BioNTech unveils its first mRNA manufacturing facility in Africa

German biotechnology company BioNTech unveiled its new $150 million modular messenger RNA vaccine manufacturing facility made of a set of stacked shipping containers in Kigali on Monday — the company’s first on the African continent. African leaders, among others, gathered for the ceremony to celebrate this unveiling as a step toward the continent’s goal of achieving pharmaceutical sovereignty. “It means Africa will have one of the most advanced manufacturing facilities in the world,” said Uğur Şahin, the chief executive officer and co-founder of BioNTech, during the ceremony. Within two years, the Kigali facility is expected to be able to produce up to 50 million mRNA vaccine doses per year. The company transformed the shipping containers into a manufacturing unit in Europe and then shipped them to Rwanda in March. Through this centralized production, it aims to provide consistent manufacturing processes anywhere these units are used globally. They’ve dubbed the group of containers that comprise the manufacturing unit as “BioNTainers.” The company said the Kigali facility is the first of a broader end-to-end vaccine manufacturing network of these BioNTainers that it expects to create across the continent. mRNA is a technological basis for the development of therapeutics and vaccines that became popular during the COVID-19 pandemic because the company used it to create a highly effective vaccine. The technology has wide support in the scientific community for further development of vaccines to combat other diseases because it’s agile and adaptable — allowing for a more rapid response to disease threats. The company is also working to develop mRNA vaccines for tuberculosis, malaria, HIV, and mpox. Clinical trials for mRNA vaccine candidates against TB and malaria are ongoing in South Africa and the United States respectively. Next year, the company aims to host clinical trials for mRNA vaccine candidates against malaria, TB, and HIV in Africa. Given the flexibility of the mRNA technology, the facility in Kigali will be capable of producing any kind of mRNA vaccine — either for commercial use or clinical trials. The first BioNTainer, already on site, is intended to manufacture mRNA drug substance — which is the purified mRNA substance before the final formulation is made. Another BioNTainer unit will be ready for shipment from Europe in the first quarter of next year and will manufacture the formulated bulk drug product — which is the final version of the vaccine substance before it’s filled into a vial. The filling of the vials will be done elsewhere. The facility is still not ready for production. In the coming year, the company says it will complete the construction of all warehouses, offices, and laboratories and training of local personnel, which will include training on artificial intelligence. The company acquired a tech company that specializes in AI this year. Most of the staff at the Kigali facility are from Africa, Rwandan President Paul Kagame said during the ceremony, including the site manager, who is an engineer from Nigeria. When fully operational, the facility will employ about 100 people. In 2025, the company expects to manufacture test batches for regulatory approval, Şahin said. The facility could become the first commercial-scale mRNA manufacturing facility on the continent, he added. But it’s also not the only mRNA initiative on the continent vying for that position — South Africa hosts the world’s first mRNA vaccine technology transfer hub which is working to train facilities, including in African countries, on how to produce mRNA vaccines. The decision to launch the Kigali facility was made due to the lengthy delays in delivering COVID-19 vaccines to African nations during the pandemic as a result of supply chain disruptions because of hoarding, lockdowns, and export restrictions. Even when the vaccines did arrive on the continent, countries had issues rolling out the vaccines in time, as many were donated vaccines nearing their expiration dates. “Vaccine inequity hit Africa hard during the pandemic,” Kagame said. “We found ourselves knocking on every door in search of doses. The situation was intolerable.” In the heat of this crisis, the African Union and Africa Centres for Disease Control and Prevention spearheaded the Partnership for Africa Vaccine Manufacturing to ensure the situation would never repeat itself. The partnership aims to elevate the continent from locally producing only about 1% of the vaccines consumed by its population to 60% by 2040. BioNTech’s facility in Kigali is seen as one part of this broader effort. The company announced its intentions to construct the facility in October 2021. “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,” Kagame said. “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. That was all wrong. It is possible.” But even though the Kigali facility unveiling is a more rapid turnaround than the skeptics Kagame spoke about projected, BioNTech’s decision to send containers produced in Europe to Kigali instead of transferring their technical know-how on how to produce the vaccines to the South African mRNA technology transfer hub has received criticism for unnecessarily delaying African populations access to the lifesaving technology. Médecins Sans Frontières Access Campaign wrote in 2022 that in addition to the Kigali project the company should “urgently” transfer its technological know-how to South Africa’s mRNA hub and send it BioNTainers. They wrote this is the “fastest way to boost vaccine manufacturing capacity in low- and middle-income countries.”