WHO's mRNA Technology Transfer Programme Enters Phase 2.0, Targeting Commercial-Scale Production in Low- and Middle-Income Countries
核心洞察
The WHO and Medicines Patent Pool (搜索)'s mRNA Technology Transfer Programme is transitioning to Phase 2.0 (2026-2030), moving from proof of concept to commercially sustainable manufacturing in 15 partner countries across Latin America, Africa, Eastern Europe and Asia.
The initiative aims to empower regional manufacturers to scale up GMP-grade production of mRNA vaccines (搜索) for pandemic and priority diseases including influenza (搜索), TB, HIV (搜索), malaria (搜索), dengue (搜索), and leishmaniasis (搜索), as well as mRNA therapeutics for oncology applications.
Several manufacturers including Bio-Manguinhos (搜索), Sinergium (搜索), BioFarma (搜索), and Biovac (搜索) are already piloting investment roadmaps with detailed market and regulatory modeling, while Afrigen Biologics (搜索) is approaching GMP accreditation.
The World Health Organization's groundbreaking mRNA Technology Transfer Programme is advancing to Phase 2.0, marking a critical transition from technology sharing to commercially viable manufacturing across low- and middle-income countries. The initiative, discussed during the G20 Health Working Group meetings in Johannesburg, represents a pivotal shift toward sustainable pandemic preparedness and regional health security.
Launched in 2021 by WHO and the Medicines Patent Pool (搜索) with support from South Africa, France, Belgium, Canada, the European Union, Germany and Norway, the programme has successfully transferred foundational mRNA technology to 15 partners across Latin America, Africa, Eastern Europe and Asia. Phase 2.0, spanning 2026-2030, aims to empower these regional manufacturers to achieve Good Manufacturing Practices (GMP)-grade production at commercial scale.
"The mRNA Technology Transfer Programme is delivering on its promise to build capabilities in low- and middle-income countries," said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. "The Pandemic Agreement adopted by the World Health Assembly also includes legally-binding commitments to strengthen local production. We must now translate those commitments into capacity on the ground, so that when the next pandemic strikes, we meet it more equitably and more effectively."
Expanding Therapeutic Applications
The programme's scope extends beyond pandemic preparedness to encompass a diverse portfolio of mRNA applications. Product focus areas include mRNA vaccines (搜索) for pandemic and priority diseases such as influenza (搜索), tuberculosis (搜索), HIV (搜索), malaria (搜索), dengue (搜索), and leishmaniasis (搜索). Additionally, the initiative targets mRNA therapeutics including oncology treatments and monoclonal antibody (搜索) therapies, alongside biologicals beyond mRNA to support facility viability.
Prof. Petro Terblanche, CEO of Afrigen Biologics (搜索), highlighted the programme's progress: "We have successfully progressed with the technology transfer to eight Partners — a testament to the strength and openness of this platform. What comes next is even more exciting: Afrigen is on the cusp of receiving GMP accreditation, positioning us not only as a technology originator but as a sustainable manufacturing and innovation partner for the Global South."
Tailored Business Models for Regional Needs
Phase 2.0 recognizes the need for customized approaches based on regional dynamics. Manufacturers are developing tailored business strategies considering national health needs, policy frameworks, regulatory maturity, and market conditions. Several partners, including Bio-Manguinhos (搜索) and Sinergium (搜索) in Latin America, BioFarma (搜索) in Indonesia, and Biovac (搜索) in South Africa, are already piloting investment roadmaps with detailed market, regulatory, and cost of goods sold modeling.
The programme's sustainability hinges on country and regional-level procurement commitments, pooled purchasing mechanisms, and cross-border alignment, particularly in Africa and Asia where national markets alone may be insufficient to support GMP-level manufacturing scale.
"We need to back science with smart policy," said Dr Mmboneni Muofhe of South Africa's Department of Science, Technology and Innovation. "This is about creating a new ecosystem for public health security, grounded in regional ownership, long-term strategy and investments."
Addressing Market Opportunities and Challenges
While market opportunities for mRNA vaccines (搜索) and therapeutics continue expanding from seasonal influenza (搜索) and HPV (搜索) to innovative cancer (搜索) treatments, the programme acknowledges significant structural barriers. These include misinformation and vaccine hesitancy, shifting donor funding priorities that reduce funding availability, high clinical trial costs, and the need for supportive policies and well-defined procurement pathways.
Charles Gore, Executive Director of the Medicines Patent Pool (搜索), emphasized the critical nature of this transition: "This is a unique opportunity, driven by the pandemic. The foundations are in place — but without sustained political will, the promise of equitable mRNA access could slip through our fingers. What we need now is the courage to build on our investment to date, to align, and to realise the full value and impact of what we started."
The programme also highlights growing interest in regional R&D consortia focused on diseases of regional relevance like leishmaniasis (搜索) and malaria (搜索), while advancing next-generation technologies emphasizing dose sparing, reduced cost of goods, and thermostability. This comprehensive approach positions the initiative as a cornerstone for global health equity and pandemic preparedness in the coming decade.