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

Project Title The Food and Drug Administration's Postlicensure Rapid Immunization Safety Monitoring Program: Strengthening the Federal Vaccine Safety Enterprise
Date
Thursday, January 19, 2012
Location
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.

Corresponding Author

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

Authors

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