Centers for Disease Control and Prevention (CDC), Procurement and Grants Office, 2920 Brandywine Road, Colgate Building, Atlanta, Georgia 30341-4146

R -- PRODUCTION OF SMALLPOX VACCINE POC Sherry Smallwood, Contract Specialist, (770) 488-2641 The United States Government requires a new smallpox vaccine to deal with the consequences if smallpox were used as a terrorist weapon against the civilian population. The Department of Health and Human Services (DHHS) is currently seeking potential sources (a) to develop candidate smallpox vaccines using vaccinia in cell culture, (b) to provide pilot lots for testing in accordance with Food and Drug Administration (FDA) requirements for investigational vaccines, and (c) to produce at least 40 million doses of the most promising of the candidate products. The objective is to achieve FDA licensure and initiate large-scale production of a new vaccine in the shortest time possible. PRODUCT SPECIFICATIONS: Smallpox vaccine should be partially purified vaccinia virus packaged in freeze-dried units of 100 doses per container when administered by bifurcated needle (multiple pressure or multiple puncture administration). Minimum vaccine potency should be not less than 100 million plaque forming units per milliliter (100 million infectious vaccinia viruses per ml). CELL CULTURE SUBSTRATE: Vaccine should be produced in primary chick embryo fibroblast cell culture or equivalent cell culture substrate. VACCINE SEED STOCK: Determination of vaccine seed lot to be used for large scale production will be made following initial pilot lot production and human safety and immunogenicity trials. The following candidate seed virus strains may be compared with existing DRYVAX smallpox vaccine originally produced by Wyeth: (1) Plaque purified vaccinia from The Salk Institute produced by the Department of Defense (TSI-Connaught); (2) Wyeth DRYVAX seed produced in cell culture; and (3) Strain LC16m8 Serum Institute, Japan (assuming availability). Other candidate seed virus strains may be considered for pilot lot evaluations. SAFETY AND IMMUNOGENICITY TESTING: Each pilot lot product will be tested in 30-50 human adult volunteers. The manufacturer will NOT be responsible for conducting the Safety and Immunogenicity testing, but only for producing the pilot lots. Human testing may be done in conjunction with existing U.S. Government contracts. Time frames for production of pilot lots and initial production lots should be indicated. SEED VIRUS SELECTION: The contractor will NOT be responsible for seed virus selection. SEED LOT ANALYSIS: The contractor shall analyze the selected seed lot following standard assays to determine genomic integrity, absence of adventitious agents and other tests as appropriate as decided upon in consultation with the FDA. REQUEST LICENSURE: An initial request for licensure will be limited to adult applications. After licensure for adult use, additional studies will be required for seeking licensure for pediatric use. Organizations capable of performing these services are invited to submit a capability statement to the Contracting Officer at the address identified above no later than August 23, 1999. The capability statement must be submitted in an original and one copy and, at a minimum, describe the offeror's qualifications and experience for performing similar services. This sources sought announcement is for planning purposes only. It is not a Request for Proposals (RFP) and should not be construed as a commitment of any kind by DHHS to issue a solicitation or award a contract. Posted 07/20/99 (I-SN356406). (0201)

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