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Safety of Inactivated Flu Vaccine in Children

Investigators examining the safety of trivalent inactivated influenza vaccine found no increased risk for any serious condition in children 6 to 23 months old.

Morbidity from influenza is greater in children <2 years old than in any other age group except adults >65. Beginning in 2004, the CDC and the American Academy of Pediatrics recommended universal influenza vaccination for 6- to 23-month-old children. The only influenza vaccine approved for these children is the trivalent inactivated vaccine (TIV). Safety data are limited for this age group, however.

Now, using records from the Vaccine Safety Datalink project, which links the administrative databases of eight managed-care organizations, researchers have screened for adverse events following TIV injection in 45,356 6- to 23-month-old children from 1991 through 2003 (69,391 TIV injections). Although the investigators examined all medically attended adverse events that occurred within 42 days after vaccination, the primary outcome measure was those occurring within 14 days. The odds of an event occurring during the 14 days after vaccination were compared with the odds for two control periods: 15–28 days before vaccination and 15–28 days after vaccination.

Fourteen diagnoses, including upper respiratory infection, otitis media, asthma, and cough, occurred at significantly different rates during the 14 days after vaccination than during the control periods. The only diagnosis found significantly more frequently during the 14 days after vaccination was "gastritis/duodenitis"; however, chart review ruled out an association with the vaccine. The other 13 diagnoses occurred less frequently following vaccination. No diagnoses occurred significantly more often 15–42 days after vaccination than during the control periods.

Comment: These data regarding the safety of TIV are reassuring. In July 2006, after completion of this study, the CDC and the American Academy of Pediatrics extended their recommendation for routine influenza vaccination to include all 6- to 59-month-old children.

— Robert S. Baltimore, MD

Published in Journal Watch Infectious Diseases November 1, 2006

Citation(s):

Hambidge SJ et al. Safety of trivalent inactivated influenza vaccine in children 6 to 23 months old. JAMA 2006 Oct 25; 296:1990-7.

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