Supply of Epizootic Haemorrhagic Disease Serotype 8 (EHDV-8) Vaccine

The Authority is seeking to identify existing and potential suppliers of Epizootic Haemorrhagic Disease Serotype 8 (EHDV-8) vaccine who have product currently under development. We are keen to understand the timelines for applications to the Veterinary Medicines Directorate (VMD) for a marketing authorisation or emergency use consideration under Schedule 4 of the Veterinary Medicine Regulations 2013, as well as for production timescales for any product to be made available to the UK market.<br/><br/>We are specifically interested in: <br/>o the types of inactivated or novel (e.g. RNA) EHDV-8 vaccine being developed.<br/>o the efficacy and period (onset and duration) of immunity they might offer.<br/>o which species they are being developed for<br/>o whether the vaccine is DIVA<br/>o available safety data in the target species<br/>o the proposed number of doses in the vaccination schedule, <br/>o storage conditions<br/>o readiness to submit the necessary information to the Veterinary Medicines Directorate<br/>o the extent to which the UK livestock sector could be supplied with such product in 2025 <br/>o any information that might be provided about potential costs; any expectations around the vaccines being manufactured under the conditions of Good Manufacturing Practice (GMP). <br/>o The Authority will not be considering live EHDV vaccines. <br/><br/>The Authority is seeking this information to inform decisions around guarantees of supply to the UK market. An estimated total value is therefore not provided at this stage.