(PORTLAND, Ore.) - The largest study ever conducted of flu vaccine safety in children ages six to 23 months has found that flu shots are safe for this age group. Researchers looked at more than 69,000 vaccination records to review any reason a child saw a doctor in the six weeks after getting a flu shot and to look for possible side effects. The study found very few instances that required medical attention, and none of these were serious or significantly associated with the flu vaccine. The results will appear in the October 25, 2006 issue of the Journal of the American Medical Association.

The study was conducted by researchers at eight major health plans in the United States, including four Regions of Kaiser Permanente. The researchers are part of the Vaccine Safety Datalink (VSD) Project, which is funded by the Centers for Disease Control and Prevention (CDC). The VSD Project involves a large database that links medical records at these health plans. This allows researchers to analyze very large numbers of vaccination records for any possible safety issues.

Study co-author John Mullooly, PhD, who recently retired as a senior investigator at Kaiser Permanente's Center for Health Research, says, "These results should reassure parents and pediatricians that flu shots are safe for infants and young children six to 24 months of age. Earlier studies suggested that flu shots are safe for young children, but these studies were much smaller in size. Finding no serious medically attended side effects among more than 69,000 vaccinations provides strong evidence that flu vaccinations are safe for this age group"

Flu vaccines - specifically, trivalent inactivated influenza vaccine - have been in use for decades, and the vaccine currently in use in the United States has been available since 1981. Until the winter season of 2004-2005, its use in children was recommended only for those with chronic medical conditions - asthma, for example - that could put them at higher risk for influenza infection. Because of increasing evidence of high illness rates from influenza infection in young children, the CDC began recommending the use of trivalent inactivated influenza vaccine in all children six to 23 months old. By January 31, 2005, nearly half of all children in this age group had received the vaccine.

Kaiser Permanente's Center for Health Research, founded in 1964, is a non-profit research institution whose mission is advancing knowledge to improve health. Kaiser Permanente Northwest is a group practice health care organization serving the medical needs of 485,000 people in Oregon and Southwest Washington.

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Released: October 24, 2006