BioNTech, a leading biotechnology company, has joined forces with the Coalition for Epidemic Preparedness Innovations (CEPI) to develop a messenger RNA (mRNA) vaccine for MPOX, a viral disease caused by the monkeypox virus. The partnership aims to ensure that effective tools are available to combat future outbreaks of infectious diseases.
Under the agreement, CEPI will provide up to $90 million to support the development of BioNTech’s MPOX vaccine candidate, BNT166. CEPI, a global partnership dedicated to accelerating the development of vaccines and other products for epidemics and pandemics, has previously played a crucial role in developing multiple vaccines during the COVID-19 pandemic.
MPOX, also known as monkeypox, is an infectious disease characterized by symptoms such as skin rash or lesions, fever, headache, and muscle pain. It can be transmitted through skin-to-skin contact with an infected individual. While smallpox, a member of the same viral family, was eradicated in 1980 through successful vaccination campaigns, global-population immunity to Orthopoxviruses has been decreasing.
Currently, there are two vaccines available for MPOX. Jynneos, developed by Bavarian Nordic, received FDA approval in 2019 for both smallpox and monkeypox. ACAM2000, manufactured by Emergent BioSolutions, was approved for smallpox in 2007. However, limited access to these vaccines has been a concern.
BioNTech’s MPOX vaccine candidates utilize mRNA technology, similar to their successful COVID-19 vaccine, to stimulate an immune response. The vaccines encode surface antigens expressed in two infectious forms of the monkeypox virus. In the Phase 1/2 clinical trial, approximately 196 healthy volunteers who have or have not received a smallpox vaccine will be enrolled to evaluate the safety, tolerability, immune responses, and any adverse effects of the vaccines.
The partnership between BioNTech and CEPI aligns with CEPI’s “100 Days Mission,” which aims to accelerate the development of vaccines against potential future pandemic viruses for rapid regulatory authorization and manufacturing. If the collaboration results in a successful MPOX vaccine, it could significantly enhance the vaccine supply for future outbreaks. Additionally, the data generated from the MPOX trials could help expedite the development of mRNA-based vaccines against other Orthopoxviruses.
“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,” stated CEPI CEO Richard Hatchett. This partnership represents an important step towards preventing future pandemics and strengthening preparedness against emerging infectious threats.
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