Supply of Classical Swine Fever (CSF) Vaccine

Description

The Authority is seeking to identify existing and potential suppliers of Classical Swine Fever vaccine who have products with robust evidence of quality, safety, and efficacy. We are keen to hear from suppliers who are in a position to supply suitable Classical Swine Fever vaccine products to the UK vaccine bank as early as March 2025.<br/><br/>The Authority is specifically interested in:<br/>• Vaccines against Classical Swine Fever.<br/>• The efficacy and period (onset and duration) of immunity in pigs (Suids). <br/>• Safety data in pigs (Suids).<br/>• The proposed number of doses in the vaccination schedule.<br/>• Storage conditions.<br/>• Any information that might be provided about potential cost.<br/>• Whether the vaccine is or will be manufactured under the conditions of Good Manufacturing Practice (GMP).<br/>• Whether quality aspects are considered such that the vaccine is manufactured and stored according to the WOAH Terrestrial Manual Chapter 3.9.3. <br/>• Whether the product has DIVA capabilities.<br/>• Whether the vaccine can be used in wildlife.<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 options for supply of vaccines to the UK Classical Swine Fever Vaccine Bank, for delivery by 28 March 2025. If a decision is taken to renew the vaccine bank for CSF, vaccine products must be available for use by the Authority from the commencement of any contract, either as an authorised product or for emergency use under Schedule 4 of the Veterinary Medicines Regulations 2013 (as amended). This could be as early as April 2025. The Authority will consider products which have good evidence of quality, safety, and efficacy.<br/><br/>The Authority is interested in:<br/>• The details of CSF vaccine products.<br/>• Number and size of dose.<br/>• Data on safety and efficacy.<br/>• Data on the onset and duration of immunity.<br/>• Storage conditions and bottle sizes available.<br/>• The type of technology used to develop the vaccine.<br/>• Production capacity.<br/>• Species that can be vaccinated and any data on the minimum age that animals can be vaccinated.<br/>• Whether the vaccine is produced to GMP standard.<br/>• Whether the vaccine is manufactured and stored according to the WOAH Terrestrial Manual Chapter 3.9.3. <br/>• Whether the vaccine is currently authorised for use with a valid marketing authorisation, and if so where is the vaccine authorised.<br/>• Whether the vaccine has been used elsewhere in the world under permit rather than as an authorised vaccine.<br/>• Whether the vaccine has DIVA capabilities.<br/>• Whether it can be used in wildlife and whether different formulations for use in baits are available.<br/>• Timelines for submitting applications for a marketing authorisation to VMD (if relevant).<br/>• The likely cost of the product. 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 Contracts 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 Melanie Swain (melanie.swain@defra.gov.uk) by the 23rd August 2024 to inform our strategy development.