The COVID-19 pandemic laid bare the asymmetries of the global vaccine landscape. While high-income countries secured doses early, low- and middle-income countries (LMICs) waited months—hindered by delays in signing purchase agreements, production bottlenecks, and other supply constraints.
Today, the global vaccine market remains highly concentrated, with just ten manufacturers producing nearly three-quarters of all doses globally. Meanwhile, Africa still imports 99 percent of its vaccines and produces less than one percent locally.
These gaps have triggered a surge of political interest in regional vaccine manufacturing, especially in Africa and Latin America. A growing constellation of global, regional, and national initiatives has since emerged, backed by billions in donor commitments. But these efforts remain disparate and have not materialized into a cohesive strategy.
With domestic health budgets tightening and donors retrenching, political and financial momentum risks stalling further. And given current fiscal pressures, long-term manufacturing goals may be in tension with near-term immunization needs.
This blog distills takeaways from recent CGD analysis, highlighting unresolved questions and technical, political, and economic trade-offs shaping the future of the global vaccine manufacturing ecosystem.
Six key takeaways
Below, we offer a non-exhaustive summary of key takeaways from CGD’s research over the past two years.
1. Regional vaccine manufacturing has received political attention and billions in commitments—but lacks a coherent, actionable strategy
In the wake of COVID-19, governments across Africa and Latin America made ambitious new commitments to expand regional production of vaccines and other health products. International actors followed suit with a wave of investments in development finance initiatives, technology transfer hubs, and workforce development, with some estimates putting commitments in Africa alone at over $5 billion (for the manufacturing of all health products).
Yet progress so far is mixed at best. Efforts have not yet coalesced into a cohesive strategy: the landscape is crowded, priorities are diffuse, and coordination is limited. The result is a patchwork of fragmented and duplicative efforts with uneven attention to the interconnected aspects of a viable vaccine manufacturing ecosystem. For instance, there is an imbalance in manufacturing capacity on the African continent: excess fill/finish capacity, yet too little antigen production, which is essential for end-to-end manufacturing.
Different regions also start from notably different baseline capacities. While Africa and Latin America are both highly dependent on vaccine imports, Latin America benefits from a larger base of more established manufacturers and more robust domestic financing.
A coherent path forward will require clearer regional strategies and stronger alignment among partners to reinforce progress.
Related work: Diversifying Manufacturing of Health Products: Ideas for the EU and Geographical Diversification of Vaccine Production: Challenges for Africa and Latin America
2. Investments in regional manufacturing can be in tension with immunization objectives and pandemic preparedness goals
Expanding vaccine manufacturing involves balancing multiple objectives: establishing a stable industry to meet routine immunization needs, bolstering surge capacity to respond to pandemics, promoting equity through regional expansion, and strengthening global supply resilience. But these goals often pull in different directions, requiring distinct technologies, incentives, and investments.
Gavi’s African Vaccine Manufacturing Accelerator (AVMA) illustrates these tensions. It seeks to build a sustainable African vaccine manufacturing base while also advancing supply resilience and pandemic preparedness—objectives that are not fully synergistic. Facilities designed to produce routine vaccines for more stable markets may not be able to pivot to pandemic-ready platforms, given that rapid scale-up in an emergency requires more flexible production methods.
A related challenge is how investments in regional manufacturing fit within efforts to expand global capacity. Manufacturers have weak incentives to build advance capacity needed for pandemics despite its enormous social value. Investing roughly $60 billion upfront and $5 billion annually thereafter in advance capacity to vaccinate 70 percent of the world against a new virus within six months would generate over $500 billion in social value. This underscores that pandemic capacity is a global public good and raises key questions: where should manufacturing be located, how flexible should facilities be, and is the ultimate goal regional equity, global surge capacity, or both?
Moving forward, funders and partners must explicitly define objectives and internalize trade-offs, ensuring that investments and financial tools prioritize specific goals and address underlying incentives.
Related work: Accelerating Vaccine Manufacturing in Africa: Three Considerations for Gavi
3. Weak and uncertain demand remains a major constraint
Since COVID-19, most regional manufacturing investments have focused on supply: facilities, technology transfer, R&D, and workforce development. While necessary, manufacturers cannot sustain production without strong, predictable demand. As noted in a recent report from the Regionalized Vaccine Manufacturing Collaborative, there has been “a lot of emphasis on building factories, but not on expanding the market.”
Regional demand is influenced by higher costs for LMIC-made vaccines compared to imports. Namely, African-made vaccines may carry a price premium over the lowest-cost global manufacturers. Without a guaranteed market or visibility into future demand, LMIC manufacturers have little incentive to take on higher production costs and risk becoming stuck in a high-price, low-volume trap that discourages scaling production.
Recent examples highlight this demand challenge. South Africa-based Aspen Pharmaceuticals halted production of the Johnson & Johnson COVID-19 vaccine after receiving no orders from African governments. Meanwhile, Moderna cancelled its planned mRNA project in Kenya after two years of lower-than-expected demand. And although three African vaccine manufacturers are on track to receive WHO prequalification for nine vaccines by 2030, no committed market demand yet exists.
A central outstanding challenge remains: Despite strong political commitments, it is unclear whether governments are willing, and able, to pay higher premiums for regionally produced vaccines. As donor funding shrinks and countries transition out of Gavi support, domestic budgets will need to shoulder a large share of costs.
Until demand-side dynamics are addressed, supply-side investments alone will not deliver scale or sustainability.
Related work: Gavi’s AMC for African Vaccine Manufacturing: Start With These Three Foundational Questions
4. Regional manufacturing relies on inconsistent and unreliable solidarity
While sustaining vaccine manufacturing depends on governments fulfilling commitments to purchase regionally produced products, political economy dynamics further complicate purchasing decisions.
For instance, the Forum for the Progress and Integration of South America’s attempt to expand manufacturing capacity across South Africa failed when countries disagreed on where manufacturing investments should be located.
Similar challenges arise in Africa, where budget pressures may prevent countries from upholding pan-African solidarity. This raises questions such as whether a government like Ghana will consistently choose to buy more expensive African-made vaccines over comparatively cheaper imports from India.
The need for consistent, reliable regional solidarity is often overlooked, yet it plays a critical role in determining the viability of a nascent vaccine manufacturing industry.
Related work: Globalizing Vaccines: A Post-COVID Perspective on Industrial Policy, International Health Cooperation, and the Characteristics of Vaccine Production and Gavi’s AMC for African Vaccine Manufacturing: Start With These Three Foundational Questions
5. Current regulatory systems are unsuitable for regional manufacturing
Strong regulatory systems are a foundational building block of viable regional manufacturing—essential for timely and equitable access to safe, effective, and quality-assured vaccines. Yet many LMICs, especially in Africa, lack fit-for-purpose regulatory pathways to support regional production.
Historically, WHO’s Prequalification Programme (WHO PQ) has been the primary regulatory pathway for vaccine approvals in LMICs. But its limitations—lengthy timelines, duplicative reviews, and limited in-country approval pathways—are increasingly mismatched with evolving regulatory capacity in LMICs and a changing global health ecosystem.
Regional initiatives, such as the African Medicines Agency and newly designated WHO-Listed Authorities, signal important progress. There is also promise in recent draft revisions, which enable WHO PQ to draw on assessments from trusted regulators rather than re-review dossiers from scratch. Still, these advances have yet to be fully embedded in global regulatory practice or procurement rules, and regionally produced vaccines face cumbersome routes to market.
As manufacturing expands and procurement increasingly shifts from donors to governments, a more diversified regulatory ecosystem is needed. This should include: 1) modernizing WHO PQ; 2) diversifying regional and national regulatory pathways; and 3) aligning the procurement policies of purchasing mechanisms (e.g., Gavi/UNICEF and the African pooled procurement mechanism) to recognize alternative pathways.
Related work: The Role of Regulation in Advancing African Vaccine Manufacturing and A Roadmap for Strengthening and Diversifying Regulatory Pathways in Africa.
6. There is no comprehensive picture of global vaccine manufacturing capacity, leaving blind spots for pandemic preparedness
Despite progress, assessing global vaccine manufacturing capacity remains challenging. There is no comprehensive, up-to-date view of where capacity exists, at what scale, on which platforms, and how quickly it can pivot in an emergency.
COVID-19 exposed these blind spots. Decision-makers lacked timely information, making it difficult to anticipate supply shortfalls or identify facilities capable of scaling quickly.
Most existing assessments lack a consistent definition of “manufacturing capacity,” focus on static rather than dynamic capacity, and do not comprehensively capture critical dimensions such as supply chain bottlenecks and surge potential. The current literature also has an uneven geographic focus: the most detailed assessments concentrate on regions with limited existing manufacturing—particularly Africa and parts of Latin America—while global analyses tend to provide less granular insights.
Building a stronger global evidence base is essential for funders, governments, and manufacturers to make informed decisions about where to locate manufacturing, how much surge capacity to maintain, and how to finance rapid scale-up when the next pandemic occurs.
Related work: What We Know (And Don't Know) About Global Vaccine Manufacturing Capacity
Conclusion
Diversifying vaccine manufacturing requires more than just building factories—supply-side investments alone do not automatically lead to more equitable access. Without predictable demand, careful attention to political economy realities, diversified regulatory pathways, and greater visibility into global capacity, initiatives to diversify manufacturing capacity risk stalling. Real progress will depend on balancing long-term manufacturing goals with short-term immunization objectives—a trade-off that is further complicated by resource constraints in today’s environment.
Thank you to Rachel Bonnifield, Anthony McDonnell, Ainhoa Petri-Hidalgo, and Asti Shafira for helpful comments.
