Author
Mina Adel, PMP
IAVI- Consultant for Global Access, Alliance & Product Optimization
BGP- Coordinator of WHO mRNA Vaccine Technology Transfer Hub Program
Introduction
The COVID-19 pandemic illuminated the stark inequities in global vaccine distribution, especially for low- and middle-income countries (LMICs). While wealthier nations secured early access to vaccines, many LMICs struggled to obtain enough doses, prolonging the pandemic and contributing to the rise of new variants. This disparity underscored the urgent need for more equitable vaccine access, especially in the context of global health security.
In response to these challenges, the World Health Organization (WHO) and the Medicines Patent Pool (MPP) launched the mRNA Technology Transfer Hub Program. This ambitious initiative aims to reduce dependency on global vaccine suppliers by enabling local manufacturers in LMICs to independently produce mRNA vaccines. While this effort directly addresses COVID-19, it also lays the groundwork for future vaccine production against other infectious diseases. One of the key players in this initiative is Egypt, which has become a leader in mRNA vaccine production in the Middle East and North Africa (MENA) region.
This article explores the progress, challenges, and future potential of the WHO/MPP mRNA Technology Transfer Hub, with a focus on Egypt’s role in reshaping vaccine manufacturing in LMICs.
The WHO/MPP mRNA Technology Transfer Hub: Goals and Importance
The WHO/MPP mRNA Technology Transfer Hub was designed to empower LMICs by sharing mRNA vaccine technology with qualified local manufacturers. The initiative seeks to democratize vaccine production, allowing countries to meet their own vaccine needs and reduce reliance on external suppliers. mRNA vaccines, which were first developed to combat COVID-19, represent a breakthrough in vaccinology due to their flexibility, rapid development timeline, and potential to tackle a wide range of pathogens.
Egypt recognized the transformative potential of mRNA technology early on. In addition to addressing COVID-19, the government and healthcare stakeholders in Egypt understood that local mRNA manufacturing could help protect against other diseases, such as seasonal influenza, rabies, and polio. These diseases, traditionally difficult to tackle in LMICs, could potentially be controlled using mRNA-based vaccines.
As a key partner in the program, Egypt has worked closely with WHO, MPP, and other stakeholders to ensure the successful transfer and application of mRNA technology. The project’s impact has been significant, not just for Egypt, but for the entire MENA region. Through collaboration and technical exchanges, Egypt is laying the foundation for a future of self-sufficient vaccine production.
Scope and Implementation: Establishing an mRNA Vaccine Manufacturing Facility in Egypt
The journey to establishing an mRNA vaccine production facility in Egypt began with a comprehensive needs assessment. In partnership with WHO and MPP, Egypt conducted an in-depth evaluation of its infrastructure, workforce, and regulatory environment. This assessment was vital in determining the feasibility of setting up such a facility, as well as identifying gaps in technology and capacity that needed to be addressed.
To build the necessary expertise, Egypt’s healthcare professionals, along with representatives from the Egyptian Drug Authority (EDA), were trained at South Africa’s mRNA training center. This training covered essential aspects of mRNA production, such as sequencing, formulation, and quality control, enabling the team to gain hands-on experience in laboratory-scale production.
Returning to Egypt, the team began establishing pilot production facilities to adapt the lessons learned in South Africa to local conditions. Collaboration with the Ministry of Health’s Preventive Affairs Sector and WHO’s Eastern Mediterranean Regional Office (EMRO) was critical in ensuring that Egypt’s vaccine production capabilities aligned with both national and regional needs.
A major milestone was reached when Egypt successfully established a functional pilot production line capable of producing test batches of mRNA vaccine material. This achievement marked Egypt’s entry into mRNA vaccine production, setting the stage for future advancements in local vaccine manufacturing. With continued support from WHO and MPP, Egypt is on track to scale these efforts into a full-fledged manufacturing facility that could meet both national and regional vaccine needs.
Overcoming Challenges in the Technology Transfer Process
Building a local mRNA vaccine manufacturing facility is not without its challenges, particularly in LMICs where infrastructure and regulatory systems may not be fully equipped to support such advanced technologies. In Egypt, navigating the regulatory landscape for mRNA vaccines presented a significant hurdle. Unlike traditional vaccines, mRNA vaccines require specialized equipment and stringent storage and transport conditions to maintain stability and efficacy. These requirements necessitated a complete overhaul of existing regulatory frameworks to ensure they were aligned with global standards.
To address this, Egypt worked closely with the Egyptian Drug Authority (EDA) to develop a regulatory framework that would accommodate the unique needs of mRNA vaccine production. This involved a series of technical consultations and iterative adjustments to meet both local and WHO standards. While time-consuming, this process has helped ensure that Egypt’s vaccine production meets the highest standards of quality and safety.
In addition to regulatory challenges, securing sustained funding and resources has been another major obstacle. Although the WHO/MPP provided initial funding, the costs associated with infrastructure development, staff training, and equipment procurement quickly exceeded initial estimates. As Project Manager, I oversaw resource allocation, managed budgets, and engaged with potential investors to explore alternative funding sources to ensure the financial sustainability of the project.
Logistical challenges also arose, particularly in the international shipping of specialized equipment. Key components, such as bioreactors and purification systems, had to be imported, which required navigating complex trade regulations and supply chain disruptions. Despite these obstacles, Egypt’s commitment to overcoming these challenges has paved the way for significant progress in local mRNA vaccine production.
Regional and Global Impact of Local mRNA Production
The establishment of an mRNA vaccine manufacturing facility in Egypt has wide-reaching implications for both the MENA region and the global health landscape. By reducing its reliance on external suppliers, Egypt is enhancing its health security and establishing itself as a regional leader in vaccine production. This capability will not only improve Egypt’s ability to respond to future pandemics but will also help mitigate the impact of infectious disease outbreaks in neighboring LMICs.
The success of the mRNA Technology Transfer Hub also demonstrates the power of international cooperation in health technology transfer. Through partnerships with organizations like WHO and MPP, Egypt is showing that LMICs can play a crucial role in addressing global health challenges. This collaborative model may inspire similar programs in other regions, creating a network of self-sustaining vaccine manufacturers capable of responding to emerging health threats.
Beyond COVID-19, mRNA vaccines have the potential to address a wide array of diseases. Egypt’s growing expertise in mRNA technology positions it to expand its vaccine portfolio, including vaccines for influenza, rabies, and even certain types of cancer. As Egypt builds on its mRNA capabilities, it is also contributing to the regional economic growth and improving public health outcomes, making healthcare systems more resilient in the face of future challenges.
Future Prospects and Next Steps
Looking ahead, Egypt plans to continue expanding its mRNA production capacity. The progress achieved so far has laid a strong foundation, but scaling up production, optimizing manufacturing processes, and exploring new vaccine targets are key priorities. To achieve this, Egypt is actively seeking new partnerships and funding opportunities to support its continued growth in mRNA vaccine production.
Collaborations with global health organizations like the Serum Institute of India and Sinopharm are instrumental in diversifying Egypt’s vaccine production capabilities. These partnerships will help Egypt localize additional vaccine technologies, such as viral vector and recombinant vaccines, which will further enhance its ability to respond to diverse health threats in the region.
Additionally, Egypt aims to become a regional training hub, offering technical support and capacity-building services to other LMICs interested in developing their own vaccine manufacturing capabilities. By sharing knowledge and expertise, Egypt can help other nations achieve self-sufficiency in vaccine production, contributing to a more equitable global health ecosystem.
Conclusion
The WHO/MPP mRNA Technology Transfer Hub Program represents a transformative step toward global vaccine equity, and Egypt is proud to be at the forefront of this initiative. Through the transfer of mRNA technology, Egypt is building a self-sufficient healthcare system capable of addressing its own vaccine needs and contributing to regional health security. The progress made thus far highlights the importance of international cooperation, regulatory adaptability, and financial sustainability in establishing resilient vaccine production infrastructures.
As Egypt continues to expand its mRNA capabilities and form new partnerships, it is playing a pivotal role in reshaping the future of vaccine manufacturing in LMICs. The path toward vaccine self-reliance is challenging, but with continued support from WHO, MPP, and other international stakeholders, Egypt is on track to achieve a sustainable and resilient healthcare ecosystem that can respond to both current and future health challenges.
References
World Health Organization (WHO), 2021. The mRNA vaccine technology transfer hub. Available at: https://www.who.int/initiatives/the-mrna-vaccine-technology-transfer-hub
· WHO. (2022) mRNA vaccine technology transfer spokes launch event. Available at: https://www.who.int/news-room/events/detail/2022/02/18/default-calendar/mrna-vaccine-technology-transfer-spokes-launch-event
· WHO. (2022) WHO Director-General’s remarks at the Munich Security Conference – 18 February 2022. Available at: https://www.who.int/director-general/speeches/detail/who-director-general-s-remarks-at-the-munich-security-conference-18-february-2022
