Amendment 9: DRIVe EZ Broad Agency Announcement

Office of Biomedical Advanced Research and Development
Authority (BARDA) Division of Research, Innovation & Ventures

(DRIVe)

Amendment 009 Issuance for Easy Broad Agency Announcement

(EZ-BAA) BAA-22-100-SOL-00003

The purpose of this Amendment #009 is the following:

1) Reopen the following Area of Interest (AOI):
AOI #21: Vaccines on Demand

INTRODUCTION AND OVERVIEW INFORMATION

A. Development Opportunity Objective:

Under this Amendment, DRIVe is doing the following:
1)

Reopening the following research Area of Interest (AOI), which is reopened to support project Next Gen:
AOI #21: Vaccines on Demand

We are seeking abstract submissions for the following AOI: AOI #21: Vaccines on Demand
Vaccines can be highly effective long-term medical countermeasures against biological attacks as well as emerging infectious diseases with pandemic potential. At current, vaccine-based preparedness and response strategies rely solely on centralized, commercial scale manufacturing processes followed by the stockpiling of vaccines, if needed. This strategy is operationally inefficient and financially burdensome when considering the resources needed to manufacture, distribute, and administer vaccines during public health emergencies.
The development and deployment of vaccines in response to the COVID-19 pandemic revealed a number of impediments to rapid response capability that are now critical areas for improvement. These include:
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Bottlenecks in centralized large-scale manufacturing practices; Long lead times in raw material acquisition, release testing, and availability of manufacturing space;
Geographic limitations of the stockpile and manufacturing facilities that compromise the timely distribution of vaccines; and
Lengthy processes for clinical evaluation and regulatory approval.

Accordingly, BARDA is seeking technologies to enable the On Demand Manufacturing of next generation COVID-19 vaccines at or near the point-of-service. Technologies that will address one or more of the following key aspects of technology are of particular interest: 1. Easily definable inputs: The platform would utilize materials for vaccine manufacture that are easily sourced and handled within the device.
2. Minimal to no release testing: The platform would enable decentralized production by integrating in-line production testing and traceable documentation into the manufacturing process.
3. In-line formulation capabilities: The platform would enable formulation in a single, closed