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Guidance: General licence for bluetongue serotype 3 (BTV-3) vaccine

Veterinary Medicines Directorate

September 26
15:34 2024

Defras Secretary of State has permitted the use of 3 unauthorised bluetongue serotype 3 (BTV-3) vaccines within the United Kingdom, subject to licence.

Although these vaccines are not authorised, the Veterinary Medicines Directorate (VMD) has assessed them. They consider the vaccines to be of a consistent quality and safety, and to demonstrate consistent efficacy. Therefore, they meet the administration criteria under Schedule 4 of the Veterinary Medicine Regulations 2013 (VMR 2013).

Unlike the authorised vaccines for other BTV serotypes, the BTV-3 vaccines claim to reduce viraemia rather than prevent it. This means they may not prevent your animals from being infected or infectious, but (depending on the vaccine) their claims include reduction or prevention of clinical signs experienced or mortality.

For this reason, all movement controls and trade restrictions still apply to vaccinated animals. You should not test vaccinated animals as part of a pre-movement test in bluetongue zones until 7 days after their vaccination. This will prevent interference with BTV-3 monitoring.

The general and specific licences only allow vaccination in England. Scotland, Wales and Northern Ireland have not licensed the use of vaccination for BTV-3 but will keep this position under review.

Discuss the merits of vaccination for your animals and business with your private veterinarian.

Animal keepers not in a high-risk county should apply for a specific licence (not a general licence), through Animal and Plant Health Agency (APHA). Check if youre in a high-risk county with the interactive bluetongue virus map.

Veterinarians should read theadvisory notebefore prescribing any BTV-3 vaccine.

The general licence allows the use of BTV-3 vaccines in England only. Governments in Scotland, Wales and Northern Ireland have not licensed the use of vaccination for BTV-3 but will keep this position under review.

Reporting your use of BTV-3 vaccinations

You must report your use of the BTV-3 vaccine as a condition of this licence.

Complete the vaccine reporting form within 48 hours of the date of vaccination.

This will meet your legal requirement under condition 3 of the general licence.

Updates to this page

Published 16 September 2024
Last updated 26 September 2024 +show all updates
  1. You must report your vaccine activity. Information and a reporting form for this task has been added to the page.

  2. Link to the advisory note for veterinarians has been fixed.

  3. First published.

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