BioNTech Starts Construction of First mRNA Vaccine Manufacturing Facility in Africa

BioNTech SE (Nasdaq: BNTX, “BioNTech”) has reached the next milestone in the establishment of scalable mRNA vaccine production in Africa on its planned schedule. Today, BioNTech welcomed its African partners for the first time on the African continent as construction works for the initial African mRNA manufacturing facility began in Kigali, Rwanda, with a target for the first set of manufacturing BioNTainers to be delivered to the site by the end of 2022. The company expects to set up additional factories in Senegal and South Africa in close coordination with its partners in the respective countries. The initial site will become a node in a decentralized and robust African end-to-end manufacturing network. All vaccines to be manufactured in the network will be dedicated to people residing in member states of the African Union.

During the event in Kigali, BioNTech provided an update on the joint establishment of mRNA manufacturing facilities and the development plans for BioNTech’s malaria vaccine candidates. Attendees included President Paul Kagame of Rwanda, President Nana Akufo-Addo of Ghana, Chairperson Moussa Faki Mahamat of the African Union Commission, Ursula von der Leyen, President of the European Commission (by video), Olaf Scholz, Chancellor of the Federal Republic of Germany (by video), Minister of Foreign Affairs Aïssata Tall Sall of Senegal, WHO Director General Dr. Tedros Adhanom Ghebreyesus, WTO Director General Dr. Ngozi Okonjo-Iweala, CEO Nardos Bekele-Thomas of the African Union Development Agency-NEPAD, Secretary General Wamkele Mene of the African Continental Free Trade Area, and Prof. Ugur Sahin, M.D., Co-Founder and CEO of BioNTech. In attendance from development finance institutions were Managing Director Makhtar Diop of the World Bank’s International Finance Corporation and European Investment Bank Vice President Thomas Östros.

BioNTech, the biopharmaceutical company which co-developed the first approved mRNA-based vaccine (Pfizer-BioNTech COVID-19 vaccine), will work with staff from its sites in Germany to accelerate the training of about 100 colleagues who will be running the production and all associated laboratory and quality assurance tasks on site. The hiring of the initial local personnel is commencing now and will include about 20 roles, which can be found here.

At the Malaria and Neglected Tropical Diseases Summit, held in Kigali occurring in parallel to Commonwealth Heads of Government Meeting (CHOGM), Ugur Sahin introduced the Company’s program aiming at the development of a highly effective malaria vaccine based on BioNTech’s mRNA platform. The vaccine candidates are expected to enter first-in-human trials later in 2022.

The Rwandan facility, with a size of about 30,000 square meters, will be initially equipped with two BioNTainers (one for the production of mRNA, and one for the production of the formulated bulk drug product). The BioNTainers will be equipped to manufacture a range of mRNA-based vaccines targeted to the needs of the African Union member states, which could conceivably include the Pfizer-BioNTech COVID-19 vaccine and BioNTech’s investigational malaria and tuberculosis vaccines, if they are successfully developed, approved or authorized by regulatory authorities. The estimated initial annual capacity of e. g. the Pfizer-BioNTech COVID-19 vaccine will be about 50 million doses. Manufacturing in the BioNTainers in Rwanda is expected to commence approximately 12 to 18 months after their installation.

BioNTech supports the international treaty on climate change (“Paris Agreement”). To this end, the Company is committed to operate its African manufacturing sites, including the initial plant in Rwanda, on a climate-neutral basis using renewable energy. Izuba energy will work to facilitate supply of the site with renewable energy.

In February 2022, the Company introduced its approach to scalable vaccine production by developing and delivering turnkey mRNA manufacturing facilities based on a container solution.

Further media material can be downloaded here: link. This section will be updated regularly during the day.

Quotes

H.E. Paul Kagame, President of the Republic of Rwanda: “The groundbreaking for BioNTech’s state-of-the-art mRNA production facility is a pivotal milestone. We are happy to have BioNTech as a partner, and I applaud the company’s commitment to working with Africa on a continental basis to help secure our vaccine resilience for the future, and invest in new research to address the endemic diseases that disproportionately affect our people. Working with our partners, Rwanda intends to build on this investment to attract a vibrant biopharmaceutical research and manufacturing sector.”

H.E. Macky Sall, President of the Republic of Senegal and President of the African Union: “I welcome and support the investment that BioNTech plans to make in Senegal for the production of vaccines, to be followed by the operationalization of its partnership with Institut Pasteur in Dakar. We look forward to welcoming you to the new city of Diamniadio.”

H.E. Nana Akufo-Addo, President of the Republic of Ghana: “Today represents a momentous day for Mother Africa. Another step in the process towards self-reliance has been taken, and I thank the German biotechnology company, BioNTech, and the kENUP foundation for their contribution to this end. This plant will help the continent achieve self-sufficiency in vaccine production to meet future continental needs for health security. Ghana reaffirms her determination to make this Pan-African vaccine project work and succeed.”

H.E. Ursula von der Leyen, President of the European Commission: “Today, we are laying the foundations for the first mRNA vaccine production facility in Africa, in Kigali. We are turning a simple but ground-breaking idea into reality, in record time. The ‘Vaccine Equity for Africa’ project is a milestone – not only in the fight against COVID-19. This project represents the immense potential of African and European cooperation. Our partnership will bring vaccine manufacturing in Africa to the next level.”

H.E. Olaf Scholz, Chancellor of the Republic of Germany: “Today, an essential foundation is being laid for more people to benefit from the blessing of vaccines in the future. And if BioNTech’s projects are realised, Africa’s supply of urgently needed vaccines will improve significantly – vaccines against COVID-19, but ultimately also against malaria, against tuberculosis, against HIV. (…) An essential foundation is also being laid for Africa to be better prepared for the next virus pandemic. (…) We have said and heard it many times before: a pandemic can only end when all people have access to vaccines. Today, we are putting those words into action. The BioNTainers will take the world one large step closer to vaccine equity. (…) This co-operation between African states and a German company – supported by the African Union, by the European Union and by the World Health Organization – proves how our two neighbouring continents benefit from mutual cooperation.”

Dr Tedros Adhanom Ghebreyesus, WHO Director-General: “The COVID-19 pandemic has exposed the need for significantly greater local production of vaccines and other essential products in all regions of the world, especially in Africa which relies heavily on imported products and was left behind in the global rush for COVID-19 vaccines. I welcome BioNTech’s efforts to establish manufacturing sites in Rwanda, Senegal and South Africa, as well as its plans to commence clinical trials of its malaria vaccine candidates later this year.”

Makhtar Diop, Managing Director of International Finance Cooperation: “IFC is committed to working with our public and private sector partners to develop Africa’s multi-vaccine manufacturing capabilities across the value chain to create vaccine equality and bolster the continent’s health resilience. This goes beyond COVID-19 and the demands of the pandemic. It is a long-term imperative to create a sustainable and commercially viable vaccine manufacturing ecosystem in Africa. The project in Rwanda is a vital part of this.”

Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech: “We have reached the next milestone with the construction start of the first African mRNA manufacturing facility based on our BioNTainers – just four months after we introduced the BioNTainer concept in February. This factory will be the first in an African network to provide sustainable production capacity for mRNA pharmaceuticals. Further manufacturing facilities in Africa and on other continents are planned to follow. The goal we pursue together with governments and regulatory authorities is to produce vaccines for Africa here with highly skilled professionals from Africa.”