FOI release

FOI2025/00399 - Canine Leptospira L4 vaccines adverse events

Published 19 March 2026

Your request

For the period 1 January 2021 to 31 December 2024, please provide the following information relating to canine Leptospira L4 vaccines authorised for use in Great Britain, specifically:
  *   Eurican L4
  *   Nobivac L4
  *   Versican L4 / Versican Plus L4
1. Suspected adverse event reports
For each product listed above, please provide:
  *   The total number of suspected adverse event reports received by the VMD in dogs
  *   A breakdown of those reports by seriousness (serious vs non-serious, as defined by VMD)
  *   Where available, a breakdown by reaction category (e.g. hypersensitivity/anaphylaxis, immune-mediated disorders, injection-site reactions, systemic signs)

1. Exposure data
   For the same period and products, please provide either:
     *   The number of doses sold or supplied in Great Britain, or
     *   If exact figures cannot be disclosed, exposure bands or indexed exposure values sufficient to allow comparison of reporting rates between products.

2. Reporting rates
   If available, please provide any VMD-calculated reporting rates (e.g. reports per 10,000 doses sold) for these products during the same period.
   If any part of this request cannot be fulfilled due to commercial sensitivity, I would be grateful if partial disclosure could be provided, including relative or normalised comparisons between products.
   I am content to receive the data in tabular form and understand that all reports represent suspected adverse events and not confirmed causality.

Our reply

Nobivac L4, Eurican L4 and Versican Plus L4 are veterinary medicinal products (VMP) containing 4 serovars of leptosira, for use in dogs. Further details on these VMPs can be located on the VMD’s Product Information Database: https://www.vmd.defra.gov.uk/ProductInformationDatabase

The data provided below are not subject to independent verification and the VMD does not guarantee their accuracy. The figures are based on adverse events submitted to the VMD for the purposes of pharmacovigilance. VMD databases change over time as new and follow-up information is constantly being received and reviewed. 

The data below includes adverse event reports: 

• where an adverse event has occurred that is already listed on the Summary of Product Characteristics
• 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 prescribing cascade
• 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.

Duplicate reports are combined, however if there is doubt as to whether two reports are true duplicates then both reports will be included.

Seriousness classification in VMD’s database is based on the internationally recognised VICH definition and guidance, referred to in our VMD guidance. The VICH definition of a serious adverse event, as per VICH GL24 is: “any adverse event which results in death, is life-threatening, results in persistent or significant disability/incapacity, or a congenital anomaly or birth defect. For animals managed as a group only an increased incidence of serious adverse events as defined above exceeding the rates normally expected in that particular group is considered a serious adverse event.” All adverse events are included in VMD’s pharmacovigilance activities, regardless of seriousness classification

Evaluation is dependent on the accuracy and quality of data received from veterinary professionals and animal owners, and reporting frequency can vary over time (reporting frequency may be affected by a product being new to the market or social media interest, for example). 

The VMD are unable to provide the sales data for individual products as this is commercially sensitive, however the VMD have provided the reporting rates so that comparisons between the products can be made. Reporting rates are based on incidence calculations, details of how the VMD performs these calculations are located here: Calculation of adverse event incidence for veterinary medicines - GOV.UK

For the period of time requested (1st January 2021 to 31st December 2024):

Product	Total number of UK adverse event reports received by the VMD in dogs for 01 JAN 2021 to 31 DEC 2024	Total number of UK serious adverse event reports for 01 JAN 2021 to 31 DEC 2024	Total number of UK non-serious adverse event reports for 01 JAN 2021 to 31 DEC 2024	Reporting rates e.g. reports per 10,000 doses sold for these products in the UK during the same period
Eurican L4	0*	0*	0*	0 (no sales)*
Nobivac L4	4255	1503	2752	Less than 3 reports per 10,000 doses sold
Versican Plus L4	Full data not available**	Full data not available**	Full data not available**	Full data not available**

*For Eurican L4, this was authorised on 02/06/2023, therefore there are no UK sales or adverse events prior to this date. Between 02/06/2023 and 31/12/2024 there were no adverse events and no sales.

**For Versican Plus L4, the VMD only hold the full data (sales and all adverse event reports) from 1st January 2021 to 31st July 2022. Prior to 17th May 2024, non-serious adverse event reports from Marketing Authorisation Holders (MAHs) did not have to be submitted electronically but could instead be submitted within Periodic Safety Update Reports (PSURs), these were submitted at regular intervals depending on the individual product. Following the changes to the Veterinary Medicines Regulations in 2024, from 17th May 2024 all MAHs have been required to submit all adverse event reports, both serious and non-serious, electronically within 30 days of awareness. During this current transition period, backlogs of adverse event reports not previously submitted via PSUR or electronically are continuing to be submitted by MAHs.

The VMD holds complete adverse event data and sales data for Versican Plus L4 for the period of time from 1st January 2021 to 31st July 2022. For this period there were 6 adverse event reports, 3 of which were non-serious and 3 were serious. Based on this number of reports and the sales data for the corresponding time period (i.e. 1st January 2021 to 31st July 2022), the calculated reporting rate was less than 2 reports per 10,000 doses sold. However be aware that the sales data is provided divided per year, and therefore to calculate the sales data for the partial year of 2022, the VMD divided the total sales for that year by 12 and then multiplied by 7 (for the 7 months of 2022 that VMD holds complete adverse event report data for). The use of this approach may affect the final figure provided.

Regarding your request for a breakdown by reaction category, all adverse events submitted to the VMD have their clinical signs coded using the Veterinary Dictionary for Drug Regulatory Activities (VeDDRA).  Below is the number of adverse event reports detailed in the table broken down by System Organ Class (SOC), which is a hierarchical level of VeDDRA for the grouping of clinical signs. Further information regarding VeDDRA can be located on the European Medicines Agency website, including the VeDDRA list of clinical terms for reporting suspected adverse events and the Guidance notes on the use of VeDDRA terminology. There might be multiple SOCs per report and if one report has multiple signs that fit one SOC, the SOC will appear multiple times in that report. Therefore, the total number of reports containing a particular SOC will be higher than the total number of reports.

Eurican L4- no reports therefore no SOC breakdown provided.

Versican Plus L4- breakdown of reports by SOC, for 1st January 2021 to 31st July 2022

SOC	Number of reports
Immune system disorders	4
Systemic disorders	4
Application site disorders	4
Cardio-vascular system disorders	1
Digestive tract disorders	1
Investigations	1
Neurological disorders	1
Skin and appendages disorders	1

Nobivac L4- breakdown of reports by SOC, for 1st January 2021 to 31st December 2024

SOC	Number of reports
Systemic disorders	5508
Investigations	2717
Digestive tract disorders	2294
Neurological disorders	1588
Immune system disorders	1199
Application site disorders	1189
Respiratory tract disorders	1133
Behavioural disorders	962
Skin and appendages disorders	839
Musculoskeletal disorders	681
Eye disorders	450
Cardio-vascular system disorders	406
Blood and lymphatic system disorders	166
Ear and labyrinth disorders	157
Renal and urinary disorders	147
Other event	66
Hepato-biliary disorders	56
Reproductive system disorders	40
Medication and product use errors	38
Neoplasia	22
Endocrine system disorders	14
Mammary gland disorders	6
Metabolism and nutrition disorders	4

Although adverse event report information can be useful to provide a general overview of a 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.  

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 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. The VMD continually assess and update our findings relating to products used within the United Kingdom and should there be sufficient data to suggest that an SPC requires alteration or that another appropriate action is required, this will be carried out within the required timeframe, as set out by the current legislation surrounding that veterinary medicinal product or region.   

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.