BioNTech and CEPI Enhance Africa's mRNA Vaccine Ecosystem

BioNTech and the Coalition for Epidemic Preparedness Innovations (CEPI) have announced an expansion of their strategic partnership to enhance local research and development (R&D), along with clinical and commercial-scale manufacturing capacities for mRNA vaccines in Africa. This collaboration aims to address Africa's unique healthcare needs by ensuring vaccine accessibility and affordability, particularly for low and middle-income countries (LMICs) on the continent.

CEPI will provide up to $145 million to support the establishment of mRNA vaccine development and manufacturing capabilities at BioNTech's facility in Kigali, Rwanda. This funding will help broaden the scope of the Kigali facility to better prepare for future epidemic and pandemic threats in Africa. The facility, which was first announced in 2021 and inaugurated in December 2023, features advanced, digitally enabled modular manufacturing units known as BioNTainers. These units are designed to produce a range of mRNA-based vaccines.

BioNTech's Kigali facility has the potential to become the first commercial mRNA vaccine manufacturing site in Africa. This initiative aligns with the African Union's and Africa CDC's goal of producing 60% of the vaccines required on the continent by 2040. Under the partnership terms, BioNTech will ensure that vaccines produced at the Kigali facility are made available at affordable prices, with a priority on supplying African countries. The vaccines targeted include those for malaria, mpox, and tuberculosis, provided they are successfully developed and receive regulatory approval.

The BioNTech-CEPI partnership will focus on three main areas to bolster Africa's pandemic preparedness and vaccine ecosystem:

1. Commercial-scale Manufacturing: CEPI's funding will support regulatory authorization measures needed for the Kigali facility, expected to begin in 2025. In the event of a disease outbreak, BioNTech will allocate up to half of the facility's manufacturing capacity to produce emergency response mRNA vaccines, subject to regulatory approval. This effort aligns with the 100 Days Mission, a global initiative aimed at developing vaccines within 100 days of an outbreak, championed by CEPI and endorsed by global leaders and industry stakeholders.

2. End-to-end Clinical-scale Manufacturing: A significant portion of CEPI's funding will be used to set up clinical-scale manufacturing capabilities for mRNA-based vaccine candidates at the Kigali facility. This will enable BioNTech to produce vaccines on both a clinical and commercial scale, thereby broadening the facility's manufacturing scope and supporting a sustainable use case while enhancing Africa's vaccine development ecosystem.

3. Strengthening the African R&D Ecosystem: CEPI's support will enable BioNTech to allocate manufacturing capacities for third-party projects. These projects will support pre-clinical and clinical activities by African-based researchers, academic groups, local businesses, and non-profit organizations. Projects will be selected in collaboration with global, regional, and national healthcare organizations. This effort aims to foster R&D activities for novel mRNA-based vaccine candidates against pathogens with epidemic or pandemic potential.

BioNTech and CEPI are committed to equitable access to vaccines, underscoring the importance of affordable pricing for the vaccines produced at the Kigali facility. Their partnership also aims to facilitate a rapid response to outbreaks on the African continent, whether caused by known viral threats or novel pathogens with epidemic or pandemic potential.

Dr. Richard Hatchett, CEO of CEPI, emphasized the importance of this partnership in addressing vaccine inequities and enhancing Africa's resilience to future pandemics. Prof. Ugur Sahin, CEO and Co-founder of BioNTech, highlighted the significance of this collaboration in establishing a sustainable mRNA vaccine ecosystem in Africa.

Supporting statements from key figures, including Rwanda's Minister of Health, the Director General of Africa CDC, and the WHO Director-General, underscore the critical role of this partnership in strengthening local vaccine production and pandemic preparedness in Africa. These endorsements highlight the collaborative effort to create a robust and resilient health security framework on the continent.

Overall, the BioNTech-CEPI partnership represents a significant step towards achieving vaccine equity and strengthening Africa's capacity to respond to public health emergencies through advanced mRNA technology. The initiative aims to ensure that Africa can produce a substantial portion of its vaccine needs locally, thereby improving health outcomes and resilience against future pandemics.

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