65 -- Advanced Development of Recombinant Influenza Virus Vaccines

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. Continuous outbreaks of human disease caused by highly pathogenic avian influenza H5N1 viruses from infected birds have occurred since late 2003 in Asia, Europe and/or Africa. Ongoing influenza surveillance reveals that H5N1 viruses are endemic in bird populations and suggests that continued human exposure is likely. As a result, the threat of a pandemic caused by highly pathogenic influenza viruses continues. The primary means to reduce influenza mortality and decrease disease severity is prophylactic immunization. DHHS has undertaken a portfolio matrix approach to modernize and diversify influenza vaccines and to expand domestic influenza vaccine manufacturing surge capacity. Specific measures were implemented that support advanced development of cell-based influenza vaccines and antigen-optimization approaches for pandemic influenza vaccines, stockpiling of pre-pandemic influenza vaccines and building of domestic influenza vaccine manufacturing infrastructure. DHHS now seeks to leverage recombinant-based technologies to decrease the timeline of vaccine production in response to a newly emerged pandemic influenza strain. The timeline for the availability of egg- and cell-based inactivated pandemic influenza vaccines in the U.S. is estimated at 20-23 weeks post-pandemic onset, which may be towards the end of a first pandemic wave. Recombinant-based influenza vaccines, which may not be dependent on pandemic influenza virus reference strain availability and the production and calibration of potency assay reagents needed for inactivated influenza vaccines, may be available 8 to 12 weeks post-pandemic onset. The effect of vaccination combined with influenza antiviral drugs and community mitigation measures may delay the peak incidence of pandemic influenza disease and reduce mortality and morbidity during a severe pandemic. The U. S. Department of Health and Human Services, through the Office of the Assistant Secretary for Preparedness and Response, contemplates single or multiple contract awards to develop recombinant influenza vaccines based on hemagglutinin genes or proteins (plasmid DNA, virus-vectors, peptides, subunit proteins and virus-like particles) and leading towards FDA-licensure and human usage. The scope of activities for which the Offeror may request funds include clinical investigation lot manufacturing, scale-up process development, clinical evaluation, validation of manufacturing process systems and manufacturing facility concept design but not facility construction. Contracts will be awarded to vaccine manufacturers that have vaccine manufacturing facilities located in the U.S. or have partnerships with companies owning vaccine manufacturing facilities in the U.S. Other requirements for offerors include the following: (1) a completed final report of Phase I clinical trials for safety, immunogenicity and cross-reactivity or cross-neutralization of antigenically drifted influenza strains using a recombinant influenza vaccine (2) written evidence of firm commitment to establish and maintain the necessary facilities in the U.S. to manufacture bulk and final container recombinant pandemic influenza vaccine with a manufacturing surge capacity of 50 million doses within six months, (3) a manufacturing production cycle that permits recombinant pandemic influenza vaccine lot release within 12 weeks of a pandemic declaration. (4) a comprehensive development plan and timeline for U.S licensure of a recombinant pandemic-like influenza vaccine. 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 three to five years or 36 - 60 months. Additional details and requirements will be described in the solicitation. RFP-DHHS-BARDA-07-06 will be available electronically through the FedBizOpps on or about September 14, 2007. Proposals will be due a minimum of 45 days after RFP issuance. 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-DHHS-BARDA-07-06, 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 March 2008.