MCMi regulatory science update
The breadth and durability of the human immune response to infection with Ebola virus and Marburg virus—as well as the vaccine-induced immune response in individuals vaccinated with investigational vaccines against those viruses—is not well understood. This lack of understanding can create challenges for the development of medical countermeasures (MCMs) to combat these threats.
To help address these challenges, FDA is supporting a study of the immune response in Ebola Virus disease and Marburg Virus disease survivors as well as in individuals vaccinated with investigational Ebola vaccines. This study will help the evaluation of the performance of existing MCMs while also supporting the development of next-generation MCMs.
FDA awarded this contract in September 2019 to the University of California, Los Angeles (UCLA) School of Public Health, who—in collaboration with the Congolese Institut National de la Recherche Biomédicale (National Institute for Biomedical Research)—will expand a biobank of plasma and peripheral blood mononuclear cell (PBMC) samples to help support the development of MCMs against Ebola and Marburg viruses.
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