INFLUENZA ADVANCED DEVELOPMENT AND STOCKPILING

BARDA supports a number of programs to develop and acquire a broad array of medical countermeasures for pandemic flu, including vaccines, therapeutics, diagnostics, and non-pharmaceutical countermeasures. BARDA's stockpiling efforts are focused on building reserves of critical countermeasures as they emerge from advanced development. Stockpiled medical countermeasures directly support readiness, as the stockpiled products can help to mitigate the effects of an event or outbreak. Establishment of the stockpile helps to ready suppliers to meet the increased demands that an event will bring about, becoming practiced in the production and delivery of products.

BARDA's acquisitions for the stockpile are not one-time events, complete upon the approval / licensure of a product. Rather, programs are structured to include incremental milestone acquisitions during late stage development, to make available products still in development that may increase preparedness in an event, pending Emergency Use Authorization. Furthermore, we aim to establish stockpiling milestones to address long term commitments post-licensure.

HHS/BARDA Vaccine Advanced Development Milestones

  • BARDA has supported the development of cell-based systems for influenza vaccine production. BARDA awarded contracts to accelerate development and production of new cell-based and antigen-sparing technologies for influenza vaccines towards U.S.-licensure with manufacturing surge capacities for domestic production. In November 2012, Flucelvax® became the first US-licensed cell-based influenza vaccine.
  • BARDA has supported the development of recombinant based influenza vaccines and helped to bring them to licensure. BARDA issued several contract awards, including two in February 2011, for the advanced development of influenza vaccines using recombinant technologies. These awards require the contractors to provide domestic manufacturing surge capacity that makes first doses of vaccine available within 12 weeks and of 50 million doses of pandemic influenza vaccine within 6 months.
  • BARDA is leading a HHS interagency-industry partnership for a study called Mix-N-Match to detrmine whether H5N1 antigens from one manufacturer may be used effectively with adjuvants from other manufacturers to enable extension of the pandemic vaccine supply. Results of these studies indicate that adjuvants not only greatly enhance the effectiveness of the H5 vaccines but also broaden the cross reactivity of the response to the vaccine. Dose-sparing effects were also observed when adjuvants were combined with H1N1 vaccines.

Pre-Pandemic Vaccine Stockpiling

  • BARDA established pre-pandemic influenza vaccine stockpiles, resulting in the development and manufacture of egg-based inactivated split monovalent bulk vaccines (bulk batches of ready-to-use single-strain vaccines) against circulating H5N1 avian influenza virus strains. Such emergency stockpiles are essential for immunizing critical personnel upon a pandemic influenza outbreak, pending the production of a vaccine against the actual pandemic strain. BARDA supported the development and manufacturing of the first licensed H5N1 vaccine.

 

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