FOI release

FOI - Adverse events in Australian Shepherd dogs to Versican L4 vaccinations

Published 19 November 2025

ATI1105 Request

Information request, to send me information regarding adverse events in Australian Shepherd dogs to Versican L4 vaccinations and how this compares to adverse events to vanguard 7 (L2) in this breed. If possible, it would be interesting to know if there is any evidence to support an increase risk of adverse events in Australian Shepherds compared to other breeds to L4 vaccination.

Our reply

All medicines whether for human or animal use come with risk, and the benefits of use in wider populations need to outweigh the potential risks. Information on adverse events that have been known to occur following administration of a particular product are summarised in sections 3.6/4.6 of the Summary of Product Characteristics (SPC). The SPC is a document describing the properties and the officially approved conditions of use of a medicine. The SPC and associated product information are updated as new information is available, and the latest version of an SPC can be found on our publicly available Product Information Database. It is important for veterinary professionals to ensure that this information is reviewed, and any risks discussed with the animal owner or keeper, prior to administering the product. A rolling 6-month list of Summary of Product Characteristic (SPC) changes for veterinary medicines can be found on the monthly medicines update page Vet practice & supply.

Pharmacovigilance updates are published on gov.uk at https://www.gov.uk/guidance/urgent-safety-updates-for-veterinary-medicines; this also includes any updates involving non-veterinary medicines used in animals. To receive these pharmacovigilance updates via email, please click on the ‘Get emails about this page’ button.

In our database, there are three recorded cases associated with Versican Plus Lepto 4, and seven cases associated with Vanguard 7 (L2) in Australian Shepherd Dogs. Some of these data were retrieved from our historical records, where not all reports specified breed, which may influence the accuracy of the results.

Our database shows no evidence of an increased risk of adverse events in Australian Shephard Dogs following a Lepto 4 vaccination, compared with other breeds. However, differences in breed population sizes may influence the number of adverse event reports per breed.

The information above includes all adverse event reports. The number of adverse event reports includes reports:

• where more than one product was used

• when the product was used off-label, that is using a medicine in a way that is not specified on the product’s label, including prescribing of unauthorised medicines following the cascade

• where the reporters, medical professionals or MAH did not consider an association between the product administration and the adverse event to be likely

• where, on further evaluation, there were other reasons for the adverse event occurring such as underlying illnesses or an alternative cause for the clinical signs seen

Evaluation of adverse event reports is dependent on the accuracy and quality of data received within adverse event reports from veterinary professionals and animal owners.

Although adverse event report information can be useful to provide a general overview of a veterinary medicinal product (VMP), it is important for any clinical decisions regarding the use of a VMP to be based on a risk/benefit discussion specific to the animal or group of animals being administered the VMP. An overall frequency of an adverse event occurring for a VMP does not reflect the actual risk for an individual animal, as there are many individual factors that may contribute to the likelihood of an adverse event occurring.

Data published by the VMD are not subject to independent verification and the VMD does not guarantee their accuracy. Figures may be different to those provided by different regulatory authorities, pharmaceutical companies, and other authorities within the United Kingdom.