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.
The RPF Chairman, 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.
IN his speech, he commended high-ranking officials for showing up at the launch, particularly pointing out BioNTech founders Dr. Ugur Sahin and his wife Dr. Ozlem Tureci.
“We are very proud to have you, and all who have worked tirelessly to deliver this project,” the Chairman said.
President Kagame also commended the Africa Center for Disease Control (CDC), for coordinating the partnership for Africa vaccine manufacturing.
“You may remember that the consensus at first was that mRNA vaccines could not even be administered in Africa. It was said to be too complicated for our health systems, then when we embarked on this journey to manufacture these vaccines on our continent, we were told that it would take a minimum of 30 years,”
Speaking at the launch, Sahin, who is also the 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.”
