Request of Proposals (RFP) - BARDA Vaccine Medical Countermeasures for Pandemic Influenza Preparedness & Response
BARDA will fund a contractor that can manufacture influenza vaccines and related antigens/adjuvants for pandemic preparedness and response, including regulatory and manufacturing-readiness support.
⚑ Federal contract solicitation, not a grant. · Mandatory eligibility requires a vaccine manufacturer with a U.S. influenza vaccine license or prior influenza vaccine BLA submission. · U.S. facilities preferred. · Not a university-led opportunity.
Unit fits — one characterization, each unit's own rules
| Tom Love Innovation Hub | 30 weak | prototyping/demonstration stage; deep-tech content |
| IPPRA | 15 none | university cannot apply directly (ineligible) |
| Physical Sciences & Engineering (demo) | 15 none | university cannot apply directly (ineligible) |
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.
Eligibility
Applicant restrictions (federal contract). Set-aside: No Set aside used. Notice type: Solicitation. Organization: HEALTH AND HUMAN SERVICES, DEPARTMENT OF / OFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE / BARDA - ASPR / DAAPPO / BARDA DCMA.
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Proposal brief SEE AN EXAMPLE →
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