Pharma Focus Asia

BioNTech and CEPI Partner to Enhance Africa's mRNA Vaccine Ecosystem

Thursday, May 30, 2024

BioNTech SE (Nasdaq: BNTX) and the Coalition for Epidemic Preparedness Innovations (CEPI) are expanding their strategic partnership to establish a robust and sustainable vaccine manufacturing ecosystem in Africa. CEPI will provide up to $145 million to support BioNTech in setting up mRNA vaccine research, development, and manufacturing capabilities in Kigali, Rwanda. This effort aims to enhance responses to future epidemics and pandemics in Africa.

The commercial-scale production facility in Kigali, unveiled in 2021 and inaugurated in December 2023, employs BioNTech's advanced digital, modular production units known as BioNTainers to produce a variety of mRNA-based vaccines. This facility could become Africa's first commercial mRNA production site, supporting the African Union and Africa CDC's objective to locally produce 60% of the continent's vaccines by 2040.

BioNTech and CEPI are committed to ensuring equitable vaccine access. Under the agreement, BioNTech will prioritize affordable access to vaccines for malaria, Mpox, and tuberculosis produced at the Kigali facility, provided they are successfully developed and approved. African countries will be given priority for vaccine supplies from this facility, especially during outbreaks caused by known or new pathogens.

The partnership focuses on three key areas to bolster pandemic preparedness and build a vaccine ecosystem in Africa:

  1. Commercial-scale production: CEPI's funding will aid in obtaining regulatory approval for the Kigali facility, expected to start operations in 2025. In the event of a disease outbreak, BioNTech will allocate up to half of the facility's production capacity for emergency mRNA vaccine production, subject to regulatory approval, in support of the "100 Days Mission." This initiative aims to develop vaccines for new pathogens within 100 days, led by CEPI with support from G7 and G20 countries and industry leaders.
  2. Clinical-scale production: The majority of CEPI's funding will help BioNTech establish clinical-scale manufacturing capacity for mRNA-based vaccines at the Rwanda facility. This will enable production at both clinical and commercial scales, ensuring sustainable use of the facility and strengthening the African vaccine development ecosystem. BioNTech is developing mRNA-based vaccine candidates for diseases like tuberculosis, malaria, and HIV, with clinical trials ongoing in Europe, the U.S., and South Africa, and plans for trials in Africa.
  3. Strengthening the African R&D ecosystem: CEPI's funding will also support third-party preclinical and clinical activities by providing manufacturing capacity for projects led by African researchers, academic groups, local companies, public-private partnerships, and non-profits. Projects will be selected in collaboration with global, regional, and national health organizations. This initiative aims to support the development of innovative mRNA-based vaccine candidates against epidemic or pandemic pathogens.

CEPI, emphasized the importance of addressing vaccine inequality exacerbated by the COVID-19 pandemic, noting that CEPI's funding will bolster BioNTech's efforts to enhance Africa's capacity for integrated mRNA vaccine research, development, and rapid manufacturing. Prof. Dr. Ugur Sahin, CEO and co-founder of BioNTech, stated that the partnership is a significant step in their strategy for sustainable mRNA vaccine production in Africa, aiming to improve the health of millions on the continent.

The partnership has received support from key figures such as Dr. Sabin Nsanzimana, Rwanda's Minister of Health, HE Dr. Jean Kaseya, Director General of Africa CDC, and Dr. Tedros Adhanom Ghebreyesus, Director-General of WHO. They all underscored the importance of local vaccine development and manufacturing for equitable and rapid responses to health crises.



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