Extending Logistic Regression Likelihood Ratio Test Analysis to Detect Signals of Vaccine-Vaccine Interactions in Vaccine Safety Surveillance

• Activity Number: 372
• Type: Contributed
• Date/Time: Tuesday, August 11, 2015 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Kijoeng Nam* and Nicholas C. Henderson and Patricia Rohan and Emily Jane Woo and Estelle Russek-Cohen
• Companies: CBER/FDA and University of Wisconsin - Madison and CBER/FDA and CBER/FDA and FDA
• Keywords: Vaccine-vaccine interactions ; Vaccine safety ; Adverse event ; Signal detection

Abstract

Adverse vaccine effects (AVEs) might arise from vaccine interactions in addition to AVEs from individual vaccines and may not be detected until the postmarket stage. The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). The VAERS database contains reports of adverse events associated with immunization and disproportionality analysis can be used to explore vaccine interaction adverse effects (VIAEs). In this paper, we develop a logistic regression based likelihood ratio test (LR-LRT) for detecting interactions between vaccines that may signal potential safety concerns. We evaluate our procedure with several numerical simulations, and we compare our results with known safety profiles, to validate the ability of our method to detect potential VIAEs.