65 -- Improved Process Manufacturing

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. Although domestic vaccine supply and usage has gradually risen over the past decade and incremental expansion of domestic influenza vaccine manufacturing capacity is anticipated over the next decade, private sector investment in surge capacity to meet the vaccine requirement in a pandemic is unlikely. One means to increase vaccine capacity is to increase the yield of vaccine product incrementally at various stages in the vaccine manufacturing process. Further modifications of present influenza vaccine manufacturing processes may be productive in increasing product stability. Taken together these improvements could have positive impacts on surge capacity during times of vaccine shortage and 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 contract awards to improve the manufacturing process of influenza vaccines to achieve greater product yields and potentially shorter production cycles. Contracts will be awarded to influenza vaccine manufacturers or their corporate partners, which have vaccine manufacturing facilities located in the U.S. and which plan and implement a coordinated and integrated systematic strategy to enhance influenza vaccine manufacturing. The vaccine manufacturing activities that may be pursued include raw material selection and qualification, upstream processing, downstream processing, vaccine formulation, and final product presentation. Other activities supported by this RFP include manufacturing, clinical evaluation, and validation of pilot investigational and commercial scale lots of influenza vaccines manufactured by the improved processes. Eligibility requirements of vaccine manufacturers for these contracts include the following: (1) Licensure and manufacturing of vaccines for human usage; (2) 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 (3) Documented development program for pandemic influenza vaccines using influenza viruses or genes. The primary purpose of this Request for Proposal (RFP) is to expand the domestic influenza vaccine capacity for seasonal and pandemic influenza. 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-05-07 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-05-07, 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 a