BIONtech breaks ground for manufacturing site in Rwanda

According to BioNtech, the facility will be initially equipped with two BioNTainers, and is expected to employ about 100 staff by 2024. However, the Mainz-headquartered company will start clinical trials with seversal malaria vaccine  candidates llater this year. Africa currently makes around 90% of the US$80 bn malaria vaccine market. However, climate change might change this, with both Plasmodium and its host moving polewards.

The Rwandan facility will be equipped to manufacture a range of mRNA-based vaccines targeted to the needs of the African Union member states, which could conceivably include the Pfizer-BioNTech COVID-19 vaccine and BioNtech’s investigational malaria and tuberculosis vaccines. The estimated initial annual capacity of e. g. the Pfizer-BioNTech COVID-19 vaccine will be about 50 million doses. Manufacturing in the BioNTainers in Rwanda is expected to commence approximately 12 to 18 months after their installation. BioNTech is hiring a head of quality assurance for Rwanda.

On the occasion of the start of construction Ursula von der Leyen, President of the European Commission, said:  “Today, we are laying the foundations for the first mRNA vaccine production facility in Africa, in Kigali. We are turning a simple but ground-breaking idea into reality, in record time. The ‘Vaccine Equity for Africa’ project is a milestone – not only in the fight against COVID-19. This project represents the immense potential of African and European cooperation. Our partnership will bring vaccine manufacturing in Africa to the next level.”

BioNtech expects together with African partners to set up additional factories in Senegal and South Africa. The initial site will become a node in a decentralized and robust African end-to-end manufacturing network. All vaccines to be manufactured in the network will be dedicated to people residing in member states of the African Union.

At the Malaria and Neglected Tropical Diseases Summit, held in Kigali occurring in parallel to Commonwealth Heads of Government Meeting (CHOGM), Ugur Sahin introduced the Ccompany’s program aiming at the development of a highly effective malaria vaccine based on BioNTech’s mRNA platform.

Phase II study data for CIS43LS, a monoclonal antibody developed at the NIH that targets Plasmodium sporozoites, are underway. CIS43LS was the first treatment able to prevent infection in over 80% of 40 patients vaccinated in a Phase 1 trial. However, information on whether BioNTech’s malaria vaccine pipeline included mRNA encoding the appropriate antigen triggering CIS43LS in the body was not available.