This white paper delves into the critical Learnings derived from the COVAX initiative, offering valuable insights for strengthening global pandemic preparedness and response frameworks. COVAX, with its unparalleled experience in orchestrating a worldwide vaccine rollout during the COVID-19 pandemic, encountered numerous challenges that significantly impacted the pursuit of equitable vaccine access. This paper meticulously examines these hurdles, the responsive measures undertaken by COVAX, and formulates key recommendations to guide future global health strategies.
This document is the culmination of an extensive internal review process, capturing the detailed learnings from COVAX partners. It is intended to serve as a foundational framework for COVAX’s active participation in crucial global dialogues concerning pandemic readiness and response. Accompanying this paper is an annex that comprehensively catalogs over 50 workstreams and innovative solutions that were developed during the pandemic to ensure the successful operation of COVAX. The annex details their impact and highlights ongoing challenges that must be addressed in future endeavors.
It is important to note that COVAX partners are also engaged in independent evaluations assessing the effectiveness of COVAX’s strategies, governance, and operational processes throughout the COVID-19 pandemic response. These evaluations will be published separately.
Introduction
The COVID-19 pandemic starkly illuminated the urgent need for enhanced global preparedness to confront public health emergencies of such magnitude in the future. Ensuring rapid and equitable global access to essential medical interventions—including therapeutics, diagnostics, and especially vaccines, which stand as the primary defense against vaccine-preventable diseases—is paramount. To create a more resilient and effective global health architecture capable of responding swiftly to pandemic threats and mitigating their impact, it is crucial to proactively identify and address potential barriers to equitable access.
COVAX, as the vaccine pillar of the Access to COVID-19 Tools Accelerator (ACT-A), was established at the onset of the pandemic with the core mission of facilitating access to potential COVID-19 vaccines for the most vulnerable populations worldwide, irrespective of their income levels. By uniting the expertise and resources of four leading institutions within the global vaccine ecosystem—the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance (Gavi), the World Health Organization (WHO), and the United Nations Children’s Fund (UNICEF)—COVAX aimed to safeguard lives and livelihoods and accelerate the end of the acute phase of the pandemic through equitable vaccine distribution. COVAX commenced global vaccine shipments in late February 2021 and has since delivered over 1.7 billion COVID-19 vaccine doses to 146 countries.
COVAX’s unique experience in managing a historic global vaccine rollout during a pandemic, including the significant challenges encountered, underscores the critical importance of incorporating key global governance, policy, and funding considerations into the design of future pandemic preparedness and response architectures. While the precise nature of the next pandemic threat remains unpredictable, these considerations are grounded in the most robust empirical evidence available to date. They must be regarded as realistic assumptions about global dynamics during any pandemic. Recognizing, anticipating, analyzing, and addressing these factors—and implementing necessary improvements and proactive solutions—is vital for global health security in advance of the next pandemic.
Key Learnings
1. Learnings on Equitable Access: An End-to-End Public Health Centered Solution is Essential
The Challenge
Achieving equitable access to medical interventions during a pandemic is not merely an ethical imperative; it is the most effective strategy to curtail the duration and overall impact of the emergency for all nations and individuals. However, securing vaccine supply and translating those vaccines into actual vaccinations requires a comprehensive, end-to-end solution, underpinned by robust investments across the entire value chain. This includes early-stage Research & Development (R&D), scaling up manufacturing capacities, negotiating procurement agreements, establishing consistent policy guidance, and developing robust operational, logistical, regulatory, and legal frameworks—extending all the way to delivering shots in arms. This holistic approach encompasses not only the vaccines themselves but also essential ancillary supplies, such as cold chain infrastructure, safe injection equipment, international freight and logistics, and in-country delivery resources, including Personal Protective Equipment (PPE) for healthcare workers.
A truly effective end-to-end solution must prioritize public health and the needs of the most vulnerable populations—high-risk groups, lower-income countries, and populations in humanitarian settings—at every stage. Implementing such a solution to rapidly and equitably reach billions of people across the globe simultaneously demands exceptional real-time planning and seamless coordination among all stakeholders involved in the value chain. Practically, this entails ensuring that the right supplies are allocated at the right times to those who are both in need and prepared to receive them. It requires providing tailored delivery support, equipment, and resources to all countries to facilitate effective rollout. Crucially, these supplies must be available, possess the appropriate characteristics for the specific setting, and arrive in the right countries, in the right quantities, and at the right times. Assisting countries in converting vaccines into vaccinations necessitates that all these processes are conducted in a predictable and reliable manner, to the greatest extent possible.
However, the most consistent element in a pandemic is its inherent unpredictability. Despite meticulous planning, working assumptions will inevitably shift. At the outset of the vaccine value chain, uncertainty prevails regarding R&D outcomes, with numerous candidates in various developmental phases and multiple manufacturing scale-up initiatives underway—all facing uncertain regulatory approvals and efficacy results, compounded by continuously evolving scientific understanding and data. Throughout the chain, epidemiological shifts, the progression of the pandemic, and their subsequent impacts on policy recommendations and optimal public health strategies will necessitate constant recalibration, affecting all operational aspects. Concurrently, the needs of countries and vulnerable populations must remain central, yet these too will be dynamic and diverse. Each country operates within its own unique and ever-changing political, cultural, and socioeconomic contexts, policies, legal and regulatory frameworks, evolving strategies, needs, and rollout plans. Reaching the most vulnerable populations in humanitarian, fragile, and conflict settings presents additional complexities. The imperative to deliver supplies, translate vaccines into vaccinations, and effectively protect those at highest risk everywhere must contend with each country and context’s unique logistical, infrastructural, and delivery system challenges.
Navigating this inherently uncertain environment demands sophisticated and agile stakeholder management and problem-solving capabilities, coupled with rapid decision-making processes. Success hinges on effective coordination, collaboration, information sharing, and transparent, real-time data accessibility across the entire value chain—particularly concerning countries’ needs and priorities—as well as clear protocols for managing data asymmetries from diverse sources. Furthermore, it necessitates building in robust fail-safes that account for inevitable global realities and ensuring that response mechanisms possess the resources, flexibility, and capacity to take calculated risks. These critical aspects are further explored in learnings 2 and 3 below.
The Response
The establishment and operationalization of COVAX necessitated the collection, analysis, and continuous communication of vast amounts of data and information from multiple sources. These included COVAX’s core partners, other global, regional, and national organizations, participating countries, and industry stakeholders. This encompassed data spanning the entire value chain—from R&D progress, policy guidance, vaccine portfolio development, regulatory status and advancements, allocation inputs, and country readiness assessments to transport logistics, administration and utilization, coverage and absorption rates, and more—all requiring real-time or near real-time updates.
COVAX’s ability to achieve large-scale delivery was rooted in its networked approach, leveraging the pre-existing expertise, resources, stakeholder relationships, and infrastructure of its core partners. These partners brought decades of experience working collaboratively to deliver vaccines at scale, particularly focusing on immunization programs for the most vulnerable populations in lower-income countries. This model allowed each organization to concentrate on its core competencies and established strengths, rapidly establish cross-functional teams and functions as needed, monitor and understand the evolving needs of lower-income countries, and draw upon the expertise of other relevant global actors. This ensured seamless hand-offs between each step of the value chain, eliminating critical gaps. The pre-existing relationships and established working methods among staff and teams were instrumental in COVAX’s rapid setup as a response mechanism during the emergency and its capacity to adapt and evolve as required.
This inherent familiarity enabled COVAX partners to collaborate effectively, swiftly establish cross-organizational workstreams, develop innovative mechanisms, tools, and processes, expand existing initiatives as necessary, monitor and understand the evolving needs of lower-income countries, consult and engage a diverse range of stakeholders, and make rapid decisions. This continuous evolution of the COVAX model ensured its ongoing fitness-for-purpose as working assumptions and policy targets shifted. Significant examples of this adaptability include the development and implementation of a dose donation model to address urgent supply shortages, consistently raising ambitions and fundraising targets to align with evolving global needs, and adapting to downstream gaps by increasing country-level support and funding when it became evident that sufficient global financing for delivery from other sources was lacking.
Recommendations
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Prioritize strengthening end-to-end capabilities during non-pandemic periods to ensure a resilient ecosystem is in place before an emergency. Countries must invest in fortifying their health systems and infrastructure, with a specific focus on response/surge capacity, emergency processes, and systems. Countries must be equipped to rapidly scale up operations during a pandemic or similar health emergency (e.g., surge healthcare worker capacity, pre-positioning health system infrastructure and supplies, developing potential deployment plans, etc.). The resources and pre-planning required for this surge capacity must not be underestimated. This dedicated response capacity must be underpinned by consistent and substantial investments in primary healthcare services, cold chain infrastructure, vaccine track and trace systems, human resources, and data monitoring systems, particularly in low-income countries. Simultaneously, regulatory readiness, harmonization, policy development, and related activities must remain a central focus of preparedness efforts.
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Integrate access for the most vulnerable into the pandemic architecture from the outset. This necessitates acknowledging that disparities in countries’ readiness levels, infrastructure, and capacity will inevitably exist when the next pandemic strikes. A successful response framework must be designed to navigate these disparities and minimize the access barriers they pose.
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Specifically, an equity-focused end-to-end solution must account for the disproportionate impact of such emergencies on hard-to-reach populations in fragile, conflict, and humanitarian settings. Response frameworks must be designed considering the unique contexts of these communities, where access to even basic services is often a challenge. Successfully reaching these groups requires understanding and overcoming the limitations of working outside traditional state-based architectures—limitations that are not unique to public health or emergency response but can be amplified during a pandemic. These barriers can be mitigated by incorporating humanitarian contingencies and waivers into various aspects of pandemic response architecture, including financing, risk management, liability, importation regulations, and other critical areas.
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To prevent duplication of efforts, maximize the impact of past investments, and increase the likelihood of a successful response, comprehensively map existing global health mechanisms, networks, expertise, policies, frameworks, and tools—and retain, incorporate, and evolve these as needed. This includes leveraging established innovations that have proven effective during COVID-19, such as Emergency Use Listing, model indemnification and liability agreements, and the No-Fault Compensation Scheme.
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To ensure end-to-end access can be prioritized from the very beginning of a response, sufficient resources with rapid disbursement mechanisms should be readily available for all aspects of the vaccine and ancillary product value chain—from R&D and procurement to in-country delivery—operating in parallel.
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Establish clear standards, processes, and expectations for rapid and agile end-to-end governance, decision-making, communication, transparency, and risk-sharing within a pandemic response mechanism, proactively, before a crisis strikes. These must be underpinned by pre-established frameworks for comprehensive and reliable information sharing, data transparency, and solutions for addressing data asymmetry—including data related to country demand, prioritization of specific pandemic response strategies, and other essential health interventions and services. These frameworks are crucial for coordinating preparedness efforts during non-pandemic periods but become absolutely fundamental during a pandemic response. During a pandemic, the work pace is rapid, technically and politically complex, and decisions must be made quickly based on the best available information. The buy-in of all stakeholders is essential for the successful implementation of the response.
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Set up processes and expectations—in advance—for systematic consultation and regular updates to all relevant stakeholders, particularly lower-income countries and civil society organizations, during both preparedness and response phases. Establishing clear guidelines for collaboration outside the pressured environment and power dynamics of an emergency will enhance buy-in from all stakeholders, further improving the effective implementation of response activities while also avoiding duplication of processes in a resource-constrained environment.
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Similarly, processes and expectations for transparency should be carefully considered in advance. Transparency must be a guiding principle. However, effective solutions must acknowledge the challenges posed by unreliable, constantly changing, or non-existent data and the reliance on numerous stakeholders to share this data. Solutions must also recognize and address the inherent tensions between the need for transparency, the urgency of action, and the necessity of stakeholder buy-in. Consultation with all stakeholders is key to inclusive decision-making, but in the complex and politically sensitive environment of a global emergency, differing views are highly likely. Reaching consensus can consume valuable time or lead to impasses, while acting proactively without consultation may discourage many actors from participating and sharing critical data and insights. In some situations, consensus may be unattainable. It is beneficial to have these discussions outside of an emergency environment. Careful consideration must be given to understanding needs, challenges, and competing incentives to identify potential gaps or areas for improvement and to manage expectations across the value chain regarding what information can and will be shared, how, with whom, when, and who ultimately makes those decisions.
2. Learnings on Nationalism and Hoarding: Anticipating and Mitigating Inevitable Behaviors
The Challenge
During a global crisis, particularly when uncertainty surrounds the availability of effective medical interventions, governments will prioritize the protection of their own citizens. As seen during both the 2009 H1N1 pandemic and the COVID-19 pandemic, wealthier governments utilized their resources to hedge against unknowns by placing orders for vast quantities of doses, effectively placing the majority of the world at the back of the queue. Similarly, both pandemics witnessed detrimental forms of nationalism impacting global supply chains, including export restrictions imposed by governments worldwide. These restrictions not only impeded the free flow of vaccines but also crucial components and materials essential for their manufacturing.
However, overcoming this systemic challenge is not straightforward. Actors within the pandemic ecosystem—including countries, private sector entities, and global organizations—will inherently respond to their established incentives. These incentives—prioritizing domestic populations, favoring the fastest and highest bidders to de-risk investments, and adhering to entrenched priorities, processes, and stakeholder requirements—are deeply rooted in rational motivations and cannot be easily disrupted overnight or guaranteed by agreements established during “peace-time.” Efforts in areas such as climate change and peace negotiations have faced comparable obstacles for decades.
The Response
Anticipating this inherent nationalistic behavior, COVAX strategically adopted a demand-pooling mechanism, not only for lower-income economies but also for wealthier nations that possessed resources but lacked the negotiating power to secure bilateral deals in a supply-constrained market. This included upper-middle-income countries that had been excluded from access during the 2009 H1N1 pandemic. COVAX’s primary objective was to leverage a fair allocation mechanism to ensure vaccine doses were available to cover at least 20% of the population—or high-risk groups—in all participating countries, recognizing this as a critical public health imperative. Alongside fully-funded doses provided through the COVAX AMC to lower-income countries, COVAX established a self-financing model, granting these wealthier nations access to the same insurance mechanism in the face of R&D uncertainties and potential failures. This combined approach, developed through extensive consultation with countries, resulted in over 160 nations joining COVAX within months, eventually reaching more than 191 participants in total—an unprecedented demonstration of global solidarity in an environment where political buy-in was crucial for success.
This pooled demand, combined with self-financing participant contributions and donor funding, empowered COVAX to make large-scale investments and build a diversified vaccine portfolio. Ultimately, COVAX secured agreements for access to 11 vaccine candidates across four technology platforms, ten of which received regulatory approval, totaling over 4 billion doses—the largest portfolio globally.
Despite the rapid display of global solidarity, the processes of designing, consulting, implementing, and fundraising for COVAX still consumed several critical months. During this period, the race to secure early access to vaccines was intensely competitive. The initial lack of advance and at-risk funding meant that COVAX entered the arena later than countries with readily available resources at the onset of the global emergency, placing COVAX several months behind in establishing a broad portfolio. Consequently, with a limited number of approved products available in the early stages of global rollout, COVAX was disproportionately affected by manufacturers prioritizing earlier bilateral customers for initial supplies. Export restrictions further compounded the issue, significantly impacting the supply of the majority of volumes anticipated to be available to COVAX in the first half of 2021.
Recommendations
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Institute models—proactively—that ensure volumes supplied to high-income countries (HICs) are accompanied in parallel (not sequentially) by proportionate doses for lower-income countries to guarantee equitable and timely distribution of available supply. These models must be supported by reliable sources of at-risk financing and enhanced standards for transparency and coordination regarding how limited global supply is allocated during a pandemic. This ensures that allocation decisions are not solely dictated by for-profit entities.
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Increase and geographically diversify vaccine manufacturing capacities—expanding global supply capabilities from the outset and ensuring all countries have access to viable regional suppliers, particularly across Africa. This strategy can potentially minimize the impact of export restrictions. Support technology transfer initiatives to further this objective, including contingency plans in case of limited R&D success. Explore new demand-side financing mechanisms to support a sustainable and diversified manufacturing base.
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Strengthen multinational trade-facilitation measures to ensure the free flow of vaccines, manufacturing supplies, and other life-saving equipment during health emergencies. For example, implement an exemption/waiver model that allows agencies involved in global health response to ship essential medical countermeasures and materials to low- and middle-income countries and humanitarian contexts without facing trade barriers.
Zipline staff at the arrival of COVID-19 vaccines in Ghana. Credit: Zipline/2021
3. Learnings on Risk-Taking: Embracing Calculated Risks for Effective Pandemic Response
The Challenge
During a pandemic, delays are costly and can result in significant loss of life. Rapid response is crucial for minimizing the duration and impact of the emergency. An effective rapid response in an inherently uncertain environment requires not only end-to-end coordination but also agility, flexibility, and, critically, an enhanced capacity to take calculated risks. Preparing for all potential scenarios necessitates allocating resources to establish insurance mechanisms and redundancies, even with the near certainty that some, if not many, of these scenarios may not materialize. Furthermore, pandemic response is an iterative process; implementation must occur concurrently with continuous planning for future developments as working assumptions evolve.
Contingent funding must be in place from the outset and remain accessible throughout the response to ensure global health agencies can mount a global response swiftly upon the crisis’s onset, possess the surge capacity to adapt, and readily invest in new solutions as needed. We accept this level of redundancy in other critical sectors—defense, for example—when the potential cost of failure is deemed unacceptably high. A similar approach must be adopted for pandemic preparedness. This means contingent funding is not only needed before outbreaks occur; it must also be immediately deployable and at-risk.
When COVAX was established, no dedicated funding of any kind existed. Moreover, global health organizations and other international development agencies are not inherently structured to assume the types of risks that sovereign states, particularly those with substantial budgets, can undertake. In the context of COVID-19, even before the safety and efficacy of any vaccines were confirmed, wealthy governments were willing to leverage their significant budgets to secure advance deals for doses, acknowledging the inherent risk that specific vaccines might fail. Entities that cannot readily tolerate this scale of risk are immediately disadvantaged in securing early access to critical interventions.
The Response
COVAX not only lacked initial funding—necessitating fundraising efforts as it operated—but also had to break new ground in increasing organizational risk tolerance while simultaneously establishing risk-sharing and mitigation measures.
Recognizing the urgent need for investment in R&D and manufacturing to create a large and diverse portfolio of vaccines with the required volumes, COVAX partners provided at-risk “push” funding to manufacturers in the form of forgivable loans when no other funding sources were available, and at-risk “pull” funding to enable large-scale procurement. This involved rapidly taking on substantial risks in the face of unknowns regarding R&D success and the pandemic’s trajectory. Similarly, COVAX partners invested core budget funds in readiness and delivery, financed the setup and staffing of COVAX before any dedicated funding was secured, and underwrote financial and legal agreements with Facility participants.
Faced with uncertainties and the need to plan with limited or yet-to-be-determined resources, COVAX partners integrated risk-sharing and mitigation strategies into the model, frequently innovating and adapting as necessary. These measures included bringing together over 190 participants to pool demand, investing in a broad portfolio of diverse vaccine candidates, and establishing safeguards such as the cost-sharing mechanism in case sufficient donor funding did not materialize or additional doses were required—enabling countries to purchase doses at COVAX-negotiated prices. COVAX partners leveraged existing innovative financing mechanisms and developed new ones to de-risk investments or make contingent funding available for early-stage investments.
A key component of risk mitigation was the ability to act urgently, decisively, and with flexibility. When confronted with urgent supply challenges in the second and third quarters of 2021, COVAX identified an alternative source of doses. It urgently appealed for dose donations from countries with excess supply, rapidly establishing a mechanism and legal agreements between COVAX, manufacturers, and donors within months to secure, plan for, allocate, and ship donated doses to countries in need.
These early at-risk investments, coupled with high risk tolerance, risk-sharing and mitigation measures, flexibility, and innovative financing, enabled COVAX to start from nothing and successfully secure access to billions of doses, delivering over 1.7 billion doses worldwide. However, this was not without significant challenges. Development agencies, whose processes are typically based on aid budgets, are not inherently designed for this level of risk tolerance. While COVAX partners were able to assume these risks through the support of their governance mechanisms and stakeholders, negotiating risk tolerance and risk-sharing, including among partners, still required considerable time and effort.
Recommendations
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Ensure that response mechanisms are flexible and agile, equipped with the appropriate funding and risk tolerance necessary to operationalize an effective response. Mechanisms must be capable of continuously updating working assumptions related to epidemiology, policy recommendations, supply, demand, R&D, manufacturing, country-level challenges, and other critical factors—and adapt freely to meet evolving goals.
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Outline a clear, shared understanding of risk thresholds and risk-sharing within and across relevant organizations in advance—recognizing that higher risk thresholds are essential for rapid decision-making, adaptation, and action in a fast-paced and uncertain environment. A successful pandemic response mechanism must have the capacity to plan effectively for multiple scenarios, some of which may not materialize, making at-risk investments unavoidable.
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Make available, proactively, contingent at-risk funding for global health agencies and mechanisms that is immediately deployable when needed (covering the entire end-to-end spectrum, from R&D to procurement of medical countermeasures and ancillary supplies, as well as in-country delivery needs). This funding should include a proportion that can be used with no regrets to secure vaccines at any R&D stage, even with the inherent risk of vaccine failure.
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Sustain and leverage existing financing mechanisms (e.g., the International Finance Facility for Immunization (IFFIm), contingent capacity mechanisms, EIB liquidity facilities, DFC Rapid Financing, and MedAccess Risk Sharing) or create new mechanisms that prioritize flexibility in response and help ensure sufficient scale of at-risk capital is available from day one of a pandemic.
On 11 March 2021, syringes and vaccine safety boxes – part of the first consignment of COVID-19 vaccines shipped to Nepal through the COVAX Facility. © UNICEF/UN0430537/
Annex: Key Workstreams and Innovations
The following list outlines over 50 critical workstreams and innovations that were necessary to develop and implement COVAX, ensuring its fitness-for-purpose in enabling rapid vaccine access and achieving global-scale delivery during a pandemic.
It captures the solutions developed by COVAX partners across the value chain in real-time, their impact, and highlights additional challenges in each area that should be considered when designing effective preparedness and response mechanisms for future pandemics. These experiences have informed the recommendations presented in the main body of this report.
This list was compiled through extensive engagement and dedicated sessions involving the leadership, technical teams, and staff of the four COVAX co-lead organizations.
