BioNTech & CEPI Expand Partnership to Strengthen Africa’s mRNA Vaccine Ecosystem

BioNTech SE 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. CEPI is committing up to US $145 million¹ to support BioNTech to establish mRNA vaccine R&D, clinical, and commercial-scale manufacturing capabilities at the company’s facility in Kigali, Rwanda. These capabilities will contribute to efforts to better prepare for potential future epidemic and pandemic threats in Africa.

BioNTech’s commercial-scale manufacturing facility in Kigali was first announced in 2021 and inaugurated in December 2023. The facility is based on the company’s high-tech, digitally enabled modular manufacturing units called BioNTainers, designed to manufacture a range of mRNA-based vaccines. BioNTech’s Kigali manufacturing facility could become the first commercial mRNA facility in Africa, intended to support the African Union’s and Africa CDC’s goal of producing 60% of total vaccine doses required on the continent by 2040.

BioNTech and CEPI are committed to enabling equitable access. Under the terms of the agreement BioNTech intends to provide affordable access to BioNTech’s prophylactic vaccines manufactured at the Kigali facility, 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 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, would dedicate up to half of the facility’s manufacturing capacity to produce emergency response mRNA vaccines, subject to regulatory authorization. This effort aims to contribute to the 100 Days Mission, a global initiative to accelerate the development of safe and effective vaccines in response to an outbreak of a novel Disease X in as little as 100 days. The 100 Days Mission is spearheaded by CEPI and embraced by the G7, G20 and industry leaders.

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, and thus broaden the manufacturing scope, in support of a sustainable use case for the facility while strengthening the wider African vaccine development ecosystem.

BioNTech 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.

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 organizations². 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.

“Africa still has to import 99% 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 Dr. Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations (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,” added Prof. Ugur Sahin, MD, CEO and Co-founder 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.”

BioNTech and CEPI first announced their strategic partnership in September 2023.

CEPI was launched in 2017 as an innovative partnership between public, private, philanthropic and civil organizations. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need. CEPI has supported the development of more than 50 vaccine candidates or platform technologies against multiple known high-risk pathogens or a future Disease X. Central to CEPI’s pandemic-beating five-year plan for 2022-2026 is the ‘100 Days Mission’ to compress the time taken to develop safe, effective, globally accessible vaccines against new threats to just 100 days.

Biopharmaceutical New Technologies (BioNTech) is a global next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor (CAR) T cells, several protein-based therapeutics, including bispecific immune checkpoint modulators, targeted cancer antibodies and antibody-drug conjugate (ADC) therapeutics, as well as small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global and specialized pharmaceutical collaborators, including Biotheus, DualityBio, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer, and Regeneron.