(BRIEF) BioNTech has reached a vital milestone in expanding mRNA vaccine production in Africa with the opening of its Kigali facility, which includes the first production unit known as BioNTainer. The move is part of BioNTech’s broader efforts to create a sustainable environment and resilient African vaccine ecosystem, focused on research, clinical trials, production, and education of local skilled personnel. The facility features complex modular production assemblies capable of generating mRNA-based vaccines and will be upgraded frequently to stay ahead of the curve. ARNm. La company has invested about $150 million in this project and plans to produce vaccines tailored to the wishes of African Union members, adding prophylactic vaccines against diseases such as malaria, tuberculosis, HIV and others. Further expansion of production facilities in Africa is planned, with clinical trials for various vaccine applicants planned for 2024.
(PRESS RELEASE) MAINZ, Dec. 19, 2023 /EuropaWire/ — BioNTech SE (Nasdaq: BNTX, “BioNTech” or the “Company”) has taken the next step in building mRNA vaccine production functions in Africa with the opening of the company’s facility in Kigali, Rwanda. The inauguration took place in the example of the status quo of the first production unit called BioNtainer. This effort is one of multiple BioNTech projects to help build a sustainable and resilient African vaccine ecosystem and equitable access to new medicines. Globally: encompassing studies and development, clinical trials, production, and local education of specialized personnel.
At a full-day convention titled “Working Together to Advance Vaccine Equity in Africa” that preceded the site’s inauguration, BioNTech met with representatives from the World Health Organization (“WHO”), the Coalition for Epidemic Preparedness Innovations (“CEPI”), Africa Centers for Disease Control and Prevention (“Africa CDC”), the Rwanda Food and Drug Administration (“Rwanda FDA”), the Health Emergency Preparedness and Response Authority (“HERA”), the Bill & Melinda Gates Foundation, and the South African Department of Health. Productos. La Regulatory Authority will discuss the opportunities and challenging situations of building a sustainable and resilient vaccine ecosystem in Africa. At the invitation of His Excellency President Paul Kagame of Rwanda, Heads of State and Government from around the world, the top leaders of the African Union, the European Union, as well as WHO and CEPI attended the opening rite of the BioNTech site. The company’s production facility in Kigali has the potential to become the first commercial-scale mRNA production facility on the continent.
The facility is based on the company’s high-tech, virtual modular production assemblies called BioNTainers. They are designed to manufacture a variety of mRNA-based vaccines. BioNTainers are also designed to be updated regularly, as BioNTech needs them to remain one of the most complicated mRNA production facilities in the world. First of all, the production plant will be supplied with two BioNTainers. The boxes of the first BioNTainer, which were recently installed in the production corridor and will be used to manufacture mRNA as a drug substance, arrived in Kigali in March 2023. The current BioNtainer unit will be used to manufacture the bulk formulated drug and will be ready for shipment to the Rwanda site in the first quarter of 2024.
The Kigali production facility has been fully funded to date by BioNTech. The Company has committed a total investment of approximately $150 million for the entire site structure, adding production units. The total site is approximately 35,000 square meters in length and will employ approximately one hundred workers once it is fully compatible with the national one. In 2024, BioNTech plans to complete all of the site’s buildings, adding a warehouse, offices, and quality laboratories. The company anticipates that, following the local training of the specialized body of workers in 2024, it will be able to start generating batches of mandatory mRNA vaccines for validation of the procedure in 2025. The facility is intended to manufacture vaccines tailored to the wishes of African Union members. . Its production capacity depends on the mRNA product being manufactured and its various points such as dosage and formulation. For example, BioNTech could manufacture up to 50 million doses per year of a product with 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 vaccine ecosystem in Africa, BioNTech is progressing the development of prophylactic mRNA vaccines targeting infectious diseases such as tuberculosis, malaria, and HIV, and is 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 malaria, tuberculosis and HIV in 2024. 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.
While in Kigali, Prof. Ugur Sahin, M. D. , CEO and co-founder of BioNTech, met with His Excellency Macky Sall, President of the Republic of Senegal, and discussed the progression of a prospective studies partnership between BioNTech and the Pasteur Institute in Dakar. with a theme on infectious diseases applicable to the African continent.
Multimedia materials for the inauguration of the site can be obtained at the following link, which will be updated later with more material: https://www. biontech. com/int/en/home/newsroom. html
Quotations delivered at the opening ceremony:
HE. Paul Kagame, President of the Republic of Rwanda: “Inequalities in immunization have hit Africa hard during the pandemic. But BioNTech’s partnership with Africa demonstrates that vaccine generation can be democratized, so that Africa is fit and resilient no matter what happens in the future. .
Macky Sall, President of the Republic of Senegal: “This is a special day for Africa. BioNTech has taken a vital step toward greater vaccine equity. It is a wonderful example of a company acting with wonderful social responsibility. I am absolutely into what BioNTech is doing in Rwanda and we look forward to advancing a study partnership in Senegal with the Pasteur Institute in Dakar. “
Ursula von der Leyen, President of the European Commission: “The opening of BioNTech’s first site in Africa in Kigali is a vital step towards African vaccine sovereignty. Manufacturing mRNA-based vaccines in Africa for others in Africa will be a game-changer in the fight against diseases and pandemics. The EU is proud to work with Rwanda and BioNTech to expand a colorful biopharmaceutical industry on the continent. Global Gateway, Europe’s investment strategy, invests in Africa’s vaccine production and the right skills, jobs and capabilities to drive fitness innovation across the continent.
African Union Chairperson Moussa Faki Mahamat of the African Union Commission: “This is a vital day for Africa. The continent is committed to expanding the accessibility and quality of vaccines and other medicines needed to make them available to all Africans. This is also the propósito. de the African Medicines Agency, based here in Kigali. In this regard, we believe that this BioNTech and AMA facility will contribute to our collective vision of a self-reliant Africa. Creating a high-quality regulatory environment and ensuring vaccine independence are critical to our long-term ability to prepare for, respond to, and recover from pandemics. Working together to advance vaccine equity in Africa remains our priority.
Hon. Annalena Baerbock, Federal Minister for Foreign Affairs of the Federal Republic of Germany: “The path to a fair foreign fitness architecture is not a short race, but a team marathon. That is why Team Europe supports the goal of African vaccine production, from conception to To Today, only one out of every hundred vaccine doses administered in Africa is actually produced there; By 2040, this figure is expected to be 60 times higher. Global Gateway makes this imaginable by offering €1. 2 billion until 2027, of which €550 million will come from Germany alone. BioNTech’s opening of Africa’s first mRNA vaccine factory in Rwanda is not yet the end point, but it is a real milestone and a source of hope for millions of people.
Dr. Jean Kaseya, Director General of the Africa Centers for Disease Prevention and Control (Africa CDC): “The local production program represents Africa’s second independence, and the inauguration of BioNTainer’s production facility represents a vital milestone in our collective efforts to develop vaccines. production capacity, physical security, and access to life-saving vaccines across the African continent.
Prof. Ugur Sahin, M. D. , CEO and Co-Founder of BioNTech: “We are committed to building a sustainable mRNA vaccine ecosystem in Africa, focusing on developing mRNA vaccines against infectious diseases with medical best wishes and forging state-of-the-art solutions. . for local production. Today’s groundbreaking occasion, the construction of the first “BioNtainer” module for mRNA production, is a milestone in this journey. Together with our partners, we are moving towards our first commercial-scale mRNA installation in Africa, a cornerstone of our shared vision. of a long-term sustainable health plan. I would like to express my gratitude to our local and foreign partners for their contributions to this joint effort, as well as to the entire BioNTech team for their committed work that made this inauguration possible.
Sierk Poetting, Ph. D. , BioNTech’s Chief Operating Officer: “The BioNTainer-based facility goes beyond an undeniable physical structure. It represents the concept of revolutionizing pharmaceutical production by combining virtual generation with standardized mRNA production. BioNTainers are designed to deliver consistent production processes that can be implemented globally and tailored to regional needs. We’ve configured the BioNTainers to be up-to-date in order to remain one of the most complex mRNA production facilities in the world.
Please review the perils and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended September 30, 2023, and BioNTech’s upcoming filings with the SEC, found on the SEC’s online page at https. www. sec. gov/. Excepto required by law, BioNTech disclaims any objective or duty to update or revise any forward-looking statements contained in this press release, whether as a result of new information, long-term developments or otherwise. These forward-looking statements are based on BioNTech’s existing expectations and speak only as of the date hereof.
Media Contacts:
SOURCE: BioNTech
MORE ON BIONTECH, ETC. :BioNTech Establishes Multi-Year Strategic Partnership with Victoria, Australia to Boost Local mRNA EcosystemBioNTech to Showcase Advances in Cancer Therapy at ESMO 2023BioNTech to Announce Third Quarter 2023 Financial Results and Host Series of InnovationsPfizer and BioNTech Report Promising Results for Combined mRNA Flu and COVID-19 VaccineBioNTech and CEPI Join Forces to Expand Expansion mRNA-based vaccine for the prevention of mpoxEU authorises BioNTech-Pfizer’s adapted Comirnaty XBB. 1. 5 COVID-19 vaccine for autumn campaignsEMA recommends Pfizer and Omicron XBB. 1. 5-Adapted from BioNTech BioNTech strengthens its leadership team with new general counsel, James Ryan, to drive strategy and legal operations. BioNTech Second Quarter 2023 Update: Advances Oncology Portfolio and Prepares for Omicron-Adapted COVID-19 Vaccine RolloutBioNTech Consolidates Advances in Artificial Intelligence with Acquisition of InstaDeep
EuropaWire (EW) is, in fact, the first pan-European press release and press release distribution service for Europe and the European Union, which aims to consolidate Europe’s global voice of news agencies and the media. Submission forms, flexible PR pricing and budgets, granular targeting, unlimited maximum success across countries, markets, verticals, sectors, audiences, languages, etc. , translation and localization for greater local PR impact, detailed distribution, reporting, metrics. and insights, adding measured PR success, reads, interactions, impact, etc. , with no limits on words, images, and multimedia to accompany your post, among other things. Your press releases will be among the largest press releases and top vital companies, brands and establishments in Europe.
HOW DO I START?