Backed by the eradicateMalaria initiative, German company BioNTech has announced a malaria project involving the development of an mRNA-based vaccine against the disease and the evaluation of mRNA vaccine production in Africa.
The initiative is to receive substantial financing from Team Europe, including for the late-stage trials of BioNTech’s project.
The Team Europe approach was born in the context of COVID-19 and was initially conceived as a way to brand collective European support for partner countries in response to the pandemic. The team comprises EU institutions, EU countries and their implementing organisations, well as various development banks.
eradicateMalaria is run by the kENUP Foundation and benefits from the convening power of the World Health Organization and the Africa Centre for Disease Control and Prevention. The project also aims to expand vaccine production capacity across Africa.
BioNTech co-developed the first mRNA-based COVID-19 vaccine with its partner Pfizer. The company has benefited from two European Investment Bank (EIB) loans under the Investment Plan for Europe for its cancer and COVID-19 research.
The scientific and entrepreneurial progress made during the pandemic raises hopes that a highly efficacious vaccine could soon help to eradicate malaria. This goal has thus far been out of reach, despite enormous financial and public health efforts of the global community.
BioNTech is the first major vaccine developer in more than 30 years to commit to working towards eradicating malaria. The company follows a two-pronged approach. First, it aims to develop a first-generation mRNA vaccine, using a known antigen, the CSP protein. The clinical trial for this is expected to start at the end of 2022.
Second, it will run a dedicated antigen discovery process to potentially identify new antigens, which may pave the way for a second-generation vaccine with higher efficacy. In addition, the company has pledged to manufacture the potential vaccine in African facilities – either with licensed production partners or on its own.
BioNTech aims to use revenues from the COVID-19 vaccine to develop its malaria vaccine candidates and bring them to the first phase of clinical trials. The EIB and the European Commission pledge to support companies that aim to eradicate malaria via the joint InnovFin Infectious Diseases Finance Facility, backed by Horizon 2020.
EIB investment will cover projects that enter late-stage clinical development, which primarily aims to demonstrate the efficacy, safety and cost-effectiveness of a medical product.
“Malaria is a tricky disease to vaccinate against – this is why it takes a lot of courage and dedication to embark on the endeavour to which BioNTech has just committed,” said Werner Hoyer, president of the EIB.
“Finding an efficient vaccine is the only way to eradicate one of the biggest causes of death in children in less developed countries. mRNA technology has proved to be a game changer to end the pandemic, and the EIB confirmed its support for this innovative approach with two loans to BioNTech, one in 2019 for developing cancer treatments and the other in 2020 for research on the COVID-19 vaccine. If mRNA can revolutionise malaria vaccine development as well, the EU bank would be proud to support this mission.”
Ursula von der Leyen, president of the European Commission, said: “We are witnessing the start of a revolution in medical science – the revolution of messenger RNA technology, pioneered by BioNTech and others. Thanks to this, billions of doses of a COVID-19 vaccine are being produced for Europe and the world. And mRNA technology can be a game changer in the fight against other diseases too – including malaria. Eradicating malaria is a realistic goal and now we know that it might be achieved already in this generation.”
In parallel to developing a malaria vaccine, BioNTech will evaluate how to establish sustainable mRNA manufacturing capabilities on the African continent.
The company plans to co-locate its potential African facilities with the technology transfer hubs under development by the World Health Organization. The hubs will strengthen low- and middle-income countries’ capacity to manufacture COVID-19 vaccines and increase global vaccine production.
BioNTech’s commitment to vaccine production on the African continent supports Team Europe’s Sustainable Healthcare Industry for Resilience in Africa (SHIRA) initiative, as the company’s projected mRNA vaccine manufacturing facilities could also produce the existing vaccine against COVID-19 or an envisioned tuberculosis vaccine – pending successful development of candidates and regulatory approval.
The fight against malaria has been one of the European Union’s priorities in the health and development sectors for some years now. In 2019, the EIB and the European Commission supported the EU Malaria Fund, a public-private partnership between the European Union, international organisations, corporations, and civil society, initiated by the kENUP Foundation.
With the advancement of the BioNTech malaria vaccine candidate on a proven technology platform, the EU Malaria Fund accomplished its mission earlier than expected. Therefore, on June 30, its investment period came to an end. The fund has successfully initiated more than two dozen novel scientific approaches to fighting malaria and financed several innovative companies.
Issued by European Investment Bank