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 developing a potential research partnership between BioNTech and the Institut Pasteur de Dakar with a focus on infectious diseases relevant 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
About the Inauguration Rite: Participants in the Inauguration Rite of the Inauguration of the Inauguration Rite. Paul Kagame, President of the Republic of Rwanda, H. E. Macky Sall, President of the Republic of Senegal, H. E. H. E. Nana Akufo-Addo, President of the Republic of Ghana, H. E. Mia Amor Mottley, Prime Minister of Barbados, H. E. Ursula von der Leyen, President of the European Commission, Chairperson of the African Union Moussa Faki Mahamat of the African Union Commission, H. E. H. E. Annalena Baerbock, Federal Minister for Foreign Affairs of the Federal Republic of Germany, H. E. Dr. Mathume Joseph Phaala, Minister of Health of the Republic of South Africa and Ambassador Gervais Abayeho, Minister of Affairs of the East African Community of the Republic of Burundi. Among the progression financial institutions, Dr. Akinwumi Adesina, President of the African Development Bank and Vice-President of the European Investment Bank, Gelsomina Vigliotti.
H.E. Paul Kagame, President of the Republic of Rwanda: “Vaccine inequity hit Africa hard during the pandemic. But BioNTech’s partnership with Africa demonstrates that vaccine technology can be democratized, so that Africa is ready 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 President 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 necessary medicines so that they are available for all Africans. This is also the purpose of the African Medicines Agency, based here in Kigali. In this sense, we believe that this BioNTech and AMA facility will contribute to our collective vision of a self-reliant Africa. Create a regulatory environment of High quality and ensuring vaccine independence are critical to our long-term ability to prepare for, respond to, and recover from pandemics. Working together to promote vaccine equity in Africa remains our priority.
Dr. Jean Kaseya, Director-General, Africa Centers for Disease Prevention and Control (Africa CDC): “The local manufacturing agenda represents the second independence of Africa, and the inauguration of the BioNTainer manufacturing facility represents a significant milestone in our collective efforts to strengthen vaccine production capabilities, enhance health security, and improve access to life-saving vaccines across the African continent.”
Agur Sahin, M. D. , CEO and Co-Founder of BioNTech: “We are committed to building a sustainable mRNA vaccine ecosystem in Africa, focusing on the progression of mRNA vaccines against infectious diseases with medical best wishes and forging cutting-edge technology 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 for long-term sustainability in health. 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 cadres who 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.
About BioNTechBiopharmaceutical New Technologies (BioNTech) is a next-generation immunotherapy company pioneering cutting-edge treatments for cancer and other serious diseases. The company operates a wide variety of drug discovery and cure informatics platforms for the immediate progression of new biopharmaceuticals. Its broad portfolio of oncology product applicants include individualized and commercially available mRNA-based treatments, cutting-edge chimeric antigen receptor (CAR) T cells, protein-based therapeutics that add bispecific immune checkpoint modulators, targeted cancer antibodies, and antibody-drug conjugates (ADCs). as well as small molecules. Drawing on its deep expertise in mRNA vaccine progression and in-house production capabilities, BioNTech and its collaborators are submitting applicants for mRNA vaccines for a variety of infectious diseases, across its diverse oncology portfolio. BioNTech has established a wide variety of relationships with a number of global companies. pharmaceutical collaborators, including Duality Biologics, Fosun Pharma, Roche Group member Genentech, Genevant, Genmab, OncoC4, Regeneron, Sanofi and Pfizer. For more information, visit www. BioNTech. com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, among others, statements relating to: BioNTech’s ability to produce, deliver and install container production facilities of mRNA for the African continent, adding the capacity to meet all mandatory infrastructure, generation and regulation needs within the planned time frame; BioNTech’s plans to upgrade BioNTainers; BioNTech’s ability to sign agreements with potential collaboration partners in Africa, adding a prospective study partnership with the Pasteur Institute of Dakar in Senegal; develop quality capabilities; the spread of local knowledge and education in Africa; BioNTech’s vaccine progression systems against malaria, tuberculosis, HIV, mpox and other infectious diseases (adding qualitative evidence of available knowledge, potential benefits, clinical trial expectations, origination agreements and the timing of delivery of the vaccines corresponding doses, efforts to ensure equitable access globally). to approved vaccines, the anticipated timing of regulatory submissions, regulatory approvals or authorizations, as well as anticipated production, distribution and sourcing); the timing of the variety of clinical applicants for those systems and the initiation of clinical trials, as well as any data readings; the nature of collaboration with the African Union, Africa CDC, WHO and other parties; the progression of sustainable RNA vaccine capacity, production and sourcing in Africa and the nature, timing and feasibility of those responses. All forward-looking statements contained in this press release are based on BioNTech’s existing expectations and ideals regarding long-term events and are subject to a number of risks and uncertainties that may cause actual effects to differ. materially and adversely from those stated or implied through said information. forward-looking statements. These dangers and uncertainties include, but are not limited to: the potential protection and effectiveness of product applicants; discussions with regulatory agencies regarding the timing and needs of additional clinical trials; the ability to produce comparable clinical effects in long-term clinical trials; possible delays in the construction of BioNTainers and BioNTech operations in Africa due to unforeseen progressions, adding to, among others, global origin chain issues; and the rate and degree of market acceptance of BioNTech’s investigational medicines, if approved.
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.
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