The National Strategy for Pandemic Influenza (November 2005) (PDF - 710 KB) and The National Strategy for Pandemic Influenza Implementation Plan (2006) (PDF - 404 MB) directed HHS to build a domestic manufacturing surge capacity able to provide pandemic influenza vaccine for the entire country, and to establish a pre-pandemic influenza vaccine stockpile to immunize the critical workforce. To these strategic goals, BARDA aimed to provide more and better vaccines sooner by supporting initially the development of modern production technologies and adjuvants for the manufacturing of seasonal and pandemic influenza vaccines. More recently BARDA addressed the need for better vaccines by supporting the development of more effective influenza vaccines with universal vaccine potential. With nearly a decade of BARDA investments, FDA has licensed since 2012 two (2) vaccines manufactured with cell- or recombinant-based technologies for seasonal influenza and a pandemic influenza vaccine formulated with a new oil-in-water emulsion adjuvant — all three of which were first-in-class influenza vaccines in the U.S. The following programs have augmented national pandemic influenza preparedness and response resources and capabilities and laid the foundation for BARDA’s new universal influenza vaccine initiative in 2015.
Cell-based vaccines afford more rapid and flexible surge production for seasonal and pandemic influenza than older egg-based technologies in the U.S., and may provide less mismatched seasonal vaccines. BARDA support accelerated the pace of advanced development of six (6) cell-based influenza vaccines since 2006; and led to licensure of two (2) seasonal vaccines in Europe from Novartis and Baxter in 2009, and one seasonal vaccine in the U.S. (Flucelvax®) from Novartis in 2012. In June 2014, the FDA licensed Flucelvax®, manufactured at the Novartis facility in Holly Springs, NC, ensuring that cell-based seasonal and pandemic influenza vaccines would be available for U.S. needs. BARDA continued to support one remaining set of cell-based seasonal and pandemic influenza vaccine candidates with GlaxoSmithKline (GSK) towards FDA licensure with the renewed support in 2015.
Since 2007, HHS/BARDA has supported directly four (4) projects for the advanced development of pandemic influenza vaccines formulated with adjuvants, which may provide antigen-sparing, broad immunity across many influenza viruses, and prime-boost immunity for influenza vaccines. In November 2013, FDA licensed GlaxoSmithKline’s Q-PAN H5N1 pandemic vaccine with AS03 adjuvant, whose development was supported by BARDA. This was the first adjuvanted pandemic influenza vaccine licensed in the U.S. The availability and intrinsic properties of these adjuvants have increased our pandemic influenza vaccine manufacturing capacity multifold.
Recombinant- and molecular-based technologies for seasonal and pandemic influenza vaccine development offer further options for meeting domestic pandemic influenza vaccine manufacturing surge capacity goals. These technologies do not rely on the ability of influenza viruses to make vaccines and also may afford vaccine availability much sooner than egg- and cell-based technologies. In January 2013, FDA approved the licensure of FluBlǾk®, Protein Sciences Corporation’s recombinant-based seasonal influenza vaccine supported by BARDA. In October 2014, FDA expanded the age indication of FluBlǾk® from 18-50 years old to greater than 18 years old. Recently FDA approved the production of this vaccine at a U.S. manufacturing site with several fold greater production capability. Advanced development of other seasonal and pandemic recombinant-based influenza vaccine candidates from VaxInnate and Novavax continued in 2015 with Phase 2 clinical trials.
In response to a national need to develop optimized viruses for influenza vaccine production, BARDA established the IVMI Initiative and led collaborations among influenza vaccine manufacturers and influenza experts from BARDA, CDC, FDA, and NIH. IVMI support has enabled preparation of candidate vaccine viruses (CVV) using synthetic genomics, and development and testing of potential virus backbone donors to confer higher antigen yield to CVVs in eggs and cells. Future goals include optimizing CVV and alternative potency assays and encouraging widespread adoption of rapid sterility assays for vaccine manufacturing to facilitate more rapid availability of seasonal and pandemic vaccines.
The National Strategy for Pandemic Influenza (November 2005) (PDF - 710 KB), the HHS Pandemic Influenza: Plan (2005) (PDF – 5.7 MB), and the The National Strategy for Pandemic Influenza Implementation Plan (2006) (PDF - 404 MB) directed HHS to build a domestic manufacturing surge capacity able to provide pandemic influenza vaccine for the entire country and to establish a pre-pandemic influenza vaccine stockpile to immunize the critical workforce. To these strategic goals, BARDA aimed to provide more and better influenza vaccines sooner by supporting initially the development of modern vaccine production technologies and adjuvants to build capacity for the manufacturing of seasonal and pandemic influenza vaccines.
More recently BARDA addressed the need for better vaccines by launching in 2015 a new program to support the advanced development of more effective influenza vaccines with universal vaccine potential. The long-term aspirational goal is a truly universal influenza vaccine that elicits more effective and stronger immunity among all populations, longer-lasting and broader spectrum protective immunity against a wide range of divergent influenza strains for both seasonal and pandemic influenza, and that may serve as a primer vaccine for pandemic influenza vaccine and reduce the overall pandemic influenza vaccine demand.
Currently NIH/NIAID and BARDA are partnering with industry and academia to develop and manufacture new universal influenza vaccine candidates for evaluation in preclinical studies and clinical trials. Additionally, BARDA launched its more effective influenza vaccine development program by releasing a Request for Proposal (RFP) on March 16, 2015, following consultation with interagency and industry partners. The development and potential licensure of more effective/universal influenza vaccines will address the need for a new and more effective vaccine that may provide "influenza immunity for life" and transform our pandemic influenza preparedness readiness and response capabilities.