VaccineAdministeredTradeNameCode

Administrable Vaccines

This content is designed for use when populating a record at the point of immunization; it consists of concepts from the Proprietary Medicinal Product class and from the SNOMED CT Pharmaceutical / biologic product hierarchy, that are described using their trade name (brand name). All these concepts will be created in the Canadian Edition because they are specific to Canada. 

Scope definition:

The scope of this subset is vaccines that are currently licensed for use in Canada and those obtained through special access programs for use in Canada. The subset includes concepts described by the trade name (brand name) of the vaccine administered to the client. This content is intended to be used when populating a record at the point of immunization. 

General rules applied to this section

• A list of Canadian Edition (conceptID including 1000087) concepts and descriptions can be found in this subset;
• In most cases, the vaccine trade name will be represented as displayed in the Health Canada Drug Product Database (DPD) : it may be a mix of capital and lower-case letters. The product monograph may be used for validation of additional details.

Fully Specified Name

The format for the Fully Specified Name (FSN) is as follows:  

• Trade Name Strength Dose Form Marketing Authorization Holder (MAH) (real clinical drug) 
  • g.: Avaxim 80 units per 0.5 milliliter suspension for injection Sanofi Pasteur Limited (real clinical drug)

FSN Components

• The word ‘vaccine’ is not added to the FSN description of the ‘administrable vaccine’ concepts.
• Some products have more than one (1) formulation but the same concentration which is intended for different target populations. In such a case, when the two products are part of the subset . The FSN will display the strength as per the product monograph and will not contain a qualifier.
  • For example, 1:
    • FSN: Vaqta 25 units per 0.5 milliliter suspension for injection Merck Canada Inc (real clinical drug)
    • PT: [HA] VAQTA
  • For example, 2: 
    • FSN: Vaqta 50 units per milliliter suspension for injection Merck Canada Inc (medicinal product)
    • PT: [HA] VAQTA pediatric 
• Influenza (flu) vaccines

• • The strength related to the influenza vaccines that are trivalent or quadrivalent will be included once only to represent the ‘hemagglutinin (HA)’ count. The strain strengths are not cumulated.
    • For example:
      • Vaxigrip is a trivalent vaccine, i.e. it contains 3 strains of Types A and B (Split Virion), where a 0.5 mL dose is formulated to contain 15 μg of hemagglutinin (HA) for each strain listed. Therefore, the FSN is: Vaxigrip 15 micrograms per 0.5 milliliter suspension for injection Sanofi Pasteur SA (product)
    • The strength in other products that are quadrivalent or x-valent will be cumulated.
      • For example:
        • Gardasil, quadrivalent product has a strength of 120 micrograms per 0.5 milliliter because it contains 20 μgof HPV 6 L1 protein + 40 μg of HPV 11 L1 protein + 40 μg of HPV 16 L1 protein + 20 μg of HPV 18 L1 protein. There is no “unit of presentation” description in the FSN (no description of vial, ampoule, pre-filled syringe etc.) as there is currently no business requirement for this.
• COVID-19 vaccines :
  • are known to potentially have different compositions from year to year.
  • The PHSC considered important to differentiate first COVID-19 vaccines (COMIRNATY, NUVAXOVID, SPIKEVAX)
  •  to the seasonal vaccine with the same trade names. The FSN of first vaccines was modified to add “original strain” to differentiate them from seasonal (year to year) new vaccines.
    • For example: 
      • COMIRNATY (original strain) messenger ribonucleic acid 30 micrograms per 0.3 milliliter suspension for injection BioNTech Manufacturing GmbH (real clinical drug)
      • COMIRNATY messenger ribonucleic acid 30 micrograms per 0.3 milliliter suspension for injection BioNTech Manufacturing GmbH (real clinical drug)

Marketing Authorization Holder (MAH)

• The MAH is the organization who distributes the vaccine in Canada. It may be different from manufacturing company. The MAH is the organization displayed in the COMPANY element in the Health Canada Drug Product Database (DPD) .
• Note there is sometimes more than one (1) name used by a company. The abbreviation list provides one recognized abbreviation for similar companies. 
• The source of truth for the MAH abbreviation is the Table 1: Vaccine List
  • For example: The manufacturer abbreviation is SP for any of the following: Sanofi Pasteur Inc. or Sanofi Pasteur SA or Sanofi Pasteur Limite
  • The MAH (Supplier in SNOMED CT) concept will be created based on the DPD COMPANY name, but the MAH abbreviation will be the one that is part of the Vaccine list.
• Please refer to the Immunization page for details.

Trade Name

• Written as described in Health Canada Drug Product Database (DPD) . Product monograph could be used to have more detailed information
  • When creating of a new product that has the same product name as an existing one, additional information will be added to the Preferred Synonym to avoid confusion and decrease the patient safety risk.
    • For example:  Gardasil (represents the HPV 4-valent trade name product) vs Gardasil 9 (represents the HPV 9-valent trade name product)
    • Some products have the same trade name for both an adult and child presentation, or for administration to a specific group of patients (e.g.: patient on dialysis)
    • No qualifier is added to FSN since the FSN is already explicit and unambiguous because the strength is described as presentation strength. 
    • Refer to the Preferred Synonym in this section for more information.

Strength

• The unit is described as per the product monograph (e.g. 50 units per milliliter). No normalization of the unit to a unitary concentration (e.g. 100 units in 1 milliliter) is performed.
• Words are used to designate the units of measure for the strength (as opposed to symbols).  For example: micrograms per liter.
• When there are more than two (2) active ingredients, the strength is not part of the FSN For example: Boostrix suspension for injection GlaxoSmithKline Inc. (product)
• Where two (2) active ingredients are part of the product their names are not part of the FSN, but the strength will be represented as the PHAC Abbreviation order.
• For example:  PHAC Abbreviation: HA-Typh-I, Vivaxim 160 antigen units and 25 micrograms suspension for injection Sanofi Pasteur SA (product)
  • In this concept Hepatitis A has a strength of 160 antigen and the Typhoid has a strength of 25 microgram
• A range will be documented as per the active ingredient is in the monograph.
• For example:
  • Oligosaccharide conjugated to 12.5 to 25 μg CRM197 will be represented as follows: 12.5 to 25 micrograms
  • IMMUNE SERUM GLOBULIN (HUMAN) 15 to 18 percent solution for injection Grifols Therapeutics Inc. (product)

Dose Form

• Use lower case for this component.
• “suspensions‘’ and ‘’solutions” are not consistently represented in the monograph. 
• ‘’sterile’’ does not need to be added to the FSN when found on the monograph as an additional qualifier to ‘’suspension for injection’’. Omitting has no consequence on comprehension or interpretation. The term “injection” implies sterile as all monographs (e.g. the European Pharmacopoeia) have sterility as one of their conformance tests.
• ‘’pellet’’ = powder. Powder will be in FSN rather than ‘’pellet’’.
• ‘’reconstituted product for injection‘’, will not be put as is in the FSN. The monograph will provide details as to what is the form of the ingredients that will be reconstituted for injection.
• For example: ACT-HIB has a dose form of “powder and diluent for solution for injection”, therefore this will be added to the FSN for unambiguity.
• "Lyophilized powder for injection" will not be added to the FSN as an additional qualifier unless it alters the pharmaceutics of a medicine (which is not the case for vaccines). The monograph will provide details as to what is the form of the ingredients that will be reconstituted for injection.
  • For example:    
    • M-M-R II has a dose form of “powder and diluent for solution for injection.”

(real clinical drug)

This is the semantic tag representing the context of use within SNOMED CT for any concept that is within the Pharmaceutical / biologic product hierarchy.

Preferred Synonym (English)

The format for the Preferred Synonym (PS) is as follows: 

• [PHAC Product Abbreviation] Trade Name (qualifier)(strength) (Marketing Authorization Holder (MAH) Abbreviation if required)
  • g.: [HA] Avaxim 
  • g.: [Inf] Intanza 

PS Components

For further information about the editorial guidelines for the PS please refer to Picklists Editorial Guidelines, under the Preferred Synonym for tradename.

PHAC Product Abbreviation

Is taken from the web provided Table 1: Vaccine List. The PHAC abbreviation is in square brackets [ ]

MAH Abbreviation

• For general information, please see above
• The MAH is added in brackets only if there is another product with the same tradename but marketed by another manufacturer (to help differentiate them) as per the Clinicians Picklists guidelines.

Trade Name

• The manufacturer trade name as provided on the monograph is used (matching case)
• Must be unique: this is done by adding the MAH Abbreviation.

Qualifier and Strength

• If (and only if) the trade name is insufficient to produce unambiguous and unique PSs, the following is used:
  • A qualifier may be added to differentiate between two products with the same strength that differ only in the volume for different target population (of the unit of presentation), where the smaller volume presentation is intended for pediatric use. This qualifier aligns with the Public Health ‘common usage’ 
  • If the trade name has “Junior” as opposed to “Pediatric”, then Junior will be part of the description.
    • For example: [HA] Havrix Junior
  • The qualifier is not capitalized (unless it is capitalized on the Trade name). 
    • For example: 
      • [HB] Recombivax HB dialysis
      • [HA] Avaxim pediatric                                   
    • A “strength” qualifier may be added to the PS when neither a target age or target population qualifier is appropriate
      • For example: 
        • [Inf] Intanza 9 mcg/ 0.1 mL
        • [Inf] Intanza 15 mcg/ 0.1 mL
      • When trade name is the same (exact match) as the PHAC abbreviation, the abbreviation is represented as follows:
        • For example:   BCG BCG Vaccine SP becomes [BCG] BCG vaccine

Special access and out of country products

Stakeholders of the Public Health Community have requested to create terminology concepts for the WHO-authorized vaccines administered outside of Canada. This is to support use cases related to international travel back to/into Canada (e.g. snowbirds, newcomers, etc.). This will help with immunization surveillance and will allow to have a more comprehensive understanding of vaccination coverage rates in Canada.

Special Access Products (SAPs) and international vaccines cannot be found on DPD. There is no MAH for these products as they are not licensed in Canada. The new pattern will be as follows: 

• FSN: Trade Name (qualifier) Strength Dose Form (real clinical drug)  
• English PT: [PHAC Product Abbreviation] Trade Name (qualifier) (strength) (MAH Abbreviation if required)

strength and MAH are displayed only if another product has the same tradename and there is no other possible way to differentiate them (Clinicians Picklists guidelines)

With Preservative or Without Preservative 

When required to differentiate a vaccine product “with preservative” or “without preservative” the format to be used is: 

Product with preservative 

The format for the descriptions is as follows: 

• FSN: Trade Name Strength (with preservative) Dose Form (real clinical drug)  
• English PT: [PHAC Product Abbreviation] Trade Name (qualifier) (strength) (with preservative) (MAH Abbreviation if required)

Example: 

• FSN: Td ADSORBED 5 limit of flocculation units and 2 limit of flocculation units per 0.5 milliliter with preservative suspension for injection Sanofi Pasteur Limited (real clinical drug)  
• English PT: [Td] Td ADSORBED with preservative. 

Product without preservative 

The format for the descriptions is as follows: 

• FSN: Trade Name Strength (without preservative) Dose Form (real clinical drug)  
• English PT: [PHAC Product Abbreviation] Trade Name (qualifier) (strength) (without preservative) (MAH Abbreviation if required)

Example: 

• FSN: Td ADSORBED 5 limit of flocculation units and 2 limit of flocculation units per 0.5 milliliter without preservative suspension for injection Sanofi Pasteur Limited (real clinical drug)  
• English PT: [Td] Td ADSORBED without preservative. 

English Preferred term was replaced in the February release to align with Picklists guidelines.

COVID-19 vaccines

Marketed in Canada or about to be marketed in Canada. 

The COVID-19 vaccines marketed in Canada follow the same guidelines as for any other vaccines. The vaccine development technology is added to the FSN. If there is not an official abbreviation for the technology, it is not added to the PT.

 Pattern: 

• FSN: Trade Name technology spelled out Strength Dose Form MAH (real Clinical drug)  
• English PT: [PHAC Product Abbreviation] Trade Name (qualifier) (strength) (MAH Abbreviation)
• French PT: [PHAC Product Abbreviation] Trade Name (qualifier) (strength) (MAH Abbreviation) 

Examples: 

• FSN: COMIRNATY messenger ribonucleic acid 10 micrograms per 0.2 milliliter suspension for injection BioNTech Manufacturing GmbH (real clinical drug) 
• English PT: [COVID-19] COMIRNATY pediatric 10 mcg/0.2 ml 
• Preferred French synonym: [COVID-19] COMIRNATY pédiatrique 10 mcg/0.2 mL

Bivalent COVID-19 products 

The naming convention is not standardized amongst the different products. Some are using slashes ( / ) and special characters like &, parentheses and others, when these are not acceptable in FSN.

The guidance for these is as follows:

• Develop the FSN based on the Product monograph and the appropriate guidelines for the VaccineAdministeredTradeNameCode, even if not compliant to the SNOMED International guidelines
• Develop the PT based on the Product monograph and the appropriate guidelines for the VaccineAdministeredTradeNameCode,
• Add an acceptable synonym that will remove the special characters
• For Tradename that may cause confusion about the type of variant because it is not explicitly stated in the Tradename, the variant may be explicitly named.
  • For example: The Omicron variant in the SPIKEVAX™ Bivalent (Original / Omicron) product is BA.1. The variant has been added to the FSN and PT as follows:
    • FSN: SPIKEVAX Bivalent (Original / Omicron BA.1) messenger ribonucleic acid 0.10 milligrams per 1 milliliter dispersion for injection Moderna Therapeutics Inc. (real clinical drug)
    • EN FT: [COVID-19] SPIKEVAX Bivalent (Original / Omicron BA.1) 0.10 mg/mL
    • FR PT: [COVID-19] SPIKEVAX vaccin bivalent (Original / Omicron BA.1) 0.10 mg/mL

Pattern: 

• FSN: Trade Name technology spelled out Strength Dose Form MAH (real Clinical drug)  
• English PT: [PHAC Product Abbreviation] Trade Name (qualifier) (strength) (MAH Abbreviation if required)
• French PT: [PHAC Product Abbreviation] Trade Name (qualifier) (strength) (MAH Abbreviation if required)

Examples: 

• FSN: COMIRNATY Original / Omicron BA.1 messenger ribonucleic acid 30 micrograms per 0.3 milliliter suspension for injection BioNTech Manufacturing GmbH (real clinical drug) 
• English PT: [COVID-19] COMIRNATY Original / Omicron BA.1 30 mcg/0.3 mL
• Preferred French synonym: [COVID-19] COMIRNATY Original / Omicron BA.1 30 mcg/0.3 mL

International COVID-19 vaccines 

These concepts are created with less details as it is often difficult to get all required information, as we do not always have one source of truth for the detailed information or the product monograph.

The strength, dose form and manufacturer/market authorization holder are not included in the Fully Specified Name of these concepts. The vaccine development technology is added to the FSN. If there is not an official abbreviation for the technology, it is not added to the PT.

Pattern:  

• FSN: Trade NameCOVID-19 technology spelled out vaccine (real medicinal product) 
• English PT: [PHAC Product Abbreviation]Trade Name

Example: 

• FSN: CoronaVacCOVID-19 whole inactivated virus vaccine (real medicinal product) 
• English PT: [COVID-19]CoronaVac
• Preferred French synonym: [COVID-19]CoronaVac 

COVID-19 development technology 

Only COVID-19 vaccines will include the development technology in their FSN. Where an abbreviation for the technology exists, it will be added to one of the syn. The editorial guidelines around this information are presented in detail in the present section. 

The development technologies may be: 

• messenger ribonucleic acid (mRNA)
• non-replicant vector 
• recombinant spike protein 
• whole inactivated virus 

COVID-19 vaccines that do not have a Tradename.  

The same pattern will be applied as what was done for Pzifer-BioNTech, or AstraZeneca vaccines when they were first created. (Note that their names have changed in the September 2021 release). The vaccine development technology is added to the FSN. If there is not an official abbreviation for the technology, it is not added to the PT.

Pattern:

• FSN: Manufacturer/MAH COVID-19technology spelled out vaccine (real medicinal product) 
• English PT: [PHAC Product Abbreviation]Manufacturer/MAH 

Example: 

• FSN: SINOPHARM-WIBP COVID-19whole inactivated virus vaccine (real medicinal product) 
• English PT: [COVID-19]SINOPHARM-WIBP
• Preferred French synonym: [COVID-19]SINOPHARM-WIBP 

Recombinant spike protein vaccines 

The following provides the format for the FSN and Syns for concepts that are International or on the CA market.

Pattern:

• FSN: ... recombinant spike protein(vaccine) ... 
• Syn: ... recombinant spike protein(vaccine) ... 
• Syn: ... protein subunit(vaccine) ...

Examples:

• FSN: NUVAXOVID recombinant spike protein5 micrograms per 0.5 milliliter suspension for injection Novavax Inc. (real clinical drug)
• Preferred synonym: [COVID-19] NUVAXOVID
• Syn: NUVAXOVID recombinant spike protein5 micrograms per 0.5 milliliter suspension for injection Novavax Inc.
• Syn: NUVAXOVID protein subunit5 micrograms per 0.5 milliliter suspension for injection Novavax Inc.
• Preferred French synonym: [COVID-19] NUVAXOVID

• FSN: COVOVAX COVID-19 recombinant spike protein vaccine(real medicinal product)
• Preferred synonym: [COVID-19] COVOVAX
• Syn: COVID-19 COVOVAX COVID-19 recombinant spike protein vaccine
• Syn: COVOVAX COVID-19 protein subunit vaccine
• Preferred French synonym: [COVID-19] COVOVAX

Preferred Synonym (French)

Pour plus de détails sur les règles éditoriales pour le Preferred Synonym French, veuillez-vous référer à la page Picklists Editorial Guidelines.

• La plupart des synonymes privilégiés en français sont les même qu’en anglais, à l’exceptions de certaines abréviations qui peuvent différer.
• Certaines références de termes accompagnant le nom commercial ont été traduit et ont pu être trouvés sur différents sites internet, comme :
  1. Le site de l’Agence de la santé publique du Canada sur la page ‘Contenu des agents immunisants utilisés au Canada’.
     • Par example:
       • Le vaccin ‘Liquid PedvaxHib’a été traduit en français par ‘PedvaxHib liquide’
     • Le site du manufacturier ou du détenteur d'autorisation de mise en marché Sanofi Pasteur
       • Par exemple:
         • Td Adsorbedest traduit: Td adsorbées
         • Td Polio Adsorbedest traduit: Td Polio adsorbées
         • Imovax Rabiesest traduit: Imovax Rage

Comme en anglais, quand le nom commercial est le même que l’abréviation du vaccin, l’abréviation sera représentée deux fois.

• Par exemple : Le vaccin ‘[BCG] BCG Freeze-dried Glutamate BCG Vaccine’ se lit comme suit: ‘[BCG] BCG lyophilisé avec glutamate Japan JBCG’