The United States Government (USG) has a need to acquire and supply the Strategic National Stockpile (SNS) with 25 million doses of Final Drug Product (FDP) of recombinant protective antigen (rPA) anthrax vaccine. The FDP shall be packaged as single dose units or multi-dose vials with a minimum expiry period of 24 months manufactured in accordance with current Good Manufacturing Practice (cGMP). The rPA anthrax vaccine will initially be accepted into the SNS once the successful Offeror has supplied sufficient safety, efficacy, and stability data to support FDA (Food & Drug Administration)/CBER (Center for Biologics Evaluation & Research) Current Thinking for the potential use under a declared emergency under Emergency Use Authorization (EUA) for a post exposure prophylaxis indication (PEP), concurrent with antibiotics indication. The successful Offeror will be required to seek and achieve licensure for their rPA anthrax vaccine. Initial licensed product will be used in a pre-exposure general use prophylaxis (GUP) indication in adults. The Contractor shall also seek label extension for PEP plus antibiotic indication in adults in the base contract.

The Government intends to have a full & open competition for this requirement in the form of a Request For Proposal (RFP). This synopsis is not a RFP; an RFP is anticipated on February 29, 2008, with proposal submission in May 29, 2008. The Government expects to make 1 or more awards, subject to the availability of funds, on or about September 26, 2008.



Comments to this announcement, referencing synopsis RFP-BARDA-08-15 may be submitted to Brian K. Goodger, Contracting Officer at 202-260-0333 or in writing to Brian.Goodger@hhs.gov



This proposed acquisition is subject to the availability of Project BioShield Funds.