FOI - Bluetongue Virus Serotype 3 [BVT 3] Vaccine
Published 19 November 2025
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ATI1098 Request
Please provide the following records:
- A copy of the Public Assessment Report [PAR] for BVT 3 Vaccine confirming safety and efficacy. I have not been able to locate the document from the hyperlink provided by Welsh Government.
- Reference to the statute /regulations permitting use of unauthorised vaccines.
Our reply
1. A copy of the Public Assessment Report [PAR] for BVT 3 Vaccine confirming safety and efficacy. I have not been able to locate the document from the hyperlink provided by Welsh Government.
We conducted evaluations of the unauthorised Schedule 4 products (Syvazul BTV 3, Bluevac-3, Bultavo 3) and provided our advice to Defra and the Chief Veterinary Officers. UK Public Assessment Reports are not prepared by VMD for unauthorised vaccines used under Schedule 4 and the Summary of Product Characteristics for these vaccines are available at Bluetongue serotype 3 (BTV-3) vaccination - GOV.UK.
Since then, Marketing Authorisation Applications have been submitted by the vaccine manufacturers for these vaccines, we have conducted further assessments and granted Provisional Marketing Authorisations for these three products. UK PARs are published on our Product Information Database:
Bluevac-3 Suspension for Injection for Sheep and Cattle (04/04/25 – MA 30824/5002). The Public assessment Report is available at: https://www.vmd.defra.gov.uk/ProductInformationDatabase/product/A014065
Bultavo 3 Suspension for Injection for Sheep and Cattle (04/04/25 – MA 08327/5048). The Public Assessment Report is available at: https://www.vmd.defra.gov.uk/ProductInformationDatabase/product/A014064
Syvazul BTV 3 Suspension for Injection for Sheep and Cattle (19/06/25 – MA 31592/5006). The Public Assessment Report will be published in due course, likely to be by the end November.
2. Reference to the statute /regulations permitting use of unauthorised vaccines.
The Veterinary Medicines Regulations, as amended, Sch. 4, para. 4 provides that: In the event of serious epizootic diseases or emerging diseases the Secretary of State may permit in writing the administration of immunological veterinary medicinal products without a marketing authorisation, in the absence of a suitable medicinal product and may publicise any permit as the Secretary of State sees fit.