About the MCDC Project

Currently, there are no U.S. Food and Drug Administration (FDA) approved mRNA vaccines for SUDV, MARV, or LASV, and a single vaccine approved for the prevention of EBOV. The highly pathogenic filoviruses EBOV, SUDV, and MARV cause sporadic outbreaks of severe human diseases, mostly in Central and West sub-Saharan Africa. The disease syndrome caused by these viruses is characterized by fever, malaise, myalgia, hemorrhage, and death, with case fatality rates ranging between 25% and 90%. The arenavirus LASV, also endemic in parts of West Africa, can progress to hemorrhage, vomiting, intense pain, and respiratory distress in up to 20% of cases, ultimately leading to death. The high mortality rate and the potential use of these viruses as an agent of bioterrorism remains a risk that necessitates an urgent development of a vaccine. The development of these prototype vaccines, funded in part by The Medical CBRN Defense Consortium (MCDC), will shorten the timelines for emergency response to biological threat outbreaks and prevent or minimize the impact of these threats to military personnel.

The goal of this project is to rapidly develop mRNA-based vaccines using advanced vaccine platforms to counteract biological threat agents. The goal of this program is to expedite the development of mRNA vaccine(s) through a Phase 1 clinical trial as soon as possible or advance the development of existing vaccines. If Phase 1 solutions show promise, the Government may further pursue Phase 2 and 3 activities through U.S. Food and Drug Administration (FDA) licensure. To address this requirement, Dr. Bukreyev at UTMB, in partnership with Moderna, will further develop and demonstrate prototype mRNA vaccines under the FDA Animal Rule that will target the Ebola (EBOV), Sudan (SUDV), Marburg (MARV), and Lassa (LASV) viruses.