VaccineAdministeredTradeNameCode

General Note

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/in to Canada (e.g. snowbirds, newcomers, etc.). This will help with immunization surveillance and will allow to have a more comprehensive understanding of COVID-19 vaccination coverage rates in Canada.

It was agreed that whenever a new product is under review by WHO or is present on the international market, it could be a potential candidate for a new COVID-19 vaccine concept. Infoway will create the new vaccine product once a request for change is submitted through InfoRMS. Given the time needed to configure in systems, stakeholders will request the concept in advance of approval so their system can be updated as soon as possible to support the data capture when it is ready at point of care.

What's new in this release?

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: 

Pattern:  

FSN: Trade Name Strength (with preservative) Dose Form MAH (real clinical drug) 

English PT: PHAC Product Abbreviation Trade Name (qualifier) (strength) (with preservative) MAH Abbreviation

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 ADSORBED with preservative SP 

Product without preservative 

The format for the descriptions is as follows: 

Pattern:  

FSN: Trade Name Strength (without preservative) DoseForm MAH (real clinical drug)? 

English PT: PHAC Product Abbreviation Trade Name (qualifier) (strength) (without preservative) MAHAbbreviation  

Acceptable English Syn: PHAC Product Abbreviation Trade Name (qualifier) (strength) (preservative free) MAHAbbreviation 

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 ADSORBED without preservative SP 

Acceptable English Syn: Td ADSORBED preservative free SP 

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) (technology abbreviated) MAH Abbreviation  

 French PT: The same pattern as the English PT will be applied, except when there is a qualifier like "pediatric". In that case, the qualifier will be properly worded to reflect normal language: vaccin pédiatrique contre la COVID-19 

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 mRNA PB 

Preferred French synonym: COVID-19 COMIRNATY vaccin pédiatrique contre la COVID-19 10 mcg/0.2 ml ARNm PB 

FSN: COMIRNATY messenger ribonucleic acid 30 micrograms per 0.3 milliliter suspension for injection BioNTech Manufacturing GmbH (real clinical drug)

English PT: COVID-19 COMIRNATY 30 mcg/0.3 ml mRNA PB 

Preferred French synonym: COVID-19 COMIRNATY vaccin contre la COVID-19 30 mcg/0.3 ml ARNm PB 

Bivalent COVID-19 products 

The naming convention is not standardized amongst the different products. Some are using slashes ( / ) and special charaters 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 explicitely stated in the Tradename, the variant may be explicitely 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 mRNA Mod
    • FR PT: COVID-19 SPIKEVAX vaccin bivalent (Original / Omicron BA.1) contre la COVID-19 0.10 mg/mL ARNm Mod

Pattern: 

 FSN: Trade Name technology spelled out Strength Dose Form MAH (real Clinical drug)  

 English PT: PHAC Product Abbreviation Trade Name (qualifier) (strength) (technology abbreviated) MAH Abbreviation  

Acceptable EN Syn: Trade Name (variant: the parentheses are removed, the slash between the variant types (Original/Omicron) is removed and replaced by "and", keep the slash between the variant strains (BA.4/BA.5), ensure the strains are completely spelled out (BA.4/5, would be replaced by BA.4/BA.5) (qualifier)(strength)(technology abbreviated) NOTE: There is no vaccine code at the beginning of the synonym and there is no MAH at the end of the synonym.

French PT: PHAC Product Abbreviation Trade Name (qualifier) vaccin contre la COVID-19 (strength)(technology abbreviated) MAH Abbreviation  

Acceptable FR Syn: Trade Name (variant: the parentheses are removed, the slash between the variant types (Original/Omicron) is removed and the wording ... souche originale et variant...added, the slash between the variant strains (BA.4/BA.5), ensure the strains are completely spelled out (BA.4/5, would be replaced by BA.4/BA.5) (qualifier)(strength)(technology abbreviated) NOTE: There is no vaccine code at the beginning of the synonym and there is no MAH at the end of the synonym.

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 mRNA PB

Acceptable EN Syn: COMIRNATY bivalent Original and Omicron BA.1 30 mcg/0.3 mL mRNA

Preferred French synonym: COVID-19 COMIRNATY Original / Omicron BA.1 vaccin contre la COVID-19 30 mcg/0.3 mL ARNm PB  

Acceptable FR Syn: COMIRNATY bivalent souche originale et variant Omicron BA.1 30 mcg/0.3 mL ARNm

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 Name COVID-19 technology spelled out vaccine (real medicinal product) 

English PT: PHAC Product Abbreviation Trade Name (technology abbreviated) 

Example: 

FSN: CoronaVac COVID-19 whole inactivated virus vaccine (real medicinal product) 

English PT: COVID-19 CoronaVac

Preferred French synonym: COVID-19 CoronaVac vaccin contre la COVID-19

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 is presented in details 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-19 technology spelled out vaccine (real medicinal product) 

English PT: PHAC Product Abbreviation Manufacturer/MAH technology abbreviated

Example: 

FSN: SINOPHARM-WIBP COVID-19 whole inactivated virus vaccine (real medicinal product) 

English PT: COVID-19 SINOPHARM-WIBP

Preferred French synonym: COVID-19 SINOPHARM-WIBP vaccin contre la COVID-19

COVID-19 alternate name 

Additional synonyms are added when there is an interim product name used for registration during clinical trials. These names are officially available either on WHO or Health Canada's sites. 

Pattern:  

Alternate EN Syn:  COVID-19 (Tradename)(qualifier) Alternate name (strength) vaccine

Example: 

FSN: Sputnik V COVID-19 non-replicating vector vaccine (real medicinal product) 

English PT: COVID-19 Sputnik V 

Alternate EN Syn:  COVID-19 Gam-Covid-Vac vaccine

Preferred French synonym: COVID-19 Sputnik V vaccin contre la COVID-19

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 mRNA PB

Alternate EN Syn: COVID-19 COMIRNATY pediatric BNT162b2 10 mcg/0.2 ml vaccine 

Alternate EN Syn: COVID-19 COMIRNATY pediatric tozinameran 10 mcg/0.2 ml vaccine 

Preferred French synonym: COVID-19 COMIRNATY vaccin pédiatrique contre la COVID-19 10 mcg/0.2 ml ARNm PB 

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 protein 5 micrograms per 0.5 milliliter suspension for injection Novavax Inc. (real clinical drug)

Syn: NUVAXOVID recombinant spike protein 5 micrograms per 0.5 milliliter suspension for injection Novavax Inc.

Syn: NUVAXOVID protein subunit 5 micrograms per 0.5 milliliter suspension for injection Novavax Inc.

Preferred French synonym: COVID-19 NUVAXOVID NOV 

Acceptable French synonym: COVID-19 VACCIN NOVAVAX CONTRE LA COVID-19 NOV 

FSN: COVOVAX COVID-19 recombinant spike protein vaccine (real medicinal product)

Syn: COVOVAX COVID-19 recombinant spike protein vaccine

Syn: COVOVAX COVID-19 protein subunit vaccine

Preferred French synonym: COVID-19 COVOVAX

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 of 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 found in the product monograph or as published by the Vaccine Vigilance Working Group: it may be a mix of capital and lower case letters.

Fully Specified Name

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

Trade Name Strength Dose Form Manufacturer or Marketing Authorization Holder (MAH) (product) 

e.g.: Avaxim 80 units per 0.5 milliliter suspension for injection Sanofi Pasteur Limited (product)

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 a qualifier is added to the Preferred Synonym. The FSN will display the strength as per the product monograph and will not contain a qualifier.

  For example: Vaqta 25 units per 0.5 milliliter suspension for injection Merck Canada Inc. (product) (intended to be used for pediatric use)

                Vaqta 50 units per milliliter suspension for injection Merck Canada Inc. (product) (intended to be used for adult use) 

• Influenza (flu) vaccines   
  • are known to potentially have different compositions from year to year. When this happens the trade name is followed by the year. This is not reflected in the trade name concepts. For example, FLUVIRAL that is (2014-2015) or FLUVIRAL that is (2015-2016) would not be created as two (2)  distinct concepts. There will only be one (1) concept of FLUVIRAL available for data capture.  The year can be entered in a different field if it is important to access the product details for that specific year. 
• 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 μg of 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.

Trade Name

• Written as per the product monograph
  • 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”

Manufacturer vs Marketing Authorization Holder (MAH) 

The MAH is the organization who distributes the vaccine and may be different from manufacturing company.

• The manufacturer name or the MAH name provided on the product monograph (matching case)
• When there are discrepancies between the product monograph and PHAC list, the source of truth is PHAC.
• Discrepancies in manufacturer name have been added to the manufacturer’s list. Refer to Immunization Home Page - Main Reference Documentation section.

(product)

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) PHAC Manufacturer or Marketing Authorization Holder (MAH) Abbreviation

e.g.: HA Avaxim pediatric SP

e.g.: Inf Intanza 15 micrograms SP

PS Components

PHAC Product Abbreviation

• Is taken from the Abbreviations for Products Available in Canada in the Canadian Immunization Guide and the Standardized Vaccine Abbreviations List provided by the VVWG.

Trade Name

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

Qualifier and Strength

• No ‘’adult’’ qualifier will be added to the PS for an adult when there is a product with a pediatric dose provided as well
• 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 GSK 

• The qualifier is not capitalized (unless it is capitalized on the Trade name). 

     For example:  HB Recombivax HB dialysis MC 

                                    HA Avaxim pediatric SP                                    

• 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 micrograms SP

                                            Inf Intanza 15 micrograms SP

• When trade name is the same (exact match) as the PHAC abbreviation, the abbreviation is represented once only.

    For example:   BCG BCG vaccine SP     becomes: BCG Vaccine SP

•  When a trade name is very similar but could allow easier retrieval when searched upon, both terms are kept.

    For example: MMR M-M-R II MC

Manufacturer or MAH PHAC Abbreviation

• This is taken from the PHAC Manufacturer’s Abbreviation List provided by PHAC.
• Note there is sometimes more than one (1) name used by a company. The abbreviation list provides one recognized abbreviation for similar companies.

   For example: The manufacturer abbreviation is SP for any of the following: Sanofi Pasteur Inc. or Sanofi Pasteur SA or Sanofi Pasteur Limited

Preferred Synonym (French)

• 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 exemple :

• • • • Le vaccin ‘BCG Vaccine’ a été traduit en français par ‘vaccin BCG’
      • Le vaccin ‘Liquid PedvaxHib’ a été traduit en français par ‘PedvaxHib liquide’
        
        

2. Le site du manufacturier ou du détenteur d'autorisation de mise en marché Sanofi Pasteur

Par exemple:

• • • • Td Adsorbed est traduit: Td adsorbées
      • Td Polio Adsorbed est traduit: Td Polio adsorbées
      • Imovax Rabies est traduit: Imovax Rage
        
        

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

Par example : Le vaccin ‘BCG Freeze-dried Glutamate BCG Vaccine’ ne contient qu’une fois l’abréviation BCG et se lit comme suit: BCG lyophilisé avec glutamate Japan JBCG