German biotechnology company, BioNTech, on Monday, December 18, unveiled its first African site in Rwanda's capital, Kigali, as part of the firm's efforts to facilitate the production of mRNA vaccines.
Nestled in Kigali Special Economic Zone, in Gasabo District, in a section earmarked for biopharma manufacturing, the facility spans approximately 300,000 square meters. It will employ at least 100 staff upon reaching full operational capacity.
President Paul Kagame alongside First Lady Jeannette Kagame joined several Heads of State and Government from Africa and beyond, high-ranked officials of the African Union, European Union as well as the World Health Organization (HO) and World Trade Organization (WTO), who arrived in Kigali, to witness the launch of the facility.
Speaking at the launch, Ugur Sahin, the co-founder and CEO of BioNTech, said that his company plans to complete all construction works at the site and start local training of specialized personnel in the facility in 2024. The testing of mRNA validation will be initiated in 2025.
Sahin said the facility will be initially equipped with two BioNTainers, one for the production of mRNA, and another for the production of the formulated bulk drug product.
The BioNTainers will be equipped to manufacture a range of mRNA-based vaccines targeted to the needs of African Union member states, he added.
This could, potentially, include the Pfizer-BioNTech Covid-19 vaccine and BioNTech's investigational malaria and tuberculosis vaccines, once they are successfully developed, approved, or authorized by regulatory authorities.
"Africa will have one of the most advanced manufacturing facilities in the world. These BioNTainers will be able to manufacture any kind of mRNA vaccines," said Sahin, adding that they can produce more than 50 million doses, annually, for regular public supply or during a pandemic, or they can also be used to produce 10,000 mRNA doses for clinical trials.
"We are not yet there, there is a lot of work that awaits us, but we have a plan."
Sahin said his company expects to complete construction works in 2024 and initiate commissioning and the qualification process.
"We will work on regulatory processes, quality control, and most importantly the training of local personnel."
"Our goal is to ensure that these facilities operate on global standards."
How much BioNTech produces in their factory depends on the kind of mRNA product they are making and things like how much is in each dose and how it is put together.
For example, BioNTech could manufacture up to 50 million doses annually of a product that has an RNA process similar to that of the Pfizer-BioNTech Covid-19 vaccine.
"We stand here today as a living example of the concrete steps that are being taken to remove the deficit that has existed between citizens who have been unable to access medicines that are available but not affordable. Medicines that are there but not accessible."
Barbados Prime Minister Mia Motley said; "Today marks a concrete step for the people of Africa and its children and its adults to be able to turn the corner. Not just in the fight against pandemics, which we have all learned is critical, but equally, simply, in our next act to ensure that our people can have access to the best possible therapeutics and biologics that are available on this planet."
A story of teamwork
For Ursula Von der Leyen, President of the European Commission, who was also present in Kigali for the launch, while mRNA vaccines were produced in record time, faster than any other vaccine in history, ramping up global production capacities remains a huge challenge.
She shared an account of vaccine inequity during the Covid-19 pandemic.
"Billions of people around the globe needed their doses, but only a few plants were able to deliver. We agreed together that Rwanda and Europe must work together not only to bring vaccines to Africa but to bring vaccine production and mRNA technology to Africa."
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"This cutting-edge facility would not have been possible without the shared experience and expertise that we each bring to the table. It is a story of teamwork between pioneering scientists and innovative businesses between Africa and Europe and between government, finance and regulation."
At the launch was also Presidents Macky Sall of Senegal, Nana Akufo-Addo of Ghana, and other leaders.
BioNTech intends to carry out clinical trials in Africa for vaccine candidates targeting malaria, tuberculosis, and HIV, in 2024. These diseases are widespread in Africa, causing over two million deaths each year, with a significant impact on child mortality.
If these vaccines are successfully developed and approved by regulatory authorities, BioNTech aims to make them available to lower-income countries at a not-for-profit price.
