Advanced Development of More Effective/Universal Influenza Vaccines

Prevention of disease caused by seasonal and novel influenza strains of pandemic potential continues to be a public health challenge. Vaccination is the primary medical intervention for prevention of infection with these viruses. Seasonal influenza vaccines, which are produced and administered annually, are only 30% to 70% effective. Excess morbidity and mortality caused by seasonal influenza virus disease can be devastating in terms of years of life lost and economic productivity. The emergence of novel strains of influenza viruses presents a public health threat, with potential rapid global spread among people with no pre-existing immunity to the virus, causing catastrophic morbidity and mortality. The Department of Health and Human Services (HHS), through the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response (ASPR), is launching a new initiative supporting the advanced development of influenza vaccine candidates with the goal to provide enhanced, long-lasting protection from a broad range of antigenically divergent influenza viruses within and across subtypes. These new vaccines will be more effective than current vaccines in providing protection from influenza infection in people of all ages and in people generally considered high-risk for severe disease associated with influenza infection. Additionally, these new vaccines may serve as a priming dose during non-pandemic periods to enable a single dose of a pandemic influenza vaccine to be effective. As such, promising experimental data providing evidence that the new vaccine may serve as a primer for a pandemic influenza vaccine booster will be evaluated favorably. Offerors are required to develop these vaccine candidates towards final FDA licensure for prophylaxis against disease caused by seasonal and pandemic influenza. HHS/ASPR Acquisition Management, Contracts and Grants (AMCG) intends to publish a Request for Proposal (RFP) to support the advanced development of new influenza vaccines that are more effective than currently licensed vaccines as a step towards development of a universal influenza vaccine with potential prime- boost vaccine properties for pandemic influenza. This RFP will provide additional details regarding the desired characteristics for the development towards a universal influenza vaccine candidate through a defined target product profile (TPP). BARDA contemplates a single or multiple contract award(s) to develop, manufacture, and evaluate more effective influenza vaccine candidate(s) toward US licensure. Offeror(s) shall demonstrate their ability to meet the following mandatory criteria: - Evidence of greater cross-reactive immune responses elicited by the proposed influenza vaccine candidates compared to U.S.-licensed seasonal and pandemic influenza vaccines from proof-of-concept in-vitro and relevant animal studies, - Evidence of progress towards advanced development of proposed influenza vaccine candidates from Phase 1 dose-ranging clinical studies that demonstrates the vaccine candidate is well tolerated and able to induce cross-reactive immune responses to a range of antigenically divergent influenza viruses, - Evidence of commitment for U.S. licensure of vaccine product from documentation of an investigational new drug (IND) submission to the U.S. Food and Drug Administration, AND - Evidence of domestic manufacturing capability, either alone or in partnership with other manufacturers, or plans for technology transfer to a domestic production site. The anticipated period of performance includes a four to five year base period with a four to five year option period. Additional details and requirements will be described in the solicitation. The RFP will be available electronically through the Federal Business Opportunities (FedBizOpps) website (www.fbo.gov) on or about February 11, 2015, with proposals being due on or about April 11, 2015. 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. It is the Offeror's responsibility to monitor this website (www.fbo.gov) for the release of the solicitation as well as any subsequent amendments to the solicitation. Potential offerors will be responsible for downloading their own copy of the solicitation and any amendments via www.fbo.gov. No collect calls will be accepted. No facsimile transmissions of proposals will be accepted. All responses and/or inquiries concerning this requirement MUST be identified with the RFP number, name of firm, name of requestor, mailing address, telephone number, email address and should be submitted to the primary and/or secondary point of contact identified in this notice. Multiple awards may result from this solicitation with an estimated award date of September 2015.