Building on two decades of mRNA research and its clinical stage mRNA platform, the German biotech said its broader strategy is to find sustainable vaccine production and supply solutions for the undersupplied continent. Toward this goal it is exploring possibilities to set up state-of-the-art mRNA manufacturing facilities with partners or on its own.

The African manufacturing capabilities would be co-located with the technology transfer hubs under development by the World Health Organization, WHO, in alignment with the continent-based manufacturing strategy created by the Africa CDC.

Collaboration with the institutions under the partnership for African Vaccine Manufacturing is designed to ensure that enabling factors such as regulatory alignment and policy transfer, as well as country coordination are in place.

BioNTech said the collaborations would help 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.

For its malaria project – part of the “EradicateMalaria” initiative led by the research-based nonprofit kENUP foundation –  the company plans to assess multiple vaccine candidates featuring known disease-related 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 would be selected for clinical development, with trials expected to start by the end of 2022. BioNTech’s chief operating officer, Sierk Poetting, told news media the German company would fund the research and initial production of the malaria vaccine itself and liaise with partners to support large-scale trials as well as setting up infrastructure such as fill & finish sites and providing local training.

“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,” Ugur Sahin, CEO and co-founder of BioNTech, commented.

The biotech already has undertaken comprehensive discovery processes to identify antigens for various vaccine candidates apart from Covid or malaria. Since 2019, it has collaborated with the Bill and Melinda Gates foundation to develop HIV and tuberculosis programs as well as provide affordable access to vaccines for low- and middle-income countries.

For TB, BioNTech plans to begin clinical trials with a malaria vaccine candidate in 2022, about two years after the program was initiated. Simultaneously it is working with partners to develop vaccines against nine different infectious diseases as well as for cancer.

For both malaria and TB, the biotech’s antigen discovery processes are being conducted by specialized teams at the Mainz headquarters, where together with partners it is developing vaccines against nine different infectious diseases. The company also is continuing to develop 15 oncology programs at clinical stage based on four different drug classes, including mRNA.

Caused by a parasite that evades recognition by the immune system, malaria kills more than 400,000 people annually in the poorest parts of Africa, most of them babies and young children. In 2019, according to the WHO, there were an estimated 229 million cases worldwide, with 94% of cases and death reported on that continent.

Scientists worldwide have been working for decades to develop a safe and effective vaccine for malaria. The world's first and only such licensed vaccine, Mosquirix, was developed by GlaxoSmithKline over many years of clinical trial across several African countries, but is considered to be only around 30% effective.

Researchers at Oxford's Jenner Institute led by Adrian Hill, one of the lead scientists behind the Oxford Covid-19 vaccine marketed by AstraZeneca, reportedly are also developing a potential new malaria vaccine.

Author: Dede Williams, Freelance Journalist