Ghana, Rwanda, and Senegal have formed a partnership with BioNTech SE, a German biotechnology company, to fill, finish, and package BioNTech mRNA vaccines in Africa as the first step in a chain of domestic vaccine production that will improve vaccine supply in the continent.
This was announced at a high-level meeting in Marburg, Germany, on Wednesday, February 16th, 2022, where President Nana Addo Dankwa Akufo-Addo, alongside Presidents Macky Sall of Senegal and Paul Kagame of Rwanda, witnessed the presentation of a BioNtech modular production facility solution for the production of mRNA vaccines in Africa.
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President Ursula von der Leyen of the European Commission and Tedros Adhanom Ghebreyesus, Director General of the World Health Organization, were also in attendance.
Together with BioNTech’s CEO and Co-Founders Prof. Ugur Sahin and CMO, Prof. Özlem Türeci, and COO Dr. Sierk Poetting, they jointly discussed the infrastructural, regulatory and technological requirements to establish an end-to-end manufacturing network for mRNA-based vaccines in Africa.
BioNTech SE has introduced this approach to establish scalable vaccine production by delivering turnkey mRNA manufacturing facilities based on a container solution.
At a high-level meeting at BioNTech’s manufacturing facility in Marburg, and at the invitation of kENUP Foundation, the company presented the container solution named “BioNTainer” to key partners of its efforts in Africa.
Describing the modular production facility as a “BioNTainer”, it will consist of one drug substance and one drug product module, each built of six ISO sized containers.
They are clean rooms which BioNTech equips with state-of-the-art semi-automated manufacturing solutions.
Each module requires 800 sqm of space and offers an estimated capacity of several hundred of million doses of mRNA-based vaccines, depending on the specific vaccine.
The BioNTainer will be equipped to manufacture a range of mRNA-based approved or authorized vaccines targeted to the needs of people in African Union member states, like BioNTech’s COVID-19 vaccine, and its malaria and tuberculosis vaccines, if they are successfully developed and approved.
The first BioNTainer is expected to be shipped to the African Union in mid-2022. BioNTech expects to ship BioNTainers to Rwanda and Senegal in close alignment with the respective country and the African Union. BioNTech will be responsible for the delivery and set-up of the modules, while local authorities and governments will ensure the needed infrastructure.
Ghana will support manufacturing with fill-and-finish capacities. In cooperation with WHO, Africa CDC/AMA, and the European Union, BioNTech is supporting, identifying and setting up the necessary regulatory framework.
BioNTech will initially staff, own and operate the facilities to support the safe and rapid initiation of the production of mRNA-based vaccine doses.
In the longer term the company plans to transfer manufacturing capacities and the know-how to local partners to enable sustainable production of mRNA vaccines in Africa. Vaccines manufactured in these facilities are expected to be dedicated to domestic use and export to other member states of the African Union at a not-for-profit price.
Speaking at the event, President Akufo-Addo indicated that the meeting heralds an important step in end-to-end vaccine manufacturing in Africa.