Otitis media (OM) is a highly prevalent pediatric disease worldwide. The recently available statistics indicate that 24.5 million physician’s office visits were made for OM in 1990, representing a greater than 200% increase over those reported in the 1980's. OM is the most frequently diagnosed illness in children (<15 yrs.) and is the primary cause for emergency room visits. The morbidity associated with OM is significant. Hearing loss is the most common complication of OM with behavioral, educational and language development delays being additional consequences of early onset otitis media with effusion. The socioeconomic impact of OM is also great, with direct and indirect costs of diagnosing and managing OM exceeding $5 billion annually in the U.S. alone. To date, antibiotic use, both therapeutically and often prophylactically, has been largely relied upon for medical management of the spectrum of clinical entities known collectively as OM. Widespread use of antibiotics for OM has met with controversy, however, with the emergence of multiple-antibiotic resistant microorganisms.
This alarming increase in bacterial resistance to antimicrobials, including all three of the genera of bacteria commonly associated with OM (Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis), is hardly surprising when one considers that antibiotic use in children under 15 is more than three times greater than that in any other age group and in fact, 40% of all outpatient antibiotic use in children is for treatment of OM. Clearly, there is a tremendous need to develop more effective and accepted approaches to the management, and preferably, the prevention of OM through vaccination. While there are currently licensed vaccines targeting S. pneumoniae and H. influenzae type b, more than 90% of H. influenzae OM infections are due to non-typeable strains (NTHI). BMI is applying its Immune Dampening and Refocusing Technology to outer membrane proteins (OMPs) of NTHI that are involved in early bacterial colonization and adherence.