Skip to main content

COVID-19 Patients & Long COVID

    Basic Details
    Last Updated
    Thursday, March 7, 2024
    Original Posting Date
    Health Outcome(s)
    long COVID
    Methods and Development
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    On April 5, 2022, the Biden Administration issued a Presidential Memorandum directing the Secretary of Health and Human Services (HHS) to coordinate a new effort across the federal government to develop and issue the first-ever interagency national research action plan on “long COVID,” a term used to describe the long-lasting effects of having been infected with COVID-19. In response, FDA’s Office of Surveillance and Epidemiology (OSE) formed a working group tasked with outlining OSE's research plan on long COVID for fiscal years 2023-2024. As part of these efforts, an analysis was conducted to explore the use of FDA Sentinel’s electronic health record (EHR) data sources (specifically TriNetX) to identify and characterize long COVID, specific outcomes associated with long COVID, and relevant covariates (e.g., COVID-19 vaccination, prior COVID-19 infection, and treatments received during the acute disease phase). Results found under capture of long COVID cases in EHR data, with the most frequent signs/symptoms being in line with what has been reported in the literature.