The Food and Drug Administration's Postlicensure Rapid Immunization Safety Monitoring Program: Strengthening the Federal Vaccine Safety Enterprise

    Basic Details
    Date
    Thursday, January 19, 2012
    Type
    Publication
    Description

    This article describes the creation of the Postlicensure Rapid Immunization Safety Monitoring (PRISM) program, which used data from national health insurance plans and immunization registries to monitor the safety of the H1N1 influenza vaccine, and the integration of PRISM into the FDA's Mini-Sentinel pilot program.

    Author(s)

    Michael Nguyen MD; Robert Ball MD, MPH, ScM; Karen Midthun MD; Tracy A. Lieu MD, MPH

    Corresponding Author

    M. Nguyen, Center for Biologics Evaluation and Research, FDA, Silver Spring, MD, USA. E-mail: michael.nguyen@fda.hhs.gov