By Ron Chen, Correspondent ASEAN Region

BioNTech SE has announced that the Company plans to initiate the construction of the first state-of-the-art manufacturing site for mRNA-based vaccines in the African Union in mid-2022. This is the next step in BioNTech’s efforts to implement sustainable end-to-end vaccine supply solutions on the African continent.

The decision is the result of a meeting between Rwanda’s Minister of Health, Dr. Daniel M. Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, M.D., CEO and Co-Founder of BioNTech Ugur Sahin and COO of BioNTech Sierk Poetting as well as Director-General of Rwanda Biomedical Centre Dr. Sabin Nsanzimana, and Directeur-General of Institut Pasteur de Dakar in Kigali, Rwanda, Dr. Amadou Alpha Sall. The meeting occurred upon the invitation of the kENUP Foundation and took place as a side-event of the Second Ministerial Meeting of the African Union and the European Union and resulted in a Memorandum of Understanding (MoU). This comes after the parties signed a Joint Communiqué at a previous meeting in Berlin on August 27, 2021.

“I would like to thank all participants of today’s meeting for the support and trust to establish the first mRNA manufacturing facility within the African Union. Together, we will work on developing a regional manufacturing network to support the access to vaccines manufactured in Africa, for Africa,” said M.D., CEO and Co-founder of BioNTech, Ugur Sahin. “Our goal is to develop vaccines in the African Union and to establish sustainable vaccine production capabilities to jointly improve medical care in Africa. We have made great progress in the past few weeks, which will help us on our way to turn these plans into reality.”

COO of BioNTech Sierk Poetting added: “We aim to accelerate the building of a GMP-certified manufacturing facility and plan to begin the construction on site in mid-2022. The MoU underlines that time is a critical success factor in the development of sustainable vaccine production for the African Union. We have finalized the planning and initial assets for the new facility have already been ordered.”

The parties agree to jointly establish end-to-end manufacturing capacities for mRNA-based vaccines in Africa starting immediately. BioNTech has finalized the construction plans and ordered the assets, which will be delivered by mid-2022. The new manufacturing facility could become the first node in a decentralized and robust African end-to-end manufacturing network enabling an annual manufacturing capacity of several hundreds of million mRNA vaccine doses.

BioNTech plans to develop and implement a scalable construction network based on the expertise and learnings from the ramp-up of the Company’s production facility in Marburg. To enable an expedient set-up of production capacities according to GMP standards, BioNTech will start with the construction and validation of a first production line enabling the manufacturing of drug product for about 50 million of e.g. COVID-19 vaccine doses per year, once fully operational. The capacity will be increased sequentially by adding further manufacturing lines and sites to the manufacturing network on the continent, supporting the production of several hundreds of millions of mRNA vaccine doses.

BioNTech will initially staff, own and operate the facility to support the safe and rapid initiation of the production of mRNA-based vaccine doses. BioNTech plans to transfer manufacturing capacities and the know-how to local partners. Therefore, BioNTech, Rwanda Development Board and Institut Pasteur de Dakar in Senegal agreed to swiftly build-up the required human resources capacity and systems so that the partners can take over ownership and operational duties. In parallel, the Republic of Rwanda and the Institut Pasteur de Dakar have committed themselves to scale-up fill and finish capacities to complete the local end-to-end manufacturing process. In addition, BioNTech is in discussions about an expansion of the current partnership with Cape Town-based vaccine manufacturer Biovac, which is part of the Pfizer-BioNTech COVID-19 vaccine manufacturing network.

Minister of Health of the Republic of Rwanda Dr. Daniel Ngamije said: “Bringing end-to-end vaccine manufacturing of biologicals to Africa is essential for our continent’s health security and prosperity. Rwanda is committed to working with the African Union, the European Union, BioNTech, and other technology partners to make this a reality as quickly as possible.”

“The BioNTech partnership will not only build physical infrastructure but also strengthen human capacity in Africa to develop the most advanced vaccine technologies,” said Minister of Foreign Affairs Aïssata Tall Sall. “With decades of experience manufacturing yellow fever vaccines, the Institut Pasteur de Dakar is ready to partner with BioNTech to rise to the challenge of developing mRNA vaccines for Africa.”

Deputy Chairperson of the African Union Commission Dr. Monique Nsanzabaganwa commented: “By working together, in the spirit of this meeting, the African Union, the European Union, key technology partners, and other stakeholders, can make decisive contributions and effective coordination in the fight against this pandemic, and future health challenges.”

European Union Commissioner for International Partnerships Jutta Urpilainen offered: “I am proud to welcome this next, concrete step towards making mRNA-based vaccines in Africa, for Africa. Through our Team Europe Initiative on local manufacturing and access to vaccines, medicines and medical technologies, the European Union is committed to making this initiative a success.”

World Health Organization Regional Director for Africa Dr. Matshidiso Moeti commented: “State-of-the-art facilities like this will be life-savers and game-changers for Africa and could lead to millions of cutting-edge vaccines being made for Africans, by Africans in Africa. This is also crucial for transferring knowledge and know-how, bringing in new jobs and skills and ultimately strengthening Africa’s health security. WHO is ready to work with countries to step up their commitment to vaccine manufacturing.”

Executive Chairman of kENUP Foundation Holm Keller said: “Global vaccine equity is key to accelerating the end of the pandemic. Today’s announcement is an important next step towards sustainable vaccine production in Africa. We are grateful to our partners for their decisive contribution and their relentlessness towards making swift Africa vaccine production a reality.”

The initiative is aligned with the Team Europe Initiative on manufacturing and access to vaccines, medicines and medical technologies (MAV+) led by the European Commission in collaboration with the EU Member States and the European Investment Bank.