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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 Epidemiological data were based on published studies and unpublished Active Bacterial Core Surveillance System (ABCs) data.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.)

Introduction: Recommendations for adult pneumococcal vaccination in the U.S. were revised in 2022 after the introduction of 15- and 20-valent pneumococcal conjugate vaccines (PCV15 and PCV20) to call for routine PCV use among immunocompetent adults with risk conditions aged 19-64 years. The present study estimated the size of this newly recommended population., Methods: A retrospective cohort study was conducted using the Optum de-identified electronic health record (EHR) dataset. Patients who were active in the EHR between January 2016 and June 2021 and had ≥1 condition included in the current pneumococcal recommendation without an immunocompromising condition were included. Data were weighted to account for potential differences between the EHR and U.S., Population: Data analyses were conducted in 2022., Results: Of 45.6 million adults aged 19-64 years in the database, 12.5 million met inclusion criteria and had ≥1 qualifying condition, primarily smoking, with chronic lung disease/asthma and/or diabetes also common. After weighting, the U.S. population aged 19-64 years newly eligible for PCVs was approximately 56 million., Conclusions: Approximately one in four U.S. adults aged <65 years is now recommended to receive PCV15 or PCV20, which highlights the need for providers to assess vaccination status, administer the vaccine, or refer patients as appropriate, as well as the need for tools to facilitate patient identification and vaccination., (Copyright © 2023 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.)

Background: In November 2019, the US Advisory Committee on Immunization Practices recommended shared clinical decision-making (SCDM) for use of 13-valent pneumococcal conjugate vaccine (PCV13) among immunocompetent elderly adults. The impact of SCDM on PCV13 use in this population, immunocompromised persons, and vulnerable subgroups has not been well documented., Methods: Using Medicare Research Identifiable Files (01/2018 - 09/2020), monthly uptake of pneumococcal vaccine (PCV13, 23-valent pneumococcal polysaccharide vaccine [PPSV23]) was identified among fee-for-service beneficiaries aged ≥ 65 years with Part B coverage and no evidence of prior PCV13. Uptake was stratified by vaccine, risk profile, and demographics., Results: Among the > 12 M beneficiaries included each month, PCV13 uptake declined from > 70% of pneumococcal vaccinations before SCDM to < 60% after SCDM (02/2020). Reductions in PCV13 uptake were consistent across vulnerable subgroups as well as immunocompromised persons., Conclusions: PCV13 use decreased among immunocompetent and immunocompromised persons alike, despite continued routine PCV13 recommendation for the latter group., 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. Derek Weycker and Ahuva Averin are employees of Policy Analysis Inc. (PAI), which received funding from Pfizer in connection with the development of this manuscript. Sapna Prasad is an employee of Clarify Health, and Mahesh Kumar was an employee of Clarify Health when the work was conducted; both organizations received financial support for this study from Pfizer Inc. Jeffrey Vietri, Reiko Sato, and Erica Chilson are employed by Pfizer Inc., (Copyright © 2023. Published by Elsevier Ltd.)

Background: Persons with Down syndrome (DS) experience an increased risk of pneumonia. We determined the incidence and outcomes of pneumonia and relationship to underlying comorbidities in persons with and without DS in the United States., Methods: This retrospective matched cohort study used de-identified administrative claims data from Optum. Persons with DS were matched 1:4 to persons without DS on age, sex, and race/ethnicity. Pneumonia episodes were analyzed for incidence, rate ratios and 95 % confidence intervals, clinical outcomes, and comorbidities., Results: During 1-year follow-up among 33796 persons with and 135184 without DS, the incidence of all-cause pneumonia (pneumonia) was substantially higher among people with DS than those without DS (12427 vs. 2531 episodes/100000 person-years; 4.7-5.7 fold increase). Persons with DS and pneumonia were more likely to be hospitalized (39.4 % vs. 13.9 %) or admitted to the ICU (16.8 % vs. 4.8 %). Mortality was higher 1 year after first pneumonia (5.7 % vs. 2.4 %; P < 0.0001). Results were similar for episodes of pneumococcal pneumonia. Specific comorbidities were associated with pneumonia, particularly heart disease in children and neurologic disease in adults, which only partially mediated the effect of DS on pneumonia., Conclusions: Among persons with DS, incidence of pneumonia and associated hospitalizations were increased; mortality among those with pneumonia was comparable at 30 days, but higher at 1 year. DS should be considered an independent risk condition for pneumonia., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: ENJ received support from the Linda Crnic Institute for Down Syndrome and NIH RO1:AI108479. JLN, TA, JV, AM, EC, QY, DM, and REI are employees of Pfizer Inc. and may hold stock or stock options., (Copyright © 2023. Published by Elsevier Ltd.)

The addition of pneumococcal conjugate vaccines (PCVs) to the United States (US) national immunization program led to significant reductions in incidence, mortality, and associated sequelae caused by pneumococcal disease (PD) in children and adults through direct and indirect protection. However, there remains clinical and economic burden due to PD caused by serotypes not included in the current 13-valent PCV (PCV13) formulation. To address this unmet need, 15-valent PCV (PCV15) and 20-valent PCV (PCV20), containing additional serotypes to PCV13, were recently approved in the US for adults and are anticipated for pediatrics in the near future. The study objective was to estimate the annual number of cases, deaths, and economic burden of PD due to serotypes included in PCV13, PCV15, and PCV20 for both US pediatric and adult populations. An Excel-based model was developed to calculate clinical and economic outcomes using published age-group specific serotype coverage; incidence of invasive PD, community-acquired pneumonia, and acute otitis media; case fatality rates; and disease-related costs. The results showed that across all age groups, the estimated annual PD cases and associated deaths covered by PCV13 serotypes were 914,199 and 4320, respectively. Compared with PCV13 serotypes, the additional 2 and 7 serotypes covered by PCV15 and PCV20 were attributed with 550,475 and 991,220 annual PD cases, as well as 1425 and 3226 annual deaths, respectively. This clinical burden translates into considerable economic costs ranging from $903 to $1,928 million USD that could be potentially addressed by PCV15 and PCV20. The additional serotypes included in PCV20 contribute substantially to the clinical and economic PD burden in the US pediatric and adult populations. Despite the success of the PCV13 pediatric national immunization program and increased adult uptake of PCV13 and 23-valent polysaccharide vaccine, broader PCV serotype coverage is needed across all ages to further reduce pneumococcal disease burden., Competing Interests: Declaration of Competing Interest All authors are employees of Pfizer Inc and may hold stock or stock options., (Copyright © 2022 The Pfizer Inc. Published by Elsevier Ltd.. All rights reserved.)