Scientific Publications by FDA Staff

Hum Vaccin Immunother 2017 Jul 3;13(7):1705-13

Evaluation of optic neuritis following human papillomavirus vaccination.

Sridhar G, Tian F, Forshee R, Kulldorff M, Selvam N, Sutherland A, Bryan W, Barone S, Xu L, Izurieta HS

To assess the relationship between human papillomavirus (HPV) vaccination and occurrence of optic neuritis (ON) and to evaluate a claims-based algorithm for identification of ON. Females of 9-26 year olds in the HealthCore's Integrated Research Database (HIRDSM) with and without claims evidence of HPV vaccination between 2007 and 2012 were included in this study. Potential ON cases were identified using the claims-based algorithm, positive predictive value (PPV) was determined using medical chart review. For the claims analysis, two study designs, a self-controlled temporal scan statistic and a retrospective matched cohort analysis, were used. ON was defined based on an algorithm developed using diagnosis and procedure codes from the medical claims. The PPV for ON cases using charts that had enough information for reviewers to make a determination was 62.5% (95% CI: 49.5%-74.3%). With the self-controlled temporal scan statistic, the primary analysis restricting on recommended vaccination schedule timing showed an increased risk of potential ON after second dose (RR = 3.39; p = 0.03), this finding was not confirmed for any of the additional analyses performed for individual or combined doses. With the cohort design, there was no increased risk of potential ON following vaccination in either individual or combined dose analyses. The risk of potential ON was higher among participants with a history of prior autoimmune diseases. In conclusion, identifying confirmed ON cases through administrative claims data proved challenging. The claims-based analysis in this study did not provide evidence for an association of ON with HPV vaccination.