Corporate report

100DM: how the UK is contributing to the global mission to develop pandemic-fighting tools within 100 days

Published 7 August 2023

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Foreword

This foreword is from Isabel Oliver, UK Health Security Agency (UKHSA) Chief Scientific Officer.

The 100 Days Mission (100DM) is an important initiative launched under the UK’s 2021 G7 presidency. The 100DM aims to better prepare the world for the next pandemic by pre-emptively and proactively driving the development of diagnostics, therapeutics and vaccines (DTVs) so that they can be rapidly made available within the first 100 days of a future pandemic threat being identified.

Global progress towards the 100DM is reported annually by an independent International Pandemic Preparedness Secretariat (IPPS). Their 2022 implementation report showed that nations have gripped the challenge and ambition of the mission, but there is more to be done. The IPPS’ report mapped progress against pandemic preparedness themes and identified proposed areas where efforts should be focused to keep the 100DM within reach and strengthen the world’s pandemic preparedness.

This is an important moment to reflect on the UK’s progress and commitment to a global collective effort with the potential to save millions of lives and protect our economies and public services in the event of a future pandemic.

I am pleased to introduce this publication, which sets out UK government progress up to the end of 2022 made against the ambitions of the 100DM. It also sets out the actions the UK is taking over the course of 2023, including how the UK will continue to work with our partners both domestically and internationally.

This report is a valuable reminder of the criticality of the 100DM to the UK’s and the world’s pandemic preparedness. The COVID-19 pandemic has demonstrated the vital importance of rapid access to DTVs and the severe disruption that health crises can have across the world. The COVID-19 pandemic simultaneously demonstrated the art of the possible when governments, industry and academia worked together to translate scientific advancements into public health action.

There is still more to do. The UK government is working with stakeholders across the pandemic preparedness space, both globally and domestically, to support rapid detection and control of future pandemic threats to prevent impacts on health and society.

UKHSA has established a Secretariat to monitor and coordinate 100DM activities. Together with a range of UK government departments, UKHSA is driving forward both UK-based and global activity to contribute to the 100DM.

I am excited that the UK is actively providing global leadership, work and funding to help identify and tackle ongoing and emerging health threats, harnessing much of the UK’s scientific capacity and capability to play a significant role on the global, national, and local stages.

The UK will continue to build on the experience of recent years, strengthening strategic partnerships made stronger in the pandemic with government, industry, academia and organisations across the world, including the Global South, to maintain momentum and adopt a unified approach. The UK government has reinforced its commitment to, and pursuit of, the 100DM as part of pandemic preparedness efforts.

Introduction

In June 2021, during the UK’s presidency of the G7, global leaders welcomed the 100DM and committed to work together to develop safe and effective DTVs available within the first 100 days of a future pandemic threat being identified. The first 100 days are crucial to changing the course of an epidemic or pandemic. COVID-19 has demonstrated that the UK needs to work collaboratively across borders, sectors and organisations to achieve this.

The recent outbreaks of diseases, such as mpox (monkeypox) and Ebola, serve as stark reminder of the ongoing threat from infectious diseases and the need for global preparedness. These events emphasise the importance of continuing to invest in research and development, public health systems and infrastructure, and disease surveillance systems to ensure the UK and the world are prepared to respond to health crises.

UKHSA has a leadership role in protecting the public’s health and supporting the public health system to be ready for threats. The agency works with:

  • the Department of Health and Social Care (DHSC), including the Office for Health Improvement and Disparities (OHID)
  • other central government departments
  • local government
  • devolved administrations
  • the wider NHS
  • health and social care partners

UKHSA works in partnership with counterparts around the UK. This includes regular meetings that bring together senior officials from both government and public health bodies from each nation to discuss issues that are affecting the UK as a whole. These meetings discuss pandemic preparedness and work is ongoing between respective health policy teams. There are also ongoing meetings focused on technical expertise, to outline areas of cooperation and opportunities for collaboration.

Progress so far

In June 2021, the first 100DM report was authored by scientific, governmental and industry experts from within and beyond the G7. It proposed 25 recommendations to harness scientific innovation and strengthen public-private collaboration to reduce the time from discovery to deployment of DTVs. This was followed in December by the first implementation report (2021), published by G7 Scientific Advisers. It highlighted the practical steps already taken to implement the 100DM recommendations by their owners, and the corresponding timelines.

An independent Secretariat (the IPPS) was established in 2022 to ensure join-up between governments, the private sector, and global health institutions in support of the 100DM (1). This international secretariat is led by a small steering group that provides oversight and accountability for its work, and the Science and Technology Expert Group provides technical advice and galvanises support from the global scientific community. In January 2023, the IPPS published the second implementation report (2022).

A UK Secretariat has been established in UKHSA. The Secretariat will leverage UKHSA’s role as a critical focal point for pandemic preparedness within the UK health system, monitoring and coordinating progress and bridging engagement with the rest of UK government, industry, academia as well as international partners, including the IPPS. The UK Secretariat provided an overview of UK progress to feed into the 2022 implementation report.

This report provides insight into how the UK is making progress on the ambitions of the 100DM. It examines UK government achievements against the core themes of:

  • surveillance
  • DTVs research and development
  • manufacturing
  • clinical trials and regulation
  • financing

These themes are important coalescent points to drive momentum behind the 100DM recommendations.

This publication reports on progress up to the end of 2022. Some activities began prior to the launch of the 100DM or before 2022, but nonetheless are instrumental to fulfilling the mission’s ambitions and were active during 2022. Where those activities have resulted in activity in 2023, the report acknowledges this, for example where research funds have been awarded, but this does not represent a new stocktake. However, it deliberately does not capture wholly new actions since the UK fed into the 2022 IPPS report.

Several activities which feature in this report contribute to multiple elements of work within the 100DM. For simplicity and to avoid duplication, each activity is only reported on against the theme it most relates to.

The report also looks to the year ahead and sets out how the UK will continue to work with partners both domestically and internationally to achieve a shared goal of faster, more efficient and more effective pandemic preparedness in the future.

Progress towards the 100DM

Surveillance

Governments need to quickly identify and characterise novel threats to help make rapid policy and investment decisions that enable the UK and the world to mitigate the impact of such threats and inform the response to them. This requires building adequate surveillance capability, including accurate diagnostics capacity and data sharing capability and capacity.

Domestic examples of surveillance initiatives

Surveillance is a core capability for the UK and the government is continuing to strengthen surveillance domestically through a range of initiatives.

The UK is embedding surveillance across many parts of UK government, such as:

  • UKHSA
  • DHSC
  • Food Standards Agency (FSA)
  • Animal and Plant Health Agency (APHA)
  • other appropriate devolved agencies

Officials in these departments work to identify novel pathogens and changes in the characteristics of known pathogens that may result in an increased risk to public health. A range of domestic and global surveillance systems underpin this activity, drawing together cases and events to identify patterns and provide early warning of potential public health threats.

The UK government is continuing to strengthen its commitment to a One Health approach. A One Health approach is intended to recognise the interdependencies between humans, animals and the environment.

For example, the UK is leading innovation in pandemic surveillance. This includes scoping additional means to build surveillance including through a networked, integrated One Health surveillance capability across the 4 nations of the UK through a UKHSA-led National Biosurveillance Network (NBN) (2).

The data from the NBN will underpin the Cabinet Office’s Biothreats Radar, which will provide decision makers with a comprehensive picture of known and developing biological threats.

Additionally, across all 4 nations, the potential for wastewater surveillance to identify threats that are a shared concern is being tested, by:

  • developing an evidenced, scientific basis for the utilisation of wastewater-based epidemiology to enable timely access to standardised data and insights
  • building on surveillance developments undertaken during the COVID-19 pandemic to scope and explore the development of wastewater surveillance

The threat posed by COVID-19 is monitored through a range of surveillance systems and genomics capabilities. These report on infection rates, hospitalisations and the risks posed by new variants. For example:

The UK has developed extensive expertise in community and border surveillance, which are under active consideration for ongoing surveillance.

Advances in genomic science and technology have proved transformative for national health service delivery and protecting public health as a core capability across the world. These include UKHSA’s genomics capability, which allows rapid identification and surveillance of different pathogens, including:

  • SARS-CoV-2
  • a range of gastrointestinal pathogens (Salmonella, Listeriosis and E.Coli)
  • a range of influenza viruses, including seasonal and avian influenza (H5N1)
  • multidrug-resistant tuberculosis (MDR-TB)

Devolved governments work in partnership with wider UK capabilities to ensure surveillance meets national needs. For example, along with the existing genomic capability and capacity outlined in the Genome UK: 2021 to 2022 implementation plan, the Welsh government launched the Genomics delivery plan 2022 to 2025 on 1 December 2022 to harness advances in the understanding and application of genomics to transform public health strategy and delivery of care. It includes a priority to strengthen genomic surveillance to support public health response and policy making, while continuing to build world-leading diagnostic services.

International examples of surveillance initiatives

The UK also remains committed to strengthening global surveillance through a range of international initiatives.

UKHSA’s New Variant Assessment Platform (NVAP) deploys the UK’s unique genomics expertise. The UK was at the forefront of utilising genomic sequencing data during the pandemic response to increase global capability to detect new variants.

NVAP has provided support bilaterally to several countries and works collaboratively with several multi-lateral partners (3). Support includes training, equipment and reagents, and direct access to sequencing capacity in the UK. This is in order to:

  • increase regional capacity and capability on genomic surveillance
  • improve sequencing quality
  • help improve reporting and data sharing on variants and pathogens of pandemic potential

Whilst NVAP was originally focused on rapid identification and characterisation of COVID-19 variants, its focus is currently expanding to strengthen genomic surveillance more widely. The UK supports the delivery of the World Health Organization’s (WHO) Global Genomic Surveillance Strategy, covering mpox, cholera and other pathogen sequencing.

By enabling early detection and sharing of data on new variants and other pathogens, NVAP contributes to the ambitions of the 100DM to develop vaccines and countermeasures rapidly.

For example, through technical calls and external quality assurance scheme sponsorship, UKHSA has worked to upskill both wet and dry lab scientists in partner countries to process SARS-CoV-2 data effectively and make these available through international repositories, such as Global Initiative on Sharing All Influenza Data (GISAID) and the European Nucleotide Archive (ENA). This data feeds into platforms, such as outbreak.info and CoV-Spectrum, which is used by the international community to assess lineage growth and variants of interest.

The UK provided support to the International Pathogen Surveillance Network (IPSN), led by the WHO Hub for Pandemic and Epidemic Intelligence (WHO Pandemic Hub), was endorsed by the G7 under the UK’s presidency (originally conceived as the Global Pandemic Radar). The IPSN will support the development of faster and better national policy responses, medical countermeasures (MCMs) and evidence-based prevention, intervention and treatment.

The UK government provided technical expertise and leadership through 2022, including co-chairing the Implementation Coordination Group, which culminated in launching the network in May 2023. NVAP has been invited to join the IPSN Country Accelerator Forum to share experience and knowledge exchange with other members of the IPSN forum.

The UK provides routine provision of SARS-CoV-2 variants of concern and WHO’s BioHub. The BioHub has been developed as a reliable, safe, and transparent mechanism for WHO Member States to voluntarily share novel biological materials without replacing or competing with existing systems.

The UK also routinely contributes to related initiatives including:

To strengthen collaboration in outbreak analytics and public health intelligence more broadly, the UK government initiated the convening of the Global Pandemic Data Alliance (GPDA) (4) under the UK’s G7 presidency in 2021.

The GPDA has worked to map interoperability among health information management systems and epidemiological analysis software solutions, and initiated a multilateral collaboration with Mastercard, University Javeriana and University of Los Andes, in which Mastercard will be sharing financial transaction data to analyse the effect of non-pharmaceutical interventions on economic behaviour in Latin America. The GPDA also works with the London School of Hygiene and Tropical Medicine.

Surveillance: next steps

The UK will continue to work to strengthen global surveillance and diagnostics capabilities spanning the One Health Spectrum. This includes working with the WHO through the IPSN and capacity building programmes and the WHO’s efforts on the BioHub as appropriate, engaging technical colleagues across the UK system.

The UK will work with the One Health quadripartite organisations (World Health Organization, World Food and Agriculture Organization, World Organisation for Animal Health and the United Nations Environment Programme) on implementation of their One Health Joint Plan of Action (2022 to 2026).

The Joint Plan of Action, published in October 2022, provides activities which aim to strengthen collaboration, communication, capacity building and coordination and address complex multidimensional health risks with more resilient health systems at global, regional and national levels.

The quadripartite organisations are consulting on the Implementation Plan, which is due to launch later in 2023. Successful implementation of the Joint Plan of Action will facilitate efforts to strengthen global surveillance.

Diagnostics, therapeutics and vaccines research and development

MCMs, which might include DTVs need to be available for countries to respond to pandemic threats. This includes having sufficient core products and research to build on: the rapid development of COVID-19 vaccines was possible because of existing messenger ribonucleic acid (mRNA) vaccine research and development. The capability to scale and deploy MCMs once global surveillance systems have identified and characterised a novel threat is also essential.

Domestic examples of DTV initiatives

The UK supports efforts to provide timely, safe and effective DTVs within 100 days through strengthening domestic capabilities, global contributions, partnerships and investments in research and development.

This includes successful contributions to the development and evaluation of DTVs for a range of pathogens through ongoing research and collaboration with global partners and support for product development partnerships (PDPs).

Funding initiatives such as the Health Technology Regulatory and Innovation Programme, a £7 million fund to help UK HealthTech small and medium enterprises (SMEs) with regulation. The fund is a joint initiative between UK Research and Innovation (UKRI) and the Association of British HealthTech Industries (ABHI).

There are over £500 million private sector investments, including expansion at:

  • Fujifilm Diosynth Biotechnologies (Billingham)
  • ThermoFisher Scientific (Swindon)
  • Wockhardt (Wrexham)
  • Oxford Biomedical (Harwell)

UKHSA’s creation of its own Vaccine Development and Evaluation Centre (VDEC) to support the development and laboratory (in vivo and in vitro) evaluation of new vaccines and vaccine technologies is part of pandemic preparedness efforts. VDEC secures the legacy from the COVID-19 pandemic and brings together UKHSA’s laboratory-based activity, expertise and leadership in vaccine discovery, development and evaluation, as well as applying UKHSA’s expertise in partnership with industry and academia.

UKHSA is also continuing work to identify diagnostic requirements for each pathogen group and advancing diagnostic development activity. To minimise duplication and ensure a consistent approach, UKHSA is engaging with organisations such as the Foundation for Innovative Diagnostics (FIND) and the Bill and Melinda Gates Foundation (BMGF).

Industry and academia are essential to the UK’s ability to explore and develop DTVs. The UK government actively supports programmes to maintain working partnerships with the pharmaceutical industry, university research bodies and health protection research bodies, allowing DTVs to be explored pre-emptively and proactively during non-emergency times and made available rapidly during a pandemic.

For example, the UK’s 10-year strategic partnership with Moderna was announced in December 2022. The 3 connected strands of the deal cover:

  • the building of a UK manufacturing facility, biomarker laboratory and supply of mRNA vaccines to the UK
  • substantial investment in mRNA research and development
  • the capability to scale up and respond in the event of a future pandemic

Further information about the partnership is covered in the Manufacturing capability and capacity and Clinical trials and regulation sections of this report.

International examples of DTV initiatives

The UK has also invested globally to support the development of DTVs.

For example, the UK government invests in international public-private partnerships, including PDPs with the Drugs for Neglected Diseases initiative (DNDi), which require access and affordability provisions (5).

The UK government are growing relationships are growing with multilateral bodies to improve international cooperation, supporting inclusive and equitable partnerships for collaborative research with low- and middle-income countries (LMICs).

The UK is delivering with multilateral agencies on flagship initiatives. For example, the Foreign and Commonwealth Development Office (FCDO) recently acted as co-chair for the Access to COVID-19 Tools (ACT) Accelerator Facilitation Council Working Group Report on Diagnostics and Therapeutics, making recommendations for improved global access (6).

The UK is approaching product design through a One Health perspective with complementary research and development investments in human and animal health, such as in the Centre for Veterinary Vaccine Innovation and Manufacturing. This is a joint investment by the:

  • Biotechnology and Biological Sciences Research Council (BBSRC) (£8.5 million)
  • BMGF ($20 million)
  • FCDO (£10 million)

The Centre aims to bridge a specific research and development gap, the limited access to good manufacturing practice (GMP) capacity to take candidate vaccines to market in developing countries. The centre will build GMP at Pirbright and develop GMP vaccines for use in clinical trials in partnership with private sector vaccine developers.

The social enterprise diaTROPIX was founded in 2020 in partnership between the Institut Pasteur de Dakar (IPD) and UK Mologic. It manufactures rapid diagnostic tests (RDTs) and receives support, among others, from:

diaTROPIX became the first facility in a low-income country certified to produce COVID-19 RDTs.

The UK government also supports the IPD’s Project MADIBA, which will set-up a vaccine manufacturing facility in Dakar. The FCDO’s Manufacturing Africa programme assisted the development of the MADIBA business case which catalysed $200 million in investment. Since then, through FCDO and DHSC investments in CEPI, the UK has continued to invest in this work (8).

The UK supports the implementation of CEPI’s 2.0 Strategy on a range of initiatives to support global pandemic preparedness.

In March 2022, the UK government hosted the Global Pandemic Preparedness Summit, which raised over $1.5 billion for CEPI’s 2.0 strategy. During the summit, the UK pledged £160 million in support to CEPI, in addition to previous UK funding of £276 million since CEPI’s inception in 2017.

At this summit, the UK government also signed a joint statement on delivering 100DM along with:

  • CEPI
  • the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
  • the Association of the British Pharmaceutical Industry (ABPI)
  • the BioIndustry Association (BIA)
  • the Biotechnology Innovation Organization (BIO)
  • the Developing Countries Vaccine Manufacturers Network (DCVMN)

Associations and industry partners in attendance also committed to develop new manufacturing methods to adapt and quickly expand manufacturing capacity for new vaccines to address future public health emergencies and reduce manufacturing complexities.

There is the development of assays and assessment of vaccine effectiveness. For example, UKHSA is an Implementing Partner for High-Containment Animal Modelling to Support Product Development and a member of the CEPI Centralised Laboratory Network. Through this work with CEPI, UKHSA has supported:

  • COVID-19 vaccine evaluation
  • SARS-CoV-2 variant assessment (the Agility Program)
  • standardisation of assays for COVID-19 and mpox

The UK supports vaccine research and development on priority pathogens, pan-coronavirus vaccines and platform development for responsive vaccine production, including partnerships, such as DHSC’s UK Vaccine Network (UKVN).

In autumn 2022, CEPI and WHO worked with the Government of Uganda to support scaling up clinical trials and manufacturing in response to the Sudan ebolavirus in Uganda. This allowed 3 vaccine candidates to get to the clinical trial stage in 79 days, one of which was from the University of Oxford. It was based on the successful Oxford/AstraZeneca COVID-19 vaccine, with early development funded through DHSC’s UKVN with support of FCDO. More than 40,000 doses were manufactured in partnership with Serum Institute India.

The supply of a trial vaccine complemented a wider coordinated response, led by the Government of Uganda, the WHO and CEPI. The UK (DHSC and FCDO) funded specific actions to support the response, for social sciences research with Ugandan partners, and for deploying specialists from the UK-Public Health Rapid Support Team who worked with national and international response partners on infection, prevention and control (IPC).

DTV research and development: next steps

The UK government will continue international collaboration for the development of DTVs. Building on our existing capabilities, it will develop and evaluate prototype tools for pathogens of pandemic potential through the National Institute for Health and Care Research (NIHR).

The UK government will continue to work closely with partners such as academia, industry and international partners, including those in LMICs (9). This will also be supported by continued funding for PDPs.

The UK will also continue to enable better coordination across funders and the different international partners and organisations, for example with FIND and CEPI. This will be to develop diagnostic assays and will support CEPI to deliver work such as building the global vaccine library within 5 to 10 years, which will build on the combined pledge at the Global Pandemic Preparedness Summit.

Utilising the life sciences sector was integral to the COVID-19 response, including:

  • development of the Oxford/AstraZeneca vaccine
  • the partnerships between industry and academia
  • the RECOVERY trial
  • the growth of a diagnostics industry that is sequencing emerging COVID-19

The UK will continue to work with the life sciences industry to help ensure it remains ready and able to collaborate with international partners including within LMICs, utilising the 2021 Life Sciences Vision and particularly the Vaccines mission within it (10).

The 100DM is also supported by the UK Biological Security Strategy (BSS), launched in June 2023. Implementation of the strategy will help the UK’s defence against infectious disease outbreaks, antimicrobial resistance, and biological incidents and attacks.

The BSS sets out clear actions on biosecurity, reflecting lessons learned during the COVID-19 pandemic and rapid advances in science and technology and outlines how the government will tackle a wide range of threats by 2030. The BSS also helps progress work with industry to reduce the impact of future pandemics by making DTVs available within 100 days of a future pandemic threat being identified.

Manufacturing capability and capacity

Developing manufacturing capability and capacity both domestically and internationally reduces costs, streamlines manufacturing process and improve access to DTVs.

Domestic examples of manufacturing initiatives

The UK is strengthening domestic manufacturing through a range of initiatives.

Investments of over £405 million through the Vaccine Taskforce (VTF) have been made, to secure and scale up vaccine manufacturing capabilities to ensure a robust response to COVID-19 and potential future health emergencies (11). This includes support for the RNA Centre of Excellence in Darlington. Hosted by the CPI, the centre will support the development, scale-up and manufacture of new ribonucleic acid (RNA) therapies and vaccines.

The Life Sciences Innovative Manufacturing Fund (LSIMF) will provide £60 million in capital grants for investment in the manufacture of human medicines, medical diagnostics and MedTech products in the UK. It will help to:

  • grow our economy
  • boost health resilience
  • deploy innovation
  • minimise environmental impacts
  • support levelling up

LSIMF builds on the pilot Medicines and Diagnostics Manufacturing Transformation Fund, which provided a total of £9.5 million in grants to 5 companies, unlocking £65 million in private investment.

As part of the Moderna Strategic Partnership, Moderna will build a new innovation and technology centre with the capacity to produce up to 250 million doses of mRNA vaccines annually in the event of a health emergency. Within this is a commitment to ensure early vaccine development supports the ambitions of the 100DM. Information on this partnership can also be found in the Diagnostics, therapeutics and vaccines research and development and Clinical trials and regulation sections of the report.

The UK is focusing on domestic testing ability to help rapidly develop and scale up appropriate tests for an outbreak. This is achieved through pre-existing strategic relationships with testing platforms suppliers, production of lateral flow assays for mass testing and further considerations of effective supply chains.

Work is ongoing to reduce the need to stockpile large volumes of diagnostic tests with fixed shelf-life through intelligent design, rapid production facilities and the flexibility to rapidly update tests due to pathogen evolution whilst ensuring the test is fit for purpose with quality assurance and regulatory compliance. The concept of a Diagnostic Accelerator function, where there is full support from UKHSA throughout the end-to-end process of diagnostic development and implementation, is a key part of delivering this approach.

Governments across the UK’s 4 nations are in regular contact with vaccine manufacturers regarding products in development, to obtain information around:

  • clinical trials
  • the position around licensing and regulation of products
  • vaccine characteristics, and storage and deployment considerations
  • informing horizon scanning
  • future planning considerations in advance of market authorisations

UKHSA and the Medicines and Healthcare Products Regulatory Agency (MHRA) work with vaccine manufacturers to support new processes, such as with bivalent vaccines for COVID-19, where the UK was the first country to licence a mRNA bivalent vaccine.

International examples of manufacturing initiatives

The UK’s global relationships and scientific expertise mean that global manufacturing is also supported.

UKHSA and its predecessor organisations have a track record of developing, evaluating and implementing diagnostic tests for hazardous pathogens working with the NHS, non-governmental organisations (NGOs) and countries where diseases are endemic and in response to outbreaks.

Developing tests for use in endemic countries can control outbreaks and reduce the risk of spread to neighbouring countries, supporting UK government and NGO plans for infection control. This includes pathogens such as Ebola, Lassa and Dengue which UKHSA will continue to develop whilst working with commercial partners and NGOs, such as WHO and FIND.

For example, in 2022, UKHSA expanded mpox testing to deal with the outbreak in the UK through UKHSA labs and supported NHS labs wanting to set up local testing and tested pan FluA/B/COVID-19 lateral flow devices (LFDs). UKHSA routinely reviews diagnostic methods for performance, introducing and/or replacing them as required.

Building on the legacy of the COVID-19 response, UKHSA engages with the commercial sector to develop the necessary diagnostics in the correct format for various scenarios. This is through engagement at country level or with partners through Gavi and CEPI, to support regional manufacturing development, including for outbreak response.

For example, FCDO supported DHSC’s UKVN to work with Serum Institute to make a vaccine available, for potential use in a clinical trial in just 80 days and FCDO and DHSC supported the IPD’s project MADIBA. For further information, see Diagnostics, therapeutics and vaccines research and development.

Manufacturing capability and capacity: next steps

The UK government’s strategy for international development, announced in May 2022, set out the immediate priority to transition towards ensuring appropriate capacity and capability to manage endemic COVID-19. It also set out a commitment to prepare for new threats through:

  • supporting research and development
  • transfer of technology and know-how on a voluntary basis
  • sustained manufacturing capacity

All these actions will help enable new interventions (DTVs) to be safely authorised and available equitably as soon as possible after a threat is identified.

Similarly, the Global Health Framework, announced in May 2023, affirmed the need to continue to work in international partnerships with academia and the private sector to support:

  • research and development
  • manufacturing innovation
  • strengthening of the international clinical trials ecosystem in LMICs

The UK government will continue to work with industry, academia, funders, regulators and public sector organisations to constantly review and improve ways to strengthen the UK’s manufacturing capability, capacity and resilience, including the supply chain.

Clinical trials and regulation

The UK is engaged with a range of global partners to enable better collaboration in funding global clinical trials, exploring how to run clinical trials in emergency situations and developing more responsive, equitable global clinical trials, including running more trials in diverse settings with under-represented populations.

Domestic examples of clinical trial initiatives

The UK is a recognised world leader in delivering clinical trials and continues to deliver initiatives to strengthen clinical trials domestically.

The UK is advancing regulatory proposals to enhance the UK’s clinical trial framework. The enhanced framework aims to provide a more streamlined and flexible regime to make it easier and faster to run trials in the UK, to support:

  • patient access to safe, new treatments
  • bolster the attractiveness of the UK as a destination for innovative trials of life-changing medicines

The UK is leading major trials into the efficacy of therapeutics, such as global trials to find new treatments for COVID-19. This includes treatments in the community to reduce the need for hospital admission and get better sooner such as:

  • PANORAMIC, the world’s largest community trial
  • RECOVERY, the trial where the UK is partnering with several countries, including India

The COVID-19 Treatment Accelerator, funded through a partnership between the UK, Wellcome and BMGF continued to test new therapeutics through clinical trial partnerships with LMICs. This included launching a phase 3 follow up of the most promising anti-malarial medicine tested through a phase 2 trial for COVID-19 treatment, with the Medicines for Malaria Venture.

NIHR coordinates and funds the Clinical Research Network, a UK-wide study delivery system which means the UK can place and deliver studies including trials at the right sites at pace. This model and its associated processes will be used for future research delivery pipelines including global commercial research. There are strong research infrastructures around the UK for vaccine development and delivery, such as the Centre for Trials Research at Cardiff University, and the Systems Immunity Research Institute which works with a range of UK partners.

The UK government (DHSC and UKHSA) works with industry and academia to streamline study design and conduct via the National Immunisation Schedule Evaluation Consortium (NISEC). NISEC is a collaboration between Academic Clinical Research groups and UKHSA which has standardised study protocol templates, study databases and Standard Operating Procedures (SOPs) across the UK (12). Through the Moderna-UK Strategic Partnership, Moderna will run a significant number of clinical trials in the UK and has also pledged to fund grants for UK universities, including PhD places and research programmes.

The UK government funds clinical trial platforms through investments in PDPs and other public-private partnerships and funding platforms. The UK government is also engaging with partners such as the Medical Research Council (MRC), BMGF, and the Wellcome Trust to explore more collaboration in funding global clinical trials.

The UK’s regulatory regime is continually reviewed for opportunities to enhance the system to ensure it balances agility with assuring quality.

The UK is taking forward legislative changes across medicines, devices and clinical trials, without compromising quality. For example, making enhancements to UK legislation to provide a world-class regulatory environment that supports the safe development and access to innovative medical products, for the benefit of patients and public health.

MHRA has incorporated the principles of the 100DM within their:

  • in vitro diagnostics (IVD) roadmap
  • emergency and pandemic preparedness plan
  • development of the new UK regulatory framework

Together, these projects strive to better define criteria and standards for effectiveness, quality and use cases for diagnostics. MHRA will work with other regulatory authorities to help define international assessment protocols and develop guiding principles, alongside more effective quality assurance processes.

The UK Coronavirus Test Device Approval (CTDA) was established to evaluate COVID-19 tests. During the pandemic, the UK government improved the times that it took to evaluate tests. This approach is embedded into CTDA regulations, ensuring the appropriate quality tests were allowed on the market, balancing the need for speed with the need to ensure robust quality (13).

International examples of clinical trial initiatives

The UK plays a leading role in international approaches to clinical trials.

In May 2022, the UK and Argentina co-chaired the development of a new World Health Assembly (WHA) resolution ‘Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination’. The resolution was adopted by consensus of all WHO Member States at the 75th WHA. It outlined a series of principles for governments, the WHO and NGOs to support more equitable global clinical trial ecosystems around the world so that well-designed and well-implemented trials are commonplace within more diverse settings and more readily including under-represented populations.

The UK is a member of the Group of Friends, a group of Ministries of Health (MOH) who work together to understand how they can support the adoption of the WHA resolution. The Group has a particular focus on funding multi-country clinical trial networks and trials which can be pivoted to evaluate DTVs in an outbreak or pandemic if needed.

The Member States of WHO has established an Intergovernmental Negotiating Body (INB) to draft and negotiate a convention, agreement or other international instrument under the Constitution of WHO. The UK and other member states are helping to develop the WHO’s to globally strengthen pandemic prevention, preparedness and response (PPR).

UKHSA is part of WHO’s clinical trial working group and is also a partner in the Solidarity programme, which is an international clinical trial to help find effective treatments for COVID-19.

The UK participates in the Global Research Collaboration for Infectious Disease Preparedness (GloPID-R). This includes representation from a broad range of national research funding agencies and clinical trial networks.

MHRA’s membership of, and contributions to, various global initiatives help to ensure that international regulations can also support accelerated development with safety and high-quality products.

For example, the International Coalition of Medicines Regulatory Authorities (ICMRA) works closely with WHO to increase the efficiency and effectiveness of regulatory processes and decision-making (14). MHRA is part of ICMRA and sits on several of its COVID-19 and non-COVID-19 working groups.

MHRA played a leading role, together with Anvisa, in updating the ICMRA’s 2019 framework for the involvement of Regulatory Authorities in the management of global health crises, to include experiences, learnings and examples related to the COVID-19 pandemic (15). The updated ICMRA standard operating procedure (SOP) for crisis management was published in October 2022.

The Access Consortium is a coalition of regulatory authorities that work together to promote greater regulatory collaboration and alignment of regulatory requirements. MHRA is also part of the Access Consortium and supported the Access Consortium statement on COVID-19 medicines, published in December 2021.

The statement reiterates the Consortium’s commitment to:

  • work together to expedite reviews of applications for COVID-19 medicines
  • the need for sufficient evidence of safety, quality and efficacy
  • the need for robust monitoring of post-market safety and effectiveness

Clinical trials and regulation: next steps

The UK government will continue to support the implementation of the WHA clinical trials resolution. This includes actively engaging with all relevant global consultations, such as the WHO consultation to inform WHO normative guidance and strengthen the global clinical trials ecosystem.

The UK government will continue to work with the WHO and other countries to develop guidelines and advocate for enabling policy environments to promote multi-country trials. DHSC is also scoping the development of a country-based forum to explore how member states can best work to implement any relevant recommendations that stem from the WHO consultation.

DHSC will maintain membership of other multilateral initiatives, such as the GloPID-R network. Additionally, MHRA are continuing to work on the IVD roadmap, emergency and pandemic preparedness plan and the development of the new UK regulatory framework.

The UK, along with global partners, will identify opportunities to progress clinical trial network development internationally through knowledge exchange. The UK and partners continue to advocate for activities to support mature and responsive clinical trial networks particularly in global regions where current coverage is limited, with effective mechanisms to coordinate activity between networks.

Financing

Effective public and private financing approaches underpin national and global pandemic preparedness and response (16). They enable:

  • quick action
  • capacity building
  • flexibility
  • collaboration
  • prevention efforts

These are all essential to controlling and preventing the spread of infectious diseases.

Through contributions to G20 policy development and implementation, the UK is part of global efforts to improve pandemic preparedness and response financing.

The G20 Joint Finance-Health Task Force (JFHTF) was established in 2021. The JFHTF brings together finance and health officials from G20 members or observatory countries as well as representatives of invited international organisations, with the aim of enhancing dialogue and global cooperation on issues related to PPR.

The JFHTF promotes collective action, assessing and addressing health emergencies that cross borders, and encouraging effective stewardship of resources, while adopting a One Health approach and has explored various options aimed at developing coordination arrangements between Finance and Health Ministries.

The JFHTF also catalysed the establishment of the Pandemic Fund with broad support from members of the G20 and WHO. The World Bank Board of Directors approved the establishment of a new Financial Intermediary Fund for Pandemic Prevention, Preparedness and Response, known as the Pandemic Fund, in September 2022, with announced contributions of over $1.4 billion (17).

The UK has signed its Contribution Agreement for the Fund, committing a £25 million Overseas Development Assistance (ODA) contribution.

The Pandemic Fund will help finance critical investments to strengthen PPR capacities at national, regional, and global levels, with a focus on LMICs. It will also help ensure that these countries can quickly respond to, and as far as possible contain, outbreaks before they spread across the world.

Crucially, the fund can help catalyse countries’ own financing, so the world is as equipped as possible whenever and wherever a new public health risk emerges.

Financing: next steps

The UK is committed to further strengthening collaboration between global Finance and Health Ministries for PPR.

The UK will work with partners to support the work of the G20 JFHTF, who will be key to supporting sustained and adequate financing for PPR.

In 2023, JFHTF plans to consolidate and lay the foundations for a future ‘rolling steady state’ for finance and health collaboration, centred around monitoring of PPR and ensuring joint readiness.

Working on public and private financing approaches with multilateral organisations, industry, academia and public-private partnerships will be vital to tackle the threats we face from new and emerging infectious diseases.

The year ahead

Realising the ambitions of the 100DM is a priority for the UK government. Support for the 100DM features across many UK strategies and initiatives, including:

Key 2023 publications include:

Governance mechanisms will monitor each of these strategies and hold departments to account for delivery. This means 100DM remains at the forefront of pandemic preparedness activity across government.

Japan’s 2023 G7 presidency continues to progress the 100DM at the international level, with support to the Mission as one of the core MCM research and development initiatives highlighted in the Health Ministers’ Communiqué and the Leaders’ Communiqué. The 100DM is also welcomed by G20 as well as industry, academia and the wider international community.

This publication has set out many of the ways that the UK has already taken action to support the 100DM ambition and strengthen its pandemic preparedness.

Looking ahead, UKHSA will work with partners across government, agencies and devolved administrations – together with the wider pandemic preparedness community, to take steps against each of the themes discussed in this publication.

Surveillance

The UK will strengthen global surveillance, including with the WHO and capacity building programmes, spanning the One Health spectrum.

DTVs research and development coordination

The UK will continue collaboration to increase access to DTVs and build on existing capabilities, working closely with NIHR and UKRI, and with a range of domestic and international partners.

Manufacturing

The UK will work in partnership with industry and academia to consider how best to support their efforts, including strengthening the UK’s vaccine capability, capacity and resilience, including the supply chain.

Clinical trials and regulation

The UK will support the implementation of the WHA clinical trials resolution and identify opportunities to progress clinical trial network development internationally.

Financing and procurement

The UK will strengthen collaboration between Finance and Health Ministries for PPR and work with partners to support the G20 JFHTF.

Continued collaboration

The 100DM is underpinned by collaboration. It is a public-private initiative committed to the importance of equity, resilience and security, domestically and globally. Through development assistance programs and partnerships with international organisations, the UK is working towards building stronger and more equitable healthcare systems around the world and better access to the essential tools that defeat pandemics.

The mission cannot be met by government actions alone. While this publication focuses on where government has made and aims to help the mission, this is only one part of the picture.

Looking ahead, the UK government will:

  • work with industry and academia to assess, report and celebrate 100DM progress
  • identify the UK’s most impactful contributions and develop action plans
  • grow our relationships with counterparts globally and contribute to global pandemic preparedness, including working with the independent IPPS

Monitoring and evaluation are important tools to understand how effectively these actions are being taken, whether they are on track and what other initiatives the UK might implement.

Towards the end of 2023, the UK Secretariat will begin to prepare the UK’s input into the 2023 implementation report by conducting a UK stocktake of the important progress made this year. UKHSA encourages colleagues and partners to support that stocktake through assessing and sharing their work.

Success in the Mission depends on genuine collaboration and commitment across all partners to continue the momentum and ambition of the 100DM. The UK’s vision is for the Mission to be a sustained endeavour with partners working together to drive forward progress to deliver this global public-private ambition.

References

1. The independent IPPS is led by a small steering group that will provide oversight and accountability for its work. Steering group members have been selected from:

  • the Secretariat’s supporting organisations (the BMGF, the Wellcome Trust)
  • 3 G7 presidencies (current, incoming, and prior year’s presidency)
  • the current G20 presidency
  • the International Federation of Pharmaceutical Manufacturers and Associations
  • the 2 co-chairs of the Science and Technology Expert Group

2. One Health is an integrated, unifying approach that aims to sustainably balance and optimise the health of humans, animals, plants and ecosystems. It recognises the health of humans, domestic and wild animals, plants, and the wider environment (including ecosystems) are closely linked and interdependent. The approach mobilises multiple sectors, disciplines and communities at varying levels of society to work together to foster well-being and tackle threats to health and ecosystems, while addressing the collective need for clean water, energy and air, safe and nutritious food, taking action on climate change, and contributing to sustainable development.

3. The NVAP provides support bilaterally to several countries, such as Brazil, Ethiopia, Kenya, Nigeria, Pakistan. As part of NVAP, UKHSA works collaboratively with several multi-lateral partners including:

  • WHO HQ
  • WHO Southeast Asia
  • WHO Eastern Mediterranean
  • WHO Europe

UKHSA also works closely with the Africa Centre for Disease Control and the Caribbean Public Health Agency.

4. The Global Pandemic Data Alliance, is a collaboration of data-focused organisations meeting the challenge of establishing health data as a global public good. Invited by the UK government under its G7 presidency, GPDA is working in response to a call from the Science Academies of the Group of Seven to realize a better level of ‘data readiness’ for future health emergencies. Partners of this alliance include:

  • data.org
  • the International Digital Health and Artificial Intelligence Research Collaborative (I-DAIR)
  • the Open Data Institute (ODI)
  • the Royal Society and The Trinity Challenge

5. The DNDi is an international, not-for-profit research and development organisation. In 2003, Médecins Sans Frontières, an international, independent medical humanitarian organisation, the WHO and 5 international research institutions, founded the DNDi.

6. Since April 2020, the ACT-Accelerator partnership, launched by WHO and partners, has supported the global effort to develop tools to fight a disease. The ACT-Accelerator Facilitation Council Working Group Report on Diagnostics and Therapeutics report’s central premise is that diagnostics and therapeutics, and associated test to treat strategies, are fundamental components of the pandemic response. It reflects on the main challenges and key solutions for equitable access and proposes 16 recommended actions (with potentials owners) and offers a potential high-level roadmap of where efforts should be concentrated.

7. The Institut Pasteur de Dakar (IPD) is a non-profit foundation set up in 1896 whose board comprises members of the Government of Senegal, Institut Pasteur in Paris and independent experts. The IPD is a world class infectious disease research facility and undertakes public health services including vaccine production, surveillance, education and reference laboratories.

8. CEPI is a foundation that takes donations from public, private, philanthropic, and civil society organisations to finance research projects to develop vaccines against emerging infectious diseases.

9. NIHR was established in 2006 to “create a health research system in which the NHS supports outstanding individuals, working in world-class facilities, conducting leading-edge research focused on the needs of patients and the public”. The organisation works in partnership with the NHS, universities, local government, other research funders, patients and the public and is funded by DHSC. NIHR is centred on England but collaborate closely with the devolved administrations in Scotland, Wales and Northern Ireland. They are also a major funder of applied health research in LMICs, work that is principally funded through UK aid from the UK government.

10. The 2021 Life Sciences Vision set out what government, the NHS, regulators, companies, medical research must do to create a globally competitive environment for life sciences investments in the UK. The Vision also focuses on specific missions that are technology or disease specific, including the vaccines mission. The vaccines mission aims to build on the UK’s deep expertise in vaccines, including investments made during the pandemic, to strengthen the UK ecosystem, with a particular focus on new and novel technologies including, vaccine development and manufacture.

11. UKHSA’s Covid Vaccines Unit took over the responsibility for COVID-19 vaccine supply from VTF in October 2022. VTFs onshoring responsibilities have now transferred to the Office for Life Sciences.

12. NISEC was formed in 2017 in response to a DHSC research call for vaccine evaluation to inform policy and decision-making for the national immunisation programme.

13. The UK CTDA mandates that tests must meet the minimum performance standards of specificity and sensitivity set out in the CTDA legislation in order to be approved and access the UK market. The approved register is publicly available on GOV.UK and empowers consumers by allowing them to verify that the test they are purchasing has been validated. Over 130 COVID-19 tests across various technology types have been approved, including lateral flows that combine flu and COVID-19, with around 35% of the approvals being for British-based applicants.

14. The ICMRA is a voluntary leadership entity of regulatory authorities who work together on a variety of strategic initiatives, including supply chain integrity, antimicrobial resistance, crisis management, and communication.

15. Anvisa is the Brazilian government’s health regulatory agency; The protocol describes types of scenarios that Regulatory Authorities may encounter during a public health crisis, roles and responsibilities of ICMRA members, as well as strategies for communication and international collaboration.

16. The Financing section deals with the UK’s specific financing to Pandemic Preparedness and Response rather than financing to global health more generally, which is substantial. Figures for 2022 UK AID Spend are provisional. Figures for 2021 show that health was the second largest sector (13.6%) to receive UK bilateral ODA spend. This spend was across a range of areas including the UK’s support to key institutions such as WHO, the Joint United Nations Programme on HIV and The Joint United Nations Programme on HIV/AIDS and the United Nations Population Fund, Gavi, Global Fund and the Global Financing Facility and in areas such as (but not limited to) global health research, health policy, reproductive health and nutrition.

17. This is a donor-led fund housed at the World Bank, which was set up with broad support from the G20 to finance investments to strengthen pandemic prevention, preparedness and response capacities at national, regional and global levels, with a focus on low- and middle-income countries.

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