The African continent is set to benefit hugely from BioNTech mRNA-based vaccine manufacturing site which was inaugurated in Rwanda on Monday, which is expected to address vaccine equity and help manufacture some of the highly needed vaccines on the continent.
World leaders who attended the launch of the first BioNTainer, a high-tech manufacturing solution for mRNA medicines, described the inauguration as a critical step in establishing a resilient vaccine ecosystem in Africa and future pandemic preparedness.
Speaking at the launch of the facility, President Paul Kagame said that the launch is a big milestone and comes at a time when it had been said that producing mRNA vaccines on the continent was impossible but the unveiling of the BioNTainers has proved otherwise.
“You may remember that the consensus, at first, was that mRNA vaccines could not even be administered in Africa. It was said to be too complicated for our health systems,” President Kagame said.
“When we embarked on this journey to manufacture these vaccines on our continent, we were told that it would take a minimum of 30 years. That was all wrong. It is possible. And because it is possible, it is also necessary.” President Kagame said.
The inauguration saw BioNTech reach the next milestone in the establishment of mRNA vaccine manufacturing capacities
in Africa with the inauguration of the first manufacturing unit called BioNTainer, one of the company’s multiple initiatives aimed at helping to build a sustainable and resilient African vaccine ecosystem and supporting equitable access to novel medicines globally.
Among other things, the BioNTech facility will also cover research and development, clinical trials, manufacturing and local training of specialized personnel. President Kagame hailed the partners.
The Head of State thanked BioNTech Co-Founders, Professor Ugur Sahin and Dr. Özlem Türeci for the efforts as well as partners such the African Union, Government of Germany, the World Health Organisation, Africa’s Centre for Disease Control (Africa CDC), African Development Bank (AfDB), the European Investment Bank (EIB) and the European Union Commission, among other stakeholders, who contributed to the initiative in one way or another.
President Kagame was joined by the First Lady Jeannette Kagame, President Macky Sall of Senegal, President Nana Akufo Addo of Ghana, Prime Minister Mia Amor Mottley of Barbados, Ursula von der Leyen, President of the European Commission, Moussa Faki Mahamat, Chairperson of the African Union Commission and Dr. Akinwumi Adesina of AfDB.
Others in attendance included Annalena Baerbock, Federal Minister of Foreign Affairs of Germany, Dr. Mathume Joseph Phaala, Minister of Health of South Africa and European Investment Bank Vice President, Gelsomina Vigliotti, among others.
The facility is based on the Company’s high-tech, digitally enabled modular manufacturing units called BioNTainers. They are designed to manufacture a range of mRNA-based vaccines.
The BioNTainers are also designed to be updated on a regular basis, as BioNTech aims for them to remain one of the most sophisticated mRNA manufacturing facilities in the world. The manufacturing site will initially be equipped with two BioNTainers.
The containers for the first BioNTainer, which were recently set up in the manufacturing hall and will serve to manufacture mRNA as drug substance, arrived in Kigali in March 2023. The second BioNTainer unit will serve to manufacture the formulated bulk drug product and will be ready for shipment to the Rwanda site in the first quarter of 2024.
The manufacturing facility in Kigali is fully funded by BioNTech to date. The Company has committed a total investment of approximately USD 150 million to complete the construction of the site including the manufacturing units.
The overall site has a size of approximately 35,000 square meters and will have approximately 100 employees once fully operational. In 2024, BioNTech expects to complete all buildings on site, including a warehouse, offices and laboratories for quality control.
The Company anticipates that, following local training of specialized personnel in 2024, it can start operating with the manufacturing of mRNA-based vaccine batches required for the process validation in 2025. The facility is intended to manufacture vaccines tailored to the needs of the African Union members.
Its manufacturing capacity depends on the mRNA product being manufactured and its various factors like dosage and formulation. BioNTech could manufacture up to 50 million doses annually of a product that has an RNA process similar to that of the Pfizer-BioNTech COVID-19 Vaccine.
In line with the continent’s and partner countries’ needs, BioNTech is committed to establishing additional manufacturing facilities in Africa upon the successful validation of the facility in Kigali, which serves as a lighthouse project.
Compared to the facility in Kigali, additional sites could be designed as larger facilities providing increased commercial-scale manufacturing capacities in Africa, or they could be smaller and specialized in the manufacture of batches for the clinical evaluation of product candidates.
To support the establishment of a sustainable mRNA vaccine ecosystem in Africa, BioNTech is progressing the development of prophylactic mRNA vaccines targeting infectious diseases such as tuberculosis, malaria, and HIV, and also focusing on diseases with epidemic and pandemic potential, including mpox.
Clinical trials for tuberculosis and malaria vaccine programs are already underway in South Africa and the United States, respectively. BioNTech plans to conduct clinical trials in Africa for vaccine candidates against each of malaria, tuberculosis and HIV in 2024.
Africa-based programs evaluating the safety, tolerability and efficacy of such candidates could facilitate the approval processes of successfully developed vaccines on the continent further. Malaria, tuberculosis and HIV are highly prevalent in Africa, causing over two million deaths annually, including a high degree of child mortality.
If successfully developed and authorized by regulatory authorities, BioNTech plans to provide lower-income countries with access to the four prophylactic vaccines at a not-for-profit price.
Prof. Ugur Sahin, CEO and Co-founder of BioNTech reiterated the commitment of BioNTech to contribute to Africa’s vaccine ecosystem to improve lives.
“We are committed to building a sustainable mRNA vaccine ecosystem in Africa, focusing on the development of mRNA vaccines against infectious diseases with unmet medical needs and forging high-end technology solutions for local manufacturing. Today’s inauguration event establishing the first ‘BioNTainer’ module for mRNA manufacturing is an important milestone in this journey,”
‘Together with our partners, we are advancing towards our first commercial scale mRNA facility in Africa, as a cornerstone of our joint vision of a sustainable health future. I would like to express my gratitude to our local and international partners for their contributions to this joint effort, as well as to the entire BioNTech team for their dedication and hard work which made this inauguration possible,”
According to Sierk Poetting, Chief Operating Officer of BioNTech, the facility based on BioNTainers goes beyond a mere physical structure.
“It represents the idea of revolutionizing the manufacture of pharmaceuticals by combining digital technology with standardized mRNA production. The BioNTainers are designed to provide consistent manufacturing processes that could be applied globally and could be tailored to regional needs,”
“We have set up the BioNTainers to be updated on a regular basis with the aim to remain one of the most advanced mRNA manufacturing facilities globally,” Poetting he said
BioNTech plans to complete all buildings at the Kigali site and start local training of specialized personnel in the facility in 2024, with test mRNA production for process validation to be initiated in 2025. Upon successful validation, the Kigali facility will serve as a lighthouse project for subsequent mRNA-based vaccine manufacturing facilities of smaller or larger scale to support clinical development or commercial-scale production in line with local or regional demand
In addition, BioNTech is progressing the development of mRNA vaccine candidates for infectious diseases with high medical need, including vaccine candidates against tuberculosis, malaria, and HIV, as well as against infectious diseases with pandemic potential like mpox. Upon successful development and approval, these vaccines are intended for production at the newly established site.