$90 Million Funds Mpox Vaccine Candidate Based on mRNA

As the global mpox outbreak continues impacting people in 2023, a leader in mRNA vaccines intends to enter the market with an innovative vaccine.

This announcement is essential since numerous vaccine breakthrough cases related to currently approved mpox vaccines have been reported worldwide in 2023.

BioNTech SE today announced a strategic partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) to advance the development of BNT166 for the prevention of mpox.

CEPI will provide up to $90 million to support the development of mRNA-based vaccine candidates.

BNT166 is part of BioNTech's efforts to develop novel prophylactic vaccines for various infectious diseases with a high medical need.

BioNTech aims to develop a prophylactic mRNA-based mpox vaccine with a favorable safety profile that can be manufactured at scale.

"The 100 Days Mission aims to accelerate the development of a vaccine against a novel virus with pandemic potential to just 100 days. 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," commented Richard Hatchett, M.D., Chief Executive Officer of CEPI in a press release on September 18, 2023.

The BNT166 vaccine candidates encode surface antigens expressed in the monkeypox virus's two infectious forms to efficiently fight virus replication and infectivity.

The phase 1/2 clinical trial will evaluate the safety, tolerability, reactogenicity, and immunogenicity of two mRNA-based multivalent vaccine candidates for active immunization against mpox.

This study will enroll participants with and without prior known or suspected smallpox vaccination history.

Since eradicating smallpox in 1980, the global population-level immunity against the Orthopoxvirus viral family, including mpox, has been waning. 

Mpox is a vaccine-preventable, sexually transmitted disease caused by a member of the Orthopoxvirus viral family, an infectious disease that can lead to severe, life-threatening complications.

BioNTech and CEPI also confirmed today that they are committed to enabling equitable access to the outputs of this partnership. Any licensed vaccines developed due to this strategic partnership are expected to be available at affordable prices in low- and middle-income countries.