Adverse events following quadrivalent meningococcal diphtheria toxoid conjugate vaccine (Menactra®) reported to the Vaccine Adverse Event Reporting System (VAERS), 2005-2016

Abstract

Background: Post marketing safety evaluations of quadrivalent meningococcal diphtheria-toxoid conjugate vaccine (MenACWY-D) have focused on post-vaccination risk of Guillain Barré syndrome (GBS), adverse events (AEs) after maternal vaccination, and comparative studies with the newer quadrivalent meningococcal CRM₁₉₇ conjugate vaccine (MenACWY-CRM). To provide an updated general safety assessment, we reviewed reports of AEs following MenACWY-D submitted to the Vaccine Adverse Event Reporting System (VAERS).

Methods: VAERS is a national spontaneous reporting vaccine safety surveillance system co-administered by the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration. We searched the VAERS database for U.S. reports of AEs after administration of MenACWY-D from January 2005 through June 2016. We conducted clinical reviews of serious reports after MenACWY-D administered alone, reports of MenACWY-D use during pregnancy, and reports of selected pre-specified outcomes. We screened for disproportionate reporting of AEs after MenACWY-D using empirical Bayesian data mining.

Results: VAERS received 13,075 U.S. reports after receipt of MenACWY-D; most (86%) described vaccination in adolescents, were classified as non-serious (94%), and described AEs consistent with pre-licensure studies. We did not find any evidence that reported deaths were related to vaccination. In serious reports, GBS and meningococcal infection were the most commonly reported medical conditions. Many reports of MenACWY-D use during pregnancy described inadvertent vaccination; most (61%) did not report any AE.

Conclusions: Findings from our comprehensive review of reports to VAERS following MenACWY-D are consistent with data from pre-licensure studies and provide further reassurance on the safety of MenACWY-D.

Keywords: Adolescent; Meningococcal vaccine; Surveillance; Vaccine safety.