BioNTech, the German biotech renowned for its groundbreaking mRNA COVID-19 vaccine, is embarking on clinical trials for an mRNA vaccine targeting mpox. This endeavor is supported by a substantial investment of up to $90 million from the Center for Epidemic Preparedness Innovations (CEPI), a leading organization dedicated to pandemic prevention.
The collaboration between BioNTech and CEPI is part of a broader initiative focused on pandemic preparedness. Despite the availability of Bavarian Nordic’s Jynneos in the market for mpox, BioNTech and CEPI believe that expanding the vaccine supply could prove valuable in future outbreaks. Moreover, developing a new mRNA-based shot has the potential to mitigate the spread of other orthopoxvirus-based diseases.
BioNTech initiated the development of its mpox vaccine, designated as BNT166, in response to the global spread of mpox (formerly known as monkeypox) in the summer of 2022. A Phase 1/2 clinical trial commenced in August, with plans to evaluate two similar candidates, BNT166a and BNT166c, in individuals with or without a prior history of mpox infection.
“The 100 Days Mission aims to accelerate the development of a vaccine against a novel virus with pandemic potential to just 100 days, and BioNTech’s world-class scientists, technology and facilities can make a vital contribution. Achieving this mission, and potentially preventing the next pandemic, will require gathering a wealth of knowledge and data about the performance of the latest vaccine platforms, like mRNA, which can enable rapid responses to emerging infectious threats across a broad range of viruses. Our work on mpox could broaden the portfolio of vaccines available against this potentially deadly disease, while building our understanding of how mRNA technology performs against Orthopoxviruses, a family of viruses that have long afflicted humankind and remain an ongoing threat today.”
– Richard Hatchett, M.D., Chief Executive Officer of CEPI.
The funding provided by CEPI for BioNTech’s mpox vaccine is part of CEPI’s broader “100 Days Mission.” This mission is designed to ensure that vaccine developers are prepared to design and develop a new vaccine within 100 days in the event of a dire infectious disease outbreak, similar to the COVID-19 pandemic. In a related initiative, CEPI recently announced an $80 million collaboration with University of Cambridge researchers, the same group behind AstraZeneca’s COVID-19 vaccine.
Another prominent mRNA COVID-19 vaccine manufacturer, Moderna, is also working on an mRNA-based mpox vaccine. However, Moderna’s CEO, Stéphane Bancel, has expressed reservations about diverting significant resources to this endeavor, citing skepticism regarding the disease’s level of threat to public health. Nonetheless, a Phase 1/2 trial for Moderna’s mpox vaccine commenced in the UK in August, with recruitment efforts initiated this month. Bancel indicated that even if the trial data are positive, a Phase 3 trial may not be rushed, as the vaccine may not be a high priority for the company at this time.