In a historic moment for Rwanda, German biotechnology company BioNTech has inaugurated its maiden African manufacturing site in Kigali.
Located within the Kigali Special Economic Zone in Gasabo District, this state-of-the-art biopharma manufacturing facility represents a crucial step in the nation’s efforts to bolster mRNA vaccine production.
The inauguration ceremony witnessed the presence of notable dignitaries, including President Paul Kagame and First Lady Jeannette Kagame, alongside Heads of State and Government from Africa and beyond. High-ranking officials from the African Union, European Union, World Health Organization (WHO), and World Trade Organization (WTO) also attended the event.
Addressing the audience, Ugur Sahin, the co-founder and CEO of BioNTech, outlined the company’s plans for the new facility. He stated that the completion of construction works is scheduled for 2024, with local training of specialized personnel set to commence in the same year. The testing of mRNA validation is slated to begin in 2025.
The Kigali facility will initially be equipped with two BioNTainers, dedicated to the production of mRNA and the formulated bulk drug product. Sahin emphasized that these BioNTainers have the capability to manufacture a range of mRNA-based vaccines tailored to the specific needs of African Union member states.
Potential vaccine candidates for production include the Pfizer-BioNTech Covid-19 vaccine and BioNTech’s investigational malaria and tuberculosis vaccines, pending successful development, approval, or authorization by regulatory authorities.
Sahin expressed optimism about the facility, stating, “Africa will have one of the most advanced manufacturing facilities in the world. These BioNTainers will be able to manufacture any kind of mRNA vaccines.” He highlighted their capacity to produce over 50 million doses annually for regular public supply, pandemic response, or clinical trials involving 10,000 mRNA doses.
Despite acknowledging the work ahead, Sahin outlined the company’s plan to complete construction in 2024 and initiate the commissioning and qualification process.
Distinguished leaders in attendance included Ursula von der Leyen, President of the European Commission, Moussa Faki Mahamat, Chairperson of the African Union Commission, and representatives from multilateral institutions and key stakeholders in the vaccine and public health ecosystem in Africa.
Upon completion, the Kigali manufacturing site is poised to become the first end-to-end mRNA manufacturing facility in Africa, featuring a completed manufacturing unit known as the BioNTainer, designed for the production of a variety of mRNA-based vaccines.
