Scaling COVID-19 vaccine production is difficult because it means expanding a validated system—not simply making more of one ingredient. Active-substance production, trained staff, raw materials, quality checks, regulatory review, vial filling, packaging, and temperature-controlled distribution must all keep pace. A constraint at any one stage can limit the number of usable doses.
What has to happen before a factory can make more doses?
A vaccine process must work consistently at commercial scale. Increasing a batch size or adding a production line changes how much a site can make, but the added capacity has to be supported by evidence that the product remains high quality. Regulators review manufacturing changes, and manufacturers remain responsible for operating under licensing and quality obligations.
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The European Medicines Agency (EMA) provided a concrete example in 2021: it approved an increase in batch size at Pfizer/BioNTech’s Puurs site after reviewing submitted data, and said the site could consistently produce high-quality vaccine. The important point is not the historical output of that site; it is that a proposed increase had to be assessed rather than assumed to work. The example does not establish the site’s current capacity or status.
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COVID-19 vaccine development was accelerated in part by running phases in parallel and mobilizing financial and political support. The World Health Organization (WHO) says this did not remove regulatory oversight. Faster development and manufacturing scale-up are not grounds to skip quality controls.
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Where can production get bottlenecked?
Active-substance production
The initial manufacturing stage produces the vaccine’s active substance. Increasing this output does not automatically increase the number of finished doses: subsequent stages need enough capacity to receive, fill, package, check, and store the product.
Vials, filling, and packaging
Bulk vaccine still has to be put into suitable containers. WHO identifies glass vials, pre-filled syringes, and ampoules as possible formats. Filling lines and packaging materials therefore need to match the volume and timing of active-substance production.
A second EMA example, also from 2021, shows why the stages must be coordinated. EMA recommended a new Moderna filling line in Spain intended to synchronize finished-product filling with active-substance scale-up at Lonza’s Visp site. This was a dated capacity-change example, not evidence of current output or site status.
Raw materials and components
Production can be held back by items that are less visible than the vaccine itself. During the emergency conditions discussed on 5 March 2021, WHO cited export bans and shortages of glass, plastic, and stoppers. WHO’s mRNA technology-transfer FAQ also names vials, rubber stoppers, fermentation bags, and other essential raw materials as parts of the supply challenge.
In that 2021 press conference, 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.” This statement describes the barriers WHO was addressing at the time; it should not be read as a current inventory of shortages.
People, quality systems, and regulatory capability
A production site needs skilled workers who can run and maintain the process, plus the quality and regulatory capability to demonstrate that it is operating consistently. WHO identifies gaps in workforce and regulatory capacity as obstacles to regional manufacturing. A new building, production line, or formula alone does not supply those capabilities.
Storage and transport
Finished doses count as usable supply only if they can be kept within the product’s required temperature conditions through storage and delivery. WHO describes the need for equipment such as cold rooms, refrigerated transport, and portable cold boxes. Temperature requirements vary by product: WHO’s overview includes refrigerated, frozen, and ultra-cold examples, so there is no single storage rule that applies to every COVID-19 vaccine.
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Why does adding a line or increasing a batch size require review?
Scale-up has to show that a changed process or site can reliably produce vaccine that meets quality expectations. A change can affect the amount made at one stage, but regulators need supporting evidence before that additional capacity can be treated as validated. The Puurs batch-size decision illustrates the review of a change at an established site; the Moderna filling-line example illustrates the need to align downstream filling with upstream production.
This is why capacity is better understood as a chain than as a single factory figure. If active-substance production grows faster than filling, filling becomes the limit. If filling expands without dependable containers, inputs become the limit. If products are made but cannot be stored and transported as required, the doses cannot be counted as effectively available supply.
How does technology transfer help add manufacturing capacity?
Technology transfer can extend production beyond an existing manufacturing network, including to additional regions. But it is a transfer of capability, not just a handoff of a recipe or patent. WHO describes a multilateral hub as bringing together know-how, data, formula, intellectual property, and often training, then transferring a validated process to recipients.
That distinction explains why a recipient needs more than permission to use intellectual property. It also needs trained staff, reliable inputs, appropriate facilities, quality systems, and the regulatory capacity to support production. WHO identifies these as continuing challenges for regional manufacturing.
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| Approach | What it adds | What can constrain it | What the available evidence establishes |
|---|---|---|---|
| Expand an established manufacturing network | More output at existing sites, or added capacity such as a filling line | Validated process changes, raw materials, staffing, and matching capacity between production stages | EMA’s 2021 Puurs and Spain examples show reviewed batch-size expansion and a planned filling-line addition. They do not establish current capacity or quantify how quickly output can rise. |
| Transfer technology to additional manufacturers or regions | A validated process and associated know-how made available to new recipients | Training, supply chains, skilled workers, facilities, and quality and regulatory capability | WHO describes the technology-transfer model and ongoing programme milestones, but those milestones do not establish that a specific product is authorized, commercially available, or being produced at a stated volume. |
In its 5 March 2021 press conference, WHO discussed matching vaccine producers with companies that had spare fill-and-finish capacity, alongside voluntary licensing and more coordinated technology transfer with training and infrastructure support. Matching spare filling capacity was a shorter-term way to address one bottleneck; building the broader ability to manufacture through technology transfer is a longer-term undertaking. Neither approach removes the need to validate production and meet quality requirements.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.What is the status of WHO’s mRNA technology-transfer effort?
WHO integrated its mRNA Technology Transfer Programme into the Health Technology Access Programme in 2024. WHO’s current 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 across six WHO regions are listed.
These are programme milestones, not a global production total. They do not show that a specific COVID-19 vaccine is currently authorized, commercially available, or being made at a particular volume by any recipient. WHO has not established a current, globally comparable figure for COVID-19 manufacturing capacity or output in the material cited here.
Does more manufacturing capacity guarantee more usable doses?
No. Production capacity is only one part of supply. Doses also depend on available materials and components, validated quality, suitable filling and packaging, and storage and transportation that meet the product’s temperature requirements. Increasing one stage can expose a shortage or capacity limit at another, so announced capacity should not be mistaken for doses ready to use.
Historical capacity figures need the same care. WHO reported more than 700 million doses of additional global capacity across 14 countries in connection with WHO-supported technology transfer for pandemic influenza vaccines after H5N1 in the mid-2000s. That figure concerns influenza capacity, not COVID-19 vaccine production.
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