BioNTech looks at mRNA vaccine manufacturing options in Rwanda and Senegal
BioNTech – which is developing mRNA vaccines against malaria and tuberculosis - says it intends to manufacture these vaccines on the African continent.
A joint communiqué to this effect was published after a meeting of Uğur Şahin, CEO and Co-Founder of BioNTech, BioNTech with the kENUP Foundation, President Paul Kagame of Rwanda, President Macky Sall of Senegal, and President Ursula von der Leyen of the European Commission in Berlin on Friday (27 August).
“Our goal is to develop vaccines in Africa and set-up sustainable vaccine production capabilities to jointly improve medical care,” said Prof. Dr. Ugur Sahin, CEO and Co-founder of BioNTech.
“We are committed to investing in cutting-edge research and innovation to support vaccine development in addition to the establishment of manufacturing facilities and build-up of manufacturing expertise on the African continent.”
Malaria and tuberculosis at front of efforts
Africa currently imports 99% of vaccines administered in the country (Furthermore, the continent is the most affected when it comes to diseases such as malaria: accounting for 94% of global malaria cases and deaths).
Last month BioNTech revealed it was exploring possibilities to set up mRNA manufacturing facilities on the Africa continent, which would potentially be used for vaccines against a wide range of diseases.
Having announced plans to create the first mRNA based malaria vaccine this year, BioNTech expects to put a candidate into clinical trials by 2022. Meanwhile, a vaccine candidate against tuberculosis is also set to reach clinical trials the same year after two years in pre-clinical development.
It said that building up a sustainable supply network could be done either by setting up its own mRNA manufacturing facilities or via partners.
The decision to evaluate manufacturing in Rwanda and Senegal follows the guidance of the African Union, the Africa Centres for Disease Control and Prevention (Africa CDC) and the African Medical Agency under formation.
The prospective locations of manufacturing sites are expected to co-locate with the World Health Organization’s (WHO) upcoming Vaccine Hubs. These efforts will be aligned with the Team Europe Initiative on manufacturing and access to vaccines, medicines and medical technologies (MAV+) led by the European Commission in collaboration with the EU Member States.
The joint communiqué specifies that vaccines would be manufactured end-to-end on the African continent for supply to Member States of the African Union: including manufacturing of mRNA drug substance and subsequent formulation, followed by aseptic fill and finish.
While BioNTech SE expects to invest its corporate resources into the actual bulk drug product manufacturing technology, its African partners are expected to each build the infrastructure required and set up auxiliary services as well as to ensure that eligible fill & finish facilities can provide in-country services to BioNTech according to the manufacturer’s specifications.
"Given the complex nature of the foreseen operations, Team Europe, together with other international partners, will jointly support its African partners in their efforts to build the necessary enabling environment (business systems, procurement structure, regulatory capacity, human resources, regional trade integration, logistics, supply chains, etc.), and consolidate demand," notes the joint communiqué.