RFP: Procurement of Filovirus Medical Countermeasures

Infections by Ebola (EBOV), Sudan (SUDV), and Marburg (MARV) viruses result in a highly lethal Viral Hemorrhagic Fever (VHF) with mortality ranging from 25-90 percent depending on the outbreak and the virus species by which it was caused. The 2014-2016 EBOV epidemic in West Africa highlighted the threat filoviruses pose to public health, with greater than 28,000 confirmed cases and more than 11,300 deaths. The United States Government (USG) has supported numerous responses to naturally occurring outbreaks of EBOV and MARV and additionally these agents pose a threat to national security if purposely released as a biological weapon. Procurement of filovirus therapeutics is urgently needed to enable the USG’s preparedness and response to public health emergencies and to mitigate the threat of biological attacks. In order to address this unmet need, the Office of the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) intends to use Project BioShield (PBS) to support the late-stage development and procurement of therapeutics against EBOV, SUDV, or MARV. The procured therapeutics will either be delivered to the ASPR/Strategic National Stockpile or maintained as vendor managed inventory. The USG seeks therapeutics that meet the following mandatory criteria: 1) The Offeror must have submitted an investigational new drug (IND) application related to the intended operational use of a product as a filovirus therapeutic; and 2) The Offeror must have documented FDA concurrence on the proposed regulatory path leading to approval of the product as a filovirus therapeutic.