Request for Proposals (RFP) - BARDA Vaccine Medical Countermeasures for Pandemic Influenza Preparedness & Response
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
AI Contract Overview
The Biomedical Advanced Research and Development Authority (BARDA) is soliciting proposals for the Vaccine Medical Countermeasures for Pandemic Influenza Preparedness and Response Program. The primary objective is to maintain a permanent readiness posture and commercially sustainable warm-base production capacity for the rapid manufacture of vaccines, antigens, and adjuvants during public health emergencies. Selected contractors will be responsible for producing countermeasures against influenza and other viruses with pandemic potential, generating necessary analytical, nonclinical, clinical, and chemistry, manufacturing, and controls data for FDA submission, and preparing candidate vaccine viruses. To be eligible, offerors must demonstrate successful experience in influenza vaccine manufacturing, evidenced by holding a U.S. influenza vaccine license or having submitted a Biologics License Application to the FDA. The contract is structured as an IDIQ with a five-year base period and a five-year option, totaling a potential 120-month ordering period. Award decisions will be based on the Highest Technically Rated Offerors with a Fair and Reasonable Price methodology, with a critical requirement for offerors to achieve a High Confidence rating in capabilities. Key deliverables include the submission of comprehensive manufacturing and supply chain continuity plans, surge readiness assessments, and strict adherence to CGMP guidelines and ASPR security requirements. Performance is monitored through a BARDA dose tracker, and final acceptance is contingent upon the submission of final reports and verified temperature control documentation during delivery. Invoicing is conducted quarterly via the Department of Treasury Invoice Processing Platform.
General Info
Place of Performance
Washington, DC, 20024, USASet-Aside
Timeline
Response Deadline
Organization & Contact Information
Full Description
BARDA seeks Contractor(s) to support the continuation of the Vaccine Medical Counermeasures (MCM's) for Pandemic Influenza Preparedness and Response Program. Contractors will furnish all the necessary services, qualified personnel, materials, supplies, equipment and facilities (U.S. facilities preferred) not otherwise provided by the USG as needed to provide MCMs, such as vaccines, antigens, and adjuvants, for pandemic preparedness and response or as required in response to a public health emergency; produce antigen and vaccines against influenza virus or other viruses with pandemic potential as required by BARDA; produce antigens, adjuvants, and/or vaccines to support USG efforts to further improve influenza vaccines (for which feasibility data is available); and support rapid regulatory decisions and manufacturing readiness by generating and submitting to FDA all relevant data (e.g., analytical, nonclinical, clinical, and/or chemistry, manufacturing, and controls (CMC)), including data generated during interpandemic periods.
Mandatory Qualification Requirements:
To be eligible for award, the Offeror must produce vaccines against influenza and influenza strains with pandemic potential; must demonstrate a successful experience in the manufacturing of influenza vaccine by:
1. Holding a U.S. influenza vaccine license; or
2. Have developed an influenza vaccine as evidenced by:
a. Submission of a Biologics License Application (BLA) for seasonal or pandemic influenza vaccine
Please see full solicitation details and proposal submission instructions detailed in attachments 01-19 of this notice.
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