We are working towards the eradication of Malaria, starting from the development of a novel mRNA vaccine, and the intend to manufacture it end-to-end in Africa.
BioNTech SE, co-developer of the first mRNA-based COVID-19 vaccine, aims to create a safe and highly effective mRNA vaccine with durable protective immunity for prevention of malaria and disease-associated mortality.
The company’s project is the first project of eradicateMalaria, a programme by the kENUP Foundation to accelerating the eradication of Malaria in close cooperation with the World Health Organization (WHO), supported by the European Commission, the European Investment Bank (EIB) and the Bill & Melinda Gates Foundation.
BioNTech’s manufacturing sites will co-locate with the WHO technology transfer hubs across Africa, in alignment with Africa CDC’s manufacturing strategy.
Humanized monoclonal antibodies and non-invasive, differential tests by other globally leading deep technology companies are expected to join the programme soon soon.
"As we are committed to reduce the suffering of people worldwide, we feel a duty to utilize our technology to develop and manufacture mRNA-based vaccines addressing this life-threatening disease such as Malaria. We want to develop sustainable solutions for and together with the people of Africa. The set-up of infrastructures could help to address various diseases using this disruptive technology. Building on our mRNA technology and the competencies gained from the pandemic, our efforts will include substantial investments in vaccine development as well as transferring manufacturing expertise to sites on the African continent."
Uğur Şahin, CEO and Co-founder of BioNTech
“The inequitable global access to life-saving tools during the COVID-19 pandemic has demonstrated the vital importance of scaling and diversifying R&D and manufacturing capacity in regions and countries. This is why WHO established the mRNA manufacturing hub process. Vaccines save lives but for too long, vaccine development has not been prioritized by the private sector. WHO welcomes this new initiative and looks forward to supporting African countries as they develop, trial and produce vaccines against deadly infectious diseases like Malaria.”
Dr Tedros Adhanom Ghebreyesus, World Health Organization Director-General
“This mRNA-based malaria vaccine initiative is a huge opportunity for addressing one of Africa’s biggest health problems with support from global partners. It not only brings cutting edge technology to the continent, it also puts Africans in the driving seat. This could transform the health landscape. We are excited about a potential vaccine to prevent Africa’s over 215 million malaria cases each year and around 400,000 malaria deaths. Behind every number is a mother, brother or daughter – lives lost often before they could reach their full potential.”
Matshidiso Moeti, WHO Regional Director for Africa
“Malaria is a tricky disease to vaccinate against. Still, finding an efficient vaccine is the only way to eradicate one of the biggest causes of death in children. mRNA technology has proven a game changer in the fight against COVID-19, and the EIB has confirmed its support for this innovative approach with two loans to BioNTech in 2019 and 2020. If mRNA can revolutionize malaria vaccine development as well, the EU bank would be proud to support this mission.”
Werner Hoyer, President of the European Investment Bank
The Team
How it started
BioNTech aims to develop a safe and highly effective mRNA vaccine with durable protective immunity for prevention of malaria and disease associated mortality. To this end, 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 2022.
Manufacturing in Africa
In addition, BioNTech is dedicated to the development of sustainable vaccine production and supply solutions on the African continent. BioNTech plans to co-locate its African manufacturing capabilities with the technology transfer hubs under development by WHO, in alignment with the African manufacturing strategy convened and promoted by the Africa CDC. Those initiatives aim at expanding the capacity of low- and middle-income countries (LMICs) to manufacture contemporary vaccines end-to-end, and scale up production to increase global access to these critical tools to bring current and future pandemics under control.
Initiated by the kENUP Foundation’s eradicateMalaria initiative, under the joint convening power of WHO and the Africa CDC, and supporting Team Europe’s Sustainable Healthcare Industry for Resilience in Africa (SHIRA) initiative, BioNTech will evaluate how to establish sustainable mRNA manufacturing capabilities on the African continent to supply African countries with vaccines.
This project 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. BioNTech and Pfizer pledged to deliver two billion doses of their COVID-19 vaccine to middle- and low-income countries over the next 18 months. One billion doses are planned to be provided in 2021. Doses to eligible countries will be provided at a not-for-profit price.
On July 21, 2021, BioNTech and Pfizer announced a joint manufacturing project with the Biovac Institute (Pty) Ltd a Cape Town-based, South African biopharmaceutical company, to fill & finish the Pfizer-BioNTech COVID-19 vaccine for distribution within the African Union, with additional investments in upstream manufacturing to follow from BioNTech in due time.
Established mRNA vaccine manufacturing capacities in low and lower middle income countries could be used for the production of various mRNA-based vaccines, once they have been successfully developed and approved. This approach would ensure long-term, sustainable operation of newly established mRNA manufacturing capacities.
On August 27, 2021, President Paul Kagame of Rwanda, President Macky Sall of Senegal, and President Ursula von der Leyen of the European Commission met Uğur Şahin, CEO and Co-Founder of BioNTech in Berlin at the Barenboim-Said-Akademie to discuss the development of sustainable vaccine production for Africa, in Africa.
The meeting, which was convened by the kENUP Foundation in cooperation with BioNTech, took place at the Barenboim-Said Academy in Berlin. Also in attendance were Dr John Nkengasong, Director of the Africa Centres for Disease Control and Prevention (Africa CDC), Dr Matshidiso Moeti, WHO Africa Regional Director, and Werner Hoyer, President of the European Investment Bank (EIB).
During the event, convened by kENUP Foundation, a Joint Communiqué has been issued. The document can be downloaded here.
Vaccine Equity for Africa - kENUP Conference held in Berlin on August 27, 2021.
Financing
BioNTech’s work on Malaria and end-to-end vaccine manufacturing in Africa will initially be fully funded by the company from internal resources. The company warmly welcomes the announcements of the European Commission, and the EIB to co-finance the product development once the vaccine candidate enters late-stage clinical development in Africa, and to co-finance the African-based infrastructure and auxiliary services to be built by third parties in parallel to BioNTech setting up end-to-end manufacturing capacities on the continent.
Malaria
According to WHO’s latest World malaria report, more than 1.5 billion cases of malaria and 7.6 million deaths have been averted since 2000 through global efforts to control the disease. However, in recent years, the gains in combatting malaria have plateaued, and progress towards critical targets is off track. In 2019, there were approximately 229 million new cases of malaria worldwide, an annual estimate that has remained virtually unchanged over the last 4 years. Malaria claimed some 409 000 lives in 2019 compared to 411 000 in 2018, about three quarters of them are children under five.
Stepped-up investment in research and innovation is needed to accelerate the pace of progress in the global response to malaria. In September 2019, the WHO Director-General called on the global health community to ramp up investment in the research and development of new malaria-fighting tools and approaches. This message was further reinforced in the April 2020 report of the WHO Strategic advisory group on malaria eradication.
Currently, only a first-generation malaria vaccine with moderate efficacy and a very limited number of further candidates are in the pipeline. Against this trend and for the first time in 30 years, an established vaccine developer using an innovative mRNA platform, will initiate a dedicated and ambitious malaria vaccine program. BioNTech’s contribution aims for a world free of malaria - the eradication of a disease that represents a historical scourge of mankind and trapped populations in a vicious cycle of disease and poverty.
With the advancement of the BioNTech Malaria Vaccine candidate on a proven technology platform, the EU Malaria Fund has successfully accomplished its mission earlier than expected. Therefore, on June 30, its investment period has ended. With final disbursements occurring until September 30, 2021, the Fund has successfully initiated more than two dozen novel scientific approaches to the fight against Malaria and financed six innovative companies under this scheme.
The Initiative
The initiative eradicateMalaria is managed by kENUP Foundation, a non-profit public benefit foundation supporting research-based innovation in the wider health industries for societal benefit. It aims to initiate innovations against malaria. Following the guidance of WHO and the eradicateMalaria Scientific Advisory Board, further projects by various companies may be considered under the eradicateMalaria scheme.
The European Union is committed to the fight against malaria and to support African vaccine manufacturing. The European Investment Bank (EIB) is considering substantive, long term loans to these projects brought forward by eradicateMalaria. In addition, the projects might benefit from considerable contingency support to be offered by donors and impact investors to reduce repayment obligation risks in case of product development failure. The EIB has been an early supporter of BioNTech, having provided the company with up to €150 million in two debt financings, in 2019 for immune-oncology programmes and in 2020 for COVID-19 vaccine development and manufacturing.
Since 2019, BioNTech has been collaborating with the Bill & Melinda Gates Foundation to develop Human Immunodeficiency Virus (HIV) and tuberculosis programs and provide an affordable access to the vaccine candidates to low- and middle-income countries. The Gates Foundation will support BioNTech in the development of the new mRNA malaria vaccine by enabling access to their grantee network and collaboratory platforms to accelerate research and evaluation of the vaccine.
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 into the arms of African citizens, and beyond.
Children by juniormodels, in compliance with §6 Jugendarbeitsschutzgesetz; Photography by André Wagenzik; Design by stilistica.design
