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

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.