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The BioNTech laboratory announced on Monday that it will apply the promising mRNA technology - used for some of the immunizations against COVID-19 - to the fight against malaria and that it will launch trials for a vaccine next year.
"BioNTech intends to develop the first mRNA vaccine for the prevention of malaria."
And it will occur in Africa, according to the company after an international event on the fight against infectious diseases on this continent that bears a disproportionately high share of the global burden of these diseases.
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BioNTech, the German next-generation immunotherapy company, pioneer in novel therapies against cancer and other serious diseases, releases the news supported by the leadership and important work of Uğur Şahin and Özlem Türeci, the two founding scientists who, associated with Pfizer, achieved a pioneering vaccine against covid-19 with more than 90% efficacy in 10 months.
409,000 people die each year from malaria;
230 million people are infected, and the majority of these deaths (67%) are in children under the age of five, according to data from the World Malaria Report 2020, carried out by the World Health Organization.
In 2019, more than half of the world's malaria cases were in Nigeria, the Democratic Republic of the Congo, Tanzania, Burkina Faso, Mozambique and Niger.
409,000 people, the equivalent of four times the Camp Nou filled to the brim, die each year from malaria
The disease, produced by a parasite that is transmitted by the bite of female Anopheles mosquitoes, causes a complex infection that evades recognition by the immune system. Although there is treatment and prevention, especially with nets and inseciticides, mosquitoes are becoming more resistant. The fight to eliminate it is costly and colorful. Scientists around the world have been working for decades to develop diverse methods to prevent it. Thus, the battle is fought on many fronts. One of the last has a Spanish signature and is called Proyecto Bohemia and tries to make the insect itself die by biting, turning healthy people, potential victims, into mosquito killers, and that will shortly begin trials in the heart of Mozambique.
"The probability of success is high," predicted Ugur Sahin, director and co-founder of BioNTech. The studies, which will be launched at the end of 2022, will be carried out in Africa and in “other regions where malaria is frequent”, but also in Germany, within a program supported by the World Health Organization , the European Union and the African Union Center for Disease Prevention and Control (Africa CDC) and as part of efforts to develop the continent's vaccine manufacturing capacity.
The news seems the expected consequence after the announcement a few days ago by the German pharmaceutical company and its North American partner Pfizer with South Africa for the creation of a vaccine manufacturing plant against covid 19, which would help mitigate the shortage that Africa suffers. where less than 2% of the population (of 1,300 million people) is, today, immunized and with the delta variant running through half of its 55 countries at ease.
Only 2% of the 1.3 billion Africans are vaccinated against covid-19 to date
The extraordinary scientific progress made during the covid-19 pandemic provides hope for addressing a variety of life-threatening infectious diseases. “We are already working on HIV and tuberculosis [they plan to start a clinical trial to test a candidate vaccine for tuberculosis in 2022]; malaria is the third major disease with a huge unmet medical need, ”said Sahin. In recent years, different clinical trials of possible vaccines against malaria have been developed in which, although none have been totally successful, they show that investment in science and research is the key to advancing in the fight against this disease.
An example of this is Mosquirix, the commercial name of the RTS vaccine, S, developed in the 1980s, which began to be tested in children in Malawi, Kenya and Ghana in 2019, although with efficacy rates of just 36% . Researchers at the Jenner Institute in Oxford, behind the Oxford-AstraZeneca covid-19 vaccine, are also developing another that looks promising.
On this occasion, Uğur Şahin and Özlem Türeci - awarded together with other scientists with the Princess of Asturias Award for Scientific and Technical Research 2021 - propose a proposal for the development of a malaria vaccine based on the same approach in which they have been working against to the coronavirus: a second-generation vaccine, which uses genetic material from the virus itself, messenger RNA, based on two decades of research in this field.
MRNA vaccines induce the human body to produce a protein that is part of the pathogen, which triggers an immune response. BioNTech said it will evaluate multiple candidates that target the circumsporozoite protein (CSP) as well as new antigens discovered in preclinical research and select the most promising ones for clinical trial, Reuters reported.
In this way, they hope to reduce production time while increasing the chances of efficiency. Uğur Şahin, CEO of BioNTech, acknowledged that the plan is at a very early stage, but that he believes it is "the best time to tackle this challenge" due to the knowledge that has been gained when developing an mRNA vaccine against the new SARS-Cov2 coronavirus and the growing understanding of how malaria works, and insists on the importance of this collaboration: “The response to the pandemic has shown that science and innovation can transform people's lives when all stakeholders work together towards a common goal ”.
The response to the pandemic has shown that science and innovation can transform people's lives when all stakeholders work together toward a common goal.
Uğur Şahin
The second - and no less important - objective posed by BioNTech's proposal is the development of sustainable solutions for the production and supply of vaccines on the African continent, which currently imports 99% of them.
The proposal is to develop it entirely in African countries.
For this, they are evaluating different possibilities of facilities and infrastructures that allow the manufacture of the latest generation messenger RNA and that can guarantee a sustainable supply in the continent.
However, this involvement and interest in less developed countries and endemic diseases is not new: since 2019, BioNTech has collaborated with the Bill and Melinda Gates Foundation to develop programs against other infectious diseases such as HIV and tuberculosis and to provide a affordable access to vaccines in low- and middle-income countries. He is currently working on vaccines against nine different infectious diseases while continuing to develop 15 clinical-stage oncology programs based on four different classes of drugs, including messenger RNA.
In collaboration with the African Union and the African Center for Disease Control, and within the framework of the Africa Vaccine Manufacturing Partnership Program, BioNTech's proposal will also seek to ensure that the right factors are in place, such as alignment at the legislative level and the transfer of policies, as well as the coordination between countries with the aim that the doses reach the citizens of the different African countries from the factories.
The main stumbling blocks encountered in the research of an effective vaccine against malaria so far were the lack of financial resources, together with the complexity and difficulty in identifying and isolating the parasite causing the disease, which required a lot of investment in research. BioNTech's proposal is part of the Eradicate Malaria initiative, led by the kENUP Foundation. The first phases of the vaccine will be financed with BioNTech's own resources, although it has the support of the European Commission, the European Investment Bank and the Bill and Melinda Gates Foundation as main partners.
“We are more than grateful to be part of the joint efforts of the Eradicate Malaria project. We will do everything necessary to develop a vaccine against the disease based on messenger RNA that is safe and effective and that allows to prevent, reduce mortality and guarantee a sustainable solution for the African continent and other affected regions. Our efforts will include cutting-edge research and innovation, significant investments in its development, the establishment of manufacturing facilities and the transfer of know-how to production centers on the African continent and wherever it is needed, ””ahin explained.
Pedro Alonso, director of the malaria program of the World Health Organization (WHO) is optimistic, although he asks to be very cautious with the news: “Malaria is a very complex disease, there are many questions about how the parasite affects our system immune, so the road will not be without pitfalls ".
However, a door of hope opens in the international scientific community.
Soumya Swaminathan, chief scientist of the WHO, has highlighted about the BioNTech proposal that "this is a moment of celebration as we unite technology and science to tackle one of the most deadly diseases in the world."
The Global Technical Strategy against Malaria is committed to reducing the incidence and mortality rate of this disease by 90% by 2030
The truth is that BioNTech has a challenge ahead, and not only in relation to the efficacy of the vaccine, but also to the logistics and production capacity of the same, going through issues such as the training of qualified personnel to work with Messenger RNA or keeping vaccines at certain temperatures.
This BioNTech proposal could be the beginning of a path, of a new way of proposing public-private alliances that can be extrapolated to other countries and problems. The key is to prioritize the Global Technical Strategy against Malaria, which is committed to reducing the incidence and mortality rate of this disease by 90% by 2030. As the President of the European Commission Ursula Von de Leyen has reiterated when showing the European Union support and commitment to BioNTech's proposal, “eradicating malaria is a realistic goal. And now we know that it can be achieved already in this generation. In fact, the moment is now ”.
For several decades, leading vaccine developers "have gradually abandoned" research on the subject, lamented WHO Director Tedros Adhanom Ghebreyesus at the joint conference with BioNTech and the EU.
"The extremely high efficacy of two mRNA vaccines to curb COVID-19 has shown the world how powerful this technology could be against many diseases, including malaria," he added hopefully, as he also began his career as a malaria researcher.
And for many scientists, this is a thorn in the side.
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