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Background: As of June 2023, two pneumococcal conjugate vaccines, 20- (PCV20) and 15- (PCV15) valent formulations, are recommended for US infants under a 3 + 1 schedule. This study evaluated the health and economic impact of vaccinating US infants with a new expanded valency PCV20 formulation., Methods: A population-based, multi cohort, decision-analytic Markov model was developed to estimate the public health impact and cost-effectiveness of PCV20 from both societal and healthcare system perspectives over 10 years. Epidemiological data were based on published studies and unpublished Active Bacterial Core Surveillance System (ABCs) data. Vaccine effectiveness was based on PCV13 effectiveness and PCV7 efficacy studies. Indirect impact was based on observational studies. Costs and disutilities were based on published data. PCV20 was compared to both PCV13 and PCV15 in separate scenarios., Results: Replacing PCV13 with PCV20 in infants has the potential to avert over 55,000 invasive pneumococcal disease (IPD) cases, 2.5 million pneumonia cases, 5.4 million otitis media (OM) cases, and 19,000 deaths across all ages over a 10-year time horizon, corresponding to net gains of 515,000 life years and 271,000 QALYs. Acquisition costs of PCV20 were offset by monetary savings from averted cases resulting in net savings of $20.6 billion. The same trend was observed when comparing PCV20 versus PCV15, with a net gain of 146,000 QALYs and $9.9 billion in net savings. A large proportion of the avoided costs and cases were attributable to indirect effects in unvaccinated adults and elderly. From a health-care perspective, PCV20 was also the dominant strategy compared to both PCV13 and PCV15., Conclusions: Infant vaccination with PCV20 is estimated to further reduce pneumococcal disease and associated healthcare system and societal costs compared to both PCV13 and PCV15., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: The research described herein was supported by Pfizer Inc. Mark Rozenbaum, Liping Huang, Johnna Perdrizet, Alejandro Cane, Adriano Arguedas, Kyla Hayford, Maria Tort, Vincenza Snow, Erica Chilson, and Ray Farkouh are employed by Pfizer Inc. Ruth Chapman and Des Dillon-Murphy are employed by Evidera, which received financial support from Pfizer Inc. for this study. Medical writing support was provided by Derek Weycker, Ahuva Averin, Mary Cecil, and Dhwani Hariharan at Policy Analysis Inc. and was funded by Pfizer., (Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Pneumococcal disease is a substantial contributor to illness and death in young children globally. The introduction of 7-valent pneumococcal conjugate vaccine (PCV7) in 2000 had a significant impact in preventing pneumococcal disease in both vaccinated children and unvaccinated individuals (through herd effect). A higher valent PCV13 replaced PCV7 in late 2009. This analysis was undertaken to assess how many cases and deaths have been averted over the last decade since PCV13 introduction. A model estimated the number of infants vaccinated annually with PCV13, as well as the number of cases and deaths of invasive pneumococcal disease, pneumococcal pneumonia, and acute otitis media cases averted. PCV13 vaccination was estimated to have prevented 175.2 million cases of all pneumococcal diseases and 624,904 deaths globally between 2010 and 2019. These results demonstrate the substantial public health impact of PCV13 and highlight the importance of increasing the global reach of PCV programs., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: [Betsy Hilton, Ray Farkouh, and Matt Wasserman are employees and stockholders of Pfizer Inc. Ruth Chapman, Kelly Sutton, Desmond Dillon-Murphy, and Shreeya Patel are employees of Evidera, a healthcare research firm that provides consulting and other research services to pharmaceutical and related organizations. In these salaried positions, they work with a variety of companies and are explicitly precluded from accepting any payment or honoraria directly from them for services rendered. Evidera received payment from Pfizer Inc. for collaboration on this project and article.]., (Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.)