May 31, 2012

Vanderbilt partners with state and CDC to pilot new vaccine safety reporting system

Vanderbilt partners with state and CDC to pilot new vaccine safety reporting system

The Vanderbilt Vaccine Research Program (VVRP), in collaboration with the Immunization Program of the Tennessee Department of Health and the Centers for Disease Control and Prevention (CDC), has launched a new statewide initiative to improve the reporting of potential safety concerns about vaccines.

The Vaccine Safety Advice Network (VSAN) is designed to investigate safety concerns about vaccines in real time, providing faster and more accurate tracking of potential adverse events from vaccination.

VSAN project leader Buddy Creech, M.D., MPH, associate director of VVRP, says current vaccine safety reporting systems in the United States have been very successful, but the CDC believes they can be even better. The VVRP has been selected to work with the state’s Immunization Program to pilot this new design, which is based on successful programs in Europe.

The major differences between the current system and the pilot have to do with the speed of investigation and standardized collection of data. For example, if a pediatrician has a patient who develops a severe rash, and there is concern it is related to a recent vaccination, the provider would access the new VSAN reporting site designed and maintained at Vanderbilt.

VSAN would then alert both Vanderbilt vaccinologists and the State Department of Health to assign local investigators to work with the provider to collect standardized test and assessment data in a timely manner.

Creech says the current Vaccine Adverse Events Reporting System, or VAERS, is notable for accepting reports of potential adverse events online, typically from providers, but also from family members or patients themselves. While the open-reporting system has its advantages, the data collected is often incomplete or inaccurate, and there is often a delay between reporting of events and investigation.

“With this new system we hope to be able to accomplish three things: First, to standardize and streamline the diagnostic testing that is gathered; second, to provide rapid counsel to providers about whether future vaccinations might be contraindicated; and third, to be able to quickly and strategically deal with adverse event patterns that may emerge,” Creech said.

The State Department of Health and the CDC recently launched an educational campaign to encourage all Tennessee primary care providers to use the VSAN pilot site for reporting adverse vaccine events. If this system increases sensitivity and accuracy in reporting, the CDC may adopt the system nationwide.

“We’re excited to be working with Vanderbilt in this cooperative effort to serve the public,” said Tim Jones, M.D., Tennessee Department of Health Epidemiologist. “The network has great potential for improving patient treatment and we’re optimistic more primary care providers will make it a routine function of their practices.”

Elizabeth Williams, M.D., a Vaccinology fellow at Vanderbilt, is helping spearhead the efforts, and Kathryn Edwards, M.D., Sarah H. Sell and Cornelius Vanderbilt Chair and director of the VVRP, is the principal investigator for this CDC-funded pilot. More information can be found at the VVRP website at