Funding competition SBRI - Vaccines for epidemic diseases: Readiness for clinical development and regulatory submission

Organisations can apply for a share of up to £10M inclusive of VAT, to enhance clinical and regulatory preparedness of vaccines against diseases that have outbreak potential in a low or middle income country.

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Competition sections

Description

This is a Small Business Research Initiative (SBRI), Official Development Assistance (ODA) competition funded by the Department of Health and Social Care (DHSC). The aim of the competition is to develop further research in vaccine technologies, or vaccine platforms to address the 12 diseases identified by the UK Vaccine Network, or Disease X.

Proposals can address any part of the pre-clinical, non-clinical, manufacturing, or clinical pathway, within a 1 year time frame, making technology ready to be progressed further along the developmental pathway. Your proposals must meet ODA requirements for funding.

Applicants should consider:

  • ease and speed of manufacture
  • ease of use in low to middle income countries (LMIC) settings, for example, needle free and other modes of administration
  • temperature stability
  • single dose or a low number of boosts
  • length of protection
  • vaccine platforms that can be rapidly adapted for new or re-emerging diseases.
  • vaccines that protect against several strains of a single pathogen, or against several pathogens.

In applying to this competition, you are entering into a competitive process. This competition closes at 11am UK time on the date of the deadline.

Funding type

Procurement

Project size

Projects can range in size up to total costs of £500,000 inclusive of VAT and up to 12 months duration.

Who can apply

Your project

Projects must:

  • start on 01 April 2022
  • finish by 31 March 2023
  • last up to 12 months

Applicant

To lead a project, you can:

Contracts will be awarded only to a single legal entity.

We are looking for proposals from organisations that can demonstrate a route to market for their solution. Such organisations can subcontract work to other organisations. This work will still be the responsibility of the main contractor.

Funding

A total of up to £10 million, inclusive of VAT, is allocated for this competition.

We expect to fund up to 50 projects.

The funders have the right to:

  • adjust the provisional funding
  • apply a ‘portfolio’ approach

The total funding available for the competition will be subject to government approval of funds in the spending review for 2021-2022.

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

Subsidy Control

SBRI 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.

Your proposal

The aim of this competition is to support further development of vaccine candidates and platform technologies. This will enable them to undergo clinical development and ultimately regulatory approval.

Your project can address any part of the pre-clinical, non-clinical, manufacturing, or clinical pathway. Vaccine candidates can be for human use or for animal use where there is an animal reservoir of the target diseases. Vaccine candidates or technologies must target Disease X, or one of the following diseases of epidemic potential identified by the UK Vaccine Network:

  • Chikungunya
  • Crimean-Congo haemorrhagic fever
  • Ebola
  • Hantavirus
  • Lassa
  • Marburg
  • Middle East respiratory syndrome
  • Nipah
  • Plague
  • Q fever
  • Rift valley fever
  • Zika

Projects can include, but are not restricted to, any elements of the following:

  • work to create a regulatory package suitable for endorsement by the appropriate regulatory or ethical authority, for example the 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 drug substance and drug product manufacture development
  • distinct packages of work to enable 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 low and middle income countries (LMICs)
  • improving acceptability or potential deployment of vaccines, including addressing barriers such as vaccine hesitancy

Your proposal 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 a vaccine technology addressing one of the 12 priority diseases described by the UK Vaccine Network or Disease X
  • describe the candidate vaccine, platform technology, 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, platform 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
  • give evidence that the technologies and 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 Development Assistance Committee (DAC) list’ of ODA recipients

Research categories

Technical feasibility studies:

This means planned research or critical investigation to gain new knowledge and skills for developing new vaccines.

Projects we will not fund

We 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
  • 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
  • have total eligible project costs over the amount allowed
  • are dependent on export performance
  • are dependent on domestic inputs usage

11 October 2021
Competition opens
12 October 2021
Online information event: register to attend
13 October 2021
Online briefing event: watch the recording
10 November 2021 11:00am
Competition closes
14 January 2022
Applicants notified
1 April 2022
Contracts awarded

Before you start

By submitting an application you agree to the terms of the draft contract which is available once you start your application. The final contract will include any details you have agreed with the funding authority and will be sent to you if your application is successful. The contract is binding once the contract is returned by the applicant and signed by both parties. The terms and conditions included in the draft contract should not substantially change.

When you start an application on the Innovation Funding Service you will be prompted to create an account as the lead applicant or sign in as a representative of your organisation. You will need an account to track the progress of your application.

As the lead applicant you will be responsible for:

  • collecting the information for your application
  • representing your organisation in leading the project if your application is successful

You will be able to invite colleagues from your organisation to contribute to the application.

What happens next

Your application will be assessed by independent expert assessors. All applicants will be provided feedback.

The final portfolio of projects awarded contracts will be decided by a panel of experts and the Department of Health and Social Care (DHSC) representation.

What we will ask you

The application is split into 3 sections:

  1. Project details.
  2. Application questions.
  3. Finances.

1. Project details

These sections are not scored.

Application details

The lead applicant must complete this section. Give your project’s title, start date and duration.

Who made you aware of the competition?

Select a category to state who made you aware of the competition. You cannot choose more than one.

How long has your organisation been established for?

Select a category to state how long has your organisation been established for. You cannot choose more than one.

What is your organisation’s primary area focus?

Select a category to state your organisation’s primary focus area. You cannot choose more than one.

Equality Diversity and Inclusion

We collect and report on equality, diversity and inclusion (EDI) data to address under-representation in business innovation and ensure equality, diversity and inclusion across all our activities.

All participants must complete this EDI survey and the lead applicant must then select yes in the application question. The survey will ask you questions on your gender, age, ethnicity and disability status. You will always have the option to ‘prefer not to say’ if you do not feel comfortable sharing this information.

Project summary

Please provide a short summary of your project and describe how it meets the scope of the competition.

Describe your project briefly. Be clear about what makes it innovative and how it relates to the scope of the competition. How does it tackle different aspects of the competition?

Give details of the lead organisation. Before you submit, we expect you to have discussed your application within your own organisation and any other relevant organisations.

List any organisations you have named as subcontractors.

Your answer for this section can be up to 800 words long. This section is not scored, but we will use it to decide whether the project fits the scope of the competition. If it does not, it may be rejected.

Public description

Please provide a brief description of your project. This question is mandatory but we will not assess this content as part of your application.

Describe your project in detail, and in a way that you are happy to see published. Do not include any commercially sensitive information. If we award your project funding, we will publish this description. This could happen before you start your project. We have the right to amend the description before publication if necessary, but will consult you about any changes.

Your answer can be up to 400 words long.

2. Application questions

The assessors will score your answers to questions 2 to 8, question 1 is not scored.

Your answer to each question can be up to 400 words long. Do not include any URLs in your answers unless we have explicitly requested a link to a video.

Question 1. Applicant location (not scored)

You must state the name of your organisation along with your full registered address.

We are collecting this information to understand the geographical location of all participants of a project.

Question 2. Proposed idea or technology

You must provide a description and justification for your proposal and its intended use.

Explain how these have the potential to address the aims of the competition scope.

Describe the current state of development, validation or readiness of your solution. Including its non-clinical, pre-clinical, clinical, manufacturing and regulatory status.

Explain, if necessary, why your project includes animal studies.

You can submit a single appendix as a PDF containing images and diagrams to support your answer. It can be no larger than 10MB and up to 2 A4 pages long. The font must be legible at 100% zoom.

This question will be scored against this assessment criterion: ‘Does the proposal describe a distinct piece of work that will improve the readiness of the vaccine candidate for clinical development or regulatory submission’?

Question 3. Technical project summary

You must provide background to the main technical challenges you are looking to address.

Describe or explain:

  • how you will improve the readiness of the vaccine candidate for clinical development or regulatory submission
  • what the work package is
  • evidence for the scientific and commercial merit of the project based on previous research and development
  • the research and development within your proposal that will prove the scientific, environmental and commercial merit of the project
  • the main technical deliverables
  • what might be achieved on completion of the distinct work package and how it will increase the readiness of the developmental vaccine for future clinical development

This question will be scored against this assessment criterion: ‘How valid is the technical approach?’

Question 4. Project plan and methodology

You must describe your project plan and identify the main milestones.

The plan must be comprehensive. The emphasis throughout should be on practicality. We are seeking evidence that your project will move the vaccine along the development pathway, enhancing its readiness for future clinical development and putting it in a stronger place to obtain future funds.

You must describe or explain:

  • what resources will be needed to deliver the project
  • what the main success criteria would be
  • the main technical, commercial and environmental risks and what you will do to mitigate them
  • how you would handle any IP issues which might arise during the project

You must include project management processes that will ensure you achieve the projects milestones. This must show clear evidence that time has been built in to allow for:

  • preparation time
  • contract out work
  • availability and booking of facilities
  • any ethical and regulatory approval

If you are working with subcontractors you must explain how you will maintain freedom to operate and fulfil the IP requirements detailed in the contract.

You must upload a project plan or Gantt chart as an appendix in PDF format no larger than 10MB and up to 2 A4 pages. The font must be legible at 100% zoom.

Your milestones must:

  • be clear
  • be defined using SMART (specific, measurable, achievable, realistic and time-bound) criteria
  • be associated with the appropriate deliverables and payments
  • indicate your required payment schedule by month

This question will be assessed against these assessment criteria:

‘Does the proposal show a clear plan for completing a distinct piece of work that will advance the vaccine along the developmental pathway and help the readiness of the vaccine candidate for future clinical development and funding opportunities?

Is there a clear management plan?

What are the main technical, commercial and environmental risks to project success?

Will these be effectively managed?

Are the milestones and evaluation procedures appropriate?’

Question 5. Technical team and expertise

Provide a brief description of your technical team.

Include the expertise of each team member or subcontractor that is relevant to your proposal, outlining why they are critical to the project’s success and how much of their time will be spent on the project.

This question will be scored against this assessment criterion: ‘Does the applicant have the skills, capabilities and experience to deliver the intended benefits?’

Question 6. Costs and value for money

How much will the project cost? Demonstrate how the various work items and staff costs are appropriate and represent good value for money.

Describe or explain:

  • the total eligible project costs, inclusive of VAT, you are requesting in terms of the project goals
  • how this project represents value for money for you and the taxpayer

You can submit a single appendix as a spreadsheet no larger than 10MB and up to 2 A4 pages long to support your answer. The font must be legible at 100% zoom.

Costs quoted must reflect actual costs at a “fair market value” and not include profit.

SBRI is a procurement of R&D services. If successful, you will receive a contract to deliver the proposed activity. You will submit an invoice for the work undertaken.

If you are VAT registered, your total costs are expected to include VAT that you would charge as a service provider. VAT is the responsibility of the invoicing business, and applications are expected to list total costs inclusive of VAT.

If you are not VAT registered, then you must give your costs without VAT. You will not be able to increase invoice values to cover VAT after you have submitted an application.

We cannot provide VAT advice and advise you to seek independent advice for example from HMRC.

Full Economic Cost (FEC) calculations are not relevant for SBRI competitions. SBRI is a competitive process and applications will come from a variety of organisations. Whatever calculation you use to arrive at your total eligible project costs your application will be assessed against applications from other organisations. Bear this in mind when calculating your total eligible project costs. You can include overheads but remember that this is a competitive process.

The assessors are required to judge the application finances in terms of value for money. In other words, does the proposed cost for effort and deliverables reflect a fair market price? They will score your finances against this assessment criterion: ‘Are the budget and costs realistic, justified and appropriate for the aims and methods?’

Please note information from the finances section will be used to support the assessment of this question. Proposed costs stated in this section must match those entered in the finance summary on your application.

Question 7. User or customer engagement

Describe or explain:

  • who your potential future users or customers are in low and middle income countries (LMICs)
  • how are you working with them to understand their needs and to validate your solution development

This question will be scored against this assessment criterion: ‘How is effective engagement with appropriate potential future users or customers evidenced?’

Question 8. ODA Compliance

This competition is funded from UK Official Development Assistance (ODA). In order to be eligible for ODA funding, the primary purpose of a project must be to benefit the economic development or welfare of one or more countries on the OECD Development Assistance Committee (DAC) list. Projects may have secondary benefits beyond ODA-eligible countries.

Explain why the project is eligible for ODA funding. Describe, with appropriate supporting evidence, what beneficial impact the project is expected to deliver for populations in ODA-eligible countries and over what timescale? What is the pathway to positive impact in ODA-eligible countries after the lifespan of the award?

Your proposal must demonstrate both a high industrial relevance and commercial potential and the potential to produce outputs of health or economic benefit in ODA-eligible countries.

Proposals that do not demonstrate how project outputs are likely to be of primary benefit to populations in ODA-eligible countries will be considered out of scope.

This question will be scored against these assessment criteria: ‘Is there a clear benefit to populations in ODA-eligible countries?

3. Finances

Enter your project costs, organisation details and funding details. For full information on what costs you can claim, see our project costs guidance.

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

If you are VAT registered, then 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.

If you are not VAT registered, then you must enter your project costs exclusive of VAT. You will not be able to increase invoice values to cover VAT later should you become VAT registered.

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

Background and further information

About Small Business Research Initiative competitions

SBRI provides innovative solutions to challenges faced by the public sector. This can lead to better public services and improved efficiency and effectiveness.

The SBRI programme:

  • supports economic growth and enables the development of innovative products and services through the public procurement of R&D
  • generates new business opportunities for companies
  • provides a route to market for their ideas
  • bridges the seed funding gap experienced by many early-stage companies

SBRI competitions are open to all organisations that can demonstrate a route to market for their solution. The SBRI scheme is particularly suited to small and medium-sized businesses, as the contracts are of relatively small value and operate on short timescales. Developments are 100% funded and focused on specific identified needs, increasing the chance of exploitation.

Suppliers for each project will be selected by an open competition process and retain the intellectual property generated from the project, with certain rights of use retained by the contracting authority. This is an excellent opportunity to establish an early customer for a new technology and to fund its development.

Background information

Vaccines are one of the most cost-effective health interventions ever developed, preventing millions of deaths worldwide every year. A strong need remains to develop new vaccines and improve the effectiveness and efficacy of existing vaccines, particularly for diseases that have an epidemic threat. This has been highlighted by the COVID-19 pandemic.

The UK Vaccine Network was enacted by the Prime Minister in June 2015 in response to the Ebola outbreak in West Africa. This £110M programme, to develop new vaccines and technologies to tackle diseases with epidemic potential for example, Ebola and Zika, has been delivered by the UK Department of Health and Social Care (DHSC) with its partners. The funded research and development ensure that the UK is better prepared for and remains at the forefront of the global fight against future infectious disease outbreaks. The UK Vaccine Network has worked with Innovate UK, to support clinical development of candidate vaccines, their manufacturing and delivery processes and technologies, for use in low and middle income countries (LMICs) through an SBRI programme. The continuing £70M investment has been delivered though three calls from 2016 to the present.

The aim of this new SBRI is to help consolidate existing and new projects, readying them to exploit future national, international, and business funding opportunities to develop technologies that will reduce the health and economic catastrophes that could be caused by future pandemics.

Data sharing

This competition is jointly operated by Innovate UK and DHSC.

Your submitted application and any other information you provide at the application stage can be submitted to each agency on an individual basis for its storage, processing and use. Any relevant information produced during the application process concerning your application can be shared by one agency with the other, for its individual storage, processing and use.

This means that any information given to or generated by Innovate UK in respect of your application may be passed on to DHSC

Innovate UK is directly accountable to you for its holding and processing of your information, including any personal data and confidential information. It is held in accordance with its Information Management Policy.

Innovate UK and DHSC are directly accountable to you for their holding and processing of your information, including any personal data and confidential information. Data is held in accordance with their own policies. Accordingly, Innovate UK and DHSC will be data controllers for personal data submitted during the application.

Innovate UK complies with the requirements of GDPR, and is committed to upholding the data protection principles, and protecting your information. The Information Commissioner’s Office also has a useful guide for organisations, which outlines the data protection principles.

Further help and information

If you want help to find an organisation to work with, contact the KTN.

If you have any questions about the scope requirements of this competition, email support@innovateuk.ukri.org

If you need support with the application process, email us at support@innovateuk.ukri.org or call the competition helpline on 0300 321 4357 between 9am and 11:30am or 2pm and 4.30pm Monday to Friday (excluding Bank Holidays).

Innovate UK is committed to making support for applicants accessible to everyone.

We can provide help for applicants who face barriers when making an application. This might be as a result of a disability, neurodiversity or anything else that makes it difficult to use our services. We can also give help and make other reasonable adjustments for you if your application is successful.

If you think you need more support, it is important that you contact our Customer Support Service as early as possible during your application process. You should aim to contact us no later than 10 working days before the competition closing date.

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