The Integrated Vaccine Surveillance System (IVSS): Actively Monitoring Vaccine Safety during An Influenza Pandemic

Background:
Planning for safety monitoring during large-scale vaccination campaigns is an essential component of pandemic preparedness. A vaccine safety infrastructure that includes systems designed to actively monitor, record and analyze adverse events associated with the administration of a pandemic influenza vaccine will be critical for the rapid recognition of adverse events following immunization.

Setting:
A novel user-driven active surveillance system was implemented for the active monitoring of vaccine adverse events associated with routine seasonal influenza vaccine. Study was conducted at four managed care clinics in three geographic locations (during the 2007-2008 influenza season).

Population:
The study involved adults ≥18 years at the above described locations who received routine annual influenza vaccine and who consented to be in the study.

Project Description:
IVSS captures real-time, self-reported data on adverse events following immunization, using interactive voice-response (IVR) and web technology platforms. Vaccinees report each day via either a telephone report (i.e. IVR) or internet report. Daily electronic reporting from vaccinees is displayed on a secure study website available to public health personnel.

Results/Lessons Learned:
A total of 166 vaccinees were recruited at four metropolitan area clinics during the 2007 influenza season. Seventy-seven percent (128/166) of individuals who agreed to participate reported to the system. On average participants reported for a mean of 3 days post-vaccination. The most frequently used reporting mechanisms were phone (48% of reports), web (25%), and responses to follow-up calls (27%). No trends of potential concern related to adverse events following immunization were identified during this pilot study.
IVSS allows for rapid identification of adverse events, tracking the status of enrolled vaccinees, and reassurance of vaccinees that their health is being closely monitored. In addition, it can be tailored for use in multiple locations simultaneously.