoid carrier protein
- Non-typeable Haemophilus influenzae protein D carrier
 protein
- Water for injection
- d
- Sodium chloride
- Water for injection
- Sodium chloride
- Water for injection
- HB
- Yeast protein
- Formaldehyde
- Polysorbate 20
- Sodium chloride
- Water for injection
- Neomycin
- DNA
- Formaldehyde
- Residual protein from cell culture
- Sodium borate
- Sodium chloride
- Water for injection
- Human albumin
- Lactose
- Polyalcohols
- Water for injection
- Porcine gelatin
- Monosodium L-glutamate
- Potassium chloride
- Potassium phosphate monobasic
- Residual protein from cell culture
- Sodium chloride
- Sodium phosphate dibasic
- Sucrose
- Urea
- Water for injection
- Sodium chloride
- Water for injection
- Ethanol
- L-Histidine
- L-Histidine hydrochloride monohydrate
- Magnesium chloride hexahydrate
- Sodium chloride
- Sucrose
- Water for injection
- Ascorbic acid
- Dibutyl phthalate
- Diethyl phthalate
- Erythrosine FD+C red 3
- Ethylene glycol
- Hydroxypropylcellulose-phthalate
- Lactose
- Magnesium stearate
- Red iron oxide
- Sucrose
- Titanium dioxide
- Yellow iron oxide
- Egg protein
- Gelatin
- Latex in stopper of diluent vial
- Sorbitol
Any component in a vaccine may be a potential allergen. This table identifies most common allergens; adjuvants and preservatives may be potential allergens, but this is extremely rare.
There is a potential of cross-reactive hypersensitivity between PEG and polysorbates. Therefore, individuals who are being administered a product that includes any one of these components as ingredients should be asked about any allergic reactions to either component.
Multi-dose presentation only.
Not present in COMIRNATY (Original) and COMIRNATY Original & Omicron BA.4/BA.5 vials with gray cap and label border (for 12 years of age and older).
IMVAMUNE is not available for general use.
Only used if gentamicin cannot be used. If not used, not present.

# Abbreviations

## Route-
ID
intradermal
IM
intramuscular
IN
intranasal
SC
subcutaneous

## Immunogen-
aP
acellular pertussis
ap
acellular pertussis (reduced)
BCG
Bacillus Calmette-Guerin
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
SARS-CoV-2
Severe acute respiratory syndrome coronavirus 2
T
tetanus
Typh
typhoid
Var
varicella
YF
yellow fever
ZEBOV
Zaire ebolavirus

## Adjuvant-
AAHS
amorphous aluminum hydroxyphosphate sulfate
Al(OH)3
Aluminum hydroxide
AlPO4
Aluminum phosphate
AS01B
3-O-desacyl-4'-monophosphoryl lipid A , *Quillaja saponaria- Molina, fraction 21 , cholesterol, dioleoyl phosphatidylcholine
 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
 agents authorized for use in Canada
- Polysorbate 80 
- Sucrose
- L-histidine
- L-histidine hydrochloride
- Sucrose
- Water for injection
- Sucrose
- Water for injection
- L-Histidine hydrochloride monohydrate
- Sucrose
- Water for injection
- Tri-n-butyl phosphate
- TritonX-100
- Sodium hydroxide
- Water for injection
- Glycine
- Histidine
- Water for injection
- Human plasma protein
- Sodium chloride
- Sodium phosphate
- Tri-n-butyl phosphate
- TritonX-100
Only available on an emergency basis by application to Health Canada's Special Access Programme (SAP) (). Public health should be contacted for assistance in obtaining these products. Information can also be obtained from the SAP website or by contacting the SAP office (telephone: 613-941-2108; fax: 613-941-3194; Available 24 hours a day, 7 days a week).
For further information refer to Health Canada: Botulism - Guide for healthcare professionals at 
There is a potential of cross-reactive hypersensitivity between PEG and polysorbates. Therefore, individuals who are being administered a product that includes any one of these components as ingredients. should be asked about any allergic reactions to either component.
Should be used in consultation with a specialist in immunodeficiency.

# 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
SARS-CoV-2
Severe acute respiratory syndrome coronavirus 2
T
tetanus
Vac
vaccinia
Var
varicella
N/A
Not applicable

## Preservative-
P
phenol