The government of Rwanda on Tuesday, October 26 signed a memorandum of understanding with BioNTech to initiate the construction of the state-of-the-art manufacturing plant for mRNA-based vaccines slated for mid-2022. The facility will be set up in the Special Economic Zone in Gasabo District, according to the Minister of Health Dr. Daniel Ngamije. Ngamije declined to disclose the exact cost of the project but said that that the estimated cost of the mRNA vaccine plant and the entire ecosystem will cost more than 100 millions Euro, which will in part be funded by the European Investment Bank. “The capacity of the plant will start by producing 50 million vaccines at the beginning, but production will increase depending on demand,” he said. According to Ngamije, 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. This is the next step in BioNTech’s efforts to implement sustainable end-to-end vaccine supply solutions on the African continent that was largely exposed by the inequality of Covid-19 vaccines. This was announced on the sidelines of the ongoing AU-EU ministerial meeting in Kigali, bringing together leaders of the two blocs to mull recovery strategies from the pandemic. At least 500 participants including 68 foreign ministers are attending the summit. “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,” said Ugur Sahin Chief Executive and Co-founder of BionTech. Sahin who was virtually attending the signing ceremony highlighted that his company plans to work on developing a regional manufacturing network to support the access to vaccines made in Africa, for Africa. “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. For Ngamije, bringing vaccine manufacturing to Africa is essential for the continent’s 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.” Besides Rwanda, BioNTech signed the same agreement with the Government of Senegal represented by Minister of Foreign Affairs Aissata Tall Sall. The breakdown BioNTech aims to accelerate the building of a GMP-certified manufacturing facility and plan to begin the construction on site in mid-2022, according to the Company’s Chief Operating Officer Sierk Poetting. Good Manufacturing Practice (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorisation. “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.” Poetting explained that the parties agree to jointly establish end-to-end manufacturing capacities for mRNA-based vaccines in Africa starting immediately. “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,” Poetting said. 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 vaccines per year once fully operational. At the initial stage, officials said, BioNTech will staff, own and operate the facility to support the safe and rapid initiation of the production of mRNA-based vaccine doses. The company also plans to transfer manufacturing capacities and the know-how to local partners. In parallel, Rwanda and Senegal plan to scale-up fill and finish capacities to complete the local end-to-end manufacturing process. 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,” said Dr Monique Nsanzabaganwa, Deputy Chairperson of the African Union Commission. By 2040, Nsanzabaganwa said, Africa expects to locally manufacture 60 percent of vaccines needed on the 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, said Jutta Urpilainen, European Union Commissioner for International Partnerships. Life and Game changer According to Dr Matshidiso Moeti, World Health Organisation Regional Director for Africa, the development to set up manufacturing sites in Africa is both life and game changing. “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,” she said, appearing in a televised interview. Besides Rwanda, Africa CDC identified Senegal and South Africa as potential regional vaccine manufacturing hubs in Africa.
