Jessabelle Basa, MSc. Regional Technical Lead – Association of Southeast Asian Nations (ASEAN), Regionalized Vaccine Manufacturing Collaborative (RVMC)
The Vaccine Manufacturing Landscape Pre-pandemic
While most countries have established routine immunization programs, the COVID-19 pandemic highlighted critical vulnerabilities in the vaccine manufacturing and supply chain systems and significant gaps in equitable access to vaccines as essential medical countermeasures.(1,2) During the COVID-19 pandemic, vaccines were developed at a record-breaking speed, only 10 months into the pandemic. However, access to COVID-19 vaccines was largely disparate with eight of every 10 vaccination doses having gone to high-income countries.(3) Of the just over six billion doses administered globally by the end of September 2021, 75% were administered in high- and upper-middle income countries (which constitute 50% of the global population) and only 25% in low- and low-middle income countries (which constitute the other 50%).(4)
This inequity in vaccine access and distribution during the COVID-19 pandemic has been partly due to the scale of vaccine nationalism seen throughout the pandemic and was enabled by the fact that global vaccine manufacturing capacity remains largely concentrated in certain geographical areas or few high- and upper-middle income countries.(2,5,6) Beyond China and India, vaccine manufacturers are mostly located in Europe, North America, Indonesia, and Japan.(6)
The concentration of vaccine manufacturing in high-income regions and few key upper-middle countries does not only present risk of slower vaccine access and pandemic response. It also leaves low- and middle-income countries vulnerable to supply shocks in routine immunization and regulatory bottlenecks in both routine and emergency cases.(7)
The COVID-19 pandemic have highlighted the need to establish and strengthen national and regional vaccine manufacturing capacity in low- and middle-income countries.(2,8) The COVID-19 pandemic exposed how regions without manufacturing capacity can struggle to access vaccines especially when they are needed most.(9) Expanding the geographic distribution of vaccine manufacturing capacity is critical to achieving vaccine equity.(3) Increased manufacturing capacity and significant efforts to address equitable geographical manufacturing have been initiated since the COVID-19 pandemic.(10)
The Global Push for Regional Vaccine Manufacturing
In response to ensuring geographic distribution of manufacturing capacity, governments and international organizations began investing in efforts to expand vaccine manufacturing across multiple regions.
- Some of the most prominent initiatives aimed at distributed manufacturing capacity include:
- the World Health Organization (WHO) and Medicine Patents Pool (MPP) mRNA Technology Transfer program (11),
- the Partnerships for African Vaccine Manufacturing (PAVM) under the African CDC (12),
- the African Vaccine Manufacturing Initiative (AVMI) joined by 10 manufacturers (13),
- the Regionalized Vaccine Manufacturing Collaborative (14),
The WHO-MPP mRNA Technology Transfer Program aims to build sustainable regional production of mRNA-based health products for future pandemics and ensuring sustainability in-between global health emergencies. The program has 15 partners as of May 01, 2025 – the hub in South Africa which includes Afrigen Biologics, the South African Medical Research Council (SAMRC) and Biovac plus 14 additional global partners across 6 WHO regions in Argentina, Bangladesh, Brazil, Egypt, India, Indonesia, Kenya, Nigeria, Pakistan, Senegal, Serbia, Tunisia, Ukraine and Vietnam.(11)
The Partnerships for African Vaccine Manufacturing (PAVM) was established by the African Union (AU) in 2021 to deliver a bold goal: enabling the African vaccine manufacturing industry to develop, produce, and supply over 60 percent of the total vaccine doses required on the continent by 2040, up from less than 1 percent in 2021.(12)
The African Vaccine Manufacturing Initiative (AVMI) is a non-profit, advocacy group that promotes the establishment of sustainable human vaccine manufacturing capacity in Africa. Established in 2012, AVMI currently represents several vaccine manufacturers across the continent. AVMI was instrumental in the establishment of the Partnership for African Vaccine Manufacturing (PAVM) by the Africa Centres for Disease Control and Prevention (Africa CDC). AVMI continues to support Africa CDC through the PAVM’s new iteration as the Platform for Harmonised African Health Manufacturing (PHAHM) to achieve the African Union’s ambitious goal of supplying at least 60% of Africa’s vaccine needs by 2040.(13)
Established in 2022, the Regionalized Vaccine Manufacturing Collaborative (RVMC) was formed to address inequities in the global vaccine production ecosystem revealed by the pandemic through the establishment of regional vaccine manufacturing (RVM) and supply chain networks capable of producing vaccines for routine use in a sustainable manner, with readiness for outbreak manufacturing.(7,14) RVMC released its first status report “Towards Regionalised Vaccine Manufacturing” in November 2025 which presents a baseline assessment of regionalized vaccine manufacturing (RVM) in Africa, Southeast Asia (the ASEAN member states), and Latin America and the Caribbean (LAC) and ways forward across three thematic areas of the RVMC Framework: Finance & Demand, Regulatory & Governance, and Technology & Supply.(15)
Regionalised Vaccine Manufacturing (RVM) seeks to develop capacity for development, production, procurement, and distribution of vaccines within a region, tailored to the region’s needs and health priorities.(16) A successful and sustainable local or regional vaccine manufacturing require key components: strong political commitment and governance, sufficient financial resources, predictable demand, adequate infrastructure, skilled workforce, access to technology, research and development, a secured material supply chain, and a well-functioning regulatory system.(17) RVMC has put forth a framework which specifies eight pillars or building blocks of a regional ecosystem and recommends best practices that can be translated into regionally relevant and actionable strategic options to create sustainable regional vaccine manufacturing networks.(18)
RVM in 2026: Progress and Remaining Challenges
Activities for regional vaccine manufacturing has become increasingly visible over the recent years. Several regions are developing new manufacturing facilities, improving local fill-and-finish capacity, and expanding workforce training in biomanufacturing.
The African continent had 25 active vaccine projects by June 2024 that are in different stages of project and facility maturity: five manufacturers with commercial-scale manufacturing have technology transfer signed or underway, five other manufacturers have commercial-scale capacity but have yet to sign TT agreements, and 15 additional were still in early development stages.(19) Kenya also officially launched its mRNA Technology Transfer agreement with the World Health Organization – Medicines Patent Pool (WHO–MPP) in February 2026.(20) ASEAN countries – Indonesia, Thailand, and Vietnam – have also developed and manufactured vaccines, including COVID-19, through fill-and-finish arrangements.(21)
Workforce training in biomanufacturing have been expanded with examples such as the WHO Biomanufacturing Workforce Training Initiative and the Global Training Hub for Biomanufacturing of WHO and the Republic of Korea for Low- and Middle-Income Countries (LMICs) (22), the African Union and African CDC’s Industrial Fellowship and Biomanufacturing Fellowship Programmes (23,24), and the ASEAN Vaccine Security and Self-Reliance (AVSSR) Vaccine Human Resource Development Program (25).
Recent years have seen strong political commitment and growing investment in RVM.(26) However, RVM remains in its early stages and much of the momentum needs to be translated into a coordinated action across governments, industry and partners.(9,26) RVMC’s first status report shows that regional manufacturers in Africa meet only 1% and LAC and ASEAN meet 25-29% vaccine demand in their respective regions. The regulatory environment in regions remain disparate and disjointed and technological capabilities remain uneven.(9)
WHO’s recent Global Market Landscape of Vaccine Manufacturing and Procurement released in December 2025 advocates that a whole-of-ecosystem approach needs to be established for RVM which includes national and regional commitment to buy locally/regionally, demand certainty, strengthened regulatory authorities and harmonized requirements, infrastructure investments, and workforce development.(27)
RVMC’s vision and call to action in its first status report is consistent with WHO’s message, three priorities remain central to achieving sustainable regionalized vaccine manufacturing:
- demand predictability achieved through clear policy, budgetary commitments, and supportive mechanisms such as pooled procurement as commitment to buy regionally(15,27),
- regulatory strengthening and harmonization for non-duplicative, better-aligned systems, and accelerated approvals and faster entry to market which also accelerates population access to health products(15), and
- technology and supply diversification such as production platforms that can produce multiple vaccines on the same platform to avoid building excess capacity while at the same offering acceleration, flexibility, and pandemic readiness.(15,28)
Ultimately, sustained political commitment and aligned strategic investments and coordination will help achieve these three priorities and will be integral to achieving resilient and sustainable regional vaccine manufacturing.
References:
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