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.
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:
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:
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
The below sections are currently under review due to the Immunization RedesignIf you have questions or need information, please contact us |
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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.
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.
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)
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)
For example: Gardasil (represents the HPV 4-valent trade name product) vs
Gardasil 9 (represents the HPV 9-valent trade name product)
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
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)
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
For example: M-M-R II has a dose form of “powder and diluent for solution for injection”
The MAH is the organization who distributes the vaccine and may be different from manufacturing company.
This is the semantic tag representing the context of use within SNOMED CT for any concept that is within the Pharmaceutical / biologic product hierarchy.
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
For example: HA Havrix Junior GSK
For example: HB Recombivax HB dialysis MC
HA Avaxim pediatric SP
For example: Inf Intanza 9 micrograms SP
Inf Intanza 15 micrograms SP
For example: BCG BCG vaccine SP becomes: BCG Vaccine SP
For example: MMR M-M-R II MC
For example: The manufacturer abbreviation is SP for any of the following: Sanofi Pasteur Inc. or Sanofi Pasteur SA or Sanofi Pasteur Limited
Par exemple :
2. Le site du manufacturier ou du détenteur d'autorisation de mise en marché Sanofi Pasteur
Par exemple:
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