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Presolicitation Notice - BARDA Vaccine Medical Countermeasures for Pandemic Influenza Preparedness & Response

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75A50126R00001_RFP_PreSolNotice_NPIVS-2027Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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BARDA is seeking qualified contractors to support the ongoing Vaccine Medical Countermeasures for Pandemic Influenza Preparedness and Response Program, requiring the provision of vaccines, antigens, and adjuvants to ensure rapid readiness for pandemic influenza or other viruses with pandemic potential. Contractors must deliver comprehensive services including manufacturing, regulatory documentation, and manufacturing readiness support, with a preference for U.S. based facilities. This includes generating and submitting all necessary analytical, nonclinical, clinical, and CMC data to the FDA, even during interpandemic periods, to enable timely regulatory decisions and sustain production capability. The program emphasizes continuous improvement of influenza vaccines with demonstrated feasibility and full lifecycle support from development through commercial-scale manufacturing. To be eligible, offerors must have a proven track record in influenza vaccine manufacturing, either by holding an active U.S. influenza vaccine license or by having successfully submitted a Biologics License Application for a seasonal or pandemic influenza vaccine. The solicitation, issued under number 75A50126R00001_RFP_PreSolNotice_NPIVS-2027, is open with a response deadline of August 15, 2026, and is administered by the Department of Health and Human Services through BARDA. All proposals must meet strict qualification criteria and align with the program’s goals of ensuring national preparedness, rapid response capacity, and regulatory compliance. Primary point of contact for inquiries is Laura Saddison at HHS.

General Info

BARDA seeks U.S.-based contractors to manufacture and register pandemic influenza vaccines with full lifecycle support.

Agency

Department Of Health And Human Services → Barda - Aspr / Daappo / Barda DcmaView Agency

NAICS

541714 - Research and Development in Biotechnology (except Nanobiotechnology)View NAICS

Place of Performance

Washington, DC, 20024, USA

Set-Aside

NONE

Documents

(1)

75A50126R00001+NPIVS+RFP_PresolNotice.pdf

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → Barda - Aspr / Daappo / Barda Dcma
Contacts1 person available
OfficeWASHINGTON, DC, 20515, USA
Organization / Agency
Department Of Health And Human Services → Barda - Aspr / Daappo / Barda Dcma
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Office AddressWASHINGTON, DC, 20515, USA
Contacts
Laura Saddison
contact@example.gov

Full Description

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Description:


BARDA seeks Contractor(s) to support the continuation of the Vaccine MCMs 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 BLA for seasonal or pandemic influenza vaccine

Please see attachment to this presolicitation notice for further important information.

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