When the viral spread of mpox escalated to a global outbreak last year, the healthcare system had few tools available to address it. BioNTech wants to ensure it has a place in future responses should the infectious disease rise again, and the company is testing its messenger RNA mpox vaccine candidates under a new partnership with the Coalition for Epidemic Preparedness Innovations (CEPI).
The BioNTech vaccine for mpox, BNT166, has begun a Phase 1/2 study. Under terms of the alliance announced Monday, CEPI will provide up to $90 million to support the program’s development. CEPI’s mission is to speed up the development of vaccines and other products that guard against epidemics and pandemics. This global partnership played a role in the development multiple vaccine candidates during the Covid-19 pandemic.
Mpox, formerly known as monkeypox, is an infectious disease caused by the monkeypox virus. Symptoms include skin rash or lesions as well as fever, headache, and muscle pain. It can be spread by skin-to-skin contact with an infected individual. The monkeypox virus is a member of the Orthopoxvirus genus, which also includes the smallpox virus. Though vaccines successfully eradicated smallpox in 1980, global-population immunity to this viral family has been waning, BioNTech and CEPI said.
Two vaccines are currently available for mpox. Bavarian Nordic’s Jynneos received FDA approval in 2019 for both smallpox and monkey pox. Emergent BioSolutions manufactures ACAM2000, which was approved for smallpox in 2007. But access to that vaccine is limited. Last year, the FDA made it available for preventing mpox infection under an expanded access investigational new drug application, status that allows the use of investigational products outside of clinical trials. Such use can be granted for serious or life-threatening diseases with few treatment options. Both Jynneos and ACAM2000 employ a live version of vaccinia, a virus that is related to smallpox but causes milder disease. These vaccines are intended to get the body to produce antibodies that protect against smallpox if an individual is exposed to that pathogen.
Like BioNTech’s vaccine for Covid-19, the company’s mpox candidates use mRNA to get a cell’s protein-making machinery to express antigens that prompt an immune response. For mpox, the BioNTech vaccines encode surface antigens expressed in two infectious forms of the monkeypox virus. BioNTech has selected two vaccines to evaluate in a Phase 1/2 clinical trial. The study will enroll about 196 healthy volunteers, both those who previously received a smallpox vaccine as well as those who have not. The goals of the study include evaluating the safety and tolerability of these shots as well the immune responses and any adverse effects they produce.
BioNTech and CEPI said the new partnership contributes to CEPI’s “100 Days Mission,” a goal of accelerating the development of vaccines against a potential future pandemic virus so it can be ready for regulatory authorization and manufacturing at scale within 100 days of a virus’s spread being recognized as a pandemic. The partners said this collaboration could help speed up responses to future outbreaks. For example, if the alliance yields an mpox vaccine that is successfully approved and authorized, larger supplies of vaccines could be made for use against future mpox outbreaks. The data generated from the mpox trials could also help speed up development of mRNA-based vaccines against future outbreaks from Orthopoxviruses.
“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,” CEPI CEO Richard Hatchett said in a prepared statement. “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.”
Public domain image by the National Institute of Allergy and Infectious Diseases