Why regionalized vaccine manufacturing matters in aftermath of COVID-19

Amid the chaos of the COVID-19 pandemic, one issue directly impacting the global response to the virus stood out: the world’s vaccine manufacturing system was too concentrated to respond equitably or at scale. As demand surged, lower- and middle-income regions struggled to procure lifesaving vaccines, exposing the risks of overreliance on a small number of manufacturing hubs to supply the globe.

In response, the Regionalized Vaccine Manufacturing Collaborative (RVMC) was formed to address inequities in the global vaccine production ecosystem revealed by the pandemic, with a focus on Africa, Southeast Asia, Latin America, and the Caribbean.

In November 2025, the RVMC published its first status report assessing the state of vaccine manufacturing across these regions, Towards Regionalized Vaccine Manufacturing. The report evaluates progress across eight pillars — including financing, regulation, technology, and supply chains — and is designed to assess progress toward sustainable local vaccine production, stronger regional health security, and greater vaccine equity. The implications extend well beyond the regions.

“Building robust regional manufacturing hubs would shorten lead times to treatment and reduce dependency on congested global supply chains,” says Frederik Kristensen, managing director of the RVMC. “This would not only accelerate vaccine availability but also stabilize access to critical medical supplies and components, mitigating shortages like those seen during COVID in the U.S.”

According to Kristensen, predictable demand and harmonized regulatory systems “would enable regional manufacturers to plan surge production and maintain buffer stocks, reducing both the scale and duration of disruptions across essential goods.”

A broken system

For a product as critical as vaccines, manufacturing and distribution systems in the regions assessed in the RVMC’s inaugural report were not designed to meet pandemic-scale demand. Key weaknesses included geographic overconcentration of manufacturing, fragile supply chains, market structures that perpetuated inequitable access, as well as limited deployment of newer vaccine technologies.

These weaknesses had real consequences, as delayed access to vaccines contributed to avoidable deaths and prolonged economic disruption in lower- and middle-income regions.

“When export controls, advance purchase agreements, and logistics bottlenecks occur, regions without local capacity face extended delays, which translate into higher morbidity and mortality and lower productivity,” says Kristensen. “This also laid the groundwork for the development and spread of new viral mutations that subsequently reached the U.S., further driving up morbidity, mortality, and costs there.”

These failures provided the impetus for the launch of the RVMC in 2022 by the World Economic Forum, the U.S. National Academies of Medicine, and the Coalition for Epidemic Preparedness Innovations (CEPI), and ultimately the release of the Towards Regionalized Vaccine Manufacturing report.

Regionalized vaccine manufacturing

At its core, regionalized vaccine manufacturing (RVM) aims to reduce reliance on external suppliers by building durable production capacity closer to where vaccines are needed. According to the report, many of the structural weaknesses exposed during COVID-19 can be mitigated by prioritizing long-term domestic resilience over donor reliance.

However, the report also notes that “to ensure an effective transition from donor reliance to self-sufficiency, there needs to be better coordination between donor funding and other sources of financing, including domestic funds.”

The challenge remains significant. Regional manufacturers currently supply only a small share of their regions’ vaccine demand: 29% in Southeast Asia, 25% in Latin America and the Caribbean, and just 1% in Africa.

BioNTech is advancing construction of an mRNA vaccine manufacturing facility in Kigali, Rwanda, designed to strengthen local vaccine production capacity and expand access to essential vaccines across Africa. The facility, financially supported by the European Investment Bank, the European Commission, and CEPI, will be the first commercial mRNA vaccine facility on the African continent, advancing the African Union’s goal to produce 60% of its vaccines locally by 2040.

In Africa, RVM is constrained by fragmented markets, limited skilled labor, and a lack of predictability for demand. Southeast Asia presents a mixed picture, combining pockets of strong national manufacturing capacity with uneven regional coordination. Latin America and the Caribbean are comparatively more advanced, supported by pooled procurement mechanisms, such as the Pan American Health Organization’s (PAHO) Revolving Fund, and regulatory cooperation that have helped stabilize demand and sustain local producers.

Despite these differences, all three regions remain in the early stages of RVM development.

“National efforts have laid meaningful groundwork, but regional coordination and decisive political action are essential to achieve scale and sustainability,” the report states.

Among the 97 countries assessed, 19 have achieved at least WHO Maturity Level 3 (ML3) or PAHO Reference Authority status. Regulatory harmonization remains limited, however, with approval timelines ranging from under a year to as long as three years depending on the region, creating uncertainty for manufacturers seeking to scale production and export regionally.

Beyond low levels of regional self-supply, the report finds that scaled vaccine manufacturing remains uncommon. Only three manufacturers across all three regions, one in Southeast Asia and two in Latin America and the Caribbean, produce five or more vaccines at scale. Africa has no comparable manufacturing capability.

Platform diversity is another major challenge. Manufacturing across all regions remains heavily concentrated in older vaccine technologies, according to Kristensen, with limited deployment of rapid-response platforms such as mRNA, viral vector, and protein-based vaccines.

Without keeping these platforms in active use, regions risk starting from scratch when new threats emerge. The report also highlights the limited visibility of supply chain resilience and a lack of comprehensive data on regional workforce development, which are factors that further undermine the ability to mount a faster, decentralized pandemic response.

Last week, Samsung Biologics announced a partnership with CEPI to support vaccine manufacturing preparedness for future epidemic and pandemic threats. The effort will leverage Samsung Biologics’ mammalian cell-based infrastructure and quality systems to create a process that can be activated quickly during an outbreak, providing access to up to 50 million vaccine doses during a future pandemic along with up to one billion doses of drug substance for conversion into finished vaccines. The capacity is intended to support vulnerable populations in low- and middle-income countries while also meeting domestic needs in South Korea.

Last month, SK bioscience joined a CEPI-backed effort to improve Ebola vaccine manufacturing. The collaboration, which includes Merck Sharp & Dohme and Hilleman Laboratories, will focus on improving process yield and storage to support scalable vaccine production, which currently requires ultra-low temperature storage and presents logistical challenges. SK bioscience, working with IDT Biologika, will develop the updated drug substance manufacturing process and the associated drug product, applying its vaccine manufacturing infrastructure and capabilities to support long-term supply for low- and middle-income countries.

The political reality

From a political standpoint, leaders across the regions recognize the importance of RVM, the report notes. However, stated ambition alone is insufficient.

Progress will remain limited unless political commitment is backed by concrete measures, including procurement guarantees and a willingness to accept higher short-term costs as local manufacturing scales, according to Kristensen.

“That requires both political commitment and actual budgetary allocation,” he says. “Trade policies need to be adjusted, and export and import restrictions between countries and regions must be addressed.”

Kristensen also emphasizes the importance of regulatory harmonization and what he describes as “mutual recognition” allowing countries to accept vaccine approvals from trusted regional regulators rather than requiring duplicative national approvals.

Strong and functional National Regulatory Authorities are essential for a sustainable vaccine ecosystem, the report stresses. Yet, with limited regulatory alignment and only a small share of regionally produced vaccines achieving WHO prequalification, manufacturers continue to face barriers to cross-border supply and access to global procurement channels.

What comes next?

The report ultimately argues that meaningful progress will depend on aligning political intent with practical mechanisms that connect procurement, financing, technology transfer, and regulation over time.

Key priorities include creating predictable regional demand through clear policy commitments and pooled procurement mechanisms, strengthening and harmonizing regulatory systems to accelerate approvals, and investing in diversified vaccine platforms aligned with regional health needs and supported by resilient supply chains.

“Stronger regionalized vaccine manufacturing should be viewed as a health security multiplier and a diplomatic asset,” says Kristensen. “Supporting regionally led initiatives through financing and technical assistance strengthens resilience, positions the U.S. as a collaborative partner, and increases the likelihood of U.S.-based vaccine development initiatives succeeding, as supply chains remain operational and knowledge sharing also supports national product development.”