The current approach to global vaccine research and development (R&D), manufacturing, and distribution has greatly expanded routine immunisation, achieving substantial reductions in disease burden over recent decades and helping to save lives and protect economies. Yet this approach has limitations in a world where new pathogens emerge unpredictably and regional needs are increasingly diverging from global priorities.
Regionalised vaccine manufacturing offers a path forward; it can enable equitable access for regions, alignment with regional priorities, and rapid response to outbreaks. There are evolving challenges that make regionalised vaccine manufacturing necessary for both health emergencies and routine immunisation. The geopolitical landscape has shifted dramatically. Countries and regions are increasingly aware of the vulnerabilities inherent in relying on centralised vaccine production hubs and the political interests that may shape access to scarce resources. Many countries want more self-sufficiency in vaccine manufacturing, given the lessons of the COVID-19 pandemic when there were considerable delays in accessing COVID-19 vaccines due to supply constraints and export bans.
With increasingly constrained donor funds for health, global procurement mechanisms must prioritise the most efficient allocation of financial resources to meet global demand, meaning some local health needs are unable to be met. Regions, too, want their own solutions to mobilise greater investment in health to fill these gaps.
There are structural challenges as well. R&D, innovation, and intellectual property rights for vaccines are largely concentrated in high-income settings, limiting equitable distribution of new technologies and leaving some regions without the tools to tackle endemic diseases. To address these gaps, regions need to cultivate skilled workforces and strengthen regulatory frameworks to support regionalised vaccine manufacturing.
The shift to regionalised vaccine manufacturing is already underway and will not stop. Recent commitments by international and regional bodies, as well as financing and technical support organisations, show regions and stakeholders are not only acknowledging the need for regionalised vaccine manufacturing but are also setting out concrete strategies, policies, and investments that empower regions to sustainably produce the vaccines they need to address regional health priorities.
Examples of recent commitments to regionalised vaccine manufacturing
Africa Centres for Disease Control and Prevention (CDC) initiative
In 2024, Africa CDC announced an ambitious initiative aiming to create a US$50 billion medical market focused on securing Africa's health future. This plan goes beyond procurement to support the development of infrastructure, skills, and sustainable manufacturing ecosystems capable of meeting the continent's vaccine and health technology needs.
2024 Rio de Janeiro Declaration of the G20 Health Ministers
The 2024 Rio de Janeiro Declaration of the G20 Health Ministers at the G20 in Brazil welcomed the establishment of a Coalition for Local and Regional Production, Innovation and Equitable Access centred on voluntary cooperation to promote access to vaccines, therapeutics, diagnostics, and other health technologies for neglected diseases.
Pan American Health Organization (PAHO) support for innovation and regional production of health technologies
Countries of the Americas, coordinated through PAHO, agreed in 2024 on a series of measures to incentivise innovation and bolster regional production capacity of health technologies, including vaccines. This commitment is part of a broader strategy to reduce dependency on external supply chains and ensure that regional public health needs are met promptly.
Association of Southeast Asian Nations (ASEAN) vaccine security plan
The ASEAN Vaccine Security and Self-Reliance Strategic and Action Plan (2021–25) sets out a roadmap for member states to enhance regional vaccine security. By identifying priority areas for cooperation, sharing regulatory best practices, and supporting manufacturing hubs, ASEAN seeks to reduce vulnerabilities and improve access to essential vaccines.
Gavi, the Vaccine Alliance's African Vaccine Manufacturing Accelerator (AVMA)
Through the AVMA Gavi is helping to catalyse the development of sustainable vaccine manufacturing ecosystems in Africa. This initiative supports capacity building, technology transfer, and financing mechanisms, aligning global immunisation goals with the continent's specific health priorities.
European Commission's Team Europe Initiative
The Team Europe Initiative focuses on manufacturing and access to vaccines, medicines, and health technologies in Africa. By leveraging European expertise and resources, this initiative promotes regional manufacturing capabilities, strengthens local regulatory frameworks, and fosters collaborations that address region-specific health challenges.
US International Development Finance Corporation (DFC) support
The US DFC's Surge Financing Initiative and strategic investments in global health security underscore the importance of financial tools and partnerships in expanding manufacturing capacity. By channelling investment and risk-sharing mechanisms into local production efforts, the DFC supports regions in taking the lead on their own health priorities.
The journey to sustainable regionalised vaccine manufacturing—alongside an evolving global vaccine ecosystem—is likely to be a multi-decade effort. However, if political leaders do not tackle the most urgent priorities for regionalised vaccine manufacturing soon, political and financial challenges may leave regions and the world even worse off in a new disease outbreak. Investments in strengthening and expanding facilities for regionalised vaccine manufacturing and decisions to undertake regional pooled procurement are both necessary, but much more is required. A concerted, coordinated, and aligned effort to accelerate progress is needed.
The Regionalized Vaccine Manufacturing Collaborative (RVMC) is an initiative set up to catalyse the growing momentum for a regionalised approach to vaccine manufacturing. As its Executive Committee and Secretariat, we are committed to supporting this crucial shift towards regionalised vaccine manufacturing through global and regional collaborations, data-driven decision making, and advancing effective platforms to align investors. The RVMC will launch its full vision for regionalised vaccine manufacturing in April 2025 and set out a more detailed analysis of what it will take to build and sustain strong and healthy regional vaccine manufacturing ecosystems.
To advance regionalised vaccine manufacturing, we propose three near-term priorities. Starting with these priorities is essential because they involve important choices that could shape the wider environment for regionalised vaccine manufacturing and would result in more resources being committed.
First, political will needs to be translated into action. We have seen political support in many countries for building manufacturing sites, but governments need to start tackling the hard questions. How will they agree on which countries have production, and which procure vaccines? How is a region defined? Who will pay to develop and procure regionally produced vaccines over time, and how much financing will countries contribute themselves? How will they align around an appropriate mix of vaccine technology platforms so that the region is better protected? And how will agreements be developed for mutual support in and between disease outbreaks? Clear answers to such questions will pay dividends as future investments can be aligned to a more comprehensive, regionally agreed approach.
Second, sustainable vaccine markets need predictable demand. Pooling demand on a regional basis is a good first step towards defining a regional market for vaccines. Advanced purchase agreements and pooled procurement mechanisms are important strategies to ensure predictable demand while addressing affordability and sustainability challenges. But to focus their resources, manufacturers, investors, and technology partners need to know how the market will work. Finance and trade ministries must decide this. Will regional member states be incentivised or even obliged to purchase regionally produced vaccines? How do regions analyse, discuss, and agree an acceptable price premium for regionally manufactured vaccines? Does the region intend to introduce an advanced market commitment? And is there a plan to secure investment for R&D to address regionally unmet needs? Reaching agreement on these topics is essential for the emergence and sustaining of healthy markets for regionalised vaccine manufacturing. Securing demand will encourage investment and technology transfers into regions.
Finally, a strong regulatory environment is needed to facilitate timely access to regionally produced vaccines. The harmonisation of regulations within regions will allow the pooling of demand thereby increasing market size and providing opportunities for manufacturers to scale and reduce prices. Relevant regional and national health and regulatory authorities (NRAs) need to identify regulations that will enable regionalised vaccine manufacturing to thrive and seek parliamentary approval for these changes. Such regulations are likely to include product registration requirements, mutual recognition and reliance, clinical trial regulations, and pharmacovigilance requirements. Building on the approaches of the strongest existing NRAs and strengthening regulatory workforce capacity will also facilitate a robust regulatory environment across each region that can complement—and even accelerate—mechanisms such as WHO prequalification for vaccines.
Concerted and coordinated action from heads of state, senior policy makers, and international organisations to integrate regionalised vaccine manufacturing into national and regional health agendas is needed for vaccine ecosystems to better align with regional public health priorities. Success will depend on brave leadership and an unwavering focus on the twin goals of equitable vaccine access and health security. With collective resolve and timely action, a robust and regionally driven vaccine ecosystem can become a reality to safeguard all communities and strengthen global health for generations to come.