MAGONIA, GERMANY, December 21, 2022 — BioNTech SE (Nasdaq: BNTX, “BioNTech”) has reached the next milestone in establishing scalable production of mRNA vaccines in Africa. The six ISO-size shipping containers for the first BioNtainer have completed their build in Europe, undergone quality checks by BioNTech experts and are being prepared for shipment to Kigali, Rwanda, where they are expected to arrive in the first quarter of 2023. Press material for the preparation is now available here.
In parallel, BioNTech continues to develop and build its state-of-the-art manufacturing facility in Kigali, Rwanda, following the grand opening in June 2022. The facility will house the first BioNtainers and is expected to become a node in a decentralized and robust end-to-end manufacturing network in Africa. BioNTech also hopes to send BioNtainers to Senegal and possibly South Africa in close coordination with each respective country and the African Union. The vaccines to be manufactured in this Africa-wide network will be dedicated to people residing in African Union member states, with the aim of supporting access to new medicines.
In addition, BioNTech is developing mRNA-based vaccine candidates to target malaria and tuberculosis, based on the company’s mRNA platform. The candidate vaccines are expected to enter the first human trials in late 2022 or early 2023.
About BioNTech
Biopharmaceutical New Technologies is a next-generation immunotherapy company pioneering new therapies for cancer and other serious diseases. The company exploits a broad range of computational discovery and therapeutic drug platforms for the rapid development of new biopharmaceuticals. Its broad portfolio of oncology product candidates includes ready-to-use, individualized mRNA-based therapies, innovative chimeric antigen receptor T cells, bispecific checkpoint immunomodulators, targeted cancer antibodies, and small molecules. Building on its deep experience in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a variety of infectious diseases in conjunction with its diverse oncology portfolio. BioNTech has established an extensive set of relationships with multiple global pharmaceutical partners, including Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.
For more information please visit BioNTech.com.
forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, without limitation, direct or indirect statements regarding: BioNTech’s ability to produce, deliver and install mRNA container manufacturing facilities for the African continent, including the ability to meet all necessary regulatory, technological and infrastructure requirements; Potential delays in establishing BioNtainers and BioNTech operations in Africa, due to unforeseen delays, including, but not limited to, global supply chain issues; BioNTech’s ability to reach an agreement with potential collaboration partners in Africa to establish an end-to-end manufacturing network in Africa; developing quality control capabilities to remotely support manufacturing sites in Africa; expanding local knowledge and training in Africa; BioNTech’s malaria, tuberculosis and other infectious disease vaccine development programs; schedule for the selection of clinical candidates for these programs and the commencement of a clinical trial, as well as any data reading; the nature of collaboration with the African Union, Africa CDC and WHO; the development of sustainable RNA vaccine capacities, production and supply solutions on the African continent and the nature, timing and feasibility of these solutions; the safety and potential efficacy of candidate products; and BioNTech’s anticipated market opportunity and the size of its product candidates the rate and degree of market acceptance of BioNTech’s investigational medicines, if approved; BioNTech’s efforts to combat COVID-19; the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine (including qualitative assessments of available data, potential benefits, clinical trial expectations, supply agreements, and timing of delivery of doses under the same, efforts to help ensure global equitable access to the vaccine, expected timing of regulatory submissions, regulatory approvals or clearances, and anticipated manufacturing, distribution, and supply). Any forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs about future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those stated or implied in such press release. forward-looking statements. These risks and uncertainties include, but are not limited to: discussions with regulatory agencies about the timing and requirements for additional clinical trials; and the ability to produce comparable clinical results in future clinical trials.
For a discussion of these and other risks and uncertainties, please see BioNTech’s Quarterly Report as Form 6-K for the quarter ended September 30, 2022, filed with the SEC on November 7, 2022, which is available on the site SEC website at http://www.sec.gov. All information in this press release is as of the release date, and BioNTech does not undertake any obligation to update this information unless required by law.
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