Background: Aboriginal children in remote Australia have high rates of complicated middle ear disease associated with Streptococcus pneumoniae and other pathogens. We assessed the effectiveness of pneumococcal vaccination for prevention of otitis media in this setting.
Methods: We compared two birth cohorts, one enrolled before (1996-2001), and the second enrolled after introduction of 7-valent pneumococcal conjugate and booster 23-valent polysaccharide vaccine (2001-2004). Source populations were the same for both cohorts. Detailed examinations including tympanometry, video-recorded pneumatic otoscopy and collection of discharge from tympanic membrane perforations, were performed as soon as possible after birth and then at regular intervals until 24 months of life. Analyses (survival, point prevalence and incidence) were adjusted for confounding factors and repeated measures with sensitivity analyses of differential follow-up.
Results: Ninety-seven vaccinees and 51 comparison participants were enrolled. By age 6 months, 96% (81/84) of vaccinees and 100% (41/41) of comparison subjects experienced otitis media with effusion (OME), and by 12 months 89% and 88% experienced acute otitis media (AOM), 34% and 35% experienced tympanic membrane perforation (TMP) and 14% and 23% experienced chronic suppurative otitis media (CSOM). Age at the first episode of OME, AOM, TMP and CSOM was not significantly different between the two groups. Adjusted incidence of AOM (incidence rate ratio: 0.88 [95% confidence interval (CI): 0.69-1.13]) and TMP (incidence rate ratio: 0.63 [0.36-1.11]) was not significantly reduced in vaccinees. Vaccinees experienced less recurrent TMP, 9% (8/95) versus 22% (11/51), (odds ratio: 0.33 [0.11-1.00]).
Conclusion: Results of this study should be interpreted with caution due to potential bias and confounding. It appears that introduction of pneumococcal vaccination among Aboriginal infants was not associated with significant changes in prevalence or age of onset of different OM outcomes or the incidence of AOM or TMP. Vaccinees appeared to experience reduced recurrence of TMP. Ongoing high rates of complicated OM necessitate additional strategies to prevent ear disease in this population.