MODIFICATION
65 -- Cell and Recombinant Based Pandemic Influenza Vaccine
- Notice Date
- 3/18/2005
- Notice Type
- Modification
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Health and Human Services, Office of the Secretary, Office of Public Health Emergency Preparedness, Office of Research and Development Coordination 200 Independence Avenue, SW Room 636G, Washington, DC, 20201
- ZIP Code
- 20201
- Solicitation Number
- ORDC-VB-05-04
- Response Due
- 3/31/2005
- Point of Contact
- David Beck, Chief Contracting Officer, Phone 202-690-7005, Fax 202-690-7412, - Darrick Early, Contract Specialist, Phone 202-401-3693, Fax 202-690-7412,
- E-Mail Address
-
david.beck@hhs.gov, darrick.early@hhs.gov
- Description
- Preparing to address the challenges of natural or man-made health threats is a priority of the U.S. Government. An influenza pandemic has a greater potential to cause more deaths and illnesses than virtually any other natural health threat. On the heels of three influenza pandemics in the 20th century, signs of a possible pandemic have emerged in Southeast Asia, as lethal infections of poultry and humans with avian influenza virus H5N1 continue and this virus is now endemic in bird populations, which increase the likelihood of continued human exposure. The primary means to reduce influenza mortality and decrease disease severity is prophylactic immunization. Currently U.S. licensed influenza vaccines for human usage are produced in embryonated hen’s eggs. Reliance on a single product as a substrate for influenza vaccine production has several vulnerabilities including a protracted vaccine production cycle, lethal toxicity to avian influenza viruses, and susceptibility to production drops caused by disease or nutrition. Therefore, diversification of vaccine manufacturing substrates, such as tissue culture cells and recombinant DNA expression systems may provide a more responsive and flexible influenza vaccine industry with increased overall production capacity and ability to provide ample vaccine supply rapidly in the event of an influenza pandemic. The Department of Health and Human Services through the National Vaccine Program Office and Office of Public Health Emergency Preparedness contemplates single or multiple awards of contracts to develop domestically manufactured cell- or recombinant DNA-based influenza vaccine leading towards FDA-licensure and human usage. The scope of activities that the Offeror may request funds may include manufacturing, clinical evaluation of pilot and commercial scale lots of influenza vaccine using tissue culture cell or recombinant DNA expression system substrates. Funds may be used also for scale-up development and manufacturing facility design but not facility construction. Contracts will be awarded to influenza vaccine manufacturers that have vaccine manufacturing facilities located in the U.S. or partnerships with companies having vaccine manufacturing facilities in the U.S. to provide U.S. pandemic influenza preparedness. Other eligibility requirements of vaccine manufacturers for these contracts include the following: (1) Documented history of successful development and licensure of vaccines for human usage; (2) Vaccine program that includes influenza vaccine candidates for seasonal or pandemic influenza that have successfully completed safety and immunogenicity human clinical trials (Phase I); (3) Written commitment to U.S.-based manufacturing, clinical development, and FDA-licensure of seasonal and pandemic influenza vaccines for human usage in the U.S. market; and (4) Documented comprehensive development program for pandemic influenza vaccines using influenza viruses or genes. The primary purpose of this Request for Proposal (RFP) is to facilitate the final stage development leading towards FDA-licensure of new influenza vaccines in U.S. based manufacturing facilities. The anticipated period of performance will be for a total of three to five years or 36 - 60 months. Additional details and requirements will be described in the solicitation. RFP-DHHS-ORDC-V&B-05-04 will be available electronically through the FedBizOpps on or about April 1, 2005. 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. Only written or email requests, directly from the requestor, for this solicitation will be accepted. No collect calls will be accepted. No facsimile transmissions will be accepted. See Government-Wide Numbered Note 26. All responses should be identified with RFP No. DHHS-ORDC-V&B-05-04, name of firm, name of requestor, mailing address, telephone number, fax number, email address and should be submitted to the Contracting Office Address identified in this notice. Multiple awards may result from this solicitation with an estimated award date of October 2005. NOTE: THIS NOTICE MAY HAVE POSTED ON WWW.FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (18-MAR-2005). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 29-APR-2005, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/OOS/OASPHEP/ORDC-VB-05-04/listing.html)
- Record
- SN00798690-F 20050501/050429214010 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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