The 100 Days Mission was launched in 2021 under the UK’s G7 presidency to bring together like-minded nations to better prepare for the next pandemic by pre-emptively and proactively driving the development of diagnostics, therapeutics, and vaccines (DTVs) so that they can be rapidly deployed within the first 100 days of a future pandemic threat being identified.
In this article, we will examine the key points from the Government’s paper examining the progress that they’ve made so far.
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:
- 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 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:
- UKHSA’s COVID-19 surveillance report, which summarises information from the surveillance systems which are used to monitor COVID-19 on a weekly basis
- regular reporting, as needed, via UKHSA’s SARS-CoV-2 variant technical briefings, which contributed to risk assessments and designation of new COVID-19 variants; the last routine technical briefing was in April 2023 and has been replaced with the similar but shorter output, published fortnightly at SARS-CoV-2: genome sequence prevalence and growth rate
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:
- 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 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:
- BEI Resources
- European Virus Archive – GLOBAL (EVAg)
- Global Health Security Initiative (GHSI)
- WHO Global Genomic Surveillance Strategy
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.
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).
UKHSA is 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.
International examples of DTV initiatives
The UK has also invested globally to support the development of diagnostics, therapeutics and vaccines (DTV)s.
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 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:
- the Wellcome and FCDO Joint Initiative for Research on Epidemic Preparedness and Response (JIREP)
- FIND (also FCDO funded)
diaTROPIX became the first facility in a low-income country certified to produce COVID-19 RDTs.
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.
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
The UK is strengthening domestic manufacturing through a range of initiatives.
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.
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.
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.
Clinical trials and regulation
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).