This content is current only at the time of printing. This document was printed on 29 July 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 was collected under a mandatory reporting regime that was required as a condition of the permit authorising the supply and use of the product. A mandatory reporting regime may yield a higher reporting incidence than would be the case under a voluntary reporting arrangement.
How the APVMA classifies an adverse experience
The APVMA makes an independent assessment about the 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 classification of probable, possible, unlikely or unknown.
Number of equine reports classified by the APVMA to 31 December 2015
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 31 December 2015
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||502||17|
|Coat colour change||9||2|
|Pale mucous membranes||1||1|
|Site reaction (swelling)||2||0|
|Hypersensitive to stimuli||0||1|
Reaction incidence %: equine reports classified by the APVMA as probable and possible to 31 December 2015
Reaction Incidence calculated on the understanding that 416,267 doses of vaccine have been administered from launch to 31 December 2015.
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||0.18|
|Coat colour change||0.003|
The following presenting signs each had a reaction incidence of <0.001%:
Hives, panting, site reaction, abnormal breathing, aggression, anaphylaxis, confusion, dermatitis, dyspnoea, hypersalivation, hypersensitivity reaction, pale mucous membranes, adipsia, anuria, atrophy, azoturia, bradycardia, coat discoloration, colitis, conjunctivitis, eczema, epistaxis, facial oedema, fasciculation, haematoma, hepatopathy, hyperactivity, hyperaesthesia, hypersensitive to stimuli, inflammation, laryngitis, sesions, periorbital swelling, polymyositis, respiratory problems, site reaction (swelling), urine (abnormal), walking (difficult), welts.