The National Strategy for Pandemic Influenza (November 2005) (PDF - 710 KB) describes the national approach to prepare, detect, and respond to pandemic influenza and defines the responsibilities of the federal government and others. The strategy seeks to “establish domestic production capacity and a stockpile of countermeasures to ensure sufficient vaccine to vaccinate front-line personnel and at-risk populations”. The National Strategy for Pandemic Influenza: Implementation Plan (2006) further defines 'establishment and maintenance of stockpiles of pre-pandemic influenza vaccine adequate to immunize 20 million persons against influenza strains that present a pandemic threat' to be a key capability needed for an effective pandemic response.
BARDA's Pandemic Influenza Vaccine Stockpiling Program provides preparedness for influenza pandemics maintains stockpiles of influenza vaccine antigens and adjuvants. The Program utilizes the HHS Influenza Risk Assessment Tool to identify and evaluate potential pandemic influenza virus threats. Informed by these results, BARDA implements measured responses from development of candidate vaccine viruses, virus 'seeds', clinical investigational lot production, clinical safety and immunogenicity trials, to commercial scale vaccine manufacturing for stockpiling. The quality of stockpiled vaccines is routinely evaluated through vaccine potency assays as part of master stability programs at the vaccine manufacturers that store the stockpiled vaccines, and laboratory assays that measure the cross- reactivity of sera from animals and humans immunized with the stockpiled vaccines against previous and circulating influenza viruses with pandemic potential. Clinical studies started in 2015 to evaluate the immunity afforded by old and new stockpiled vaccines. The results from all of these studies continuously shape the vaccine stockpile so that it continues to provide efficient and broadly effective protection against a potential pandemic.
BARDA maintains the pre-pandemic influenza vaccine stockpiles through public-private partnerships with domestic influenza vaccine manufacturers using egg- and cell-based vaccine and new oil-in-water adjuvant technologies. BARDA-industry partnerships proved vital during the 2009 H1N1 Pandemic when H1N1 monovalent vaccine was made available to meet U.S. demand. Together with its partners, BARDA has stockpiled hundreds of millions of doses of pre-pandemic H5N1 bulk vaccine covering several virus variants since 2005, and tens of millions of doses of H7N9 vaccine since 2013. BARDA also maintains a library of vaccine virus production 'seeds' to address lower-risk pre-pandemic threats. BARDA's Pandemic Influenza Vaccine Stockpile Program will continue to sustain and expand the dynamic pre-pandemic influenza vaccine stockpile using modern vaccine technologies and stay ready for pandemic responses with vaccine manufacturers and the capabilities of BARDA's Centers for Innovation in Advanced Development and Manufacturing.