MODIFICATION
65 -- Antigen Sparing 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-05-08
- Response Due
- 3/31/2005
- Archive Date
- 4/15/2005
- Point of Contact
- David Beck, Chief Contracting Officer, Phone 202-260-9660, 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 are comprised of 15 ?g of hemagglutinin (HA) for each included virus strain and are administered intramuscularly. Studies recently have shown that antigen sparing effects have been elicited for monovalent influenza vaccines formulated with adjuvants and trivalent influenza vaccines administered intradermally. Antigen sparing approaches may increase overall influenza vaccine capacity in the short term by reducing the amount of HA antigen that may be needed in the vaccine by using adjuvants or by administering vaccines by alternate routes such as intradermally. 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 medical devices and/or domestically- manufactured antigen sparing influenza vaccines for FDA licensure and human usage. The scope of activities for which the Offeror may request funds may include manufacturing and clinical evaluation of pilot and commercial scale lots of influenza vaccine using adjuvants or other immune enhancing substances. Funds may be used also for vaccine and medical device development and testing. Contracts will be awarded to companies or their corporate partners that have U.S. manufacturing facilities available for influenza vaccines, adjuvants, and/or medical devices, which may afford an antigen sparing effect. Other eligibility requirements of manufacturers and their corporate partners, if applicable, for these contracts include the following: (1) Documented history of development and clinical testing of vaccines, adjuvants, or medical devices for human usage; (2) Written commitment to U.S.-based manufacturing and clinical development leading toward FDA-licensure of pandemic influenza vaccines for human usage; and (3) 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 late stage development and testing leading toward FDA-licensure of new antigen sparing influenza vaccines in U.S.-based manufacturing facilities. The anticipated period of performance will be for a total of three years or 36 months. Additional details and requirements will be described in the solicitation. RFP-DHHS-ORDC-V&B-05-08 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-05-08, 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 September, 2005.
- Record
- SN00771479-W 20050320/050318211843 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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