SBRI: Vaccine development for potential epidemic diseases stage 1

To lead a project, you can:

• be an organisation of any size
• work alone or with others from business, research organisations, research and technology organisations or the third sector as subcontractors

Stage 1 projects must:

• start by 1 October 2023
• end by 31 September 2025
• last up to 24 months
• be costed in GBP sterling

Stage 1 Research and Development contracts will be up to £2 million, inclusive of VAT, for each project, for up to 24 months. We expect to fund up to 30 projects.

Your stage 1 project must:

• show that you have the required expertise to complete any pre-clinical, clinical or manufacturing work packages to the appropriate time, cost and GxP standards
• have vaccine candidates, platforms and technologies addressing a pathogen in the specified area or Disease X
• describe the candidate vaccines, platforms, technologies, manufacturing technology or supporting research for future vaccine deployment you intend to develop, explaining its relevance to epidemic disease threats, anticipated clinical application and medical value
• demonstrate how the vaccine candidates, platforms, technologies and manufacturing technologies primarily impact and are beneficial to populations in LMICs
• describe how the product or capability would be used, where and by whom, and the impact this is likely to have
• give evidence that the technologies or models are appropriate and fit for purpose
• have a defined and justified intended use
• be Official Development Assistance (ODA) compliant, meaning your project can be carried out in high-income countries, but the primary aim of the research must be to improve the health, welfare or economic development of countries on the Organisation for Economic Co-operation and Development’s OECD Development Assistance Committee (DAC) list
• include a milestone for submission of a full business case and technical plan for stage 2, this must be completed no later than month 12 of your project

Up to £30 million may be available for stage 2 projects, for costs of a maximum of £5 million inclusive of VAT, for each project, for up to 3 years.

The aim of this competition is to support further development of vaccine candidates, technologies and platforms against identified pathogens of epidemic potential, including Disease X.

This is to progress vaccines towards clinical development and ultimately regulatory approval, to decrease the likelihood of an epidemic outbreak in low and middle-income (LMIC) countries.

This funding is ODA and subject to ODA principles and must benefit low to middle income countries (LMIC)

In stage 1, your project can carry out any distinct work packages that address any part of phase 1 clinical trials, pre-clinical, non-clinical or manufacturing process design.

The UK Vaccine Network has identified priority pathogens in twelve priority viral and bacterial families. Applications for work on other pathogens within these priority families will be considered, as will technology targeting an unknown Disease X. Applications for work on pathogens outside the priority families will not be considered. Vaccine candidates or technologies must target Disease X, or one of the diseases of epidemic potential identified by the UK Vaccine Network (UKVN).

Twelve pathogen families of infectious agents for investment have been prioritised by the UK Vaccine Network Project. Within each priority family, the group has recommended the following priority or exemplar pathogens for which there is an unmet vaccine need as a focus of funding:

Priority pathogen list: viruses

Priority families : Exemplar pathogens

• Arenaviridae: Lassa fever virus
• Coronaviridae: Middle East respiratory syndrome (MERS)
• Filoviridae: Marburg virus, Sudan ebolavirus
• Flaviridae: Zika virus
• Hantaviridae: Hantaan virus
• Nairoviridae: Crimean Congo Hemorrhagic Fever (CCHF) virus
• Paramyxoviridae: Nipah virus
• Phenuiviridae: Rift Valley Fever (RVF) virus; Dabie bandavirus (formerly severe fever with thombocytopenia syndrome virus)
• Picornaviridae: Enterovirus 68
• Togaviridae: Chikungunya virus

Priority pathogen list: bacteria

Priority families: Exemplar pathogens

• Coxiellaceae: Q fever (Coxiella burnetii)
• Yersiniaceae: Plague (Yersinia pestis)

The UKVN will not fund research on individual pathogens for which there is an existing licensed vaccine, or a vaccine candidate in advanced stages of development. An exception to this is where it is within a multivalent vaccine candidate which includes pathogens for which there is no licensed vaccine.

UKVN funding will also support vaccine technology development suitable for responses to novel pathogens. These include new or newly recognised or characterised pathogens, Disease X, and known pathogens which have changed substantially and present a serious public health threat.

Applications are also acceptable for work targeting other pathogens within the priority families, where applicants can make the case for an alternative. The exception to this is any proposals for SARS-CoV-2 in the Coronavirus family, for which there are multiple licensed vaccines available, and further research will not be funded through the UKVN.

The UKVN will also not consider any proposals for funding influenza research. This reflects both the existing significant investment in this area, and that the funding would be unlikely to meet the test of ODA eligibility – which is that the primary purpose of the funding is to promote the economic development and welfare of developing countries.

You must provide a rationale if your project targets a pathogen not identified as a priority in the specified area.

Vaccine candidates can be for human use or for animal use where there is an animal reservoir of the target pathogens.

Your project can focus on, but is not restricted to, one or more of the following:

• work to create a regulatory package suitable for endorsement by the appropriate regulatory or ethical authority, for example the Medicines and Healthcare Products Regulatory Agency (MHRA) and ethics committees, to allow future work packages to start as soon as funding is available
• completion of work on pre-clinical, non-clinical and supportive assays and technologies packages to aid the transition from the laboratory to clinical trial-enabling activities
• distinct packages of work to enable vaccine substance manufacture development, clinical development, including assay development, clinical design, and production of regulatory documents
• ideas to increase technical or economic utility or acceptance of vaccines and therefore likely availability or use in LMICs
• improving acceptability or potential deployment of vaccines, including addressing barriers such as vaccine hesitancy
• phase 1 clinical trials in the UK or relevant LMIC

An online briefing event will be held on Thursday 8th June at 12 noon GMT – click here to register for a place.

An earlier briefing event was held on 31st May – a recording should be available in early June.

If you would like help to find a collaboration partner, please contact Innovate UK KTN’s Health team.