Solicited Adverse Events After Influenza Immunization Among Infants, Toddlers, and Their Household Contacts

Abstract

Influenza vaccine is well-tolerated by infants, toddlers and their household members. Post-marketing observational designs are an expedient way to assess adverse events following influenza immunization. These methods should be established and rehearsed annually in preparation for a pandemic.

Safety of Trivalent Inactivated Influenza Vaccine in Children 6 to 23 Months Old

“…7 By January 31,2005, 48% of all children in this age group in the United States had received trivalent inactivated influenza vaccine, an unprecedented high. 8 Influenza vaccine has a good record of safety, [9][10][11][12][13][14][15] although there have been documented rare complications from some annual formulations of vaccine. [16][17][18] A population-based study of the safety of trivalent inactivated influenza vaccine in children 0 to 18 years old (mean age, 10 years) found very few medically plausible associations, none of them serious.…”

Safety of Live-Attenuated Influenza Vaccination in Cystic Fibrosis

“…28 An observational study of infants and toddlers vaccinated with TIV from the provinces of Quebec and British Columbia reported that 6% (18 of 320) and 0.8% (3 of 370) of participants from Quebec and British Columbia, respectively, had at least 1 symptom compatible with oculorespiratory syndrome in the 72 hours after vaccination, which was mainly cough (both prevalent and incident) and reported more often in Quebec. 29 Our study has 3 main limitations. First, it is possible that our results are biased by time-varying effects such as changes in medications used and disease severity.…”

Safety of Trivalent Inactivated Influenza Vaccine in Children Aged 24 to 59 Months in the Vaccine Safety Datalink

“…Of 4 associations that were confirmed after medical record review, fever and limb soreness represent commonly reported adverse events of vaccination. 8,9,15,23 None of the events seemed to be serious, and none had complications. Furthermore, the final analysis with limb soreness had only 1 event.…”

“…Large postmarketing studies have an important role in detecting rare and serious vaccine adverse events that may have been missed in prelicensure clinical trials. Although TIV has a good record of safety, [3][4][5][6][7][8][9] only 2 large postmarketing studies have evaluated the safety of TIV in children: the first study 10 focused on all children younger than 18 years but was conducted well before the expanded recommendations, and the second study 11 evaluated safety only in children aged 6 to 23 months. Therefore, safety data specific to a large population of children aged 24 to 59 months are lacking.…”