Rwanda has inked a deal with Germany biotechnology giant, BioNTech, that will see the East African country host the first mRNA-based vaccines manufacturing plant that is estimated to cost $116m upwards, with construction expected to start mid-next year.
The historic announcement was made on Tuesday at the kENUP roundtable, happening on the sidelines of the 2nd African Union-European Union Ministerial Meeting hosted by Kigali.
The first highly anticipated manufacturing facility will become a node in a decentralized and robust African end-to-end manufacturing network. Once fully operational, the plant will be producing at least 50 million vaccine doses annually.
“BioNTech SE today 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 pharmaceutical giants announced.
BioNTech said that the decision was a result of a meeting in Kigali between Rwanda’s Minister of Health, Dr Daniel M. Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, Ugur Sahin, M.D., CEO and Co-Founder of BioNTech and Sierk Poetting, COO of BioNTech and other stakeholders, under the auspices of the kENUP Foundation.
The breakthrough in Kigali followed a previous meeting held in August in Berlin, Germany, during which different stakeholders agreed to advance on the ambitious project.
“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 Ugur Sahin, M.D., CEO and Co-founder of BioNTech.
“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,” he added.
The COO of BioNTech, Sierk Poetting, said during the press conference to announce the deal that plans will get underway to ensure that construction is fast tracked once it starts mid next year.
“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,” he added.
In a statement issued on Tuesday, the parties agreed to jointly establish end-to-end manufacturing capacities for mRNA-based vaccines in Africa starting immediately. BioNTech said it has finalized the construction plans and ordered the assets, which will be delivered by mid-2022.
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.
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.
Under the agreement, Rwanda and Senegal 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.
Following the signing, Dr. Ngamije told journalists that the facility will be built in the Kigali Special Economic Zone (KSEZ), next to the Kigali Innovation City.
“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,” Dr. Ngamije said.
“The BioNTech partnership will not only build physical infrastructure but also strengthen human capacity in Africa to develop the most advanced vaccine technologies,” said the 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,” she added.
Dr Monique Nsanzabaganwa, the Deputy Chairperson of the African Union Commission hailed the breakthrough for the continent.
“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,” Dr. Nsanzabaganwa said.
The European Union Commissioner for International Partnerships, Jutta Urpilainen, said the plant will improve access to vaccines on the African continent.
“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,” Urpilainen said.
The World Health Organization Regional (WHO) Director for Africa, Dr Matshidiso Moeti, welcomed the signing of the MoU, describing the planned plant as a life saver.
“State-of-the-art facilities like this will be life-savers and game-changers for Africa and could lead to millions of cutting[1]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,” said the WHO representative.
Holm Keller, the Executive Chairman of kENUP Foundation, which organised the meeting said the deal will accelerate vaccine equity.
“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.