FOI release

FOI Outcomes and results from trials on the Nobivac Lepto 4 canine vaccination

Published 19 August 2025

Request ATI1069

All available outcomes and results from trials on the Nobivac Lepto 4 canine vaccine to include:

• All Nobivac Lepto 4 canine vaccine in vivo safety trials and efficacy results
• All Nobivac Lepto 4 canine vaccine field trial outcomes and results
• All Nobivac Lepto 4 canine vaccine early phase trial outcome and results
• All Nobivac Lepto 4 canine vaccine later phase trial outcomes and results
• All Nobivac Lepto 4 canine vaccine safety testing trial outcome and results
• All Nobivac Lepto 4 canine vaccine international trial outcomes and results.

The entire list of Veterinary Adverse Events that have been reported following Lepto 4 canine vaccination.

Our reply

Nobivac L4 was originally authorised in 2012 via the European Centralised Procedure prior to Brexit and converted to a Great Britain authorisation in 2021. The public assessment report is available on the EMA’s Union Product Database and provides an overview of the assessment conducted for Marketing Authorisation, including the evaluation of quality, safety, efficacy, and benefit risk balance of the vaccine. This includes an overview of the preclinical and clinical safety and efficacy studies.

The proprietary data from trials carried out during the development of Nobivac L4 are commercially sensitive information. We judge that the Section 43 exemption of the Freedom of Information Act, information that constitutes a trade secret or would, or would be likely to, prejudice commercial interests, applies in this case. After careful consideration we conclude that the public interest in withholding the information strongly outweighs that for disclosure.

In relation to the request for the entire list of Veterinary Adverse Events that have been reported following Lepto 4 canine vaccination, we want to be as open as possible in answering requests. However, we believe that your request is potentially very broad and gathering the information together could involve a diversion of resources from our other work. We have refused this request as you currently frame it under Section 12(1) of the FOIA because we estimate that the cost of complying with the request would exceed the appropriate limit, which currently stands at £600. This is because the specifics of adverse events are submitted within a narrative section of the submission and may contain the original words of the reporter, which are later coded into standardised terms. It would require manually checking multiple reports spanning the life of the product to capture an ‘entire list’ of all terms reported to us.

But we do want to help you obtain the information you are looking for if we can. If you were to make a new request for a narrower category of information, it may be that we could comply with that request within the appropriate limit, although I cannot guarantee that this will be the case.

In reframing your request, it would help to narrow the list by specifying a particular type of adverse events and/or narrow the timeframe. For example, you could request a list of adverse events coded to Preferred Term (PT) level as per VeDDRA (VeDDRA (Veterinary Dictionary for Drug Regulatory Activities)). The list of PTs is likely to include events that have occurred within reports where more than one product was used (including events which may have occurred before one or more L4 vaccines were administered), when the product was used off-label, that is using a medicine in a way that is not specified on the product’s label, or reports where, on further evaluation, there may have been other reasons for the adverse event(s) occurring.