1479. Incidence of Acute Otitis Media in Children in the United States before and after the introduction of Pneumococcal Conjugate Vaccines (PCV7 and PCV13) during 1998-2018

BACKGROUND: Acute otitis media (AOM) leads to considerable healthcare resource utilization in children. Streptococcus pneumoniae is an important cause of AOM. Merck is developing V114, an investigational 15-valent PCV that contains PCV13 serotypes as well as 22F and 33F. To demonstrate the potential value of V114, it is important to estimate the remaining clinical burden associated with AOM. This study estimated AOM incidence rates (IRs) before and after the introduction of 7-valent and 13-valent pneumococcal conjugate vaccines (PCV7 and PCV13) in the US. METHODS: This was a retrospective observational study using IBM MarketScan(®) Commercial Claims and Encounters (CCAE) (1998-2018) and Multi-State Medicaid databases (2001-2018). AOM claims in children < 18 years old were identified using ICD9 codes 382.x and ICD10 codes H66.x and H67.x. An episode could comprise one or more AOM-related claims. A gap of at least 14 days between two AOM-related claims was required to define the start of a new episode. IRs were defined as the numbers of episodes per 1,000 person-years (PY). Annual IRs were stratified by age groups (< 2, 2-4, and 5-17), and reported separately for CCAE and Medicaid databases. RESULTS: AOM IRs declined over time among commercially and Medicaid-insured children in all age groups < 18 years old. In particular, among children < 2 years, AOM IRs declined from 1,111 in 1998 to 727/1,000 PY in 2018 in commercially plans and from 895 in 2001 to 656/1,000 PY in 2018 in Medicaid (Figure 1). In children 2-4 years, AOM IRs declined from 517 in 1998 to 400/1,000 PY in 2018 in commercial plans and from 385 in 2001 to 329/1,000 PY in 2018 in Medicaid (Figure 2). In children 5-17 years, AOM IRs declined from 112 in 1998 to 87/1,000 PY in 2018 in commercial plans and from 98 in 2001 to 87/1,000 in 2018 in Medicaid (Figure 3). Figure 1. AOM incidence in commercially and Medicaid-insured children ages 0 - 1 years, episodes per 100,000 patient-years (1998 - 2018) [Image: see text] Figure 2. AOM incidence in commercially and Medicaid-insured children ages 2 - 4 years, episodes per 100,000 patient-years (1998 - 2018) [Image: see text] Figure 3. AOM incidence in commercially and Medicaid-insured children ages 5 - 17 years, episodes per 100,000 patient-years (1998 - 2018) [Image: see text] CONCLUSION: AOM IRs declined following the introduction of PCV7 and PCV13; however, disease burden remains substantial in younger children. The impact of future PCVs on AOM will depend on the proportion of AOM caused by S. pneumoniae and vaccine-type serotypes. DISCLOSURES: Tianyan Hu, PhD, Merck (Employee, Shareholder) Yan Song, PhD, Merck (Consultant) Nicolae Done, PhD, Merck & Co., Inc. (Consultant) Eli Orvis, BA, Merck (Consultant) James Signorovitch, PhD, Merck & Co., Inc. (Consultant) Tanaz Petigara, PhD, Merck & Co., Inc. (Employee, Shareholder)