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Clinical studies started in 2015 to evaluate the immunity afforded by old and new stockpiled vaccines. 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. 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 Program utilizes the HHS Influenza Risk Assessment Tool to identify and evaluate potential pandemic influenza virus threats. 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.īARDA's Pandemic Influenza Vaccine Stockpiling Program provides preparedness for influenza pandemics maintains stockpiles of influenza vaccine antigens and adjuvants. 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 (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.

Pandemic Influenza Vaccine Stockpile Program