National Institutes of Health, National Institute of Allergy and Infectious Diseases, Contract Management Branch, Solar Bldg., Room 3C07, 6003 Executive Blvd. MSC 7610, Bethesda, MD 20892-7610

A -- DRAFT INITIATIVE MARKET RESEARCH SOL NIH-NIAID-00-26 DUE 021299 POC Mr. Paul D. McFarlane, Contracting Officer, 301-496-0349 The Government is conducting market research to determine the interest and capability of influenza vaccine manufacturers to participate in producing batches of influenza virus vaccines to support clinical studies. Proposals are not being solicited at this time. The vaccines required for the clinical studies are to be prepared from avian influenza virus subtypes with high pandemic potential. This market research is part of the NIAID/NIH contribution to the Influenza Pandemic Preparedness Plan. Information has been gathered on relevant influenza A virus subtypes, and candidate avian viruses for use in clinical studies have been prioritized: H5N1, H7N7 (Eurasian lineage) and H7N3 (North American lineage), H2N2, H9N2, and H1N1 (avian-like H1). Pilot lots of inactivated vaccine, live-attenuated vaccine, and recombinant protein vaccine against each virus subtype listed above will be prepared safety and immunogenicity of the vaccines can be evaluated in controlled clinical trials sponsored by the Government. The overall objective of this activity is to gain knowledge that will better prepare us for dealing with an influenza pandemic. As a first step, the Government would like to proceed with the development of influenza A H5N1 virus vaccines. A reassortant produced with the A/Ann Arbor/6/60 ca virus is currently available for H5N1 live-attenuated vaccine production. Additional appropriate reference viruses and reassortants for the preparation of the H5N1-inactivated vaccines are being prepared. It is anticipated that reassortants produced using A/Puerto Rico/8/34 as the high growth donor strain will be provided; however, if this is not possible, reassortants produced with the A/Ann Arbor/6/60 ca virus may be used. For recombinant protein vaccines, the Government or industry might be sources for plasmids for specific influenza A virus hemagglutinins. For each vaccine lot, the manufacturer would be expected to provide no less than 2000 single dose containers (in doses to be established by the Government) produced according to current good manufacturing practices to permit use of the vaccines in clinical trials. The manufacturer would also be expected to take responsibility for all release testing including required and appropriate tests for safety, sterility and potency, and to provide full documentation to the Government (NIH and FDA) to support Phase I and Phase II clinical evaluations of the vaccine. The Government is also seeking manufacturer input on the following issues: 1. Do manufacturers have a preference for a particular reassortant background (i.e. PR-8 versus AA/6/60)? 2. If manufacturers are not able to participate in initial production of H5N1 vaccines, is there interest in any/all of the other subtypes listed above? The timeframe for completing production of the vaccines is flexible; however, it is anticipated that the effort would be finished prior to the start of the 2000-2001 influenza vaccine production. Therefore, it would be useful for the Government to know the approximate lead-time foreseen to begin this effort upon notice of contract award. Please provide a brief (maximum 8 pages) description of your institution's interest, capability and capacity to conduct this effort. As part of this description, you may include a "rough" cost estimate of your approach to the effort. This estimate should identify the total number of hours (or total percentage), the direct labor cost (combined amount, not separated by labor category), the materials and supplies, computer costs, and any other direct costs. Please identify your institution's fringe benefit and indirect (overhead) rates as well as any profit (or other fees) which may be applied to the direct costs. This estimate will assist NIAID with its planning for this acquisition. Your institution will not be held to these figures should the NIAID choose to negotiate a contract award. Please direct any questions regarding this effort to Mr. Paul D. McFarlane, Contracting Officer, NIAID at 301-496-0349, e-mail pm24v@nih.gov or to Dr. Pamela McInnes, Respiratory Diseases Branch Chief, NIAID at 301-496-5305, e-mail pm23v@nih.gov. Your responses should be sent to the address below no later than Friday, February 12, 1999. YOU ARE REMINDED THAT THE GOVERNMENT IS NOT SOLICITING PROPOSALS AT THIS TIME. Posted 01/20/99 (W-SN289793). (0020)

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