Geneva — In its second scientific colloquium, Afrigen and the mRNA technology transfer programme are excited to share significant progress in the realm of mRNA vaccine technology, marking a transformative leap toward global health security. The science outlined in the mRNA Science Colloquium underscores the progress made at Afrigen since the start of the project and looks ahead to the next steps.

The event is also an opportunity to acknowledge pivotal collaborations, including those with NIH VRC on the pDNA process development and the University of Marseilles, who contributed to the preclinical performance evaluation of AfriVac 2121.

The highlights of this journey are remarkable. In the absence of a technology donor, South African scientists embarked on an ambitious path to develop their own mRNA vaccine platform. Beginning on a modest laboratory scale, this endeavor has relentlessly progressed towards manufacturing capabilities suitable for Phase 1/2 clinical trial material production.

Along the way, the scientific team encountered numerous challenges, including protracted lead times for critical equipment and single-use consumables, limited access to suitable GMP-grade raw materials and reagents, and a dearth of local technical support from suppliers. Despite these formidable obstacles, Afrigen, in collaboration with the World Health Organization and the Medicines Patent Pool (MPP) triumphantly crafted the mRNA COVID-19 vaccine candidate, AfriVac 2121 from early laboratory experiments in partnership with WITS University to production and characterisation of an mRNA drug substance (DS) and LNP formulated drug (DP) in the Afrigen newly constructed facilities in a period of 18 months. This groundbreaking vaccine candidate demonstrated exceptional protective efficacy against SARS-CoV-2 in comprehensive animal models. A pivotal discovery was that AfriVac 2121 suppressed viral replication in both mucosal and lung tissues to the same degree as the commercial comparator. Furthermore, three weeks post-vaccination, AfriVac 2121 induced anti-Spike IgG levels that rivaled those of the comparator. Afrigen is now embarking on the crucial scale-up to produce 1-litre mRNA drug substance, aligning its efforts with the requirements of clinical trial batch sizes.

Throughout this monumental journey, Afrigen has collaborated closely with the MPP team to facilitate the seamless transfer of critical laboratory research knowledge. To date, thirteen partners have received the first knowledge transfer packages, a testament to the programme’s commitment to disseminating the benefits of our scientific endeavours.

Prof. Petro Terblanche said, “The ultimate goal of the mRNA programme is to create sustainable research and manufacturing capabilities in LMICs, enabling them to harness mRNA technology for pandemic response and the uninterrupted supply of essential public health vaccines. Excellence in science and technology is the cornerstone of this programme, and I salute the scientists and engineers for their unwavering commitment to this pursuit of excellence.”

Charles Gore said, “I am delighted to see such significant scientific advances in such a short period of time. Afrigen works closely with the MPP on many aspects including scientific, legal, and IP rights.  I am also thrilled to see the progress that is being made by the programme partners in preparing to receive this technology and develop it further.”

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About the mRNA technology transfer programme:

The mRNA technology transfer programme is a global initiative that aims to improve health and health security by establishing sustainable, locally owned mRNA manufacturing capabilities in and for low- and middle-income countries (LMICs).The programme is based around a technology transfer “hub”  Afrigen, which is located in South Africa. They will provide the technology development, training and technology transfer, and currently 15 programme partners in LMICs across the world are receiving training and technology from the hub and will then produce and sell products commercially. Its core concept is empowerment.

About the Medicines Patent Pool (MPP):

The Medicines Patent Pool (MPP) is a United Nations-backed public health organization dedicated to improving access to life-saving medicines for low- and middle-income countries. MPP is guided by a public health-centric approach to intellectual property management, expertly balancing the interests of public health and pharmaceutical manufacturers.