This partnership builds on the initial collaboration inked between BioNTech and the Coalition for Epidemic Preparedness Innovations (CEPI) in September 2023, which outlined an aim of supporting the organization’s 100 Days Mission project and advancing messenger RNA (mRNA) Mpox vaccine development.
Now, both parties said they are expanding the collaboration to contribute to building a sustainable and robust African vaccine ecosystem through CEPI’S pledge of up to $145 million to help BioNTech “broaden the scope” of its manufacturing plant in Kigali.
In 2021, BioNTech broke ground on a modular scalable mRNA plant in Kigali. In December 2023, the 30,000 square-meter facility set up its first modular cleanrooms (BioNTainer’s) built from ISO sized containers for the manufacture of a range of mRNA-based vaccines targeted to the needs of the African Union member states.
The majority of the CEPI investment will be dedicated to set up clinical-scale manufacturing capabilities for mRNA vaccines at the Kigali site. This will enable BioNTech to produce on a clinical and commercial scale, which thus broadens the manufacturing scope and bolsters the continent’s vaccine development.
The funding will support the steps required for regulatory authorization of the facility in Rwanda, starting next year. If a disease outbreak occurs, BioNTech would be expected to dedicate up to 50% of the plant’s production capacity to produce emergency response mRNA vaccines.
"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."
Pandemic preparedness
If the vaccines are successfully developed and commercialized, BioNTech and CEPI expect to work together to rapidly respond to outbreaks on the African continent caused by identified viral threats and unknown pathogens with epidemic/pandemic possibility.
“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.
While there has been some speculation about BioNTech’s commitment in Africa, the firm said that its Kigali manufacturing plant has the potential to become the first commercial mRNA facility in Africa. Furthermore, the plant has been designed to support the Africa Centers for Disease Control and Prevention (CDC) and African Union’s goal of manufacturing 60% of total vaccine doses needed by 2040.
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