SBRI: Vaccine development for potential epidemic diseases stage 1

Overview

This is a Small Business Research Initiative (SBRI), Official Development Assistance (ODA) competition funded by the Department of Health and Social Care (DHSC) UK Vaccine Network.

Scope

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 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

You must note that the milestone for the business case and the technical plan is different and additional to the technical project summary. Applications developing standalone assays that are unrelated to specific vaccine development projects are not required to complete a business case and technical plan.

Business case and technical plan

You must read the additional guidance document to help you understand:

what is needed in your business case and technical plan
what you need to consider in your business case and technical plan to ensure that the assessors can complete their review
what we will review in your business case and technical plans as part of the selection process for Stage 2 funding
information needed to further support the independent technical review of projects seeking Stage 2 funding
timelines and the process for project selection of this 2-stage SBRI

Specific Themes

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

Stage 1: Initial technical development

This means planned research or critical investigation to gain new knowledge and for the development of new vaccine candidates or technologies and platforms.

In phase 1 the supplier:

can deliver distinct packages of work to further develop their vaccine candidate or technology
will complete and submit a business case and technical plan that includes technical data generated to date, of how the vaccine candidate platform or technologies will be developed in Phase 2 (estimated to be 3 years) and post contract development plans, no later than month 12 of your project
must add details of what should be considered in the plan, although this might vary depending on the product being developed
can resubmit a revised business case and technical plan no later than month 19 of your project

Stage 2: Advancing further technical development

This means further planned research or critical investigation, based on the outputs of the technical phase I. This is to gain new knowledge and data to further develop the technical solution including technical phase 1 clinical trials in Target populations.

Eligibility

Projects must:

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

Lead Applicant

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

More information on the different types of organisation can be found in the Official Development Assistance (ODA) Funding rules.

This competition will not fund any procurement, commercial, business development or supply chain activity with any Russian or Belarusian entity as lead or subcontractor. This includes any goods or services originating from a Russian or Belarusian source.

Contracts will be awarded to a single legal entity only. However, if you can justify subcontracting components of the work, you can engage specialists or advisers. This work will still be the responsibility of the main contractor.

Exclusions

Innovate UK will not fund projects that:

do not include complete pre-clinical, clinical, regulatory or manufacturing work packages delivered to the appropriate time, cost and GxP standards
do not have appropriate industrial expertise and commercial insight in project design
have entered funding which is not GBP sterling
focus on pathogens outside the specified priority families or Disease X
cannot be undertaken within the working restrictions of coronavirus (COVID 19)
duplicate other UK government work you have already been funded to deliver
duplicate existing innovation, or work in progress by others
are not Official Development Assistance (ODA) compliant
do not demonstrate how project outputs are likely to be of primary benefit to populations in ODA eligible countries
have total eligible project costs over the amount allowed
have not considered ethical and regulatory implications and requirements.
do not have a dedicated project manager

Innovate UK may withdraw funding from projects that do not submit a suitable business case and technical plan. This milestone must occur before month 12 of the project. Applications developing standalone assays that are unrelated to specific vaccine development projects are not required to complete a business case and technical plan.

Innovate UK cannot fund projects that are:

dependent on export performance, for example giving a subsidy to a baker on the condition that it exports a certain quantity of bread to another country
dependent on domestic inputs usage, for example giving a subsidy to a baker on the condition that it uses 50% UK flour in their product

Funding Costs

A total of up to £25 million, inclusive of VAT, is allocated to this SBRI stage 1 competition.

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

ODA funding may be subject to unavoidable changes in value or availability. These changes may potentially be communicated at short notice.

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.

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 total funding available for the competition can change. The funders have the right to:

redefine the funding available
adjust the provisional funding allocations between the stages
apply a ‘portfolio’ approach
in exceptional circumstances withdraw the funding, redefine the individual funding awards or terminate projects before the planned end date

The contract is completed at the end of stage 1. Successful applicants from stage 1, who have had their business case and technical plan approved will be invited into stage 2.

Applications developing standalone assays that are unrelated to specific vaccine development projects are not required to complete a business case and technical plan.

Projects whose business case and technical plan requires improvement, will only be invited into SBRI stage 2, if these are modified and approved before the stage 2 competition process begins.

Value Added Tax (VAT)

You must select whether you are VAT registered before entering your project costs.

VAT is the responsibility of the invoicing business. We will not provide any further advice and suggest you seek independent advice from HMRC.

VAT registered

If you select you are VAT registered, you must enter your project costs exclusive of VAT. As part of the application process VAT will be automatically calculated and added to your project cost total. Your total project costs inclusive of VAT must not exceed £2 million.

Not VAT registered

If you select you are not VAT registered, you must enter your project costs exclusive of VAT and no VAT will be added. You will not be able to increase total project costs to cover VAT later should you become VAT registered. Your total project costs must not exceed £2 million.

Research and development

Your application must have at least 50% of the contract value attributed directly and exclusively to R&D services, including solution exploration and design. R&D can also include prototyping and field-testing the product or service. This lets you incorporate the results of your exploration and design and demonstrate that you can produce in quantity to acceptable quality standards.

R&D does not include:

commercial development activities such as quantity production
supply to establish commercial viability or to recover R&D costs
integration, customisation or incremental adaptations and improvements to existing products or processes

Innovate UK competitions involve procurement of R&D services at a fair market value and are not subject to subsidy control criteria that typically apply to grant funding.

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