The United States Government (USG) has a requirement to expand domestic commercial biopharmaceutical manufacturing capabilities. To meet this need, the USG is initiating an effort to onshore the manufacturing of novel Vesicular Stomatitis Virus (VSV) Delta G based vaccine candidates, expressed in Vero cells, for protection against viral hemorrhagic fever viruses such as Marburg and Ebola Sudan. At present, there is no domestic manufacturing capability for viral hemorrhagic fever vaccines; therefore, it is in the USG’s interest to establish this capability to prepare for and respond to potential viral outbreaks. This effort will involve the technology transfer of the current candidate vaccine production processes (inclusive of bulk drug substance and drug product (formulation, fill/finish)) from their current manufacturing sites, located outside the U.S., to one or more domestic Contract Development and Manufacturing Organizations (CDMOs) located within the US.

Feedback for the Draft SOO is being collected for planning and development purposes, and any information will be shared with the US Government.  All feedback must be submitted via the form linked below.  This is not a request for white papers or proposals. White papers/proposals for this draft SOO are not being requested or evaluated at this time.  Feedback must be submitted before the deadline of August 15, 2025 at 11:59 PM ET.

Upcoming Industry Day:
A virtual Industry Day will be conducted to provide additional context on this requirement and outline the anticipated next steps. Further details about the event will be shared soon.

For any questions, please email: BioMaP-Consortium@ati.org

Released: August 4, 2025

Due: August 15, 2025 by 11:59 PM ET