BioNTech to Receive $145 Million to Expand mRNA Vaccine Production in Africa
German biotech company BioNTech and the Coalition for Epidemic Preparedness Innovations (CEPI) are expanding their strategic partnership to contribute to building a sustainable and resilient end-to-end African vaccine ecosystem. The partners said that CEPI will commit up to $145 million to support BioNTech to establish mRNA vaccine R&D as well as clinical and commercial-scale manufacturing capabilities at the company’s facility in Kigali, Rwanda.
BioNTech’s facility in Kigali, which was first announced in 2021 and inaugurated in December 2023, is based on the company’s modular manufacturing units called BioNTainers, designed to manufacture a range of mRNA-based vaccines.
Under the terms of the agreement, BioNTech intends to provide affordable access to its prophylactic vaccines manufactured at Kigali, such as vaccines against malaria, mpox and tuberculosis, to low and middle-income countries, with priority supply to African countries, if successfully developed and authorized. BioNTech and CEPI said that they intend to work jointly to rapidly respond to outbreaks on the African continent caused by known viral threats, or an as-yet-unknown pathogen with epidemic or pandemic potential.
The BioNTech-CEPI partnership aims to back the company’s existing efforts in three key areas for Africa’s pandemic preparedness and vaccine ecosystem:
- Commercial-scale manufacturing: CEPI’s funding will support measures required for the regulatory authorization of the facility in Rwanda, starting in 2025. Under the terms of the agreement, in the event of a disease outbreak or a potential disease outbreak, BioNTech, is expected to dedicate up to half of the facility’s manufacturing capacity to produce emergency response mRNA vaccines, subject to regulatory authorization.
- End-to-end clinical-scale manufacturing of novel vaccine candidates: The majority of the CEPI funding will be allocated to set up clinical-scale manufacturing capabilities for mRNA-based vaccine candidates at the Kigali facility. This will allow the BioNTech facility to manufacture on both a clinical and commercial scale.
- Strengthening the African R&D ecosystem for mRNA-based vaccines: CEPI’s funding will enable BioNTech to dedicate manufacturing capacities to third party projects with the aim of supporting, pre-clinical and clinical activities, including those by African-based researchers, academic groups, local businesses, public-private partnerships and non-profit organizations. The projects shall be selected in partnership with global, regional and national healthcare organizations. This effort by BioNTech and CEPI has the potential to enable R&D activities for novel mRNA-based vaccine candidates against pathogens with epidemic or pandemic potential.
According to BioNTech, it is separately 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 (supported by CEPI funding). Clinical trials for tuberculosis, malaria and mpox vaccine programs are underway in Europe, the United States, and South Africa. In addition, BioNTech aims to conduct clinical trials in Africa for vaccine candidates against malaria, HIV, and mpox.
“Africa still has to import 99 percent of all the vaccines it needs to protect its people from potentially deadly diseases, meaning many are left waiting far too long to get the life-saving doses they need. This must change if the world is going to avoid the terrible inequity of vaccine distribution that so clearly exacerbated the effects of the Covid-19 pandemic. Through our joint commitment to equitable access, CEPI’s investment in BioNTech’s forward-looking efforts in Africa will boost regional capacity for end-to-end research, development and rapid manufacturing of mRNA vaccines. This will contribute to Africa’s resilience and pandemic readiness and could dramatically alter the course of future outbreaks,” said Richard Hatchett, CEO of CEPI.
"Our partnership with CEPI is an important next step in our comprehensive strategy towards sustainable mRNA vaccine manufacturing in Africa. Our joint efforts are strengthening the implementation of a local mRNA vaccine ecosystem – covering the entire spectrum from research and clinical trials to commercial production,” said Ugur Sahin, CEO of BioNTech. "This, along with our continued efforts to develop mRNA vaccines against diseases like tuberculosis, malaria, HIV, and mpox is aimed at bringing lasting health benefits to millions of people in Africa."
