In September 2023 BioNTech and CEPI announced a strategic partnership to advance mRNA-based vaccine candidates for the prevention of mpox. CEPI has stated that it will provide funding of up to $90 million to support the development of these vaccines. BioNTech’s programme BNT166 is part of the company’s efforts to meet high medical needs with prophylactic vaccines, including indications that are “disproportionately prevalent in lower-income countries”. This partnership will contribute to CEPI’s 100 Days Mission. 

The need for an mpox vaccine 

The two organisations indicate that, since the eradication of smallpox in 1980, global population-level immunity against the Orthopoxvirus family, of which mpox is a member, has been waning. Recently an international outbreak drew attention to the need for safe and effective vaccines, and BioNTech is hoping to meet this need with an mRNA-based vaccine.  

Professor Ugur Sahin, CEO and Co-founder of BioNTech, commented that the global outbreak, which was declared a PHEIC, “underlines the need for a highly effective, well-tolerated, and accessible mpox vaccine”.  

“We initiated our BNT166 programme in May 2022 to help address this need. We believe our scientific approach as well as our mRNA technology have the potential to significantly contribute to deliver on CEPI’s 100 Days Mission.”  

The vaccine candidates encode surface antigens expressed in the two infectious forms of the virus (MPXV), to tackle viral replication and infectivity. A clinical trial will evaluate the safety, tolerability, reactogenicity, and immunogenicity of two mRNA-based multivalent vaccine candidates for active immunisation. The trial is a Phase I/II trial and is expected to enrol 196 healthy participants with and without prior history of known or suspected smallpox vaccination.  

100 Days Mission 

The goal is to accelerate vaccine development for future potential pandemic viruses so that a vaccine can be ready for authorisation and manufacture within 100 days of recognition of a pandemic pathogen. This is driven by CEPI but has been welcomed by the global health community and industry leaders.  

Not only could the development of a successful vaccine have applications in future mpox outbreaks, but data generated could contribute to the development of mRNA-based vaccines for future outbreaks caused by other Orthopoxviruses. CEPI’s CE Dr Richard Hatchett is glad to have BioNTech’s “world-class scientists, technology, and facilities” making a “vital contribution” to the mission. 

“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.”  

Dr Hatchett anticipates that this work could “broaden the portfolio of vaccines” for mpox and Orthopoxviruses, which have “long afflicted humankind” but “remain an ongoing threat”.  

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