RWANDA—The opening of Biopharmaceutical New Technologies (BioNTech)’s Kigali, Rwanda, facility has marked an important step forward in Africa’s mRNA vaccine manufacturing capacity.

This inauguration ceremony coincided with the release of the first production unit, BioNTainer, which is based on the Company’s high-tech, digitally enabled modular manufacturing units.

BioNTainers are designed to create a variety of mRNA-based vaccines and will be updated on a regular basis as BioNTech strives to remain one of the most sophisticated mRNA manufacturing facilities in the world. 

The production site will initially be outfitted with two BioNTainers, with the first BioNTainer arriving in Kigali in March 2023 and being set up in the manufacturing hall to create mRNA as a medicinal material.

The second BioNTainer unit will be used to make the formulated bulk medicinal product, which will be available for transportation to the Rwanda location in the first quarter of 2024.

BioNTainers are intended for international use and represent a dedication to remaining among the world’s most sophisticated mRNA manufacturing facilities.

BioNTainer is one of several BioNTech initiatives aiming at supporting in the creation of a sustainable and resilient African vaccine ecosystem and ensuring equal access to innovative medicines.

Based on BioNTech’s high-tech modular components, the Kigali production unit will be the continent’s first commercial-scale mRNA synthesis facility.

BioNTech has committed a total expenditure of around US$150 million to finish the building of the complex, which will occupy 35,000 square meters and employ approximately 100 people once fully operational.

Locals will be educated in 2024, and production of mRNA-based vaccination batches for process validation will commence in 2025.

To address the vaccine demands of African Union members, the facility’s manufacturing capacity will be adjusted dependent on dosage and formulation.

Following the successful validation of the Kigali facility, BioNTech wants to construct more production facilities across Africa in response to the region’s demands.

These locations could be large, commercial-scale manufacturing plants or smaller, specialized facilities for clinical trial batches.

This initiative covers a wide range of topics, including R&D, clinical trials, production, and local training for expert workers, which were discussed at a full-day seminar prior to the site’s official debut, titled “Working Together to Promote Vaccine Equity for Africa.”

 

The launch event was dominated by conversations with Heads of State and Government, as well as leaders from the African Union, European Union, WHO, and CEPI, on the prospects and challenges of developing a sustainable and resilient vaccine ecosystem in Africa.

During this launch, President Kagame emphasized Africa’s vaccination gap during the pandemic, noting that BioNTech’s engagement with the continent represents the democratization of vaccine technology, which would contribute to Africa’s future readiness and resilience.

In his remarks, African Union Commission Chairperson Moussa Faki Mahamat underscored the continent’s commitment to improve the availability and quality of critical vaccines.

He emphasized the importance of the African Medicines Agency (AMA), and envisioned the BioNTech facility and the AMA contributing to self-sufficiency in Africa, which is vital for pandemic preparedness and recovery.

The Africa Centers for Disease Prevention and Control (Africa CDC) Director-General, Dr. Jean Kaseya, described the BioNTainer manufacturing facility as a watershed moment in Africa’s vaccine production capacities, health security, and access to life-saving vaccines.

Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech, reaffirmed his commitment to establishing an African mRNA vaccine ecosystem and thanked local and international collaborators for their contributions to this collaborative initiative aimed at developing mRNA vaccines against infectious diseases.

To enable a sustainable vaccine ecosystem in Africa, BioNTech is creating preventive mRNA vaccines for infectious diseases such as tuberculosis, malaria, HIV, and diseases with epidemic and pandemic potential. 

Clinical studies for tuberculosis and malaria vaccines are now underway, with plans to conduct trials for malaria, tuberculosis, and HIV vaccine candidates in Africa in 2024.

If approved, BioNTech plans to provide these preventive vaccines at no cost to low-income countries, focusing on diseases that kill over two million people in Africa each year.

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