mRNA Vaccine Technology Transfer and Training Hub in South Africa: A partnership model for sustainable vaccine production

ABSTRACT

Introduction/ Background: While over 6 billion doses of Covid19 vaccines have been administered globally, only 2% of people in Africa have been vaccinated. This uncomfortable reality lead to the establishment of a mRNA vaccine technology transfer and training Hub in South Africa under the COVAX initiative lead by WHO and MPP. Methods: Afrigen Biologics is establishing a technology transfer and training hub for COVID-19 mRNA-based vaccines. In the absence of a technology transfer agreement with the holders of mRNA vaccine technology, Afrigen and its University partners are developing a firstgeneration vaccine, a fast follow-on of mRNA-1273 (Moderna vaccine). The Afrigen-based vaccine technology transfer program will provide sufficient transfer of know-how to allow a competent tech transfer recipient manufacturer in Africa and other LIMCs to successfully manufacture and release mRNA vaccines at scale to support clinical development, national/regional marketing authorization and WHO prequalification, and sustainable supply to meet local and regional vaccine demand. Results: The mRNA Hub at Afrigen has reached key milestones in terms of completion of the facility and start up phase of equipment supply, training of Afrigen core staff in drug substance and drug product production at lab scale. The development of a stable genetic construct that allows transcription of an mRNA molecule at bench scale as well as the encapsulation in a lipid nano particle is underway. This presentation will provide an overview of the progress of the mRNA Hub, its workplan as well as the long-term research and development program and the partnerships supporting the Hub. Impact The mRNA vaccine technology transfer Hub has created a public private partnership model for sustainable vaccine manufacturing on the African continent. Supported and enabled by the African Union and the African CDC, the mRNA Hub is well positioned to become one of the pillars of the African vaccine manufacturing strategy. Conclusion: The Covid19 pandemic has unleashed significant energy to ensure that Africa implement programs that will ensure sustainable supply of vaccines and preparedness for future pandemics. The Hub and Spoke model is one of the interventions that has the potential to create local innovation and contribute to the supply of vaccines.