BioNTech aims to develop the world’s first mRNA-based vaccine for Malaria prevention by the end of 2022, following the launch of its Malaria project. The project is part of the ‘eradicateMalaria’ initiative, led by the kENUP Foundation, to accelerate the eradication of Malaria by developing a well-tolerated and highly effective Malaria vaccine and implement sustainable vaccine supply solutions on the African continent.
The project has two key objectives. The first is the development of a safe and highly effective mRNA vaccine with durable protective immunity to prevent Malaria and disease-associated mortality. BioNTech will assess multiple vaccine candidates featuring known Malaria targets such as the circumsporozoite protein (CSP), as well as new antigens discovered in the pre-clinical research phase. The most promising mRNA vaccine candidates will be selected for clinical development. The start of the clinical trial for the first vaccine candidate is planned for the end of 2022. The Malaria vaccine development program is an extension of BioNTech’s COVID-19 vaccine efforts. Building on two decades of mRNA research and its clinical-stage mRNA platform, BioNTech has co-developed the first mRNA-based COVID-19 vaccine together with its partner Pfizer.
The second objective is the development of sustainable vaccine production and supply solutions on the African continent. BioNTech is exploring possibilities to set up state-of-the-art mRNA manufacturing facilities, either with partners or on its own. The facilities are expected to manufacture various mRNA-based vaccines upon approval to ensure sustainable supply operations. BioNTech plans to co-locate its African manufacturing capabilities with the technology transfer hubs under development by the WHO, in alignment with the African manufacturing strategy created by the Africa CDC. This strategy aims to expand the capacity of low- and middle-income countries to manufacture contemporary vaccines end-to-end and scale up production to increase global access.
The World Health Organization (WHO), European Commission and other organizations have been involved in the early planning phase of BioNTech’s Malaria project and have offered their support to identify and set up the necessary infrastructure. Collaboration with the African Union and the Africa CDC under the partnership for African Vaccine Manufacturing programme will ensure that the enabling factors such as regulatory alignment and policy transfer, as well as country coordination, are in place to get the vaccines from factories to the citizens of the African Union.
Prof. Dr. Ugur Sahin, CEO and co-founder of BioNTech said: “The response to the pandemic has shown that science and innovation can transform people’s lives when all key stakeholders work together towards a common goal. We are committed to bringing our innovations to those who need them most. We are more than grateful to be part of the joint efforts of the Eradicate Malaria project. Together with our partners, we will do whatever it takes to develop a safe and effective mRNA-based Malaria vaccine that will prevent the disease, reduce mortality and ensure a sustainable solution for the African continent and other regions affected by this disease. Our efforts will include cutting-edge research and innovation, significant investments in vaccine development, the establishment of manufacturing facilities, and the transfer of manufacturing expertise to production sites on the African continent and wherever else it is needed.”