The following high level vaccine-related grouper concepts are included in the |Medicinal product| hierarchy.
787859002 |Vaccine product (medicinal product)|
836368004 |Vaccine product containing bacteria antigen (medicinal product)|
1290123005 |Vaccine product containing protozoa antigen (medicinal product)|
836369007 |Vaccine product containing virus antigen (medicinal product)|
In the naming patterns below, align naming and case sensitivity with the PT for the concept that is selected as the attribute value for the 127489000 |Has active ingredient (attribute)|.
Single ingredient vaccine
Vaccine product containing <Active ingredient PT excluding "antigen"> antigen (medicinal product)
Multiple ingredient vaccine
Vaccine product containing <Active ingredient PT excluding "antigen"> and <Active ingredient PT excluding "antigen"> antigens (medicinal product)
For example,
Vaccine product containing bacteria antigen (medicinal product)
Vaccine product containing virus antigen (medicinal product)
Vaccine product containing bacteria and virus antigens (medicinal product)
Single ingredient
<Active ingredient PT excluding "antigen">-containing vaccine product
Multiple ingredient
<Active ingredient PT excluding "antigen">- and <Active ingredient PT excluding "antigen"> antigens-containing vaccine product
For example,
Bacteria antigen-containing vaccine product
Virus antigen-containing vaccine product
Bacteria- and virus antigens-containing vaccine product
Synonyms matching the FSN are not required.
Stated parent concept
763158003 |Medicinal product (product)
Semantic tag
(medicinal product)
Definition status
Defined
Attribute:
Has active ingredient
Range: <<105590001 |Substance (substance)|
Cardinality: 0..*
Exception: Top level grouper 787859002 |Vaccine product (medicinal product)| does not have a Has active ingredient (attribute).
Attribute:
Plays role
Range: <<766940004 |Role (role)|
Cardinality: 0..*
While the allowed range is broader, top level vaccine-related grouper concepts should have one and only one Plays role (attribute) with attribute value = 318331000221102 |Active immunity stimulant therapeutic role (role)|.
The "Vaccine product containing only" concept is an abstract representation of the active ingredient(s) in a vaccine product. It means that the vaccine product must contain only the active ingredient(s) specified in the FSN but may also contain a modification of the active ingredient(s) specified in the FSN. The "Vaccine product containing only" may be sufficient to serve as an interoperability layer or to support prescribing use cases.
For example,
|Vaccine product containing only Hepatitis B virus antigen (medicinal product)|
|Vaccine product containing only Vaccinia virus antigen (medicinal product)|
|Vaccine product containing only Hepatitis A and Hepatitis B virus antigens (medicinal product)|
|Vaccine product containing only Bordetella pertussis and Clostridium tetani and Corynebacterium diphtheriae antigens (medicinal product)|
Both "Vaccine product containing" and "Vaccine product containing only" concepts may be created for products that only have one active ingredient.
For example,
836374004 |Vaccine product containing Hepatitis B virus antigen (medicinal product)| and 871822003 |Vaccine product containing only Hepatitis B virus antigen (medicinal product)|
"Vaccine product containing" concepts are not created for multiple ingredient vaccine products. "Vaccine product containing only" concepts are created for multiple ingredient vaccine products.
In the naming patterns below, align terming and case significance with the PT for the concept that is selected as the attribute value for the |Has active ingredient (attribute)|.
For multiple ingredient vaccine products, the active ingredients must be listed in alphabetical order, separated by the word "and", and the word "antigen" will be omitted.
For concepts where all active ingredients are virus, the word "virus" may be omitted and added before "antigens".
Template:
Vaccine product containing only <Active ingredient PT> (medicinal product)
Vaccine product containing only <Active ingredient PT> and <Active ingredient PT> antigens (medicinal product)
Vaccine product containing only <Active ingredient PT> and <Active ingredient PT> and <Active ingredient PT> antigens (medicinal product)
For example,
Vaccine product containing only Hepatitis B virus antigen (medicinal product)
Vaccine product containing only Hepatitis A and Hepatitis B virus antigens (medicinal product)
Vaccine product containing only Bordetella pertussis and Clostridium tetani and Corynebacterium diphtheriae antigens (medicinal product)
Template:
<Active ingredient PT> only vaccine product
<Active ingredient PT> and <Active ingredient PT> antigen only vaccine product
<Active ingredient PT> and <Active ingredient PT> and <Active ingredient PT> antigen only vaccine product
For example,
Hepatitis B virus antigen only vaccine product
Hepatitis A and Hepatitis B virus antigens only vaccine product
Bordetella pertussis and Clostridium tetani and Corynebacterium diphtheriae antigens only vaccine product
Synonyms matching the FSN are not required.
Synonyms corresponding to the disorder that is the target of the vaccine are allowed.
For multiple ingredient vaccine products, the disorders must be listed in alphabetical order and separated by the word "and". Note that these are not true synonyms; they may be updated and identified as "near-synonym" descriptions when that functionality becomes available.
For example,
Hepatitis B vaccine
Hepatitis A and Hepatitis B vaccine
Diphtheria and pertussis and tetanus vaccine
Synonyms representing abbreviations for product (e.g., MMR, DTaP) will not be included in the International Release due to lack of internationally accepted reference sources.
In the pharmaceutical and biologic product model, , such as Count of base of active ingredient and Count of active ingredient, are designed under a closed-world assumption solely to ensure accurate subsumption and prevent unexpected subtype classification. These attributes do not necessarily reflect the strict biological or taxonomic relationships of the underlying antigens or organisms. They prevent multi-antigen products or products containing multiple subtypes/modifications from incorrectly subsuming under single-antigen or single-base concepts.
Additional count attributes (such as Count of active ingredient) should only be added if omitting them would cause incorrect classification. If removing a count attribute does not alter the intended subsumption hierarchy, it is considered unnecessary.
Where multiple specific subtypes or modifications share the same base category, setting the Count of base of active ingredient to 1 allows proper classification under broader grouper concepts. The specific count of subtypes can optionally be represented using |Count of base and modification pair (attribute)|.
Stated parent concept
763158003 |Medicinal product (product)
Semantic tag
(medicinal product)
Definition status
Defined
Attribute:
Has active ingredient
Range: <105590001 |Substance (substance)| excluding concepts representing structural groupers, dispositions, or combined substances
Cardinality: 1..*
There is no technical limit on the number of Has active ingredient attributes that may be added to a concept; a practical limit may be imposed at a later date.
For content in the International Release, this attribute value should represent either the organism antigen, or the organism antigen(s), including modifications or subtypes, that are contained in a manufactured product.
Attribute: Has ingredient qualitative strength
Range: < 1149484003 |Ingredient qualitative strength (qualifier value)|
Cardinality: 0..*
Attribute: Has target population
Range: < 27821000087106 |Product target population (qualifier value)|
Cardinality: 0..1
Attribute:
Plays role
Range: <<766940004 |Role (role)|
Cardinality: 0..*
While the allowed range is broader, "Vaccine product containing" concepts should have one and only one |Plays role (attribute)| of 318331000221102 |Active immunity stimulant role (role)|.
Attribute:
Count of base of active ingredient
Concrete Type: Integer
Range: >#0..
Cardinality: 1..1
For content in the International Release, this attribute value should represent the total number of discrete active ingredients, excluding modifications or subtypes.
Attribute:
Count of active ingredient
Concrete Type: Integer
Range: >#0..
Cardinality: 0..1
The following sections apply to the vaccine product concepts in the |Medicinal product (product)| hierarchy in the International Release. In the International Release, vaccine products are those concepts with |Plays role (attribute) = |Active immunity stimulant role (role)|.
See also the relevant section in Substances on .
The "Vaccine product containing" concept is an abstract representation of the active ingredient(s) in a vaccine product. It means that the vaccine product must contain the active ingredient(s) specified in the FSN but may also contain a modification of the active ingredient(s) specified in the FSN or may contain additional active ingredient(s).
For example,
836374004 |Vaccine product containing Hepatitis B virus antigen (medicinal product)|
836389008 |Vaccine product containing Vaccinia virus antigen (medicinal product)|
Both "Vaccine product containing" and "Vaccine product containing only" concepts may be created for products that only have one active ingredient.
For example,
836374004 |Vaccine product containing Hepatitis B virus antigen (medicinal product)|
871822003 |Vaccine product containing only Hepatitis B virus antigen (medicinal product)|
"Vaccine product containing" concepts are not created for multiple ingredient vaccine products.
"Vaccine product containing only" concepts are created for multiple ingredient vaccine products.
In the naming patterns below, align naming and case sensitivity with the PT for the concept that is selected as the attribute value for the 127489000 |Has active ingredient (attribute)|.
For multiple ingredient vaccine products, the active ingredients must be listed in alphabetical order, separated by the word "and", and the word "antigen" will be omitted.
For concepts where all active ingredients are a virus, the word "virus" may be omitted and added before "antigens".
Vaccine product containing <active ingredient PT> (medicinal product)
For example,
Vaccine product containing Hepatitis B virus antigen (medicinal product)
Vaccine product containing Haemophilus influenzae type B antigen (medicinal product)
<Active ingredient PT>-containing vaccine product
For example,
Hepatitis B virus antigen-containing vaccine product
Haemophilus influenzae type B antigen-containing product
Synonyms matching the FSN are not required.
Synonyms corresponding to the disorder that is the target of the vaccine are not allowed; they may be applied to the "Vaccine product containing only" concepts.
Stated parent concept
763158003 |Medicinal product (product)
Semantic tag
(medicinal product)
Definition status
Defined
Attribute:
Has active ingredient
Range: <105590001 |Substance (substance) excluding concepts representing structural groupers, dispositions, or combined substances
Cardinality: 1..*
While the allowed range is broader, "Vaccine product containing" concepts in the International Release should have one and only one |Has active ingredient| attribute.
For content in the International Release, this attribute value should represent the organism antigen, not a modification or subtype, unless explicitly identified as an exception.
Exceptions: Vaccine product containing concepts for the following substance subtypes are included (to support vaccination certificates):
161000221102 |Antigen of Corynebacterium diphtheriae toxoid (substance)|
551000221106 |Antigen of Clostridium tetani toxoid (substance)|
Attribute:
Plays role
Range: <<766940004 |Role (role)|
Cardinality: 0..*
While the allowed range is broader, "Vaccine product containing" concepts should have one and only one |Plays role| attribute with attribute value = 318331000221102 |Active immunity stimulant therapeutic role (role)|.
