German company aims to help continent that imports 99% of its vaccines develop local production facilities
BioNTech SE said it would invest some of the profits from the Covid-19 vaccine it markets with Pfizer Inc. into developing shots for malaria and tuberculosis in Africa, part of the German company’s plan to establish a large production hub for innovative medicines on the continent.
The biotech firm plans to build a factory in Africa and develop a manufacturing network with local partners to transfer its technology based on messenger RNA, a genetic molecule, to a continent that has suffered from a lack of access to vaccines and other lifesaving treatment, BioNTech Chief Executive Ugur Sahin said.
The company’s new venture aims to produce a highly effective mRNA vaccine with durable protective immunity to prevent and eventually eradicate malaria, he said.
The move marks a further expansion into the infectious-diseases market for the company, which was founded to develop next-generation cancer treatments. BioNTech has created a dedicated infectious-diseases department and plans to announce further vaccine projects for other conditions this year, Dr. Sahin said.
Monday’s announcement follows months of debate about how to tackle Africa’s shortage of Covid-19 vaccines, which emerged after rich nations bought most of the available doses and many governments, including the U.S. and the world’s biggest vaccine maker, India, restricted exports.
The U.S. has urged companies such as BioNTech to offer their patents to enable mass production in developing countries. Africa currently imports 99% of its vaccines, primarily from India.
“This [manufacturing] will be in Africa, for Africa,” Dr. Sahin said in an interview from his home in Mainz, Germany, where BioNTech is based.
“Giving away patents doesn’t create vaccines, throwing a recipe to someone doesn’t create vaccines,” Dr. Sahin said, weighing in publicly for the first time on the debate over patent waivers.
mRNA technology has been at the center of the push to build up manufacturing in Africa, after Covid-19 vaccines like those developed by BioNTech and Moderna Inc. proved more effective than other shots. Manufacturing experts say mRNA shots could be especially promising for the continent, since they are in many ways easier to produce than traditional vaccines that require live pathogens.
Tuberculosis and malaria, which is especially dangerous for children under 5, together kill some 800,000 Africans annually. Developing a shot against the pathogens—a bacteria and a parasite, respectively—could be more challenging than for the coronavirus. The BioNTech malaria shot research will focus on targeting parts of the parasite to prevent it from entering the body, as well as on programming the immune system to identify and destroy the pathogen, Dr. Sahin said.
By targeting a malaria vaccine, BioNTech is again in competition with the University of Oxford, whose scientists also developed one of the leading Covid-19 shots together with AstraZeneca PLC. Oxford in April released data from an early-stage clinical trial in Burkina Faso, where it said its experimental malaria shot proved 77% effective at preventing the disease in 450 children. It was the first malaria vaccine candidate to exceed the World Health Organization’s 75% efficacy threshold.
Last week, BioNTech and its partner Pfizer announced a deal with South Africa’s Biovac Institute to fill vials with doses of their Covid-19 vaccine, imported to Africa, and supply them to African countries. But that arrangement doesn’t include transferring the technology for making the actual drug substance and leaves Biovac dependent on deliveries from Europe—a situation that Dr. Sahin said would change with the new venture.
BioNTech is now auditing manufacturing sites and negotiating with potential partners in countries that have existing vaccine industries such as South Africa, Senegal, Egypt, Morocco and Tunisia, Dr. Sahin said. He said clinical trials for both vaccines should begin next year. Preclinical research on the tuberculosis vaccine started two years ago, and Dr. Sahin’s team has commenced work on the malaria shot.
Dr. Sahin was to present the new initiative Monday alongside leaders of a consortium that will assist the company in setting up its operations in Africa. They are WHO Director-General Tedros Adhanom Ghebreyesus, John Nkengasong, the director of the Africa Centres for Disease Control and Prevention, and Ursula von der Leyen, president of the European Commission, as well as officials from the kENUP Foundation, the Bill & Melinda Gates Foundation, and the European Investment Bank.
Özlem Türeci, Dr. Sahin’s wife and BioNTech co-founder who serves as the company’s chief medical officer, will also participate.
The company aims to replicate the strategy it has used in Europe, where it relies on a network of 20 companies to scale up the production of its Covid-19 vaccine.
The investment in Africa opens a new chapter of global expansion for what was until recently a niche research company. BioNTech has doubled its staff to over 2,000 since the beginning of the pandemic and is now hiring some 500 new people, including infectious-disease experts, to work on the new vaccine development. BioNTech, which also specializes in immunotherapies, will open a manufacturing hub in Singapore in 2023, and is awaiting authorization for its Covid-19 vaccine in China, where it partners with Shanghai Fosun Pharmaceutical Group Co. , also known as Fosun Pharma.
BioNTech and Pfizer will also start the clinical trials of a new mRNA-based influenza vaccine later this year.
Dr. Sahin said that his company had decided not to seek funding for the initial stage of the Africa vaccine development because they felt what he described as a humanitarian duty to invest and use their proprietary technology to help more people. Instead, BioNTech will invest some of its revenues from the Covid-19 shot, which it estimates to be over €12 billion, equivalent to $14.13 billion, while the European Union and others would support the second phase of the mass-scale clinical trials that usually involved tens of thousands of volunteers.
“We believe that the combination of our mRNA technology and our ability to precisely fine-tune the immune system can contribute to producing a more efficient malaria vaccine,” Dr. Sahin said. “We want to make sure that if and when the vaccine is authorized, it can be produced in Africa. What we want is not just to produce a mRNA vaccine against malaria but to invest in research, personnel and infrastructure.”
EU funds will co-finance the late-stage clinical development of the malaria vaccine in Africa, as well as the infrastructure and auxiliary services to be built by third parties in parallel to BioNTech setting up end-to-end manufacturing capacities on the continent. The Bill and Melinda Gates Foundation will do the same for the tuberculosis vaccine.
Dr. Sahin said BioNTech’s long-term engagement in Africa would help offer sustainable access to next-generation medicine. The company plans to transfer its entire vaccine-making process to Africa by training skilled staff and passing on their know-how in a sustainable way, he said.
“We must invest properly, we must hire people and train them. This is not about virtue-signaling for us—it’s an absolutely serious determination that cannot be achieved overnight but requires years of investment.”
Source: The Wall Street Journal