BioNTech Achieves Milestone at mRNA-based Vaccine Manufacturing Site in Rwanda

BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) has reached the next milestone in the establishment of mRNA vaccine manufacturing capacities in Africa with the inauguration of the Company’s site in Kigali, Rwanda. The inauguration takes place on the occasion of the set-up of the first manufacturing unit called BioNTainer. This effort is one of BioNTech’s multiple initiatives aimed at helping to build a sustainable and resilient African vaccine ecosystem and supporting equitable access to novel medicines globally: these cover research and development, clinical trials, manufacturing and local training of specialized personnel.

At a whole-day conference titled “Working together to promote vaccine equity for Africa” that preceded the site inauguration, BioNTech engaged 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 Authority to discuss opportunities and challenges in building a sustainable and resilient vaccine ecosystem in Africa. Upon invitation by His Excellency President Paul Kagame of Rwanda, Heads of State and Government from around the world, highest leadership of the African Union, European Union as well as from WHO and CEPI attended the inauguration ceremony of BioNTech’s site. The Company’s manufacturing site in Kigali could become the first commercial-scale mRNA manufacturing facility on the continent.

The facility is based on the Company’s high-tech, digitally enabled modular manufacturing units called BioNTainers. They are designed to manufacture a range of mRNA-based vaccines. The BioNTainers are also designed to be updated on a regular basis, as BioNTech aims for them to remain one of the most sophisticated mRNA manufacturing facilities in the world. The manufacturing site will initially be equipped with two BioNTainers. The containers for the first BioNTainer, which were recently set up in the manufacturing hall and will serve to manufacture mRNA as drug substance, arrived in Kigali in March 2023. The second BioNTainer unit will serve to manufacture the formulated bulk drug product and will be ready for shipment to the Rwanda site in the first quarter of 2024. 

The manufacturing facility in Kigali has been fully funded by BioNTech to date. The Company has committed a total investment of approximately USD 150 million to complete the construction of the site including the manufacturing units. The overall site has a size of approximately 35,000 square meters and will have approximately 100 employees once fully operational. In 2024, BioNTech expects to complete all buildings on site, including a warehouse, offices and laboratories for quality control. The Company anticipates that, following local training of specialized personnel in 2024, it can start operating with the manufacturing of mRNA-based vaccine batches required for process validation in 2025. The facility is intended to manufacture vaccines tailored to the needs of African Union members. Its manufacturing capacity depends on the mRNA product being manufactured and its various factors such as dosage and formulation. For example, BioNTech could manufacture up to 50 million doses annually of a product that has an RNA process similar to that of the Pfizer-BioNTech COVID-19 Vaccine.

In line with the continent’s and partner countries’ needs, 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 commercial-scale manufacturing capacities in Africa, or they could be smaller and specialized in the manufacture of batches for the clinical evaluation of product candidates.

To support the establishment of a sustainable vaccine ecosystem in Africa, BioNTech is progressing the development of prophylactic mRNA vaccines targeting infectious diseases such as tuberculosis, malaria, and HIV, and is also focusing on diseases with epidemic and pandemic potential, including mpox. Clinical trials for tuberculosis and malaria vaccine programs are already underway in South Africa and the United States, respectively. BioNTech plans to conduct clinical trials in Africa for vaccine candidates against malaria, tuberculosis and HIV in 2024. Malaria, tuberculosis and HIV are highly prevalent in Africa, causing over two million deaths annually, including a high degree of child mortality. If successfully developed and authorized by regulatory authorities, BioNTech plans to provide lower-income countries with access to the four prophylactic vaccines at a not-for-profit price.

While in Kigali, Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech, met with His Excellency Macky Sall, President of the Republic of Senegal, and discussed developing a potential research partnership between BioNTech and the Institut Pasteur de Dakar with a focus on infectious diseases relevant to the African continent.

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