Marburg virus (MARV) and Sudan virus (SUDV) Vaccines   2

Background
The Biomedical Advanced Research and Development Authority (BARDA) is issuing this Request for Proposals (RFP) to support the advanced development, licensure, and procurement of monovalent vaccines against Marburg virus (MARV) and Sudan virus (SUDV).

These viruses are identified as high-priority threats by the Department of Homeland Security due to their potential impact on national security. The acquisition aims to mitigate these threats through the development of effective vaccines for the U.S. civilian population, particularly for individuals at elevated risk of exposure. This initiative is part of the Project BioShield program, which allocates funds for the advanced development and procurement of medical countermeasures.

Work Details
BARDA seeks to procure and maintain up to 500,000 licensed regimens of monovalent vaccines against MARV and SUDV. Additionally, up to 300,000 doses may be procured prelicensure. The vaccines must meet specific requirements:
- Single-dose regimens are preferred.
- Minimum four years stability at intended storage temperatures.
- Capability for large-scale manufacturing to meet U.S. Government stockpiling needs.
- Compliance with Good Manufacturing Practices (GMP).

The contract includes various activities such as:
- CMC activities for GMP manufacture and production of PPQ lots.
- Nonclinical efficacy studies and immunogenicity studies to support FDA licensure pathways.
- Clinical studies demonstrating safety and efficacy during outbreaks.

The contract will have a five-year base period with options extending up to ten years.

Period of Performance
The total period of performance will not exceed 10 years, including a five-year base period and five option periods.

Place of Performance
The primary place of performance is anticipated to be within the continental United States, specifically at Contractor facilities approved by the U.S. Government.