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

Tender description

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. Lot 1: The Authority is exploring the status of EHDV-8 products that have the potential to be available for use in 2025 (either as an authorised product or emergency use under Schedule 4) to help to inform our control strategy for EHD and consideration as to whether government intervention is required to facilitate access to the UK livestock sector of any product that may become available. <br/><br/>EHDV-8 was identified in for the first time in southern Europe in November 2022. It is not currently present in the UK. While there is no evidence of circulation currently, we expect a continued threat of incursion as EHD could also spread to the UK if infected live animals, or their germinal products, are imported from countries where EHD is circulating. It is widely accepted that access to vaccine will be an important tool to protect the health and welfare of susceptible species and for livestock keepers for whom trade in live animals is important. <br/><br/>The Authority is interested in:<br/> the details of any suitable products currently under development <br/> the extent of developments<br/> safety and efficacy testing, timelines for submitting applications for marketing authorisation to the VMD.<br/> the type of technology used to develop the vaccine, production capacity (current and forecast)<br/> whether the specific vaccine is authorised elsewhere in the world or based on an already authorised EHDV vaccine. <br/> whether products under development will be monovalent or multivalent and which serotypes would be included in multivalent products. <br/> We are also interested to understand the likely wholesale and retail costs of any product likely to be available. Additional information: This Prior Information Notice is not a call for competition. It should be noted that this PIN invites individuals and organisations to express an interest only, and although it is not part of a formal pre-qualification process it may be used to inform discussions with vaccine suppliers. <br/><br/>You will need to express your interest in any potential future tender opportunity once/if a contract notice is published in Find a Tender and on Contract Finder. It should be noted that this PIN invites individuals and organisations to express an interest only. Those wishing to provide information requested here should contact Louise Moizer (louise.moizer@defra.gov.uk), by the end of March 2025 to inform our strategy development.