Key Takeaways
COVID-19 demonstrated that nominal manufacturing capacity cannot ensure a rapid vaccine response without transferable processes, qualified personnel, reliable materials, and coordinated supply networks.
New preparedness models are increasingly maintaining manufacturing capacity, relationships, and capabilities before an outbreak rather than attempting to assemble them after an emergency begins.
Geographic diversification can strengthen vaccine supply resilience, but regional manufacturing still depends on access to technology, raw materials, upstream and downstream capabilities, and international supply chains.
Sustainable pandemic preparedness requires manufacturing capacity to remain economically and operationally viable between emergencies through commercial production, procurement commitments, reserved capacity, or other support mechanisms.
For vaccine manufacturers and CDMOs, future readiness will depend increasingly on the ability to accept new processes, execute technology transfer, secure critical inputs, and scale production within established response networks.
Capacity Is Not the Same as Readiness
The unprecedented speed of COVID-19 vaccine development placed equally unprecedented pressure on the manufacturing systems required to turn new products into billions of doses. The resulting constraints extended well beyond the availability of production equipment. Manufacturers faced shortages of appropriate facilities, technology-transfer personnel, raw materials, and other resources, along with difficulties coordinating production stakeholders and navigating restrictions on supply. Contract development and manufacturing organizations (CDMOs) became important contributors to the scale-up effort, but expanding the number of participating facilities could not eliminate the operational requirements involved in bringing those assets online.1
The experience exposed a limitation in treating pandemic preparedness primarily as a capacity problem. Physical production assets matter, but their presence does not guarantee that they can be mobilized rapidly for an unfamiliar vaccine. The more consequential question is how much nominal capacity could actually be activated when a new pathogen emerges. That depends on facilities and equipment, but also on pre-existing manufacturing relationships, transferable processes, trained personnel, available materials, and supply chains capable of functioning under emergency conditions.
Much of the post-COVID manufacturing agenda can be understood through that broader definition of readiness. Governments, public-health organizations, manufacturers, and their partners are experimenting with ways to preserve usable capacity, distribute production more broadly, strengthen technology-transfer capabilities, develop the workforce, and create economic models capable of sustaining preparedness between emergencies. The approaches vary considerably, but they increasingly recognize that the manufacturing network responding to the next pandemic will need to be prepared before demand appears.
What COVID-19 Revealed About Manufacturing Networks
COVID-19 demonstrated how difficult it is to create large amounts of vaccine capacity on demand. Manufacturing facilities are specialized assets, and successful production depends on more than finding unused floor space or equipment. During the pandemic, manufacturers expanded facilities, optimized existing processes, outsourced production, and formed new partnerships, but shortages remained across upstream, downstream, and fill/finish operations. Technology transfer created another significant constraint, particularly because the personnel required to support transfers were themselves in limited supply.1
Time was a critical factor. Opportunities to increase vaccine production substantially within two or three months were limited, while more options emerged over approximately nine to 12 months through facility expansion, process optimization, and technology transfer. That difference is important for future preparedness because the most valuable manufacturing capacity in the early months of an outbreak may be capacity that is already qualified, staffed, connected to a supply network, and technically prepared to accept a process.1
The pandemic also underscored the extent to which vaccine manufacturing depends on international trade. Production is highly specialized and geographically concentrated, while supply chains encompass intermediate and finished goods that may move across borders before a dose reaches a patient. International flows of materials, products, and logistics services are embedded in the manufacturing model itself.2
Those lessons change the objective for preparedness. Increasing the total amount of global manufacturing capacity remains useful, but the practical goal is to reduce the interval between identification of a threat and reliable production at scale. Capacity that cannot be connected quickly to a product, supplied with the necessary materials, and operated by qualified personnel may contribute far less to an emergency response than its installed volume suggests.
From Manufacturing Capacity to Outbreak-Ready Capacity
One of the clearest post-COVID developments has been greater emphasis on maintaining manufacturing capability that can be activated rather than assuming that new production can be assembled after a crisis begins.
The European Union (EU), for example, has established the EU FAB network to reserve vaccine manufacturing capacity for future health emergencies. Participating manufacturers in Belgium, Ireland, the Netherlands, and Spain cover messenger RNA (mRNA), vector-based, and protein-based vaccine technologies, with capacity for up to 325 million vaccine doses annually. The model requires participating companies to maintain facilities, staff, and supply chains so that production can be activated rapidly when needed.3
The U.S. Biomedical Advanced Research and Development Authority (BARDA) uses a related approach for pandemic influenza. Its preparedness activities include maintaining warm-based domestic manufacturing capabilities, supporting year-round availability of essential inputs, increasing adjuvant manufacturing, and maintaining pre-pandemic vaccine seeds, antigens, and adjuvants. One stated capability is the provision of at least 150 million doses of cell-based pandemic influenza vaccine within six months of a pandemic declaration.4
The Coalition for Epidemic Preparedness Innovations (CEPI) is developing another model through a geographically distributed Vaccine Manufacturing Facility Network. Its February 2026 partnership with Samsung Biologics established guaranteed access in a future pandemic to potentially up to 50 million finished vaccine doses and an additional one billion doses of drug substance that could be converted into finished vaccines. The agreement added an East Asian manufacturing partner to a CEPI network that already included manufacturers in Brazil, India, Indonesia, South Africa, and Senegal.5
These approaches differ in their mechanisms, but they share an important feature: part of the manufacturing response is arranged before an outbreak occurs. Facilities are identified, responsibilities are defined, access is negotiated, and capabilities are maintained. That advance work addresses one of the central limitations revealed during COVID-19: meaningful production expansion may take many months if the relevant assets and relationships have to be assembled after the emergency begins.
A More Distributed Global Manufacturing Map
Readiness also depends on where manufacturing capacity is located. The global vaccine ecosystem remains highly interdependent. An analysis using 2023 data from 204 countries and 98 vaccine manufacturers found that all World Health Organization (WHO) regions depend to some degree on production outside their own region, while the geographic distribution of manufacturing varies substantially among them. The African Region sourced less than 5% of its vaccines from manufacturers headquartered within the region, compared with 89% for South-East Asia, 67% for the Western Pacific, and 54% for Europe. Innovative platforms such as mRNA and viral vectors were also concentrated mainly in the United States and Europe in the data set examined.6
Post-COVID initiatives are nevertheless broadening the geographic base of vaccine production. The WHO mRNA Technology Transfer Programme, announced in 2021, initially focused on COVID-19 vaccines and established a hub in South Africa. As of May 2025, the programme included the hub and 14 manufacturing partners, and its scope had expanded toward other mRNA vaccines and therapeutics. Its objectives include creating sustainable regional production capacity that can remain useful between emergencies and be repurposed when another pandemic occurs.7
Capacity is also expanding in Latin America. During 2024–2025, Argentina and Brazil increased production capability based on the mRNA platform, contributing to broader efforts to strengthen regional access to health technologies.8
CEPI’s manufacturing network reflects a similar emphasis on geographic distribution. Its strategy is intended to connect manufacturers in different regions with vaccine developers so that technology can be transferred and production scaled during outbreaks, particularly in regions that historically have had less access to manufacturing capacity.9
Greater geographic diversity should not be confused with complete regional self-sufficiency. WHO’s analysis emphasizes that regional manufacturing security also depends on access to raw materials and capacity across the relevant stages of production. A more distributed global network can create additional pathways for manufacturing and reduce dependence on a narrow set of locations, but those facilities will continue to operate within an interconnected international system.6
Why Building Factories Is Only the Beginning
Africa provides a particularly useful illustration of the difference between expanding installed capacity and creating a sustainable manufacturing ecosystem. A 2024 assessment identified 25 active vaccine manufacturing projects across the continent. Five manufacturers had commercial-scale facilities with technology transfers signed or underway, another five had commercial-scale facilities without signed technology transfers, and 15 projects remained at earlier stages of development.10
The distribution of that capacity across the production chain is equally important. The assessment found insufficient drug substance capacity alongside excess drug product capacity and significant uncertainty about future demand for African-made vaccines. Installed drug product capacity was projected to reach approximately 1.4 billion doses annually by 2030 and potentially two billion doses during emergencies, while drug-substance capacity remained considerably more constrained.10
That imbalance illustrates why total installed volume can be a misleading measure of preparedness. Fill/finish capacity is valuable only if sufficient vaccine drug substance is available to be filled, while drug substance facilities cannot contribute fully if the technology needed to manufacture a relevant product has not been transferred. A resilient network therefore needs complementary capabilities across the manufacturing chain rather than isolated pockets of capacity.
Commercial demand creates a second challenge. Manufacturing facilities require ongoing activity if they are to become durable parts of the vaccine ecosystem. Gavi’s regional manufacturing strategy identifies predictable demand as important to the long-term sustainability of African manufacturing, while the African Vaccine Manufacturing Accelerator (AVMA), launched in June 2024, is designed to make up to $1.2 billion available over 10 years through downstream incentives supporting commercially viable vaccine production on the continent.11,12
Manufacturing investment has to be matched with technology access, product pipelines, procurement, and demand. Building facilities establishes potential capacity. Turning those facilities into a functioning network requires enough routine activity to keep expertise current, systems operational, and commercial incentives aligned with long-term preparedness.
Platform Flexibility and Technology Transfer as Preparedness Tools
The technologies supported by preparedness networks also influence how effectively existing assets can respond to a new threat. Several major post-COVID preparedness initiatives deliberately encompass multiple vaccine platforms. EU FAB includes mRNA-, vector-, and protein-based technologies, while CEPI’s distributed manufacturing network is expanding its technological range alongside its geographic reach.3,5
The WHO mRNA programme demonstrates how a platform mobilized initially for one emergency can support broader manufacturing capability. What began as an initiative centered on COVID-19 vaccines has expanded toward additional mRNA vaccines and therapeutics, with the aim of establishing sustainable regional production that remains useful between health emergencies.7
CEPI’s Samsung Biologics partnership provides a complementary example involving recombinant proteins. Rather than waiting for the next emergency to test the manufacturing pathway, the collaboration is establishing a scalable recombinant-protein process in advance and includes a simulated response using wild-type H5 influenza. The exercise is intended to test end-to-end readiness and contribute to preparation of a generic regulatory dossier that could support a future response.5
Preparing platforms, relationships, documentation, and manufacturing capabilities in advance cannot eliminate the need for product-specific technology transfer, but it can reduce the amount of foundational work that remains after an outbreak begins. That distinction matters when each additional month required to establish manufacturing can delay the point at which meaningful supply becomes available.
For CDMOs and other manufacturing partners, adaptable infrastructure is therefore most valuable when paired with technical depth. An available facility contributes more to emergency readiness if it can accept a process efficiently, support transfer and scale-up, and move toward controlled production without first having to build the necessary capabilities from scratch.
The Workforce Is Part of Manufacturing Capacity
The COVID-19 response exposed another constraint that cannot be solved simply by installing additional equipment. Qualified personnel are required to transfer processes and operate complex manufacturing systems, and shortages of tech-transfer personnel were identified as a significant bottleneck during pandemic scale-up.1
Workforce development has consequently become part of broader efforts to expand regional biomanufacturing capability. In June 2026, WHO convened representatives from seven designated Regional Training Centres located in Brazil, China, Egypt, India, Ireland, Senegal, and South Africa. Together, the centers cover all six WHO regions and are intended to support workforce development, training delivery, and knowledge exchange.13
Expanding physical capacity without developing a trained workforce leaves an important part of that capacity unrealized. Personnel need training and practical experience in production, quality, technology transfer, and the regulatory expectations surrounding biomanufacturing. If regional capacity is expected to contribute meaningfully during future emergencies, developing that human capability alongside facilities and equipment will be essential.
Supply Chains Must Be Prepared Alongside Plants
The scale of the vaccine supply chain challenge makes clear why facility readiness alone cannot determine pandemic output. A typical vaccine manufacturing plant can use approximately 9,000 different materials sourced from 300 suppliers across 30 countries. Those requirements encompass production inputs as well as components needed to deliver finished vaccines.9
COVID-19 demonstrated what happens when parts of that network become constrained. Documented shortages involved cell culture materials, filters, single-use bioreactor bags, syringes, adjuvants, and other inputs required across production and delivery. Even when manufacturers were urgently increasing output, unavailable components could impede the larger manufacturing chain.1
Greater geographic distribution of vaccine facilities can create additional production options, but it does not necessarily diversify the underlying supply base. Multiple sites may still depend on common suppliers, scarce materials, or cross-border logistics. Manufacturing-network preparedness therefore requires visibility beyond the walls of individual plants, including an understanding of which inputs are critical, where supplier concentration exists, and where apparently independent production routes share common vulnerabilities.
This broader view is also reflected in international preparedness policy. The WHO Pandemic Agreement, adopted by the World Health Assembly in May 2025, includes measures intended to strengthen local production capacity, including through technology transfer. Member States have also directed work toward establishing a Global Supply Chain and Logistics Network intended to improve timely and equitable access to pandemic-related health products. Negotiations on the Agreement’s Pathogen Access and Benefit Sharing (PABS) annex were still continuing in July 2026, leaving that component of the framework unresolved.14–16
Theoretical output matters only if the materials, suppliers, logistics, and external manufacturing steps needed to sustain production remain available when the system is under maximum pressure.
Solving the Between-Pandemics Problem
Perhaps the most difficult preparedness challenge emerges when there is no emergency. Facilities, personnel, supply agreements, and manufacturing expertise all require ongoing investment, while pandemic demand is by definition intermittent. Maintaining substantial dedicated capacity that may not be needed for years creates an economic problem as much as an operational one.
BARDA identifies this difficulty in its vaccine preparedness activities. Products that satisfy regulatory, safety, and efficacy requirements may still struggle to achieve sufficient commercial success in the seasonal market, creating challenges for the economic sustainability of domestic manufacturing facilities. Preparedness policy therefore has to account for the business conditions that keep strategically useful infrastructure operating during ordinary periods.17
The WHO mRNA program approaches the issue by broadening the potential uses of the manufacturing capability it has helped establish. The program now encompasses mRNA applications beyond COVID-19 and explicitly seeks sustainable regional production that can remain active between emergencies and be repurposed if a new pandemic occurs.7
Gavi addresses another part of the problem by working on the demand side. Its strategy connects manufacturing sustainability with predictable procurement, while AVMA uses downstream incentives to improve the commercial prospects of African vaccine production.11,12
EU FAB and BARDA’s warm-basing model offer still other approaches by compensating, supporting, or contracting for readiness that ordinary market demand may not independently provide. The common challenge is preserving strategically valuable capabilities without assuming that manufacturers can indefinitely carry the cost of emergency preparedness on balance sheets designed around routine commercial demand.
The strongest emergency capacity may therefore be capacity that also has a productive role during normal periods. Commercial production can keep facilities active, personnel experienced, quality systems exercised, suppliers engaged, and processes current, while preparedness agreements define how some portion of that capability can be redirected when necessary.
Such a model also changes how preparedness capacity should be evaluated. Idle equipment may represent available square footage, but a functioning manufacturing operation represents accumulated knowledge and relationships. The challenge is to create enough flexibility that routine activity sustains those capabilities without making them unavailable when an emergency requires a rapid change in priorities.
Designing the Network Before the Emergency
The manufacturing response to the next pandemic will be shaped substantially by decisions made before the responsible pathogen is identified. COVID-19 demonstrated that capacity can be expanded rapidly by ordinary industry standards, but it also showed the practical limits imposed by technology transfer, specialized personnel, material supply, and the time required to bring additional manufacturing operations online.
The post-COVID initiatives now taking shape address different parts of that problem. Some preserve reserved or warm capacity. Others diversify manufacturing geographically, establish technology-transfer relationships, expand platform expertise, train regional workforces, strengthen supply arrangements, or create financing mechanisms intended to sustain manufacturing between emergencies. Their effectiveness will ultimately depend on how well those individual elements operate as a network rather than as isolated preparedness investments.
For vaccine manufacturers and CDMOs, preparedness therefore extends beyond the ability to add batches when demand rises. A more consequential capability is the ability to enter a response quickly: accept or transfer a process, apply experienced personnel, secure required inputs, coordinate drug substance and drug product operations, and work within regulatory and supply arrangements that have already been considered.
The 100 Days Mission pursued by CEPI aims for safe and effective vaccines to be ready for initial authorization and manufacturing at scale within 100 days of identifying a new pandemic threat. Manufacturing readiness will determine how effectively that scientific speed can be translated into deployable supply.5
That places much of the work of pandemic preparedness in the quieter years between emergencies. The strongest manufacturing network will not necessarily be the one with the largest amount of nominal excess capacity. It will be the one that has remained active enough to preserve expertise, connected enough to secure what it needs, flexible enough to accept new products, and economically sustainable enough to still be ready when extraordinary demand returns.
References
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2. “Using trade to fight COVID-19: Manufacturing and distributing vaccines.” Organisation for Economic Co-operation and Development (OECD). OECD Policy Responses to Coronavirus (COVID-19). 11 Feb. 2021.
3. “Addressing market challenges.” Public Health – European Commission. Accessed 10 Aug. 2026.
4. Biomedical Advanced Research and Development Authority (BARDA). “Influenza & Emerging Infectious Diseases Pandemic Vaccines and Adjuvants Program.” MedicalCountermeasures.gov. Accessed 10 Aug. 2026.
5. “CEPI and Samsung Biologics collaborate to strengthen outbreak-ready vaccine production and global access.” CEPI. 3 Feb. 2026.
6. “Global market landscape of vaccine manufacturing and procurement.” World Health Organization. 16 Dec. 2025.
7. “mRNA Technology Transfer (mRNA TT) Programme.” World Health Organization. Accessed 10 Aug. 2026.
8. “Region of the Americas.” World Health Organization. WHO Results Report 2024–2025. May 2025.
9. “Process development and manufacturing.” Coalition for Epidemic Preparedness Innovations (CEPI). Accessed 10 Aug. 2026.
10. “How has the African vaccine manufacturing landscape changed in the last year?” PATH. 18 Oct. 2024.
11. “African Vaccine Manufacturing Accelerator (AVMA).” Gavi, the Vaccine Alliance. 7 May 2026.
12. “Expanding sustainable vaccine manufacturing in Africa: Priorities for Support.” Gavi, the Vaccine Alliance. Nov. 2022.
13. “WHO convenes global biomanufacturing partners to advance workforce development and local production.” World Health Organization. 10 Jun. 2026.
14. “WHO Pandemic Agreement.” World Health Organization. Accessed 10 Aug. 2026.
15. “World Health Assembly adopts historic Pandemic Agreement to make the world more equitable and safer from future pandemics.” World Health Organization. 20 May 2025.
16. “WHO Member States continue negotiations on the Pathogen Access and Benefit Sharing Annex.” World Health Organization. 20 Jul. 2026.
17. Biomedical Advanced Research and Development Authority (BARDA). “Influenza & Emerging Infectious Diseases Vaccine Development Program.” MedicalCountermeasures.gov. Accessed 10 Aug. 2026.
