To the creation of a sustainable vaccine ecosystem in Africa, BioNTech is advancing the progression of prophylactic mRNA vaccines targeting infectious diseases such as tuberculosis, malaria and HIV, and is also focusing on diseases with epidemic and pandemic potential, adding mpox. Clinical trials for tuberculosis and malaria vaccination systems are already underway in South Africa and the United States, respectively. BioNTech plans to conduct clinical trials in Africa for malaria, tuberculosis and HIV vaccine applicants in 2024. Malaria, tuberculosis and HIV are widespread in Africa, causing more than two million deaths a year, adding to a peak in infant mortality. If it is indeed developed and approved through regulatory authorities, BioNTech plans to provide low-income countries with access to the four prophylactic vaccines at a non-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
About the Inauguration Ceremony: Among the participants in the inauguration rite were H. E. Paul Kagame, President of the Republic of Rwanda, H. E. Macky Sall, President of the Republic of Senegal, 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, Hon. Annalena Baerbock, Federal Minister of Foreign Affairs of the Federal Republic of Germany, Hon. Dr. Mathume Joseph Phaala, Minister of Health of the Republic of South Africa and Ambassador Gervais Abayeho, Minister of Community Affairs for East Africa of the Republic of Burundi. Among the progressive financial institutions, Dr. Akinwumi Adesina, President of the African Development Bank and the Vice President of the European Investment Bank, Gelsomina Vigliotti, was present.
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. “
H.E. Ursula von der Leyen, President of the European Commission: “The opening of the first BioNTech Africa site in Kigali is an important step towards African vaccine sovereignty. Local manufacturing of vaccines with mRNA technology, in Africa, for the African people, will be a game changer in the fight against diseases and pandemics. The EU is proud to work with Rwanda and BioNTech to develop a vibrant biopharmaceutical industry on the continent. Global Gateway, Europe’s investment strategy, invests in vaccine production in Africa and in the right skills, jobs and capacities to spur health innovation at the scale of the continent.”
African Union Chairperson Moussa Faki Mahamat of the African Union Commission: “This is an important day for Africa. The Continent is committed to increasing the accessibility and quality of needed vaccines and other medicines to be available to all Africans. That is also the purpose of the African Medicines Agency, which has its headquarters here in Kigali. In this sense, we believe this BioNTech facility and AMA will contribute to our collective vision of a self-reliant Africa. Creating a high-quality regulatory environment and ensuring vaccine independence is key to our future capacity to prepare, respond and better recover from pandemics. Working together to promote vaccine equity for Africa remains our priority.”
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.
About BioNTechBiopharmaceutical New Technologies (BioNTech) is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor (CAR) T cells, several protein-based therapeutics, including bispecific immune checkpoint modulators, targeted cancer antibodies and antibody-drug conjugate (ADC) therapeutics, as well as small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Duality Biologics, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, OncoC4, Regeneron, Sanofi and Pfizer. For more information, please 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.
CONTACTS
Investor RelationsVictoria Meissner, M. D. 1-617-528-8293Investors@biontech. de