November 9, 2001

Vanderbilt among vaccine safety assessment centers

Featured Image

Vanderbilt among vaccine safety assessment centers

Vanderbilt is one of eight academic medical centers in the United States serving as a Clinical Immunization Safety Assessment (CISA) center to improve the evaluation, management and understanding of adverse events possibly related to immunizations.

Funded by Centers for Disease Control and Prevention, CISA centers are a new initiative designed to improve the patient’s understanding of vaccine safety issues.

Vaccines are among the most widely used and effective public health interventions for preventing disease and among the safest medical products available, according to Dr. Kathryn M. Edwards, professor of Pediatrics. But as the incidence of life-threatening, vaccine-preventable diseases has decreased, rare adverse events following immunization have received increased attention by both parents and health care providers. This, according to Edwards, has caused some parents to withhold vaccinations for their children.

“With increasing public concerns about the safety of vaccines, the CDC and Vanderbilt investigators are working with colleagues throughout the country to evaluate adverse reactions associated with vaccine administration,” Edwards said. “Close monitoring and timely assessment of suspected vaccine adverse events are critical to prevent loss of confidence, decreased vaccine coverage and the return of epidemic disease.”

Prior to the creation of the CISA network, no coordinated facilities existed in the United States that investigated and managed adverse events on the individual level for the purpose, in addition to patient care, of systemically collecting and evaluating the experiences. This void has previously left parents, patients and health care providers on their own to find answers and/or treatments for adverse events.

The goals of the network include:

• Developing clinical protocols for the evaluation and management of adverse events possibly related to immunization, and disseminating them through professional publications or other appropriate mechanisms.

• Evaluating groups of patients with similar adverse events, using a standard protocol in order to elucidate the mechanism by which these unusual or severe adverse reactions occur—possibly determining genetic or other risk factors that predispose to these reactions.

• Providing immunization guidelines and clinical management protocol for patients who have had an adverse reaction that may not contraindicate further vaccination, but where there is concern regarding continuation of the particular vaccine series.

• Serving as a public and provider regional referral center for clinical vaccine safety inquiries.

“The primary impact of these centers will be to allow the careful assessment and collection of the numbers of cases of adverse events associated with vaccines, to direct the investigation of these adverse events using modern immunologic methods, and to monitor the events associated with new vaccines that are licensed,” Edwards said.

As part of the network, Vanderbilt providers with expertise in vaccine safety will evaluate regional patients who have had adverse events associated with vaccines, or conduct telephone consultation with the primary care physician.

Vanderbilt’s staff will also systematically evaluate cases of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS). VAERS is the national passive surveillance system for adverse events following immunization, which receives reports from health care providers and the public. Vanderbilt will also accept referrals from health care providers in the area who have treated adverse events possibly linked to immunizations.

In the United States immunization safety system, CISA centers will serve as an intermediate step between passive reporting of individual cases of adverse events with no or minimal follow-up and the more rigorous epidemiological investigations with vaccine safety, such as the use of large linked databases, clinical trials and case-control or cohort studies.

“These goals will help to better define the level of risk of an adverse event for the individual patient, identify areas for additional scientific investigation to keep vaccines safe, and help maintain the public’s confidence in our immunization programs,” Edwards said.

Centers participating in the network include Johns Hopkins University partnering with specialists at the University of Maryland; Northern California Kaiser with collaborators at Stanford University and Vanderbilt; Boston University Medical Center; and Columbia Presbyterian Hospital.