John Iskander, National Immunization Program, Vaccine Safety and Development, CDC, 1600 Clifton Road MS E-61, Atlanta, GA, USA, Karen Broder, Children's Medicine P.C, 3685 Lawrenceville Hwy, Suite 100, Lawrenceville, GA, USA, Gina Mootrey, Centers for Disease Control and Prevention, National Immunization Program, Senior Research Officer, 1600 Clifton Road, NE, MS E-61, Atlanta, Georgia, USA, Penina Haber, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, MS E-61, Atlanta, Georgia, USA, and Roseanne English-Bullard, National Immunization Program, Data Management Division, CDC, Atlanta, GA, USA.
KEYWORDS:
Vaccine, Influenza, Vaccine Adverse Event Reporting System (VAERS), Pediatrics
BACKGROUND:
Current guidelines recommend pediatric use of inactivated influenza vaccine (TIV) for specific high-risk groups. However, recent studies have demonstrated that young healthy children are at increased risk of influenza-related hospitalization. Expandsion of pediatric TIV guidelines is under consideration. Understanding the pediatric safety profile for TIV would be useful.
OBJECTIVE(S):
To review the pediatric safety profile for TIV using VAERS, a national passive surveillance system for adverse events occurring after vaccination.
METHOD(S):
US TIV adverse events reported to VAERS between 1-1-91 and 7-16-01 were reviewed for subjects <18 years. Reports were analyzed to create an overall safety profile. Case series reviews performed included death and Guillian-Barré Syndrome (GBS) cases.
RESULT(S):
Of 789 pediatric TIV reports received, 84.4% were non-serious and most occurred in children > 2 years. Commonly reported symptoms were fever, injection site reactions, rash, and convulsions (only for £2 years). Compared to universally recommended vaccines, urticaria and injection site hypersensitivity/pain were more frequently reported with TIV, while fever, rash and convulsions were less frequently reported. There were 9 death reports and no case had a definititive causal link to TIV. There were 10 reported cases of GBS, with doubt regarding diagnosis existing in 5 cases.
CONCLUSIONS(S):
Although our analysis is subject to the inherent limitations of VAERS, the majority of pediatric adverse event reports from TIV were minor. Deaths and GBS cases were rarely reported and causality was indeterminate in most cases.
LEARNING OBJECTIVES:
To understand the pediatric safety profile of inactivated influenza vaccine, based on data from a large passive surveillance system.
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