Research to Advance Vaccine Safety (R01 Clinical Trial Not Allowed)

The purpose of this Funding Opportunity Announcement (FOA) is to support research that will contribute to the overall understanding of vaccine safety. This research opportunity encourages studies that address scientific areas potentially relevant to vaccine safety, such as: 1) characterization of physiological and immunological responses to vaccines and vaccine components, including different adjuvants; 2) how genetic variations affect immune/physiological responses that may impact vaccine safety; 3) identification of risk factors (e.g., infection history, predisposition to or presence of allergic and/or autoimmune disease and biological markers that may be used to assess whether there is a relationship between certain diseases or disorders and licensed vaccines; 4) creation/evaluation of statistical methodologies for analyzing data on vaccine safety, including data available from existing data sources, such as passive reporting systems or healthcare databases; or 5) the application of genomic/molecular technologies and systems biology approaches to evaluate vaccine safety. This FOA aligns with the research goals and objectives outlined in the U.S. National Vaccine Plan).