BioNTech Reaches Milestone In Establishing mRNA-Based Vaccine Production Facility In Rwanda

• The establishment of the first BioNTainer as a high-tech production solution for mRNA drugs is a crucial step towards building a resilient vaccine ecosystem in Africa and in future pandemic preparedness
• BioNTech plans to complete all buildings at the Kigali site in 2024 and begin training local specialists; mRNA test production for process validation is scheduled to begin in 2025
• Once successfully validated, the Kigali facility will serve as a flagship project for further mRNA-based vaccine production facilities on a smaller or larger scale to support clinical development or commercial manufacturing according to local or regional needs
• In addition, BioNTech is advancing the development of mRNA vaccine candidates for infectious diseases with high unmet medical need, including vaccine candidates against tuberculosis, malaria and HIV, as well as against infectious diseases with pandemic risk such as Mpox. These vaccines will be produced at the newly established site if they are successfully developed and approved
• At the invitation of HE Paul Kagame, President of the Republic of Rwanda, heads of state and government from Africa and around the world as well as representatives of the African Union and the European Union, the WHO, the Africa CDC and the CEPI attended the official inauguration of BioNTech location in Kigali

Kigali (GLOBE NEWSWIRE) - BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") has reached the next milestone in building mRNA production capacity with the inauguration of the company's site in Kigali, Rwanda. Vaccines reached in Africa. The inauguration takes place on the occasion of the establishment of the first production unit called BioNTainer. This is one of several BioNTech initiatives aimed at building a sustainable and resilient African vaccine ecosystem and supporting equitable access to innovative medicines worldwide, including research and development, clinical trials, manufacturing and training of specialists Location.

At a day-long conference titled “Collaborating to Promote Equitable Vaccine Supply in Africa,” which 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 and Melinda Gates Foundation and the South African Health Products Regulatory Authority to discuss opportunities and challenges in building a sustainable and resilient vaccine ecosystem in Africa. At the invitation of His Excellency Paul Kagame, President of the Republic of Rwanda, heads of state and government from all over the world, leading representatives of the African Union, the European Union as well as the WHO and CEPI took part in the inauguration ceremony of the BioNTech site. The company's manufacturing facility in Kigali could become the first commercial-scale mRNA production facility on the continent.

The system is based on the company's digital, modular high-tech production units, the so-called BioNTainers. They are designed to produce a range of mRNA-based vaccines. The BioNTainers are also designed so that they can be further developed regularly in order to remain one of the most advanced mRNA production facilities in the world in the long term. The production facility will initially be equipped with two BioNTainers. The containers for the first BioNTainer, which was recently installed in the production hall and will be used to produce mRNA as an active ingredient, arrived in Kigali in March 2023 . The second BioNTainer unit will be used to produce ready-to-fill batches of the formulated active ingredient and will be ready for transport to the Rwandan site in the first quarter of 2024.

The production facility in Kigali has so far been fully financed by BioNTech. The company expects a total investment of approximately $150 million to build the site, including production units. The entire site is around 35,000 square meters in size and will employ around 100 people once it is fully operational. BioNTech plans to complete all buildings on the site in 2024, including a warehouse, offices and quality control laboratories, as well as qualifying on-site specialist staff. Manufacturing of mRNA-based vaccine batches required for process validation is expected to begin in 2025. The facility will produce vaccines tailored to the needs of African Union members. Production capacity depends on the mRNA product to be produced and various factors such as dosage and formulation. For example, BioNTech could produce up to 50 million doses annually of a product whose RNA production process is similar to that of the Pfizer-BioNTech COVID-19 vaccine.

To meet the needs of the continent and partner countries, BioNTech could establish additional production facilities in Africa following the successful validation of the Kigali facility, which serves as a flagship project. Compared to the Kigali facility, additional facilities could be larger facilities that could provide more commercial-scale manufacturing capacity in Africa, or smaller facilities that could be specialized in producing batches for clinical evaluation of product candidates.

To support the development of a sustainable vaccine ecosystem in Africa, BioNTech is advancing the development of prophylactic mRNA vaccines against infectious diseases such as tuberculosis, malaria and HIV, while also focusing on diseases with pandemic risk, including Mpox. Clinical trials for tuberculosis and malaria vaccine candidates are already underway in South Africa and the United States, respectively. BioNTech plans to conduct clinical trials in Africa in 2024 for vaccine candidates against malaria, tuberculosis and HIV. Malaria, tuberculosis and HIV are widespread in Africa and are responsible for over two million deaths annually, including high child mortality. If successful, BioNTech plans to provide the four prophylactic vaccines to lower-income countries at a not-for-profit price.

On the sidelines of the event, Prof. Dr. Ugur Sahin, CEO and co-founder of BioNTech, His Excellency Macky Sall, President of the Republic of Senegal, to discuss a possible research partnership between the Institut Pasteur de Dakar and BioNTech that could focus on infectious diseases relevant to the African continent.

Media material from the inauguration can be downloaded from the company's website. This area will be updated with additional materials:
https://www.biontech.com/de/de/home/newsroom.html

About the inauguration:
The inauguration was attended by, among others, HE Paul Kagame, President of the Republic of Rwanda, HE Macky Sall, President of the Republic of Senegal, HE Nana Akufo-Addo, President of the Republic of Ghana, HE Mia Amor Mottley, Prime Minister of Barbados, HE Ursula von der Leyen, President of the European Commission, Moussa Faki Mahamat, Chairman of the Commission of the African Union, IE Annalena Baerbock, Federal Minister of the Foreign Office of the Federal Republic of Germany, and Minister Dr. Mathume Joseph Phaala, Minister of Health of the Republic of South Africa. From the development bank side, Dr. Akinwumi Adesina, President of the African Development Bank, and Gelsomina Vigliotti, Vice President of the European Investment Bank, were present.

Quotes from the inauguration ceremony:
HE Paul Kagame, President of the Republic of Rwanda: “Vaccine inequities have hit Africa hard during the pandemic. The partnership between BioNTech and the African continent shows that vaccine technology can be democratized so that Africa can be prepared and resilient no matter what happens in the future.”

HE Macky Sall, President of the Republic of Senegal, President of the African Union: “This is a special day for Africa. BioNTech has taken an important step towards greater equity in vaccines and is a great example of a company that acts with great social responsibility. I fully support what BioNTech is doing in Rwanda and look forward to advancing a research partnership in Senegal with the Institut Pasteur in Dakar."

IE Ursula von der Leyen, President of the European Commission: “The opening of BioNTech's first African site in Kigali is an important step towards African vaccine sovereignty. The local production of vaccines based on mRNA technology in Africa for the African population can play a crucial role in the fight against diseases and pandemics. The EU is proud to work with Rwanda and BioNTech to develop a dynamic biopharmaceutical industry on the continent. The European Global Gateway initiative is investing in vaccine production in Africa and in providing the necessary skills, jobs and capacity to drive health innovation across the continent.”

HE Moussa Faki Mahamat, Chairman of the African Union Commission : “This is an important day for Africa. The African continent is working to improve access and quality of urgently needed vaccines and other medicines for all Africans. This is also the aim of the African Medicines Agency (AMA), which is based here in Kigali. We are convinced that the BioNTech production facility and the AMA will make a decisive contribution to this shared vision of a self-determined Africa. Creating a high-quality regulatory environment and ensuring vaccine independence are key to our future ability to prepare for, respond to and recover better from pandemics. Working together to advance vaccine equity for Africa remains our priority."

IE Annalena Baerbock, Federal Minister of Foreign Affairs of the Federal Republic of Germany : “The path to a fair international health architecture is not a short-distance run, but a team marathon. That's why Team Europe supports the goal of Africa's own vaccine production - from the concept to the cannula: Today only one in 100 of the vaccine doses vaccinated in Africa is also produced in Africa, by 2040 the number is expected to be sixty times more. Global Gateway is making this possible with 1.2 billion euros by 2027, with 550 million euros coming from Germany alone. BioNTech’s opening of Africa’s first mRNA vaccine factory in Rwanda is not yet the finish line – but it is a real milestone and hope for millions.”

Dr. Jean Kaseya, Director-General, Africa Centers for Disease Prevention and Control (Africa CDC): “The local production agenda represents Africa’s second independence and the inauguration of the BioNTainer production facility is an important milestone in our joint efforts to increase vaccine production capacity to strengthen health security and improve access to life-saving vaccines across the African continent.”

Prof. Dr. Ugur Sahin, CEO and co-founder of BioNTech : “We are committed to building a sustainable mRNA vaccine ecosystem in Africa. We focus on the development of mRNA vaccines against infectious diseases with high medical needs as well as high-end technology solutions for on-site production. Today's inauguration of the first BioNTainer module for mRNA production is an important milestone on this path. Together with our partners, we are making progress towards our first commercial mRNA facility in Africa. It is a cornerstone of our shared vision of a sustainably healthier future. I would like to thank our local and international partners for their contributions to this shared task, as well as the entire BioNTech team for their commitment and passionate work that made this inauguration possible."

Dr. Sierk Poetting, Chief Operating Officer of BioNTech: “The system based on BioNTainers goes beyond a purely physical structure. It represents the idea of ​​revolutionizing the production of medicines through the combination of digital technology and standardized mRNA production. The BioNTainers are designed to provide consistent manufacturing processes that can be applied worldwide and tailored to regional needs. We have set up the BioNTainers so that they can be further developed regularly in order to remain one of the most modern mRNA production facilities in the world in the long term.”

About BioNTech
Biopharmaceutical New Technologies (BioNTech) is a next-generation immunotherapy company pioneering therapies for cancer and other serious diseases. The company combines a variety of advanced therapeutic platforms and bioinformatics tools to rapidly advance the development of novel biopharmaceuticals. The diversified portfolio of oncology product candidates includes individualized therapies as well as off-the-shelf mRNA-based medicines, innovative chimeric antigen receptor (CAR) T cells, various protein-based therapeutics including bispecific immune checkpoint modulators, targeted cancer antibodies and antibody drugs. Conjugates and low-molecular active ingredients. Based on its extensive expertise in the development of mRNA vaccines and in-house manufacturing capabilities, in addition to its diverse oncology pipeline, BioNTech is developing various mRNA vaccine candidates for a range of infectious diseases together with collaboration partners. BioNTech works side by side with globally renowned collaboration partners from the pharmaceutical industry, including DualityBio, Fosun Pharma, Genentech (a Roche Group company), Genevant, Genmab, OncoC4, Regeneron, Sanofi and Pfizer.

Further information can be found at: www.biontech.de .

BioNTech Forward-Looking Statements
This press release contains certain forward-looking statements by BioNTech under the amended Private Securities Litigation Reform Act of 1995, including, but not limited to, statements, express or implied, relating to: BioNTech's ability to develop container-based mRNA production facilities for the African Continent to manufacture, deliver and deploy, including the ability to meet necessary infrastructure, technology and regulatory requirements within planned timeframes; BioNTech's plans to regularly develop the BioNTainers; BioNTech's ability to reach agreement with possible collaboration partners in Africa, including a possible research partnership with the Institut Pasteur de Dakar in Senegal; the development of quality assurance options; strengthening local expertise and training in Africa; BioNTech's malaria, tuberculosis, HIV, Mpox and other infectious disease vaccine development programs (including qualitative assessments of available data, potential benefits, clinical trial expectations, supply arrangements and expected timing of delivery of doses agreed therein), efforts, to enable equitable access to the vaccine worldwide, the expected timeline for regulatory submissions, regulatory approvals or approvals, and expected production, distribution and delivery); the schedule for the selection of clinical candidates for these programs and the initiation of clinical trials, as well as any analyzes of data; the manner of cooperation with the African Union, the Africa CDC and the WHO, as well as other parties; the development of sustainable solutions for RNA vaccine capacity, production and delivery solutions in Africa and the nature, timing and feasibility of these solutions. All forward-looking statements in this press release are based on BioNTech's current expectations and beliefs regarding future events and are subject to numerous risks and uncertainties that could cause actual results to differ materially or adversely from those contained in or contained in these forward-looking statements be implied. These risks and uncertainties include, but are not limited to: the potential safety and effectiveness of the product candidates; discussions with regulatory authorities regarding the timing and requirements for additional clinical trials and the ability to achieve comparable clinical results in future clinical trials; potential delays in the establishment of BioNTainer and BioNTech's operations in Africa due to unforeseeable delays, including, but not limited to issues in global supply chains; and the level of market acceptance of BioNTech's product candidates, if approved.

Readers are encouraged to review the risks and uncertainties under “Risk Factors” in BioNTech's Form 6-K for the quarter ended September 30, 2023 and in subsequent filings with the SEC. They are available on the SEC website at https://www.sec.gov/ . Except as required by law, BioNTech undertakes no obligation to update such forward-looking statements after the date of this press release to reflect actual results or changes in expectations. These forward-looking statements are based on BioNTech's current expectations and speak only as of the date of this press release.