Supply of Bluetongue Serotype 3 (BTV-3) Vaccine

Description

The Authority is seeking to identify existing and potential suppliers of bluetongue serotype 3 (BTV-3) 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 for 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/>The Authority is specifically interested in:<br/>- the types of inactivated or novel (e.g. RNA) BTV-3 vaccine being developed.<br/>- the efficacy and period (onset and duration) of immunity they might offer.<br/>- which species they are being developed for<br/>- available safety data in the target species<br/>- the proposed number of doses in the vaccination schedule, <br/>- storage conditions<br/>- readiness to submit the necessary information to the Veterinary Medicines Directorate<br/>- the extent to which the UK livestock sector could be supplied with such product in 2024 or 2025 <br/>- 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/><br/>The Authority will not be considering live bluetongue 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 BTV-3 vaccine products that have the potential to be available for use in 2024 or 2025 (either as an authorised product or emergency use under Schedule 4) to help to inform our control strategy for bluetongue 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/>BTV-3 was identified in northern Europe in September 2023 and the UK had its first cases of BTV-3 in November 2023, most likely from plumes of infected midges blown over from the continent. While there is no evidence of circulation currently, we expect a continued threat of incursion as weather conditions become more favourable to vector activity and virus reproduction. 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 aware that other serotypes of BTV are circulating in Northern Europe, particularly BTV-4 and BTV-8 and so information on any multivalent BTV-3 vaccines that also contain other serotypes would be of interest. <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 BTV vaccine. <br/>- whether products under development will be monovalent or multivalent and which serotypes would be included in multivalent products. <br/><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 (PIN) 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 May to inform our strategy development.