Ghana, Rwanda and Senegal are partnering with the German biotechnology company BioNTech SE to fill, finish and package BioNTech mRNA vaccines in Africa, as a first step in establishing a chain of domestic vaccine production which will help to improve vaccine supply in Africa.
The news was announced at a high-level meeting in Marburg, Germany, on Wednesday 16 February 2022, where President Akufo-Addo, together with 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.
The event was also attended Ursula von der Leyen, president of the European Commission, and Tedros Adhanom Ghebreyesus, director general of the World Health Organization.
Together with BioNTech’s co-founders Professors Uğur Şahin (who is also the firm’s chief executive officer) and Özlem Türeci (also the chief medical officer) and Dr Sierk Poetting (BioNTech chief operating officer), they discussed jointly 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 the kENUP Foundation, the company presented the container solution named “BioNTainer” to key partners for its efforts in Africa.
The “BioNTainer” modular production facility will consist of one drug substance and one drug product module, each built of six ISO-sized containers. These are clean rooms that BioNTech equips with state-of-the-art, semi-automated manufacturing solutions.
Each module requires 800 square metres of space and offers an estimated capacity of several hundred 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 authorised vaccines, targeted to the needs of people in African Union member states, such as BioNTech’s COVID-19 vaccine, and its malaria and tuberculosis vaccines, if these are developed successfully 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 countries and the African Union. BioNTech will be responsible for the delivery and set-up of the modules, while local officials and governments will ensure the needed infrastructure.
Ghana will support the manufacturing with fill-and-finish capacities.
In co-operation with WHO, the Africa Centres for Disease Control and Prevention/African Medicines Agency, 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 knowhow 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 launch event, President Akufo-Addo said the meeting heralds an important step in end-to-end vaccine manufacturing in Africa.
“This pan-African project fits very well in to Ghana’s roadmap for vaccine development and manufacturing, developed by the Vaccine Manufacturing Committee, which I constituted nearly a year ago,” he said.
The president added, “We are willing to work together with our counterparts in Rwanda and Senegal to fill, finish and package BioNTech mRNA vaccines, as a first step in the chain of domestic vaccine production.”
He told the gathering that Ghana’s Food and Drugs Authority (FDA), the principal Ghanaian regulatory agency, which is currently at WHO Maturity Level 3, being upgraded to Maturity Level 4, will be readily available to work closely with regulatory bodies from the two partner countries to enhance the regulatory capacities for domestic vaccine development and manufacturing in Africa.
Moreover, with Ghana’s growing pharmaceutical industry, which already has broad footprints in West Africa, President Akufo-Addo said that, backed by the nation’s industrious research institutions, strong political will and commitment, fuelled by lessons learned from the COVID-19 pandemic, he is of the utmost belief that Ghana is prepared for this project.
“We have gleaned a lot from this pandemic, and we are determined to enhance our ability to handle more efficiently any future outbreaks, including building domestic capacity for vaccine production. We are ready to contribute and to be part of the manufacturing of mRNA COVID-19, malaria and TB vaccines from drug substance through drug product to fill, finish and package. Ghana is raring to go,” he said.