Rapid Surveillance Capability: 2017-18 Seasonal Influenza Vaccines Surveillance

    Basic Details
    Date Posted
    Wednesday, May 22, 2019
    Status
    Complete
    Description

    This study conducted surveillance of influenza vaccines during the 2017-2018 influenza season, from October 2017 through May 2018; the last analysis was performed at the beginning of June 2018 with the available data up to that time.  Because influenza vaccines are administered during a relatively short period, the Sentinel Operations Center worked with select PRISM Data Partners to access sources of fresher data.

    The Sentinel Operations Center posted the surveillance protocol for public comment from August 4, 2017, through August 18, 2017. The public comment period is now closed.  A revised version was approved for implementation by September 6, 2017. A log of changes is included in the revised protocol.

    Additional Details
    FDA Center
    CBER
    Time Period
    2017 – 2018
    Study Type
    Protocol/Surveillance Plan
    Assessment Type
    Safety Analyses
    Data Sources
    Sentinel Distributed Database (SDD)
    Workgroup Leader(s)

    Alison Kawai, ScD; Cathy Panozzo, PhD; W. Katherine Yih, PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

    Steven Anderson, PhD, MPP; Azadeh Shoaibi, PhD, MS, MHS; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

    Workgroup Members

    Deepa Arya MD, MPH, MBA; Kinnera Chada, PhD; Richard A. Forshee, PhD; Hector S. Izurieta, MD, MPH; Joyce Obidi, PhD; Scott Proestel, MD; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

    Eric Czernizer, MPH; Tyler Jette, MPH; Lauren Zichittella, MS; James Williams, MBA; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA 

    Smita Bhatia, MCA; Annemarie Kline, MS; Cheryl McMahill-Walraven, PhD, MSW; Aetna: Aetna Informatics, Blue Bell, PA 

    Kevin Haynes, PharmD, MSCE; Lauren Parlett, PhD; HealthCore, Inc., Alexandria, VA 

    Mano Selvan, PhD; Comprehensive Health Insights, Humana Inc., Louisville, KY