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February 11, 2004

Effectiveness of Influenza Vaccine to Prevent Acute Otitis Media—Reply

Author Affiliations

Letters Section Editor: Stephen J. Lurie, MD, PhD, Senior Editor.

JAMA. 2004;291(6):692-694. doi:10.1001/jama.291.6.693-b

In Reply: We agree with Drs Heikkinen and Ruuskanen that a significant reduction in the total number of episodes of AOM might not have been determinable from measuring the proportion of children who had at least 1 episode of AOM. Accordingly, Table 4 in our article showed data from additional outcome measures, namely, the proportions of children with 0, 1, 2, and 3 or more episodes of AOM and the mean monthly rates of AOM during, respectively, the succeeding influenza and respiratory seasons in the first cohort (year 1) and the second cohort (year 2) and the 1-year follow-up period in the first cohort. As we reported, there were no significant differences between the vaccine and placebo groups on any of those measures. However, Heikkinen and Ruuskanen point out that, if one limits consideration to the numbers of episodes of AOM diagnosed within 7 days of a positive influenza culture, there was, in the 2 cohorts combined, an overall decrease in such episodes among vaccinees. Although that difference does not reach significance (13/504 vs 12/250, P = .17), limiting consideration further to the first cohort (because there was little influenza activity during the second year of the study) gives values of 8 episodes in 273 vaccinees vs 11 episodes in 138 placebo recipients, a difference that is significant (P = .04) and that translates to an estimated effectiveness of the vaccine against influenza-associated AOM of 62%.