Effectiveness of Pneumococcal Vaccines in Preventing Otitis Media in Children: A Targeted Literature Review
Author(s)
Min Huang, PhD1, Weiguang Xue, MSc2, Yanwen Xie, MPH3, Jipan Xie, MD, PhD4, Walter Albert Orenstein, MD5, Elamin Elbasha, BSc, MA, PhD6, Matthew Kelly, MD, MPH7.
1Sr. Principal Scientist, Merck & Co. Inc, North Wales, PA, USA, 2Analysis Group, London, United Kingdom, 3Analysis Group, Inc., Los Angeles, CA, USA, 4XL Source, Inc., Los Angeles, CA, USA, 5School of Medicine, Emory University, Atlanta, GA, USA, 6Merck & Co. Inc, West Point, PA, USA, 7Arkansas Children’s Hospital, Little Rock, AR, USA.
1Sr. Principal Scientist, Merck & Co. Inc, North Wales, PA, USA, 2Analysis Group, London, United Kingdom, 3Analysis Group, Inc., Los Angeles, CA, USA, 4XL Source, Inc., Los Angeles, CA, USA, 5School of Medicine, Emory University, Atlanta, GA, USA, 6Merck & Co. Inc, West Point, PA, USA, 7Arkansas Children’s Hospital, Little Rock, AR, USA.
OBJECTIVES: This study aimed to synthesize evidence on vaccine effectiveness (VE) of pneumococcal conjugate vaccines (PCVs) against otitis media (OM) in children <5 years.
METHODS: Three systematic literature reviews (SLRs) evaluating the effects of PCVs on OM were identified. A targeted literature review (TLR) was conducted in 02/2025 to identify additional studies published since 01/01/2020. The primary outcomes were all-cause and pneumococcal OM or acute OM (AOM), with VE defined as a relative reduction in OM/AOM risk comparing PCV to no vaccination. Other outcomes included recurrent AOM, OM-related surgical procedures, and complications.
RESULTS: The SLRs included 16 RCTs and 48 observational studies reporting the primary outcomes. The TLR identified 8 additional studies — 3 randomized controlled trials (RCTs) and 5 observational studies. Among these, 3 observational studies reported the primary outcomes. Median (range) of point VE estimates against all-cause OM/AOM across these three studies was 14% (2─27%) for PCV13 and 18% (5─42%) for PCV10; VE against pneumococcal OM was 86% for PCV13. Observational studies from the SLRs showed wider ranges: median (range) VE against all-cause OM/AOM was 32% (2─68%) for PCV13 (n=10), 23% (-96─84%) for PCV10 (n=15), and 20% (0─63%) for PCV7 (n=23). Median (range) VE against all-cause OM/AOM from RCTs was 14% (6─23%) for PCV10 (n=2) and 3% (-5─7%) for PCV7 (n=4), with only one significant. For pneumococcal AOM, median (range) VE was 55% (53-56%) for PCV10 (n=1) and 25% (20─34%) for PCV7 (n=2), all significant. VE estimates varied across age groups, but without consistent trend. Findings on cross-PCV comparisons and other outcomes were mixed.
CONCLUSIONS: This review supports the effectiveness of PCVs in reducing OM/AOM, particularly pneumococcal OM/AOM. However, evidence from RCTs is limited. VE estimates from observational studies vary substantially, likely due to heterogeneity in methodologies. Future research should standardize the methodology to improve the comparability across studies.
METHODS: Three systematic literature reviews (SLRs) evaluating the effects of PCVs on OM were identified. A targeted literature review (TLR) was conducted in 02/2025 to identify additional studies published since 01/01/2020. The primary outcomes were all-cause and pneumococcal OM or acute OM (AOM), with VE defined as a relative reduction in OM/AOM risk comparing PCV to no vaccination. Other outcomes included recurrent AOM, OM-related surgical procedures, and complications.
RESULTS: The SLRs included 16 RCTs and 48 observational studies reporting the primary outcomes. The TLR identified 8 additional studies — 3 randomized controlled trials (RCTs) and 5 observational studies. Among these, 3 observational studies reported the primary outcomes. Median (range) of point VE estimates against all-cause OM/AOM across these three studies was 14% (2─27%) for PCV13 and 18% (5─42%) for PCV10; VE against pneumococcal OM was 86% for PCV13. Observational studies from the SLRs showed wider ranges: median (range) VE against all-cause OM/AOM was 32% (2─68%) for PCV13 (n=10), 23% (-96─84%) for PCV10 (n=15), and 20% (0─63%) for PCV7 (n=23). Median (range) VE against all-cause OM/AOM from RCTs was 14% (6─23%) for PCV10 (n=2) and 3% (-5─7%) for PCV7 (n=4), with only one significant. For pneumococcal AOM, median (range) VE was 55% (53-56%) for PCV10 (n=1) and 25% (20─34%) for PCV7 (n=2), all significant. VE estimates varied across age groups, but without consistent trend. Findings on cross-PCV comparisons and other outcomes were mixed.
CONCLUSIONS: This review supports the effectiveness of PCVs in reducing OM/AOM, particularly pneumococcal OM/AOM. However, evidence from RCTs is limited. VE estimates from observational studies vary substantially, likely due to heterogeneity in methodologies. Future research should standardize the methodology to improve the comparability across studies.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO86
Topic
Clinical Outcomes, Epidemiology & Public Health
Topic Subcategory
Clinical Outcomes Assessment
Disease
Pediatrics, Vaccines