Competition brief: vaccines for global epidemics - preclinical
Updated 21 December 2016
1. Dates and deadlines
Competition opens | Monday 17 October 2016 |
Briefing event for applicants | Monday 31 October 2016 |
Registration deadline | Midday (12.00pm) Wednesday 21 December 2016 |
Application deadline | Midday (12.00pm) Wednesday 4 January 2017 |
2. The competition scope
This competition will support projects seeking to develop candidate vaccines and vaccine platform technologies at the preclinical stage. The aim is to enable an effective and rapid response during future outbreaks of disease. The UK Vaccine Network has identified these 12 pathogens as a priority:
- chikungunya
- Crimean-Congo haemorrhagic fever
- ebola
- hantavirus
- lassa
- marburg
- Middle-East respiratory syndrome
- nipah
- plague
- Q fever
- Rift Valley fever
- zika
We will support all aspects of vaccine candidate development at the preclinical stage. These include, but are not limited to:
- developing master seed banks
- vaccine characterisation, formulation and adjuvantisation
- proof of concept ‘in vivo’ studies
- animal toxicology studies
- process finalisation. This involves moving from engineering batches to GxP activities (such as manufacturing and regulatory safety, pharmacology and toxicology studies that follow good manufacturing practice). These will support the authorisation of future clinical trials
The competition funders are particularly keen to support:
- high-risk proof of concept work. This involves applying emerging or existing vaccine platform technologies to the 12 priority diseases
- development of vaccine platform technologies that improve the efficacy of existing vaccination strategies. This might include, for example, new and improved adjuvants
- development of human vaccines based on promising data from animal vaccines or animal models
- development of animal vaccines for the 12 priority diseases, where these could realistically be used in relevant animal populations to reduce the risk of disease transmission to humans
- vaccine delivery technologies that would allow for easier, simpler and more efficient administration of vaccines
- diagnostics to demonstrate markers of safety and/or correlates of immunity, including those geared to demonstrating functional correlates of immunity
- other genuinely innovative technologies to allow for more effective development and deployment of vaccines for diseases
- vaccine platforms that can be rapidly adapted for new or re-emerging diseases
We are also interested in supporting ambitious multivalent candidate vaccines. These could protect against multiple strains of a single pathogen, or against multiple pathogens. For example, applicants could develop a multivalent ebola vaccine, a multivalent ebola plus marburg vaccine, or a vaccine against ebola, marburg and lassa.
This competition is wholly funded by Official Development Assistance. This means that vaccines developed as part of the competition should be appropriate for use in low and middle-income countries (LMICs) and outbreak settings. Therefore applicants should also consider:
- ease and speed of manufacture
- ease of use in LMIC settings
- temperature stability
- vaccines that require a single dose or a low number of boosts
- length of protection
- serologic markers of efficacy
- biomarkers or correlates of vaccine safety
3. Projects that we won’t fund
In this competition we are not funding projects covering:
- diagnostics that do not meet the criteria set out above
- the discovery of wholly new antigens
- vaccines that are not on the UK Vaccine Network’s priority list
4. Find out if you are eligible to apply
This competition is open to academic, industry and government bodies. You must demonstrate that your product has a realistic route to exploitation. However, we recognise that this is a complex procedure, given the diseases we have listed.
5. Funding and project details
This competition has two stages.
Stage 1
We have allocated up to £10 million for stage 1 of the competition. Applicants should explore the scientific, technical and commercial feasibility of their concept, which should focus on the development of vaccines and vaccine technology. Individual contracts will be worth up to £500,000, but we will consider making larger awards on a case by case basis. We expect projects to last for up to 12 months. Only projects that we support in stage 1 will be eligible to apply for stage 2 funding.
Stage 2
We have allocated up to £15 million for stage 2 of the competition, to take forward successful projects from stage 1. Individual contracts will be worth up to £2 million, but we will consider making larger awards on a case by case basis. We expect projects to last up to 24 months.
We expect stage 1 of the competition to fund preclinical work. Awards made at stage 2 of the competition will fund further preclinical work, up to and including good laboratory practice toxicology/manufacturing. Stage 2 awards will also fund early clinical work, where this is feasible and appropriate.
We expect to launch a further vaccine development competition, focused on the clinical development of vaccines, in January 2017. This is for organisations that can move more rapidly to clinical work with their candidate vaccine.
If the Department of Health does not distribute the entire £25 million available for this competition, it intends to re-open the competition in 2018.
Applicants must describe the candidate vaccine or vaccine platform technology that they are developing. They should give details of:
- its competitive advantage over alternative solutions
- its relevance to global epidemic disease threats
- its anticipated clinical application
- its estimated medical benefit and value. This includes its potential for use in LMICs
Project proposals must comply strictly with all regulatory requirements. Applicants should provide a project plan to show how they will demonstrate this. They should also describe how the product or capability would be used, where and by whom. They should provide evidence that their technologies and models are fit for purpose.
By the end of stage 1, successful applicants must produce a report for Innovate UK. This will form the basis of their stage 2 application. Where appropriate, this report should describe the health economic benefits of the proposed product. It should also include a product development plan and a breakdown of the costs of developing the product for licensure.
6. How to apply
To apply:
- the lead applicant must register online
- read the guidance for applicants for this competition
- watch the briefing event recording
- complete and upload your online application on our secure server
We will not accept late submissions. Your application is confidential.
External, independent experts assess the quality of your application.
Please read this carefully before you apply. Also, please read the general guidance for applicants as it will help your chances of submitting a quality application.
7. Background and further information
Vaccines are one of the most cost-effective health interventions ever developed. They prevent millions of deaths worldwide every year. However, there is a strong need to develop new vaccines and to improve the efficacy and effectiveness of existing ones.
The UK Vaccine Network was established in June 2015. Since then, it has been working with the UK Department of Health, the Medical Research Council and the Biotechnology and Biological Sciences Research Council to fund the research and development of vaccines against epidemics. This is to ensure that the UK and the wider international community are better prepared for and able to respond to, future outbreaks of infectious disease.
SBRI competitions
SBRI provides innovative solutions to challenges faced by the public sector. This can lead to better public services and improved efficiency and effectiveness. SBRI supports economic growth and enables the development of innovative products and services. It does this through the public procurement of research and development (R&D). SBRI generates new business opportunities for companies and provides a route to market for their ideas. It also bridges the seed funding gap experienced by many early-stage companies.
Applications must have at least 50% of the contract value attributed directly and exclusively for R&D services. R&D can cover solution exploration and design. It can also include prototyping and field-testing the product or service. 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
If you need more information, contact the competition helpline on 0300 321 4357 or email us at support@innovateuk.gov.uk.