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Making more COVID-19 vaccine doses is not simply a matter of running a factory faster. Manufacturers must increase output across a validated process while keeping quality consistent, securing specialized materials, coordinating bulk production with filling and packaging, and meeting regulatory requirements. If one stage expands faster than the others, it can become the bottleneck.
Why can’t a vaccine factory simply make more doses?
Vaccine production is a connected system, not one machine with a dial for output. A manufacturer needs a process that works reliably at commercial scale, facilities and equipment suited to that process, trained staff, dependable supplies, quality controls, regulatory oversight, and enough capacity to package and distribute the finished doses.
Increasing production at one site or stage can expose a constraint elsewhere. More bulk vaccine is of little practical use if there is not enough capacity to fill it into containers, package it, or keep it at the product’s required temperature during storage and transport.
What has to happen between a formula and approved doses?
Prove the process works consistently at scale
A process that produces vaccine successfully at a smaller scale must be shown to produce consistent, high-quality batches at a larger commercial scale. Manufacturers submit evidence to regulators, who review manufacturing changes and whether the site can reliably meet quality requirements. Increasing batch size is therefore a change to validate, not just a production target.
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Keep safety and quality review in the process
Before approval, regulators evaluate vaccines for quality, safety, and effectiveness. Manufacturers also operate under licensing and quality obligations; in some cases, they seek World Health Organization (WHO) prequalification. WHO describes emergency use listing as a time-limited option for a public-health emergency based on a risk-benefit assessment.
COVID-19 vaccine development was accelerated in part by running phases in parallel and mobilizing financial and political support. That sped up parts of development, but it did not remove regulatory oversight or the need to demonstrate manufacturing quality.
Why do bulk production and filling need to scale together?
Making the active substance or bulk vaccine is only one part of manufacturing. It must also be put into suitable containers, such as glass vials, pre-filled syringes, or ampoules, then packaged and prepared for distribution. Filling and finishing use their own equipment, sites, staff, and supplies, so this capacity can limit how many usable doses emerge from a larger bulk-production operation.
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Two examples from 2021 illustrate the coordination involved. The European Medicines Agency (EMA) approved a batch-size increase at Pfizer/BioNTech’s Puurs site after reviewing submitted data and said the site could consistently produce high-quality vaccine. EMA also recommended a new Moderna filling line in Spain to synchronize finished-product filling with active-substance scale-up at Lonza’s Visp site. These are dated examples of how changes were handled, not evidence of current capacity or current site status.
Which supplies and infrastructure can hold production back?
Specialized inputs must arrive in sufficient quantities and on time. In a WHO press conference on 5 March 2021, the organization cited export bans and shortages of glass, plastic, and stoppers as barriers to increasing vaccine production. WHO’s mRNA technology-transfer FAQ also identifies vials, rubber stoppers, fermentation bags, and the many raw materials needed for mRNA production.
In that 2021 emergency context, WHO Director-General Tedros Adhanom Ghebreyesus said: “We currently face several barriers to increasing the speed and volume of production of vaccines, from export bans to shortage of raw materials including glass, plastic and stoppers.” The statement describes constraints raised at that time; it should not be read as a current inventory of shortages.
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Why isn’t sharing a recipe enough to start production elsewhere?
Technology transfer means transferring production capability, not just a formula or patent. WHO describes a multilateral hub as assembling know-how, data, a formula, intellectual property, and often training, then transferring a validated process to manufacturers. A recipient also needs appropriate facilities, skilled people, reliable supplies, quality-management systems, and the ability to meet regulatory requirements.
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WHO identifies workforce and regulatory-capability gaps, alongside supply chains, as constraints on regional manufacturing. A site may receive technical knowledge yet still need time and support to build the people, systems, and operating experience needed for consistent production.
How do the two main scale-up approaches differ?
Manufacturers can add output within an established manufacturing network, or transfer technology to additional manufacturers and regions. Neither approach guarantees immediate usable supply; the result depends on validated capacity, inputs, staff, downstream operations, and quality and regulatory capability.
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| Consideration | Expand an established network | Transfer technology to additional manufacturers |
|---|---|---|
| How capacity is added | Increase output or add capacity at sites already operating within the manufacturing network; changes still require evidence and review. | Transfer a validated process, know-how, data, intellectual property, and often training to recipient manufacturers. |
| What can constrain output | Batch-production changes, filling capacity, supplies, staff, and coordination among sites. | All the same production constraints, plus the recipient’s need to develop skilled staff, suitable infrastructure, and regulatory and quality capability. |
| What determines whether added capacity is usable | Consistent commercial-scale quality, sufficient filling and packaging, and product-appropriate storage and transport. | The transferred process must be implemented and validated at the recipient site, with dependable inputs and downstream capacity. |
| What the approach does not establish by itself | A capacity change does not show how much vaccine is currently being produced or supplied. | A transfer milestone does not establish that a particular product is authorized, commercially available, or being produced at a stated volume. |
WHO’s 5 March 2021 discussion described matching vaccine producers with firms that had spare fill-and-finish capacity as a way to address a nearer-term bottleneck, while voluntary licensing and technology transfer with training and infrastructure support were part of the longer-term approach.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.What does the WHO technology-transfer programme show today?
WHO says its mRNA Technology Transfer Programme was integrated into its Health Technology Access Programme in 2024. The programme page reports that the first technology transfer was completed to Biovac in September 2024, that three additional partners received technology in 2024, and that 14 other partners are listed across six WHO regions. These are programme milestones; they do not establish authorization, commercial availability, or a production volume for a specific vaccine.
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A separate figure sometimes associated with technology transfer needs careful context: WHO reported more than 700 million doses of additional global capacity across 14 countries from technology transfer for pandemic influenza vaccines after H5N1 in the mid-2000s. That figure is about influenza vaccine capacity, not COVID-19 vaccine production.
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Why is distribution part of manufacturing scale-up?
A dose is not usable supply until it is filled, packaged, stored, and transported under appropriate conditions. WHO notes that vaccine temperature requirements are product-specific and can range from refrigerated to frozen or ultra-cold storage. There is no single temperature requirement that applies to every COVID-19 vaccine.
Storage and delivery can require cold rooms, refrigerated transport, or portable cold boxes. If these steps do not keep pace with production—or do not maintain the conditions required for the product—the extra bulk output cannot simply be counted as doses ready to use.
Is there a current global figure for COVID-19 vaccine manufacturing capacity?
The cited WHO and EMA material does not establish a current, globally comparable figure for COVID-19 manufacturing capacity or output. Historical approvals, emergency-era shortage reports, and technology-transfer milestones explain how scale-up works, but they cannot be used to infer present-day global production.
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