Policy paper

Statement of Intent: UK Veterinary Vaccine Availability

Published 11 September 2025

Ministerial foreword

Vaccines play a critical role in maintaining the health of our national animal population, and in protecting public health and our environment. Animals form an integral part of our culture and economy, and vaccines enable this, whether protecting our pets from life threatening diseases such as distemper, protecting our horse population and equine sports by mitigating the risk of equine influenza, or improving our food safety by reducing salmonella in our poultry flocks.

It is essential that the UK acts proactively to address both challenges faced today of ensuring the right vaccines are available at the right time, but also that we look forward to the future by ensuring the pipeline of new products and technology is fit for purpose. Indeed, the critical nature of vaccine availability was recognised as a key finding in the recent NAO report on resilience to animal diseases.  The current model of vaccine availability operates largely on a just-in-time basis for manufacture and supply, and to safeguard against future risks we need to transition towards a more resilient, just-in-case approach, one that prioritises preparedness to mitigate potential impacts on both animal and human health.   

This Statement of Intent sets out the strategic approach through which the animal health sector, supported by government, should join forces to deliver the tools that our vets and animal keepers need to keep their animals healthy. Greater cross sector communication, engagement and action is essential to allow us to face this challenge and achieve success, to scale up advances that have already been made and maximise the value of investments underway, such as the BBSRC and Defra fund to support vaccine platform technology. I also welcome the opportunities that this approach offers for the UK to influence and benefit from the growth potential of the animal health sector.

Finally, I thank the sector for their contribution in bringing this vision together and am excited to see this collaboration strengthen and deepen as we move forwards to jointly developing the actions required to achieve our goal.

Baroness Hayman

Executive Summary

Access to effective veterinary vaccines is vital for animal health and welfare, and therefore to One Health, food security and the economy. Vaccination of animals is also a crucial component of our national and global efforts to improve antimicrobial stewardship to mitigate the threat of antimicrobial resistance (AMR).

However, over the past two years stakeholders from across the animal health sector have reported increasing concerns over the availability of vaccines in the UK.  Stakeholder engagement has identified two key issues: supply not meeting demand for existing vaccines; and concerns over a lack of development and innovation for new vaccines to fill existing and emerging therapeutic gaps. It has also highlighted the complex multifactorial nature of this issue and the need, and desire, for all impacted stakeholders to contribute to the solution through a strategic cross-sector approach.

This Statement of Intent, authored by the Veterinary Medicines Directorate (VMD), outlines the need for veterinary vaccines and sector concerns over current and future vaccine availability, sets out the complicated landscape of issues impacting vaccine availability, and the wider context of activities already underway to mitigate these challenges. It describes the vision of safe and effective vaccines available at the right time to prevent disease and outlines a strategic framework for multi-stakeholder action to implement this vision. This framework includes four interconnected strategic themes: Work in Partnership, Improve Supply and Uptake, Support Innovation and Review Manufacturing Landscape. Activities to deliver these themes will be delivered through the development of a 5-year multi-stakeholder UK action plan, which will convene stakeholders to agree ownership and governance of activities, and set out deliverables, timelines and key performance indicators. The intention is to publish this action plan in the next 12 months. The success of this initiative will depend on action from all impacted stakeholders.

The aim of this Statement of Intent is to show the required direction of travel for future action, to signal intent, foster collaboration and act as an impetus for the wide cross sector engagement required for success.

The need for veterinary vaccines

Animals play a key role in our culture and society. Vets and animal keepers rely on effective vaccines to maintain individual animal and herd health and welfare, by preventing or reducing disease and disease spread. By protecting animal health and welfare, vaccines also underpin food production, food security, and the farming and wider economy. For example, the UK’s horse industry, which is reliant on availability of vaccines to underpin horse health, welfare and sports, contributes over £9 billion to the economy per annum (based on estimates from the British Horseracing Authority (BHA) and the British Equestrian Trade Association’s National Equestrian Survey 2023). The recent National Audit Office (NAO) report on resilience to animal diseases also recognised the key role of vaccines and the need for a strategic approach to ensure vaccine availability.

Vaccines help protect human health by reducing the risk of zoonotic disease transmission from animals to humans. They also reduce the need to treat animals with antimicrobials, helping to preserve the efficacy of these important medicines for both animals and humans. They are, therefore, a vital part of the toolkit of alternatives to antimicrobials and underpin efforts to protect One Health by minimising development of AMR. Accordingly, the UK national Action Plan on AMR (2024-29) highlights efforts to increase vaccine uptake and includes commitments to fund and deliver innovative scientific research to develop vaccines, diagnostics, and alternative therapies which meet UK and global needs.

The demand for veterinary vaccines is anticipated to increase in the future, with new disease challenges linked to a changing climate, greater interface between wildlife and domesticated animals and between people and animals, and the increased global movement of people, animals and animal products. These drivers sit alongside the increased global demand for intensive livestock production to feed a growing population.

Vaccines complement broader disease prevention and control tools, such as improvements in health and disease resistance through advances in genetics, nutrition, husbandry and biosecurity, and novel therapeutics such as phage therapy. The role of vaccines will evolve and change alongside these other pillars of animal health and will differ between each disease and animal species.

The importance of veterinary vaccines and their essential role in ensuring animal and public health is recognised globally, as highlighted by numerous strategies and initiatives led by international organisations. These include the recent United Nations (UN) Political Declaration on AMR which committed Member States to “ensure that by 2030 animal vaccination strategies are defined with an implementation plan…according to national contexts and based on scientific evidence”, as well as to “…promote the timely supply of quality and affordable essential veterinary medicines, vaccines and diagnostics…”. Both the World Veterinary Association (WVA) ‘essential medicines’ list for food-producing species and the World Small Animal Veterinary Association (WSAVA) ‘essential medicines’ list for cats and dogs include vaccines. The WVA has also published a position statement on vaccine preparedness encouraging national veterinary services to develop vaccine strategies. The World Organisation for Animal Health (WOAH) published a 2015 report and 2018 report on the prioritisation of diseases for which vaccines could reduce antimicrobial use and recently issued a technical paper that sets out common global challenges and potential actions for the 2025 General Session of Member States. 

Concerns over vaccine availability

Vaccine availability challenges were first raised in the UK by the sheep sector, but subsequent engagement with wider government and animal health industry stakeholders indicated the problem extends to vaccines for other species.

Over the past two years the VMD hosted two roundtable discussions to better understand the causes of these issues and to explore potential solutions, convening attendees from across the animal health sector including pharmaceutical industry, wholesalers and prescribers of medicines, government, farming and companion animal groups. The VMD also surveyed vaccine marketing authorisation holders (MAHs) to obtain feedback on vaccine shortages and the related drivers.

These activities aimed to help better understand the issues impacting vaccine availability and the differing roles and responsibilities of stakeholders within this. They promoted co-ownership of the problem statement and associated actions, and recognition that collaborative activity across all stakeholders will be required to address this multifaceted problem. 

The feedback from this engagement defined two key issues:

1. supply not meeting demand for some existing vaccines and
2. concerns over a lack of development and innovation for new vaccines to fill existing and emerging therapeutic gaps.

The causes and drivers of these issues, as described by stakeholders, are outlined in more detail below.

Key Issue 1: Supply not meeting demand for existing vaccines

Many factors influence the availability of vaccines. The process of product development from the initial research concept to commercialisation and use of that authorised vaccine in an animal is a complicated process, with multiple potential points of failure. Figure 1 illustrates the many steps in this development process, alongside the various potential influencing factors that can positively or negatively impact this development process and the availability and subsequent uptake of a vaccine.

Figure 1: The process from initial vaccine research and development through product authorisation and manufacture, product distribution and sale, vaccine prescription to final use in an animal. Potential influencing factors that can affect vaccine availability and uptake include social and economic influences, disease pressure, competing demands, trade agreements, and usage policies.

Supply issues arise when the demand for a veterinary vaccine exceeds the volume of product available. In some cases, this is an absolute shortage, where vaccine demand outstrips vaccine production. In other scenarios apparent shortages result from issues in the distribution of available vaccine stock.

Mismatch between vaccine supply and demand may arise due to disease outbreak or disease fluctuation, for example due to disease seasonality. This may be exacerbated by insufficient availability of data on disease occurrence and animal populations, lack of models for predicting disease occurrence, and insufficient feedback mechanisms between end users and the MAH to signal upcoming changes in demand.

The likelihood of such under production of vaccines is heightened because manufacturers aim to closely match supply with demand, to avoid having to dispose of unwanted product. In addition, the shelf life of vaccines is limited which disincentivises manufacturers and distributors from maintaining stockpiles of product to act as a buffer for unanticipated surges in demand.

When unexpected vaccine demand occurs, there is low flexibility in the manufacturing sector to respond. In the recent survey conducted by the VMD, 20% of MAHs reported a time delay of 7-12 months, and 20% a delay of 1-6 months to enhance their production.

As with all medicines, the majority of vaccines on the UK market are manufactured outside the UK and many are manufactured to serve markets in multiple countries. The UK market is therefore vulnerable to issues impacting the successful transport of these vaccines (for example maintenance of the cold chain) as well as to competing demands from other countries. Disease outbreak and increased demand for vaccines in other countries may therefore impact vaccine availability in the UK. As outlined below, there are global and national efforts underway to ensure vaccine availability; and close collaboration with other authorities is required to identify opportunities for synergy, and to ensure these initiatives do not have any negative impacts on availability in the UK. 

Globally there is a shortage of vaccine manufacturing capacity, and veterinary vaccines also compete with human vaccine production demands. Veterinary vaccine production utilises some of the same components as the human vaccine production sector and, in some cases, the same production sites. This can also present opportunities, as advances in vaccine technology benefit both human and veterinary sectors. It will be important to keep this One Health perspective when exploring solutions to availability challenges.

In some incidences vaccine shortages have arisen due to issues with manufacturing causing delay in vaccine production or inability to supply product to the market due to failures in product specification at the time of batch release. The manufacture of vaccines is a complex biological process, sensitive to small fluctuations in production conditions, in which issues can therefore arise, leading in the worst-case scenario to batch failure where the batch must be discarded and production restarted from the beginning. Some vaccines are only produced by one MAH, and this lack of plurality in production leaves the market very vulnerable to any issues with production or supply.

The long production time required for vaccine manufacture can hinder the ability of manufacturers to respond rapidly to fluctuations in demand. Manufacturers also schedule batch production months in advance, so when issues in production such as batch failure take place, replacement production may be delayed as manufacturing plants are already committed to other production lines, or simply not undertaken due to loss of profitability.

The move in recent years towards streamlining of product manufacture, while benefiting efficiency and lowering production costs, has resulted in production chains being increasingly vulnerable to interruption. Lack of diversity in sources of production elements, coupled with the international nature of production chains, where production processes are site-specific, and sites are located in different countries and in some cases different continents, also leads to greater production vulnerability. Production of active substances has increasingly been concentrated in a few countries, which again presents a supply chain vulnerability.

Knowledge gaps remain regarding the dynamic detail of shortages, including which specific vaccines are affected, for which species and the exact causes and impacts on a case-by-case basis. Quantification and assessments of causality of individual shortages are required to ascertain which drivers are common across products, and to prioritise and measure success of proposed actions. Better data are required on the immediate and longer-term impacts of unmet vaccine needs on animal health and welfare, the wider economy, and One Health.

Key issue 2: Innovation for new vaccines to fill existing and emerging therapeutic gaps

Feedback from stakeholder engagement has indicated concerns that there will not be effective new vaccines available to meet existing therapeutic gaps and future disease threats. It is currently unclear whether these concerns are warranted or if they reflect insufficient awareness of current research and development (R&D) activities, many of which are not in the public domain.

It is essential that the UK needs for development and manufacture of novel vaccines for existing, new and emerging diseases are met. The recent outbreak of Bluetongue Virus (BTV3) in the UK, where an emergency vaccine authorisation procedure was implemented by the VMD, working closely with policy leads in Department of Agriculture, Environment and Rural Affairs (Defra), to ensure farmers have access to a suitable vaccine, illustrates this risk.

In addition to novel vaccines, there is a role for novel technology which can address some of the challenges in ensuring vaccine supply can meet demand. For example, improved vaccine stability and shelf life, or more flexible production methods such as vaccine platform technology that can be adapted quickly to changing viral strains.

The Biotechnology and Biological Sciences Research Council (BBSRC) Veterinary Vaccinology Strategy, published in 2016, outlined UK research priorities informed by a survey of UK veterinary vaccine needs. This highlighted the lack of vaccines for certain important diseases, as well as a need to optimise existing vaccines to address limitations such as limited efficacy against changing pathogen strains; slow onset and short duration of immune response; poor stability; expensive adjuvants; inability to distinguish between vaccinated and infected animals; and limitations of vaccine delivery mechanisms.

Significant investments have been made to address these research gaps and the wider global priorities for innovation identified by initiatives such as the European Union (EU) funded Strategic Alliance for the Coordination of Research on the Major Infectious Diseases of Animals and Zoonoses (STAR-IDAZ) International Research Consortium on Animal Health. Established in 2011, STAR-IDAZ aims to accelerate the development of new and improved animal health strategies for major animal diseases and cross-cutting health issues affecting livestock production, including zoonoses.

The unmet vaccine needs identified through such initiatives are often challenging to address, and the time to translate initial research findings into commercially viable solutions can take years. Stakeholder concerns may reflect that advances emerging from these prioritisation exercises and the resultant research are not yet evident to relevant animal sectors or indeed are not yet public knowledge. New product development underway by manufacturers may remain under commercial confidentiality until the point of commercialisation.

However, over the past decade, new priorities, challenges and unmet needs may have emerged. For example, the need for alternative methods of control, such as vaccination, to counter increasing levels of parasiticide resistance has been highlighted. It will be important to gain an updated landscape of UK priorities to contextualise stakeholder concerns, and to map the significant body of ongoing research internationally across the previously identified needs to update R&D gaps if necessary. 

In addition to early-stage research, it is vital to ensure that innovation can be translated into commercially available and viable products. Globally there is a gap in the capacity to translate scientific discoveries into solutions for the most challenging, emerging, and urgent infectious diseases. There is limited bandwidth of large commercial manufacturers for early manufacturing process development and feasibility studies, particularly for products that are likely to offer less return on investment, so there are constraints on the developmental pipeline for veterinary vaccines.

Vaccine uptake impacts availability

Adequate uptake of currently authorised vaccines and anticipated uptake of novel vaccines is essential to guarantee the necessary market pull to incentivise industry to manufacture these products. There are many factors that influence vaccine uptake, including government and production sector policies on use, price point of the commercialised vaccine, and socio-economic factors such as the economic pressures on livestock producers and cultural acceptance of new technologies by animal keepers and consumers of animal products.

The veterinary medicines sector in the UK is a private industry, in which developing and bringing vaccines to the market is a commercial decision. Ultimately companies need to make a return on their investment in product development and manufacture through their sales. Livestock production frequently operates at low profit margins, which may impact the ability of animal keepers to invest in purchasing vaccines. Vaccine uptake may be impacted by misinformation circulating informally for example on social media.  These factors in turn influence company manufacturing strategies, and their willingness to innovate and to market products in the UK.

Guidance has been developed to signpost animal sectors on appropriate use of vaccines. The Responsible Use of Medicines in Agriculture Alliance (RUMA), an independent non-profit group representing organisations from across the UK livestock supply chain, has published a range of guidelines on vaccination. Similarly, the National Office of Animal Health (NOAH), the trade association representing the UK animal health industry, has published guidance on vaccination. Both RUMA and NOAH offer overarching and species-specific guidance on vaccination. Additionally, the British Small Animal Veterinary Association (BSAVA) publishes core and non-core vaccine recommendations for cats, dogs, ferrets and rabbits.

Uptake of vaccination is also influenced by both government and sector led policies. Vaccination for certain diseases is prohibited without a Defra licence. For example, use of vaccines for Classical Swine Fever and Foot and Mouth Disease, where use of these vaccines can result in loss of a countries disease free status and therefore impact trade.  Where available, Detecting Infected Amongst Vaccinated Animals (DIVA) tests can help mitigate such trade impacts. Defra works with livestock sectors to develop policies on vaccine use, for example joint industry and cross government vaccination taskforces have been created for avian influenza and for BTV3, which review vaccination costs, benefits, trade impacts, and practicalities of different surveillance options.

Conversely, vaccination against rabies, a zoonotic viral disease, is mandated for dogs, cats and ferrets imported into the UK. Sector bodies also recommend specific vaccination programmes to manage and mitigate the impact of disease and assure animal health and welfare. For example, the BHA requires horses to be vaccinated against equine influenza to be eligible to race. Egg producers belonging to the British Lion trade standard are required to vaccinate their birds against Salmonella enteritidis and typhimurium.

For diseases where it is unknown when or whether an outbreak may occur in the UK, and whether the national response will permit vaccination, the lack of a certain market acts as a disincentive to manufacturers. For some diseases this uncertainty can be mitigated by utilisation of a vaccine or antigen bank, for example, where control strategies rely on rapid sourcing of large quantities of vaccine, or where an unusual vaccine is needed that is not commonly available on the market. However, stored vaccines have a shelf life, may not be the correct type to protect against a disease incursion, and there is significant cost associated with maintaining stocks.

It is important that any plan to address vaccine availability concerns considers what specific policies are applicable, how these influence the pull factors for vaccine production, and that solutions take these factors into account.

National and regional efforts to ensure vaccine availability

There are initiatives underway both nationally and internationally across governments, animal production and pharmaceutical sectors, and research bodies and funders to tackle the issue of vaccine availability. Going forward, future activity will need to consider and build on this existing landscape, including exploring whether approaches employed elsewhere could benefit the UK.

Enabling regulation

It is important that regulation acts as an enabler for manufacturers seeking to bring new vaccines and new vaccine technology to the UK market, while assuring the quality, safety and efficacy of these products. The UK Veterinary Medicines Regulations 2013, as amended (VMR) support novel products and technologies.  For example, they permit the use of multi-strain dossiers for inactivated vaccines, vaccine antigen master files, and more recently vaccine platform technology. There is provision to amend the application fees and data requirements for products under exceptional circumstances, such as in the face of disease outbreak. In addition, the VMD offers scientific advice to companies seeking marketing authorisations for new products to facilitate the regulatory process. The VMR also facilitate the use of alternative products where there is no suitable UK authorised product available, including permitting special imports of products from outside the UK and the use of autogenous vaccines. The recent revision of the VMR also provided a new legal basis to require MAHs to provide early warning of shortages of their products.

The VMD collaborates closely with counterpart veterinary medicines regulators in other countries, working together to share intelligence and explore opportunities for mutual benefit. From this collaboration, the UK has opened up a new simultaneous review procedure with Canada, New Zealand, Switzerland, and Australia for manufacturers seeking product authorisation in multiple jurisdictions. The aim is to increase the attractiveness of the UK market for new products.

There have been efforts by other jurisdictions to address vaccine availability, for human and veterinary vaccines, which may be of utility for the UK. For example, a European Medicines Agency (EMA) taskforce has proposed solutions, largely regulatory, to shortages of human vaccines within the EU. These include developing a list of medicines for which shortages are most critical, developing associated shortage reporting criteria, mitigations and sanctions and improving communications. A proposal focused on veterinary medicines is anticipated for publication later in 2025. The EU has also recently proposed a Critical Medicines Act that would offer an industrial policy toolbox to reduce critical human medicine shortages and increase security of supply in the region, encouraging diversity of supply and favouring manufacturing within the EU. 

Shaping innovation

Likewise, there have been concerted international efforts to identify unmet needs, map existing research, and stimulate new research to address these challenges.

The STAR-IDAZ International Research Consortium on Animal Health publishes annual reports detailing an extensive list of research projects, programmes, consortia and collaborations. STAR-IDAZ is informed by DISCONTOOLS, a scheme to identify the gaps in knowledge to speed up the development of new DISease CONtrol TOOLS (diagnostics, vaccines and pharmaceuticals) and reduce the burden of animal disease.

Other examples of initiatives to stimulate and support innovation include the International Veterinary Vaccinology Network (IVVN), an international community of over 2,300 members working together to develop improved vaccines for livestock and zoonotic diseases, the Bacterial Vaccines Network (BactiVac), which brings together members based in academic, industry and policy sectors to accelerate the development of vaccines against bacterial infections relevant to low and middle income countries (LMICs), and the Immunological Toolbox, a repository of antibodies, other reagents and resources to promote veterinary immunology research.

To bridge the gap between early-stage research and commercialisation, the Centre for Veterinary Vaccine Innovation and Manufacturing (CVIM) has launched as a joint initiative between the BBSRC, the Foreign, Commonwealth and Development Office (FCDO) and the Bill & Melinda Gates Foundation. Recognising the need for specialised expertise and facilities to scale up novel vaccines cost-effectively, CVIM aims to accelerate the development and deployment of vaccine technologies for neglected and emerging diseases of livestock. This includes zoonotic diseases that pose a threat to public health.

While several recent funding initiatives have focused on diseases of high impact in LMICs, recognising the importance of mitigating transmissible disease in endemic areas, the technology and knowledge developed through these investments benefit the global community and could provide solutions that also translate to UK needs.

Considerable investment has also been made to stimulate innovation directly applicable to UK priorities. As examples, BBSRC and Defra have recently announced a £12.5 million funding call to support the development of next generation veterinary vaccine technology platforms, and substantive investment has been made by Defra towards developing a vaccine and associated DIVA test for bovine tuberculosis in cattle.

It is evident that there is a body of previous and ongoing efforts to assure access by vets and animal keepers to the vaccines required to maintain animal health. However, the concerns raised by stakeholders indicate that further action is required to address the issues currently impacting availability.

Vision

We need safe and effective vaccines available at the right time to prevent disease in our animal population and minimise use of antimicrobials.

This requires supply to meet demand for existing products and for the scientific, regulatory, policy, manufacturing, and distribution infrastructure to enable rapid development and use of new and innovative products in response to changing disease threats. This will support control of existing disease challenges and help ensure that the UK is on the front foot to prevent exotic disease incursions, particularly in response to climate change.

This Statement of Intent aims to illustrate how work by stakeholders across the animal health sector in the short to medium term will make progress towards this wider vision, by:

• establishing and supporting collaborative multistakeholder networks both nationally and internationally that enhance awareness and oversight of vaccine availability issues;
• implementing effective mechanisms to provide timely and accurate communications of when supply will not meet forecast demand for ‘critical vaccines’
• promoting fair distribution and uptake of available product and supporting sourcing of suitable alternative products
• laying the foundations to support and stimulate the pipeline of innovation capable of delivering future products to meet emerging and novel diseases, including encouraging new technology that addresses current challenges in manufacturing, supply and administration of biological products and
• better understanding the current manufacturing landscape and identifying what incentives or levers might be available to facilitate future growth and diversification of manufacturing to increase the resilience and flexibility of production.

A Strategic Framework for Multi-Stakeholder Action

To realise this ambition, stakeholders agree that work is required under four interconnected strategic themes (figure 2).

Figure 2: The four strategic themes and their associated workstreams which are outlined in this Statement of Intent. The Work in Partnership theme cuts across the Improve Supply and Uptake, Support Innovation, and Review Manufacturing Landscape themes.

The ‘Improve Supply and Uptake’ theme aims to address the current mismatch between supply and demand of existing products, ensure best use is made of products when available and drive further vaccine uptake where appropriate to optimise animal health. The theme of ‘Support Innovation’ will facilitate the pipeline of new products required to address new and emerging therapeutic gaps. The ‘Review Manufacturing Landscape’ theme will evaluate current manufacturing capacity and capability to provide more stable supply of current products and support the longer-term innovation pipeline.  These themes are underpinned by the need to ‘Work in Partnership’ with stakeholders both nationally and internationally to promote awareness of the issue, collaboration, action and global influence.

Workstreams and associated short- and medium-term activities and their desired impacts have been identified under each theme. These activities will run in parallel, and feedback loops will ensure outcomes and learnings will be shared across the themes to ensure join up and inform subsequent activities. The activities outlined will be refined and augmented throughout the development of a detailed multi-stakeholder UK Action Plan by representatives from the pharmaceutical industry, distributors, prescribers and suppliers of medicines, government, farming and companion animal groups.

Work in Partnership

Progress towards our ambitious vision will require co-ordinated action from stakeholders across government, pharmaceutical companies, product distributors, academia, researchers, vets, animal keepers and the wider animal health sector, with clearly defined roles and responsibilities. National progress will also be influenced by international activities, emphasising the need to understand the global landscape of opportunities, threats and potential partnerships. This is reflected in the four proposed workstreams under this theme.

The first workstream will convene stakeholders to collaboratively develop a 5-year multi-stakeholder UK Action Plan and its associated governance structure and key performance indicators. This UK Action Plan will set out in further detail the workstream activities required to deliver the strategic themes set out in figure 2, alongside agreed ownership of milestones and deliverables, and show how these contribute to the overarching vision. Publication of this UK Action Plan will be a critical tool in both indicating stakeholder commitments and driving its implementation. Due to the urgency of some of the vaccine availability issues currently faced, priority activities will commence alongside the development of this action plan where possible. The success of this initiative depends on action from all impacted stakeholders. Therefore, while the VMD will champion the development and co-ordination of this strategic approach, we will expect and challenge other sectors to own and deliver their own workstreams and activities.

Alongside this, a further workstream is required to raise awareness of the importance of veterinary vaccines and the challenges of ensuring availability, highlighting for example the essential role of veterinary vaccines in safeguarding animal health and food security as well as helping address One Health challenges such as AMR and biosecurity. Associated activities will include determining alignment opportunities with wider strategies for example: the Animal Health and Welfare Pathway in England which aims to help farmers address certain priority diseases; the Land Use Framework which considers the balance between food security, nature preservation and clean energy; the UK national Action Plan on AMR (2024-29); and the UK Biological Security Strategy which aims to strengthen the UK’s vaccine capability, capacity and resilience for priority pathogens of pandemic potential. Other activities will include convening stakeholders and active dissemination of action plan initiatives and successes. Greater awareness of the diverse role and impacts of veterinary vaccines will galvanise action to improve availability, leveraging political, strategic and financial opportunities.

Many of the challenges to vaccine availability and innovation are felt globally, emphasising the need to collaborate internationally. Work is required to map the international landscape of vaccine initiatives, to understand where such activities could bolster or hinder UK efforts. Networks of counterparts in other countries would identify where join up could enhance national actions, for example by providing greater purchasing levers, or aid in sourcing of alternative products. Such networks could also help identify vulnerabilities in global supply networks and associated mitigation options.  Utilisation of joint regulatory pathways with trusted partners will help attract new products to the UK market.

Finally, wider global initiatives to enhance vaccine availability and access will amplify UK actions. Therefore, a workstream should support multilateral agencies, for example WOAH in their work to implement the UN General Assembly recommendations to enhance vaccine uptake, and the work of other global schemes to enhance access to quality vaccines.

Improve Supply and Uptake

This strategic theme concentrates on mitigating supply issues for existing products through improved communications, whilst laying the foundations for more resilient and transparent supply and uptake of future products.

The first workstream will address the knowledge gaps required to inform actions. This includes research to better understand the causes and scale of existing supply issues, and to determine where there are recurring issues affecting multiple products.  This will guide identification, prioritisation and ownership of short-term mitigations and longer-term solutions. Research to quantify the health and economic impacts of unmet veterinary vaccine needs will evidence their importance and stimulate action. Further, gaining an understanding of the barriers and levers to vaccine uptake, including behavioural insights, and of the current disparity in perception of vaccine needs between stakeholders will help inform the design of future communication and vaccine programmes and build confidence in the associated market.

An important activity under this workstream will be to define and agree ‘critical vaccines’, for which shortages are of greatest significance and impact in the UK for example in terms of economic or One Health aspects, and to map the associated demand, including seasonality. This information will inform improved forecasting of vaccine requirements. Improved communication and mitigations to address supply shortages will be prioritised for these critical vaccines.

The workstream to enhance supply chain transparency aims to improve communication throughout the vaccine supply chain to expedite awareness of supply issues amongst impacted stakeholders, and guide the most appropriate use of available product. Short-term activities will include raising awareness of the new legislative requirement for MAHs to report medicine shortages and work to standardise associated reporting criteria and timelines. Publication of information on shortages, including causality and anticipated resolution dates, will be prioritised for critical vaccines. Alongside this, stakeholder dialogue platforms will be established drawing together representatives from pharmaceutical companies, wholesalers and distributors of products, the livestock and companion animal sectors, the veterinary profession, and government. These will enable collective determination of the best way to manage identified shortages, utilise limited stocks, handle communications and implement mitigations, recognising that approaches will need to be tailored according to the vaccine, species and disease affected. Currently supply information is largely received from MAHs and end users.  Identification of additional sources of supply intelligence, for example wholesale dealers and buying groups, and establishing a process for receipt and collation of this data will aid awareness and inform future activities. In the longer term there is ambition to establish a public database for publishing information on the availability status of all authorised veterinary medicines.

There will be a further workstream to review mechanisms to safeguard supply of critical vaccines, such as requirements for MAHs to create shortage prevention and mitigation plans. Consideration of these policies alongside the outputs from the other workstreams in this theme will help determine whether it would be beneficial to implement similar requirements in the UK.

Where a therapeutic gap exists or when vaccine supply is interrupted it is important that alternative products can be sourced. Enhancing awareness of the existing Special Import Scheme (SIS) and Autogenous Vaccine Authorisation (AVA) provisions, highlighting when their use is appropriate as well as their associated limitations, will facilitate utilisation of these routes. To further support this workstream, other routes to increase visibility of potential alternative products for critical needs will be explored, for example the stakeholder dialogue platforms. Continued regulatory prioritisation, such as for batch release, SIS and AVA applications for critical needs, will be implemented where appropriate. 

Uncertain markets and low uptake of some vaccines are cited as barriers to marketing products. Therefore, a workstream to enhance market pull is required to provide confidence to MAHs that they can achieve return on investment, thereby improving availability and encouraging innovation. Collaboration of production sectors with counterparts in other regions or countries, as outlined in the ‘Working in Partnership’ theme, could increase their sector pull in terms of procurement, in addition to exploring the value and feasibility of collective and guaranteed purchasing schemes or holding of buffer stock. These approaches could help de-risk production for pharmaceutical companies, facilitate more stable supply and provide rolling reserve stock to enable faster response to unexpected demand. Alongside this, work is required to ensure subsequent fair allocation and uptake of available product.

The workstreams and activities described under this ‘Improve Supply and Uptake’ theme should improve stock control of existing products in the short term. This will be complemented by work to augment the pipeline of new product innovation and manufacture.

Support Innovation

The development and commercialisation of new products is a longer-term ambition than can be achieved through the initial proposed 5-year action plan. However, the ‘Support Innovation’ theme aims to facilitate the future product pipeline by helping target activities and funding towards prioritised needs and challenges, encouraging the development of new technologies and ensuring that regulation acts as an enabler.

The first workstream will encourage novel products and technologies. Mapping and ranking both current therapeutic gaps (where no authorised or commercialised product exists) and potential future disease challenges, will confirm the UK priority needs. This process will utilise and build on work previously undertaken, for example the priorities highlighted in the BBSRC veterinary vaccines strategy. These priorities will be communicated to discovery phase researchers and to funders of innovation, so that vaccine pipelines and funding can be focussed on these priority diseases, and any challenges with associated product development can be identified. Action is also needed to create the right environment to facilitate innovation from initial idea through to commercialisation. Other activities in this workstream will therefore aim to convene innovators with the wider animal health sector, including policy makers, regulators and end users, at an early stage to help shape target product profiles. Stakeholder dialogue platforms will play a role in enhancing communication between sectors on disease forecasting and options for vaccine deployment. Opportunities to encourage better linkages with human vaccine and Engineering Biology research, funding and regulatory networks will also be explored. 

There is a need to optimise investment in vaccine R&D for new vaccines as well as novel technologies for vaccine development and manufacture. This investment should stimulate the pipeline of products, facilitate more agile future adaptation in response to changing disease risks and vaccine requirements, and promote more scalable vaccine production. There are already a number of funders of such research, alongside a growing interest in the capabilities of Engineering Biology, as outlined in the National Vision for Engineering Biology. Activities under this workstream will include raising awareness of funding initiatives and influencing future strategies and investment opportunities if necessary to ensure they are targeted towards identified priorities. Other activities will encourage investment to convert and scale research outputs to commercial products, including exploring opportunities offered by existing facilities that bridge the transition from innovation to manufacture (for example, CVIM). 

Regulation must continue to enable innovation whilst providing the necessary safeguards of assuring appropriate product quality, safety and efficacy. Activities will raise awareness of how innovation is supported by the VMR, such as the recent introduction of multi-strain dossiers and vaccine platform technology, and the ability to expedite regulatory processes for products that meet priority needs. Creation of an innovation hub will ensure that the regulatory framework and guidance keeps pace with innovation and is sufficiently flexible regarding adoption of new technologies.

Review Manufacturing Landscape

The ‘Review Manufacturing Landscape’ theme aims to evaluate the current UK manufacturing landscape and potential opportunities for longer term growth to support more resilient and responsive future production of vaccines to meet changing UK needs.

The first workstream will address knowledge gaps. This includes evaluating the current scope and scale of UK veterinary vaccine manufacture and product release activities, associated infrastructure and workforce, alongside the capability to expand or pivot to production of critical vaccines in future. This work will identify barriers and whether incentives to increase UK manufacture are required, as well as estimate the potential impacts of any future investment or actions in this area, to help guide next steps.

Alongside this there will be a workstream to determine and support mechanisms that could enhance flexibility in production. There are commonalities between the facilities, processes and skillsets required for human and veterinary vaccine manufacture. Work is required to identify any possible future alignment or reciprocal pivot opportunities with human vaccine R&D, manufacturing facilities or personnel, and to understand the benefits and risks, and barriers to such an approach. 

Next steps

The next steps in this initiative will be to convene stakeholders from the pharmaceutical industry, distributors, prescribers and suppliers of medicines, government, farming and companion animal groups, to determine the process through which the underpinning 5-year multi-stakeholder UK Action Plan will be developed, governed, and implemented.  This will require determination and agreement of an appropriate governance structure, steering and working groups, deliverables, milestones and key performance indicators, ownership and timelines, as well as metrics of success. The aim is to publish this agreed UK Action Plan within the next year.

Acknowledgements

Representatives from the following organisations participated in engagement activities that informed and discussed this Statement of Intent:

Animal Medicines Training Regulatory Authority (AMTRA); Animal Health and Welfare Board for England (AHWBE); British Cattle Veterinary Association (BCVA); British Equine Veterinary Association (BEVA); British Small Animal Veterinary Association (BSAVA); British Trout Association (BTA); British Veterinary Poultry Association (BVPA); Covetrus; NI Department of Agriculture, Environment and Rural Affairs (DAERA); Department for Environment, Food & Rural Affairs (Defra); National Office of Animal Health (NOAH); National Sheep Association (NSA); Pig Veterinary Society (PVS); Royal College of Veterinary Surgeons (RCVS); RCVS Knowledge; Responsible Use of Medicines in Agriculture Alliance (RUMA); RUMA Companion Animal & Equine (RUMA CA&E); Sheep Antibiotic Guardian Group; Scottish Government; Sheep Veterinary Society; Veterinary Medicines Directorate Non-Executive Board; Vetpol; and Welsh Government.