This content is current only at the time of printing. This document was printed on 6 December 2016. A current copy is located at http://apvma.gov.au/node/15786
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Summary of adverse experience reports made to the APVMA about Hendra virus vaccine
The information presented below is collected by the Adverse Experience Program (AERP) of the APVMA as part of its ongoing surveillance of the registered product.
How the APVMA classifies an adverse experience
The APVMA makes an independent assessment about the causal relationship between exposure to or use of a product and a reported adverse experience—the likelihood that the product was involved in causing the adverse experience. The outcome of the assessment is a four-tiered classification of probable, possible, unlikely or unknown.
The following table presents the number of APVMA classified reports grouped in time periods in which the adverse events occurred.
Number of equine reports classified by the APVMA to 30 June 2016 (grouped by the year of reaction)
|1 January—30 June 2016||39||20||2||7||16||84|
* Please note that as the APVMA continues to classify adverse reports received, the individual figures in the above table may also continue to rise, depending on the date of the adverse event and the date of its classification.
What do the classifications mean?
A ‘probable’ classification is given when there is a reasonable association between exposure to a product and the onset of the reported adverse experience, and the description of the presenting signs is consistent (or plausible) with the known pharmacology and toxicology of the product and there are no other alternative explanations.
A ‘possible’ classification is given when there is a reasonable association between the exposure to the product and the onset of the reported adverse experience. Therefore, it is reasonable to include the adverse reaction as a differential diagnosis, and it is one of the possible explanations for the adverse experience (for example, the use of concurrent medication), or the association is reasonable but does not meet the criteria for a probable classification.
Probable or possible off-label
This classification is given as per the classifications of ‘probable’ or ‘possible’, but where there is evidence of off-label use. That is, use that is not in accordance with the label instructions approved by the APVMA.
An ‘unlikely’ classification is given when sufficient information exists to establish that the adverse experience was not likely to have been associated with a product.
Count of presenting signs: equine reports classified by the APVMA as probable and possible to 30 June 2016
The data in the table below relates to the number of reports in which a presenting sign was identified. A single report may describe a presenting sign in multiple horses. Reports reflect the count rather than the severity of presenting signs.
|Injection site reaction||579||22|
|Coat colour change||9||2|
|Site reaction (swelling)||2||0|
|Pale mucous membranes||1||1|
|Hypersensitive to stimuli||0||1|
Reaction incidence %: equine reports classified by the APVMA as probable and possible to 30 June 2016
Reaction Incidence calculated on the understanding that 440,438 doses of vaccine have been administered from launch to 30 June 2016.
Reaction Incidence % = Total number of animals where a presenting sign has been classified as probably or possibly linked to the administration of the Hendra vaccine/number of doses sold*100
The data in the table below relates to the number of horses for which a reaction has been reported that has been assigned a classification of possible or probable.
|Presenting signs||Reaction %|
|Injection site reaction||0.2|
|Coat colour change||0.003|
The following presenting signs each had a reaction incidence of <0.001%:
Aggression, dermatitis, dyspnoea, lymphadenitis, paresis, respiratory problems, abnormal breathing, facial oedema, site reaction (swelling), welts, allergy, anaphylaxis, coat discoloration, confusion, epistaxis, hypersalivation, hypersensitivity reaction, lesions, pale mucous membranes, preputial swelling, rash, abortion, anuria, atrophy, azoturia, bradycardia, colitis, conjunctivitis, constipation, eczema, fasciculation, haematoma, hepatopathy, hyperactivity, hyperaesthesia, hypersensitive to stimuli, incoordination, inflammation, laryngitis, periorbital swelling, polymyositis, scrotitis, urine (abnormal), weakness