Expanded Recommendations for Use of Pneumococcal Conjugate Vaccines Among Adults Aged ≥50 Years: Recommendations of the Advisory Committee on Immunization Practices — United States, 2024

Objectives

The policy expands age-based pneumococcal conjugate vaccine (PCV) use to previously unvaccinated adults aged 50 years or older, aiming to prevent pneumococcal disease, reduce severe outcomes, and address inequities in disease burden and vaccination coverage.[1]The recommendation retains existing pathways for adults aged 19–49 years with risk conditions and for adults with previous 13-valent pneumococcal conjugate vaccine (PCV13) vaccination.[1]

• Extend age-based eligibility for a single pneumococcal vaccination course to all PCV-naive adults aged 50 years or older.[1]
• Prevent pneumococcal disease among older adults and people with risk conditions, recognising that approximately 90% of adults aged 50–64 years with invasive pneumococcal disease or pneumococcal pneumonia have at least one risk condition.[1][2]
• Address disparities affecting non-Hispanic Black or African American adults and non-Hispanic American Indian or Alaska Native adults, who experience higher rates of invasive pneumococcal disease caused by serotypes not included in PCV13 than the overall population.[1][2]
• Improve protection for adults aged 50–64 years, among whom vaccination coverage under risk-based recommendations has been lower than coverage among adults aged 65 years or older under age-based recommendations.[2]
• Maintain vaccination guidance differentiated by age, risk status, immunocompromising conditions, cerebrospinal fluid leaks, cochlear implants, chronic medical conditions, and prior vaccine history.[3][4]
• Update clinical guidance as pneumococcal disease epidemiology changes, including changes in circulating serotypes, vaccine-conferred immunity, and indirect effects of routine childhood vaccination on adult disease incidence.[5]

The strategic rationale reflects a substantial adult disease burden, including approximately 225,000 annual hospitalisations for pneumococcal pneumonia in the United States.[2]The material does not set quantitative vaccination-coverage targets, time-bound programme targets, or a wider strategic framework beyond the expanded clinical recommendation and its disease-prevention rationale.[1][2]

Implementation

The Advisory Committee on Immunization Practices (ACIP) developed the expansion through an Evidence to Recommendations assessment led by its Pneumococcal Vaccines Work Group between July and October 2024, and recommended expanded age-based PCV use on 23 October 2024.[6][1]Delivery is based on clinical assessment of age, risk conditions, local serotype epidemiology, and prior vaccination history rather than a single uniform vaccine schedule.[3][4][7]

• Offer eligible PCV-naive adults aged 50 years or older either a single dose of 20-valent pneumococcal conjugate vaccine (PCV20) or 21-valent pneumococcal conjugate vaccine (PCV21), or 15-valent pneumococcal conjugate vaccine (PCV15) followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23).[1]
• Apply specified intervals and follow-up options for adults who previously received PCV13 or other pneumococcal vaccines, according to their vaccination history and clinical risk.[1][3][4]
• Use shared clinical decision-making for certain adults aged 65 years or older who have completed PCV13 and PPSV23 vaccination but have not received PCV20 or PCV21.[3]
• Administer pneumococcal vaccines during the same visit as other age-appropriate vaccines when no specific contraindication applies.[7]
• Screen for contraindications and precautions using the relevant vaccine package insert, including severe allergic reaction to a vaccine component or, for PCVs, to a diphtheria toxoid-containing vaccine.[7]
• Tailor vaccine selection to local serotype distribution, particularly where serotype 4 disease is common, because PCV21 does not include serotype 4 despite including eight serotypes absent from previously recommended vaccines.[7]

ACIP’s evidence review considered pneumococcal disease incidence and mortality, vaccination coverage, racial and ethnic disparities, and economic models of vaccination from age 50 years.[6]It supplemented prior Grading of Recommendations, Assessment, Development and Evaluation reviews with updated searches of published and unpublished literature, MEDLINE via PubMed, ClinicalTrials.gov, post-licensure safety reports from the Vaccine Adverse Event Reporting System, and an analysis using Centers for Medicare & Medicaid Services data.[6]Clinical trial evidence assessed safety and immunogenicity for PCV15, PCV20, and PCV21 in adults aged 50 years or older.[8]

Implementation is supported by collaboration among the Centers for Disease Control and Prevention, ACIP, surveillance programmes, federal agencies, professional organisations, universities, and other members of the ACIP Pneumococcal Vaccines Work Group.[5][9]Surveillance should track vaccine safety, public health impact, duration of immunity, potential booster-dose needs, and the indirect effects of childhood immunisation on adult disease.[5]Active Bacterial Core surveillance, alongside surveillance in Alaska and Navajo Nation, is used to monitor invasive pneumococcal disease serotypes and inform future guidance updates.[5]

Report adverse events after vaccination to the Vaccine Adverse Event Reporting System.[7]The material does not specify operational delivery targets, provider-payment arrangements, vaccine budgets, financing sources, or a formal implementation accountability framework beyond safety reporting, surveillance, and ongoing evidence review.[1][7][5]

Monitoring & Evaluation

Monitoring and evaluation centre on evidence review, vaccine-safety surveillance, disease surveillance, vaccination coverage, and periodic updating of adult pneumococcal vaccination guidance as epidemiology changes. The material does not provide a formal implementation monitoring framework, performance targets, routine reporting timetable, or explicit accountability structure for the expanded age-based recommendation.[1][6][2][5]

• Assess evidence through the Advisory Committee on Immunization Practices (ACIP) Evidence to Recommendations framework, including pneumococcal disease incidence and mortality, vaccination coverage, economic models, and results disaggregated by race and ethnicity where available.[6]
• Review safety and immunogenicity evidence through updated searches of MEDLINE via PubMed and ClinicalTrials.gov, supplementing earlier Grading of Recommendations, Assessment, Development and Evaluation reviews of 15-valent, 20-valent, and 21-valent pneumococcal conjugate vaccines.[6]
• Monitor post-licensure safety of 20-valent pneumococcal conjugate vaccine using the Vaccine Adverse Event Reporting System and analyses based on Centers for Medicare & Medicaid Services data.[6]
• Report adverse events after administration of any vaccine to the Vaccine Adverse Event Reporting System; the cited clinical guidance provides online and telephone reporting routes.[7]
• Use Active Bacterial Core surveillance, alongside related surveillance in Alaska and Navajo Nation, to follow invasive pneumococcal disease incidence and serotype distribution.[2][5]
• Track inequities in disease burden and vaccination coverage, including higher rates of non-PCV13-serotype invasive pneumococcal disease among American Indian or Alaska Native and Black adults and lower coverage among adults aged 50–64 years subject to risk-based recommendations than among adults aged 65 years or older covered by age-based recommendations.[2]
• Monitor vaccine safety, public-health impact, duration of vaccine-conferred immunity, the possible need for booster doses, and indirect effects of routine childhood vaccination on pneumococcal disease in adults.[5]
• Update recommendations in response to changing epidemiology, including local serotype patterns relevant to vaccine selection.[5]
• Recognise surveillance limitations: the percentage of serotype 4 disease remains unknown in some western areas, although it has not been significant in monitored midwestern, eastern, and southern areas.[5]

Clinical evidence reviewed for adults aged 50 years or older included six trials of 15-valent pneumococcal conjugate vaccine, three trials of 20-valent vaccine, and seven trials of 21-valent vaccine.[8]The review reported no vaccine-related serious adverse events following 15-valent or 20-valent vaccine administration, while two vaccine-related serious adverse events had previously been reported following 21-valent vaccine administration.[8]These findings inform policy assessment, but the source does not establish indicator definitions, thresholds, data-quality procedures, reporting frequencies, or sanctions for non-performance.[6][2][7]

Costing & Financing

Costing and financing information is limited. No vaccine prices, budget allocations, funding sources, funding gaps, resource-mobilisation arrangements, programme expenditure estimates, or quantified economic assumptions are specified.[1][6][2][3][5][9]

• Review economic models of age-based pneumococcal conjugate vaccination beginning at age 50 years as one input to the ACIP policy assessment.[6]
• Consider economic evidence alongside disease incidence and mortality, vaccination coverage, safety, immunogenicity, and evidence by race and ethnicity where available.[6]
• Recognise that the supplied material provides no model outcomes, cost-effectiveness estimates, vaccine procurement assumptions, health-care cost assumptions, or comparison of financial implications between vaccine schedules.[6]
• Recognise that the clinical recommendations identify vaccine options and intervals but do not attach funding responsibilities or reimbursement mechanisms to those options.[1][3][4]

The absence of detailed financing information means that affordability, fiscal impact, funding adequacy, and the resources needed to support surveillance, adverse-event reporting, vaccine delivery, and equity-focused uptake cannot be assessed from the supplied excerpts.[1][6][2][7][5]