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Policy Research Programme - Research call on vaccine evaluation to inform policy and decision making for the national immunisation programme

Published

10 May 2022

Version

1.0 - May 2022

Contents

Timetable and Budget

Description

Deadline/Limit

Deadline for Stage 1 Applications

14 June 2022, 1 PM

Notification of outcome of Stage 1 Application

August 2022

Deadline for Stage 2 application

28 September 2022, 1 PM

Notification of outcome of Stage 2 Application

December 2022 - January 2023

Project Start

January 2023

Budget

£6,000,000

Introduction

The National Institute for Health and Care Research (NIHR) Policy Research Programme (PRP) welcomes proposals to evaluate vaccines to inform policy and decision making for the national immunisation programme.

This call is for clinical research, to inform key policy decisions on the national immunisation programme. It will provide evidence to inform the advice given to the Department of Health and Social Care (DHSC) by the Joint Committee Vaccination and Immunisation (JCVI). The research will also inform key policy decisions made by the Secretary of State for Health, Ministers, the Chief Medical Officer, Deputy Chief Medical Officer(s), DHSC Chief Scientific Adviser and DHSC policy teams on vaccine strategy and how vaccines are used.

This call represents core funds for both COVID-19 and non-COVID-19 immunisation research. Additional funds may be made available for urgent pandemic-focused work, in exceptional circumstances (see Budget section).

Background

Vaccination is a highly effective public health intervention. It reduces disease, disability and death. By protecting individuals and the wider community, vaccination also reduces the cost to the NHS of treatment of the immediate illness and management of the subsequent effects. The UK Health Security Agency’s complete routine immunisation schedule for the UK is complex and constantly evolving in response to current public health priorities.

The UK vaccination programme is based on advice from the independent JCVI, which advises the UK health departments on immunisations for the prevention of infections and/or disease. Its advice gives due consideration to the evidence on the burden of disease, on vaccine safety and efficacy and on the impact and cost effectiveness of immunisation strategies.

Throughout the COVID-19 pandemic, the JCVI has advised on vaccination to reduce the prevalence of severe COVID-19 disease in the population. For example, the JCVI have provided recommendations on;

  • new COVID-19 vaccines, such as the AstraZeneca COVID-19 vaccine in December 2020 [1]
  • optimising the COVID-19 vaccination programme for maximum short-term impact [2]
  • priority groups for COVID-19 vaccination [3]
  • mitigating the impact of the B1.617.2 COVID-19 variant [4]
  • the COVID-19 booster vaccine programme for winter 2021 to 2022 [5]
  • the vaccination of children and young people [6]

Vaccine evaluation research commissioned as part of this new contract will contribute to the evidence base for future JCVI recommendations.

Research priorities

Core research priorities

In response to emerging public health concerns, the national immunisation programme is constantly evolving, and research is needed to inform vaccination policy, including clinical trials to;

  • explore the potential to introduce innovative schedules to improve the NHS immunisation programme using, for example, sequential doses of vaccines from different manufacturers or use fewer doses than the licensed indication, where safety and efficacy allow;
  • study and compare the immunogenicity and potential impact of vaccines (e.g. on carriage) from different manufacturers;
  • evaluate the efficacy and safety of concomitant administration of vaccines;
  • help speed up the generation of evidence for, and licensure of, a new vaccine where there is a pressing need in the UK, and work with manufacturers to this end;
  • respond rapidly to new and emerging threats including pandemics, to inform decision making in times of scientific uncertainty. This may involve looking at novel vaccines and/or vaccine schedules.

Technical requirements

The Institution leading the proposal should confirm that it has the capacity and is prepared to take on sponsorship responsibilities for clinical trials undertaken as part of the programme.

Successful applicants will be required to deliver research rapidly to inform policy, particularly as new vaccines are developed and support DHSC’s response to new and emerging infections, including pandemics e.g. immunogenicity of novel vaccines. Flexible and reactive capacity is therefore essential to ensure trials can be rapidly set-up to minimise lead in time to inform policy decisions. The ability to;

  • rapidly recruit to studies from a range of different age groups (elderly to infants) and based on clinical eligibility, is considered a vital capability for the successful applicant;
  • work collaboratively with other clinical trial groups with access to specialist population groups e.g. those with specific clinical conditions or of a specific demographic and other expertise (e.g. serology, microbiology and vaccine immunology) is also required.

Where the proposal includes multi-site clinical trial activities the research unit should demonstrate that they have the experience of governance and management of clinical trials across multiple clinical trial sites.

It is expected that the contract will be awarded to one research institution or a consortium of institutions where the research proposed is of a sufficiently high standard. The research will be conducted over a three-year period to address key questions to inform policy and the considerations of the JCVI. The team/ consortium should be sufficiently staffed that individual studies carried out under the contract are conducted efficiently and to a high standard.

Arm’s-length bodies including the UK Health Security Agency (UKHSA) are eligible to apply as part of a consortium but not as the consortium lead, or as a sole applicant.

Outputs

Applicants are asked to consider the timing and nature of deliverables in their proposals. Policymakers will need research evidence in time to meet key policy decisions and timescales, so resources need to be flexible to meet these needs.

Budget and duration

The budget for this project will be £6 million. This contract is for work over three years from FY 22/23 to FY 25/26, which will include multiple projects.

This call represents core funds for both COVID-19 and non-COVID-19 immunisation research. Additional funds may be made available, in exceptional circumstances, for urgent pandemic-focused work.

When assessing proposals, the panel will seek value for money, and hence, the duration of proposed individual projects should be no longer than is appropriate for high-quality research. Applicants should address timing and nature of deliverables by maximising staff resources.

Costings can include up to 100% full economic costing (FEC) but should exclude output VAT. Applicants are advised that value for money is one of the key criteria that peer reviewers and commissioning panel members will assess applications against.

Research is due to start promptly following funding being agreed.

Governance

Day-to-day management of this research will be provided by the principal investigator. They and their employers should ensure that they identify, and are able to discharge effectively, their respective responsibilities under the Health Research Authority’s UK Policy Framework for Health and Social Care Research [7], which sets out principles of good practice in the management and conduct of health and social care research in the UK.

Management arrangements

A research oversight group including, but not limited to, representatives of DHSC, the JCVI, UKHSA and the research team will decide priorities for the research contract, and be chaired by DHSC as funder. The successful applicants for the research should be established. The successful applicants should be prepared to adapt their research programme with emerging and changing priorities with the oversight group, and to share emerging findings on an ongoing basis. They will be expected to:

  • Provide regular feedback on progress
  • Produce timely reports to the oversight group and the JCVI as required
  • Produce a final report for sign off

Research contractors will be expected to work closely with nominated officials in DHSC, its partners and the National Institute for Health and Care Research to ensure findings hold maximum relevance DHSC policy and JCVI decision making. Key documents including, for example, research protocols, research instruments, reports and publications must be provided to DHSC in draft form allowing sufficient time for review.

Any substantive changes to the scope and resourcing of the project will need to be approved by DHSC Science, Research and Evidence Directorate, which is responsible for commissioning the research through the NIHR.

References

  1. Public Health England (2020). JCVI issues advice on the AstraZeneca COVID-19 vaccine. [Online] 2020 Dec. [Accessed April 2022].
  2. Department of Health and Social Care (2021). Independent report, Optimising the COVID-19 vaccination programme for maximum short-term impact. [Accessed April 2022]
  3. Department of Health and Social Care (2020). Joint Committee on Vaccination and Immunisation: advice on priority groups for COVID-19 vaccination, 30 December 2020 - GOV.UK. [Accessed April 2022]
  4. Public Health England (2021). JCVI advice to mitigate impact of B1.617.2 variant - GOV.UK. [Accessed April 2022]
  5. Department of Health and Social Care (2021). JCVI statement regarding a COVID-19 booster vaccine programme for winter 2021 to 2022 - GOV.UK. [Accessed April 2022]
  6. UK Health Security Agency (2021). JCVI issues new vaccination advice for children and young people - GOV.UK. [Accessed April 2022]
  7. Health Research Authority (2017) UK Policy Framework for health and social care research Version 3.3. [Accessed April 2022]

Key Documents