Brief review of the clinical effectiveness of PREVENAR® against otitis media

Pre-licensure trials in Finnish and US infants demonstrated that PREVENAR was associated, respectively, with a 6% (95% CI, −4% to 16%) and an 8.9% (95% CI, 5.8–11.8%) overall reduction in clinical AOM incidence. Long-term follow-up of these cohorts revealed that there was an approximately 10–50% vaccine efficacy against recurrent otitis media or for the prevention of tympanostomy tube placement. In surveillance reports from the USA that followed infants with serious AOM, generalized PREVENAR vaccination led to an important fall in the incidence of pneumococcal otitis media, particularly for cases that would have been frequent or would have been refractory to antibiotic treatment. The rate of pneumococcal MEF isolates fell by 39% for severe otitis media [McEllistrem MC, Adams JM, Patel K, Mendelsohn AB, Kaplan SL, Bradley JS, et al. Acute otitis media due to penicillin-nonsusceptible Streptococcus pneumoniae before and after the introduction of the pneumococcal conjugate vaccine. Clin Infect Dis 2005;40(12):1738–44], by 42%, among persistent or treatment-resistant otitis media [Casey JR, Pichichero ME, Changes in frequency and pathogens causing acute otitis media in 1995–2003. Pediatr Infect Dis J 2004;23(9):824–8 [see comment]] and by 66% among severe otitis media cases or from ‘otitis-prone’ children [Block SL, Hedrick J, Harrison CJ, Tyler R, Smith A, Findlay R, et al. Community-wide vaccination with the heptavalent pneumococcal conjugate significantly alters the microbiology of acute otitis media. Pediatr Infect Dis J 2004;23(9):829–33 [see comment]].