In May 2024 CEPI announced that it is expanding its strategic partnership with BioNTech to contribute to “building a sustainable and resilient end-to-end African vaccine ecosystem”. CEPI commits up to $145 million to support BioNTech’s efforts to establish mRNA vaccine R&D, clinical, and commercial-scale manufacturing capabilities in Kigali, Rwanda. These capabilities will support preparations for potential future epidemic and pandemic threats in Africa.
BioNTech in Africa
BioNTech inaugurated the commercial-scale manufacturing facility in Kigali in December 2023. It is based on BioNTainers, high-tech, digitally enabled modular manufacturing units that are designed to manufacture mRNA-based vaccines. CEPI suggests that the facility could become the first commercial mRNA facility in Africa. It is intended to support the African Union and Africa CDC goal of producing 60% of total vaccine doses required on the continent by 2040. BioNTech intends to provide “affordable access” to BioNTech’s prophylactic vaccines manufactured at the facility; this includes vaccines against malaria, mpox, and tuberculosis.
“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.”
Three key areas
The partnership will support BioNTech’s existing efforts in three key areas:
- Commercial-scale manufacturing: CEPI’s funding will support measures required for the regulatory authorisation of the facility in Rwanda from 2025. Should an outbreak occur, BioNTech would dedicate “up to half” of the facility’s manufacturing capacity for emergency response mRNA vaccines, subject to regulatory authorisation.
- End-to-end clinical-scale manufacturing of novel vaccine candidates: the majority of the funding will be allocated to establishing clinical-scale manufacturing capabilities for mRNA-based vaccine candidates at the facility. This would allow manufacturing on both a clinical and commercial scale, broadening the manufacturing scope and supporting a sustainable use case for the facility while “strengthening the wider African vaccine development ecosystem”.
- 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. The projects would be selected in partnership with global, regional, and national healthcare organisations. This effort has the potential to enable R&D activities for novel mRNA-based vaccine candidates against pathogens with epidemic or pandemic potential.
Resilience and readiness
Dr Richard Hatchett, CEO of CEPI, reflected that Africa still imports 99% of all the vaccines it needs, meaning “many are left waiting far too long to get the life-saving doses they need”. He demands 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.”
Professor Uğur Şahin, CEO and Co-founder of BioNTech, described the partnership as an “important next step” in the “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. 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.”
Experts comment
Minister of Health for Rwanda, Dr Sabin Nsanzimana, emphasised the government’s commitment to “tackling vaccine inequities that were exposed during the pandemic”.
“We believe this innovative partnership we are building can be a demonstration to the world that Africa is not only building resilience for future pandemics but also creating a sustainable clinical ecosystem across Africa using the most advanced mRNA technology.”
Dr Nsanzimana shared that the “power of partnership” will make the project successful.
“Today is another great milestone towards creating vaccine equity.”
H.E. Dr Jean Kaseya, Director General of Africa CDC, said that “rapid and equitable access” to these life-saving vaccines “start with local development and manufacturing”.
“CEPI and BioNTech’s joint endeavour in Rwanda will contribute to Africa’s R&D ecosystem and support Africa CDC’s Platform for Harmonised African Health Products Manufacturing (PHAHM)’s goal to produce 60% of the vaccines needed by the continent by 2040. Working together, we can pave the way to strengthen Africa’s pandemic preparedness and health security.”
WHO Director-Director General, Dr Tedros Adhanom Ghebreyesus, stated that the “COVID-19 pandemic exposed the risks to global health when production of vaccines and other tools is concentrated in too few hands”.
“Strengthening local and regional production, especially in Africa and the Middle East, is critical for ensuring a more equitable response to future epidemics and pandemics, and for fighting other persistent health challenges. Public-private partnerships like this are part of a growing global movement, bringing together companies, foundations, and countries to diversify production and make the world a safe place.”
This should be seen as a “stepping stone” for other countries and parties to “come together”.
We look forward to discussing mRNA manufacturing in Africa at the Congress in Barcelona this October; do get your tickets to join us there and don’t forget to subscribe to our newsletters here.
