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BioNTech has announced that it has reached the next milestone in the establishment of its mRNA vaccine manufacturing capacities in Africa, with the introduction of the new site in Kigali, Rwanda. This inauguration marks the set-up of the first manufacturing unit, BioNTainer. 

This new facility is part of BioNTech’s initiatives aimed at helping to establish a ‘sustainable and resilient African vaccine ecosystem’ as well as supporting global equitable access to medicines. These initiatives include research and development, clinical trials, manufacturing and local training of specialised staff.

BioNTech has already met with representatives from the World Health Organization (WHO), the Coalition for Epidemic Preparedness Innovations (CEPI), Africa Centers for Disease Control and Prevention (Africa CDC), Rwanda Food and Drug Administration (Rwanda FDA), Health Emergency Preparedness and Response Authority (HERA), the Bill and Melinda Gates Foundation, and the South African Health Products Regulatory Agency to discuss its opportunities and challenges in building this vaccine ecosystem in Africa.

The facility is based on BioNTech’s digitally enabled modular manufacturing units, known as BioNTainers, which are designed to manufacture a variety of mRNA-based vaccines. The Rwanda site will have two of these manufacturing systems, the first having arrived in March 2023 and the other expected in the first quarter of 2024.

According to the company’s press release, ‘BioNTech is committed to establishing additional manufacturing facilities in Africa upon the successful validation of the facility in Kigali, which serves as a lighthouse project. Compared to the facility in Kigali, additional sites could be designed as larger facilities providing increased commercialscale manufacturing capacities in Africa, or they could be smaller and specialised in the manufacture of batches for the clinical evaluation of product candidates’.

Professor Ugur Sahin MD, CEO and cofounder of BioNTech, commented: “We are committed to building a sustainable mRNA vaccine ecosystem in Africa, focusing on the development of mRNA vaccines against infectious diseases with high medical needs and forging high-end technology solutions for local manufacturing. [The] inauguration event establishing the first 'BioNTainer' module for mRNA manufacturing is an important milestone in this journey. Together with our partners, we are advancing towards our first commercial-scale mRNA facility in Africa, as a cornerstone of our joint vision of a sustainable health future. I would like to express my gratitude to our local and international partners for their contributions to this joint effort, as well as to the entire BioNTech team for their dedicated work, which made this inauguration possible.”