Medical Countermeasures (MCM) Commercial Solutions Offering (CSO) Area of Interest (AOI) A001 COVID-19 Vaccine Fill and Finish Manufacturing Capacity   3

Biomedical Advanced Research and Development Authority (BARDA) has a current Area of Interest (AoI) W911QY-20-S-C001-A001 COVID-19 Fill and Finish Manufacturing Capacity to identify and procure US domestic aseptic fill and finish manufacturing capacity for critical vaccines and therapeutics in response to the COVID-19 pandemic to ensure uninterrupted supply throughout the COVID-19 campaign. Identifying and procuring this need is imperative as BARDA-sponsored product developers and manufacturers may not have timely access to this capacity for COVID-19 response. To that end, the government intends to reserve domestic aseptic fill and finish manufacturing capacity for critical vaccines and therapeutics. The reserved capacity shall include unallocated production slots at the specific Contract Manufacturing Organization (CMO) facilities that could be secured for future government use. Included in the capacity are the costs associated with facilities and equipment usage for a given production slot, labor, materials as well as support services necessary to fill and release a standard batch fill. The reservation shall exclude the performance of any work within the reserved capacity without explicit, written approval from the government. In accordance with the first AoI Solution Briefs must be submitted no later than 1800 on 3 July, 2020. See attachment MCM CSO AoI W911QY-20-S-C001-A001 COVID-19 Vaccine Fill Finish for the first area of interest.