Characterization of the Differential Adverse Event Rates by Race/Ethnicity Groups for HPV Vaccine by Integrating Data From Different Sources

Jing Huang, Jingcheng Du, Rui Duan, Xinyuan Zhang, Cui Tao, Yong Chen

Data from the Vaccine Adverse Event Reporting System (VAERS) contain spontaneously reported adverse events (AEs) from the public. It has been a major data source for detecting AEs and monitoring vaccine safety. As one major limitation of spontaneous surveillance systems, the VAERS reports by themselves sometimes do not provide enough information to answer certain research questions. For example, patient level demographics are very limited in VAERS due to the protection of patient privacy, such that investigation of differential AE rates across race/ethnicity groups cannot be conducted using VAERS data only. For many vaccines, racial and ethnical difference in immune responses has been found in studies based on racially diverse cohorts. It is of great interest to characterize the differential AE rates by race and ethnicity groups for vaccines. In this study, we propose a novel statistical method to integrate VAERS data with data from other resources for vaccine pharmacovigilance research. Specifically, we integrate VAERS data with CDC survey data of vaccine coverage and U.S. census data of race/ethnicity distribution to quantify differential AE rates by race/ethnicity groups for HPV vaccine. We utilize the difference of race/ethnicity distributions across U.S. states to investigate the association between AE reporting rate and race/ethnicity groups at the population level. We identify 9 AEs with significantly different reporting rates between non-Hispanic White females and other race/ethnicity groups.