Effectiveness of the seven- and thirteen valent pneumococcal conjugate vaccines against vaccine-serotype otitis media
Abstract Background Despite the demonstrated impact of pneumococcal vaccine (PCV) implementation on otitis media (OM), demonstration of real-life serotype-specific effectiveness of the 7- and 13-valent PCVs (PCV7 and PCV13) is lacking due to the paucity of culture-positive cases. . Furthermore, pre-licensure PCV13 efficacy against OM was not studied. Methods The study was conducted from October 2009 to July 2013. Cases were children aged 5-35 months-old with OM (mostly complex OM [recurrent/non-responsive, spontaneously draining, chronic with effusion) from whom middle-ear fluid (MEF) culture was obtained; controls were contemporary children with rotavirus-negative gastroenteritis in a prospective population-based rotavirus surveillance, from the same age group with similar ethnic distribution and geographic location. Vaccine effectiveness (VE, 95% CI) was estimated as one minus odds ratio using unconditional logistic regression, adjusting for time since PCV implementation, age and ethnicity. Results 223 cases and 1,370 controls were studied. Serotypes 19F and 19A together caused 56.1% of all vaccine-serotype OM. VE of ≥2 PCV doses in children 5-35m was demonstrated as follows: PCV7 against OM due to PCV7 serotypes (VT7-OM), 57.2% (6.0-80.5); PCV13 against VT13-OM, 77.4% (53.3-92.1), PCV13 against OM due to the 6 additional non-VT7 serotypes 67.4%, (17.6-87.1), PCV13 against 19F-OM, 91.3% (1.4-99.2); and PCV13 against serotype 3-OM, 85.2% (23.9-98.4%). PCV7 and PCV13 VE against serotype 19A-OM in children 12-35m was 72.4 (6.2-91.9) and 94.6% (33.9-99.6), respectively. Conclusions PCV7 and PCV13 were effective against complex OM caused by the targeted serotypes.