Medical Countermeasures for Pandemic Influenza Preparedness and Response

Medical Countermeasures for Pandemic Influenza Preparedness and Response

Human influenza pandemics continue to be a public health concern. Four human influenza pandemics have occurred in the past century. At this time it is uncertain which influenza virus variant will cause the next pandemic.

The Biomedical Advanced Research and Development Authority (BARDA) Strategic Plan 2011-2016 outlines the approach to enhance national Medical Countermeasure (MCM) preparedness and response. BARDA plans to continue the programs for the development and procurement of MCM for pandemic influenza preparedness and response.

In order to accomplish this goal, Acquisition Management, Contracts and Grants (AMCG) intends to publish a Request for Proposal (RFP) for the supply of the following items and/or services: cGMP Influenza Vaccine Master and Working Seed Lot(s), Influenza Vaccine research Lot(s), cGMP Influenza Vaccine Investigational Lot(s), cGMP Influenza Vaccine Commercial Scale Bulk Lot(s), CGMP Adjuvant: Clinical or Commercial Scale Bulk Lot(s), Formulation and Filling (Antigen: Single dose Vials, Antigen: Syringes or sprayers, Antigen: Multi-dose vials, Adjuvant: Single dose Vials, Adjuvant: Multi-dose vials, Co-formulated antigen and adjuvant: Syringes, Co-formulated antigen and adjuvant: multi-dose vials), Storage and Stability (Storage of investigational lots of antigen, Storage of commercial scale bulk lots of antigen, Storage of antigen in final container, Storage of clinical/commercial scale lots of adjuvant, Storage of adjuvant in final container, Storage of licensed product in final container), Shipping, Candidate Vaccine Virus (CVV), Potency Reagent and standards manufacture and testing, Analytical Laboratory Testing/Assay, Non-clinical studies, Clinical studies, Disposal of product, BARDA Tracking Tool Development and Testing of New Standard Data Reporting formats, and Additional Reporting.

The Department of Health and Human Services through AMCG contemplates single or multiple contract awards to companies that meet the following mandatory criteria:

The offeror shall produce vaccines against influenza and influenza strains with pandemic potential; shall demonstrate a successful experience in the manufacturing of influenza vaccine by:

• Holding a US influenza vaccine license OR

• Having developed an influenza vaccine as evidenced by:
1. Complete final Phase 3 clinical study report AND
2. Documented BLA in preparation.

The anticipated period of performance is a three year base + two 12-month option periods. Additional details and requirements will be described in the solicitation. A Request for Proposal (RFP) will be available electronically through the Federal Business Opportunities (FedBizOpps) website (www.fbo.gov) on or about January 12, 2015, with proposals being due on February 20, 2015.

Any responsible offeror may submit a proposal that will be considered by the Government. This notice does not commit the Government to the award of a contract. It is the offeror's responsibility to monitor this website (www.fbo.gov) for the release of the solicitation as well as any subsequent amendments to the solicitation. Potential offerors will be responsible for downloading their own copy of the solicitation and any amendments via www.fbo.gov. No collect calls will be accepted. No facsimile transmissions of proposals will be accepted. All responses and/or inquiries concerning this requirement MUST be identified with the RFP number, name of firm, name of requestor, mailing address, telephone number, email address and should be submitted to the primary and/or secondary point of contact identified in this notice.

Multiple awards may result from this solicitation with an estimated award date of July 2015.