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

Descriptions

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.We are specifically interested in: o the types of inactivated or novel (e.g. RNA) EHDV-8 vaccine being developed.o the efficacy and period (onset and duration) of immunity they might offer.o which species they are being developed foro whether the vaccine is DIVAo available safety data in the target specieso the proposed number of doses in the vaccination schedule, o storage conditionso readiness to submit the necessary information to the Veterinary Medicines Directorateo the extent to which the UK livestock sector could be supplied with such product in 2025 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). o The Authority will not be considering live EHDV vaccines. 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.