BioNTech aims to move mRNA vaccines for malaria, TB into clinic next year

BioNTech on Monday disclosed plans to develop the first mRNA-based vaccine to prevent malaria and says it anticipates being able to start clinical testing by the end of 2022. The company, which partnered with Pfizer to develop its widely-distributed COVID-19 vaccine Comirnaty (BNT162b2), also wants to set up a large vaccine production hub in Africa with the help of local partners and transfer its mRNA technology to a continent that has struggled with lack of access to vaccines and other treatments.

"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," said BioNTech CEO Ugur Sahin. The German biotech also plans to begin clinical trials evaluating a tuberculosis (TB) vaccine candidate in 2022.

Efficacy under 40% for current malaria vaccine

BioNTech says the malaria vaccine development programme would build on its COVID-19 vaccine success to create an inoculation that is "well-tolerated and highly effective." The company will assess multiple mRNA candidates featuring known malaria targets such as the circumsporozoite protein, as well as new antigens discovered in pre-clinical research, and select the most promising to advance for clinical testing.

GlaxoSmithKline's Mosquirix, also known as RTS,S, is currently the world's only approved malaria vaccine, with efficacy of about 36% among children ages five months to 17 months when given with a booster. Meanwhile, researchers at Oxford University are collaborating with the Serum Institute of India on a vaccine that uses Novavax's Matrix-M adjuvant. A recent study showed that their candidate, dubbed R21, prevented 77% of cases in a Phase II study of 450 children in Burkina Faso.

Sustainable mRNA vaccine production in Africa

Monday's announcement comes about a week after BioNTech and Pfizer said they reached a deal with South African biopharmaceutical firm Biovac to help manufacture millions of doses of Comirnaty for exclusive distribution on the continent. However, that arrangement does not include transferring the technology for making the actual drug substance and leaves Biovac dependent on deliveries from Europe – a situation Sahin suggested would change with the new initiative.

Sahin says his company 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. "Our efforts will include cutting-edge research and innovation, significant investments in vaccine development, the establishment of manufacturing facilities, and the transfer of manufacturing expertise to production sites on the African continent and wherever else it is needed," Sahin stated.

Bankrolled with COVID-19 vaccine proceeds

He noted that BioNTech has decided not to seek funding for the initial stage of the Africa vaccine development initiative, but will instead invest some of its revenues from Comirnaty, which it estimates to be over €12 billion ($14.2 billion). The EU and others would then support the second phase of the mass-scale clinical trials.

"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," Sahin said, adding "we want to make sure that if and when the vaccine is authorised, 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."

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