EtR Framework for Adults Aged 50–64 Years Who Have Not Received a Pneumococcal Conjugate Vaccine

About

The Evidence to Recommendations (EtR) framework describes information considered in moving from evidence to ACIP vaccine recommendations.

Summary

Question:

Should a single dose of pneumococcal conjugate vaccine (PCV) be recommended for all PCV-naïve adults aged 50–64 years?

Population:

PCV-naïve adults aged 50–64 years in the United States

Intervention:

One dose of 15-valent PCV (PCV15)*, 20-valent PCV (PCV20), or 21-valent PCV (PCV21)

*in series with a 23-valent pneumococcal polysaccharide vaccine

Comparison:

Current risk-based vaccine recommendation for adults with a risk condition†

Main outcomes:

Vaccine-type invasive pneumococcal disease; Vaccine-type non-bacteremic pneumococcal pneumonia; Vaccine-type pneumococcal death; Serious adverse events following immunization

Setting:

Currently, adults aged 19–64 years with a risk condition† and adults aged ≥65 years are recommended to receive a PCV. Expanding the recommendation to adults aged 50–64 years without a risk-based vaccine recommendation will imply a new age-based recommendation for adults aged ≥50 years.

†Alcoholism; chronic heart, liver, or lung disease; chronic renal failure; cigarette smoking; cochlear implant; congenital or acquired asplenia; cerebrospinal fluid leak; diabetes mellitus; generalized malignancy; HIV; Hodgkin disease; immunodeficiency; iatrogenic immunosuppression; leukemia, lymphoma, or multiple myeloma; nephrotic syndrome; solid organ transplant; sickle cell disease; or other hemoglobinopathies.

Perspective:

Clinical perspective

Background:

  • On June 17, 2024, 21-valent pneumococcal conjugate vaccine (PCV21, Merck) was licensed for use in adults aged ≥18 years.
  • At its June meeting, ACIP recommended PCV21 as an option for adults aged ≥19 years who are recommended to receive a PCV. In addition, ACIP requested to present a summary of data on whether age-based recommendation for pneumococcal vaccines should be lowered to age ≥50 years for all PCVs.
  • Unlike previous PCVs that were developed to target disease in children, PCV21 was developed to target pneumococcal disease in adults. It does not contain certain serotypes that are included in currently recommended PCVs (e.g., serotypes 1, 4, 5, 6B, 9V, 14, 18C, 19F, and 23F in both PCV15 and PCV20; serotype 15B in PCV20) and instead, contains 8 new serotypes that are not included in currently recommended vaccines (e.g., serotypes 15A, 15C, 16F, 23A, 23B, 23F, 31, 35B).
  • The ACIP Pneumococcal Vaccines Work Group reviewed available data to inform the use of PCV for all PCV-naïve adults aged 50–64 years and identified policy options that maximize pneumococcal disease prevention among adults, reduce disparity, and simplify recommendations to improve vaccine uptake.

Public Health Problem

Criteria Work Group Judgements Evidence Additional Considerations
Is the problem of public health importance? Yes Prior to the COVID-19 pandemic, it was estimated that ≥100,000 non-invasive pneumococcal pneumonia hospitalizations and ≥30,000 invasive pneumococcal disease (IPD) cases (IPD defined as disease with pneumococcal detection in a normally sterile site) occurred among U.S. adults each year. In 2019, IPD incidence in adults was 4.6, 15.7, and 23.7 per 100,000 population in those aged 19–49 years, 50–64 years, and ≥65 years, respectively.1 Since PCV13 use in children, IPD rates in adults aged 50–64 years have exceeded those in children aged <5 years.2 In 2020, IPD rates decreased in all age groups, likely due to COVID-19 non-pharmaceutical interventions that resulted in reduced transmission of non-SARS-CoV-2 respiratory pathogens.3 However, relaxation of COVID-19-related interventions resulted in an increase in transmission of these pathogens in more recent years4,5. Data from 2022 show that IPD rates have been nearing pre-COVID-19 baseline.2 Based on serotype distribution of IPD cases reported in 2018–2022, PCV20 and PCV21 covered 56% and 83% of IPD cases, respectively, in adults aged 50–64 years.6 Across all age groups, IPD mortality rate (per 100,000 population) has been the highest among adults aged ≥65 years and adults aged 50–64 years. IPD mortality rate has decreased over time in adults aged ≥65 years while the rate has been relatively stable in adults aged 50–64 years. As a result the rates between these two age groups have become closer in recent years.7
Ascertainment of the true burden of non-bacteremic pneumococcal pneumonia is more challenging since the cause of pneumonia is not routinely tested or identified. An analysis using claims data from 2016–2019 reported that the incidence rates of all-cause pneumonia in any setting increase by age at 953, 2679, and 6930 per 100,000 person-years in adults aged 18–49 years, 50–64 years, and ≥65 years, respectively.8
A study conducted among adults aged ≥18 years hospitalized with community-acquired pneumonia (CAP) in Georgia and Tennessee (PNEUMO study) estimated the proportion of vaccine-type pneumococcal pneumonia among CAP cases using their serotype-specific urinary antigen detection (SSUAD) assays for 30 serotypes contained in PCV15, PCV20, and PCV21 except for serotype 15B (included in PCV20). Results showed that among all adults, 12.1% had pneumococcal detection, 9.3% had a pneumococcal serotype contained in PCV21, and 4.1% with a serotype unique to PCV21 (not contained in PCV15 or PCV20).9 By age group, the proportion of PCV21, PCV20 (without serotype 15B), and PCV15 serotypes were: 8.0%, 4.7%, and 4.0% (18–49 years); 11.3%, 8.4%, and 7.3% (50–64 years); and 8.7%, 6.9%, and 5.8% (≥65 years).7
Among adults aged 50–64 years with IPD (source: Active Bacterial Core surveillance [ABCs] 2018–2021) and hospitalized pneumococcal pneumonia (source: PNEUMO study), nearly 90% had ≥1 condition with a risk-based pneumococcal vaccine recommendation.
 Success of the pediatric PCV program increased the relative burden of pneumococcal disease in adults aged 50–64 years, especially in those with risk conditions. Some Work Group members believed we should consider the absolute rate of disease, which has reduced significantly compared with rates from the pre-PCV era.

Benefits and Harms

Criteria Work Group Judgements Evidence Additional Considerations
How substantial are the desirable anticipated effects? Moderate Summary of systematic review of literature and GRADE for PCV15, PCV20, and PCV21 was previously conducted and presented to the ACIP.10–12 An updated literature search conducted in August and September 2024 identified six PCV15 trials,13–18 three PCV20 trials,19–21 and 7 PCV21 trials22–27 that included immunogenicity data for adults aged ≥50 years. Details of the search strategy are provided in the Supplementary Slides of the October 2024 ACIP meeting presentation (https://www.cdc.gov/acip/downloads/slides-2024-10-23-24/04-Kobayashi-Pneumococcal-508.pdf).2
Summary of findings from the updated literature search remains essentially unchanged. Details of the included studies are provided in the Supplementary Slides of the October 2024 ACIP meeting presentation (https://www.cdc.gov/acip/downloads/slides-2024-10-23-24/04-Kobayashi-Pneumococcal-508.pdf)2:
Findings from six PCV15 Phase 3 clinical trials showed that: compared with PCV13, PCV15 met noninferiority criteria for all shared PCV13 serotypes;15 PCV15 met criteria for statistically significantly higher responses for non-PCV13 serotypes 22F and 33F;15 compared with PCV13+PPSV23, PCV15+PPSV23 had numerically higher immune responses for most PCV13 serotypes;13,14 compared with non-concomitant administration of PCV15 and quadrivalent inactivated influenza vaccine (QIV)16 or COVID-19 vaccine (mRNA-1273),17 concomitant administration results in numerically lower immune responses for most PCV15 serotypes but met noninferiority criteria for all PCV15 serotypes. Included studies did not assess immunobridging across age groups.
Findings from one Phase 2 and two Phase 3 clinical trials showed that: PCV20 demonstrated numerically lower immunogenicity compared with PCV13 for most PCV13 serotypes but noninferiority criteria were met for all PCV13 serotypes;19–21 PCV20 demonstrated numerically higher immunogenicity compared with PPSV23 for the 7 non-PCV13 serotypes and noninferiority criteria met for 6/7 non-PCV13 serotypes (not met for serotype 8);19–21 PCV20 immunogenicity was numerically higher among adults aged 50–59 years compared with adults aged 60–64 years in 15/20 serotypes and immunobridging criteria met for all 20 serotypes.19
Findings from one Phase 2 and six Phase 3 clinical trials showed that: PCV21 met non-inferiority criteria for 9/9 shared and criteria for statistically significantly higher responses for 12/12 unique serotypes vs. PPSV23;22,27 PCV21 met noninferiority criteria for 10/10 shared and statistically significantly higher criteria for 10/11 unique serotypes vs. PCV20;23 PCV21 had numerically higher immune responses for 1-4/6 shared and all unique serotypes vs. PCV15;24 PCV21 coadministration with QIV met noninferiority criteria for 20/21 serotypes vs. sequential administration;25 and PCV21 met criteria for immunobridging for all PCV21 serotypes when comparing adults aged 18–49 years and 50–64 years22
 There are no studies that have assessed the efficacy or effectiveness of PCV15, PCV20, or PCV21 against clinical outcomes. While the majority of Work Group members believed the desirable anticipated effects are moderate, some expressed that the interpretation would depend on which PCV product is being considered.
How substantial are the undesirable anticipated effects? Minimal PCV15, PCV20, PCV21 Clinical Trial Safety Data
Summary of systematic review of literature and GRADE for PCV15, PCV20, and PCV21 was previously conducted and presented to the ACIP.10–12 An updated literature search identified six PCV15 trials,13–18 three PCV20 trials,19–21 and seven PCV21 trials22–27 that included safety data for adults aged ≥50 years.
Summary of findings from the updated literature search remains essentially unchanged: no vaccine-related serious adverse events were reported after PCV15 or PCV20 administration; two vaccine-related serious adverse events were reported after PCV21 administration. One case involved bronchospasm in a 50-year-old female in the QIV and PCV21 sequential group with bronchospasm within 30 minutes after the 2nd vaccination (PCV21).25 Duration was 23 hours and subsequently resolved. A second case was Injection site cellulitis in a 67-year-old female in Cohort 1 (prior PPSV23) with injection site cellulitis on Day 6; this lasted 1.57 weeks before resolving.24
Updated post-licensure PCV20 Safety Data
At the February 2024 ACIP meeting, post-licensure safety data of PCV20 from the Vaccine Adverse Event Reporting System (VAERS) and an analysis using Centers for Medicare & Medicaid Services data were presented.28,29 Analysis of reports to the VAERS after PCV20 vaccine in adults aged ≥19 years between October 2021 and December 2023 showed a data mining alert for Guillain-Barré Syndrome (GBS) after PCV20 vaccination. An analysis of Centers for Medicare & Medicaid Services (CMS) data through November 2023 showed that GBS incidence rate post-PCV20 administration has been rare and that the estimated incidence rate ratios and confidence intervals did not identify statistically significant risk elevation for any of the pre-specified outcomes.29
Updated analysis of VAERS reports through August 2024 revealed additional chart-confirmed GBS cases after PCV20 in adults aged ≥19 years, although the overall reporting rate remained low at 0.7 cases per million doses distributed. Updated analysis of CMS data through May 2024 showed a statistically significant signal for GBS following PCV20 vaccination in Medicare beneficiaries aged ≥65 years when using the primary definition for GBS. However, these cases were based on claims without chart confirmation and the signal was no longer statistically significant when using an alternate GBS definition or when adjusted for positive predictive value. The overall incidence remained low (<10 GBS cases per 100,000 person-years), resulting in wide credible intervals around the estimate.
Do the desirable effects outweigh the undesirable effects? Favors intervention
  • After reviewing available data on desirable and undesirable effects of PCV vaccination, the Work Group concluded that the desirable effects of PCV vaccination outweigh the undesirable effects among PCV-naïve adults aged 50–64 years.
  • Some Work Group members noted that their interpretation might differ depending on which specific PCV vaccine is under consideration.
What is the overall certainty of evidence of effects? Effectiveness of the intervention: Moderate
Safety of the intervention: Moderate
 GRADE analyses were not completed for the updated literature review. However, certainty of evidence for PCV21 studies was previously determined as follows:
  • Overall certainty of evidence was moderate for the effectiveness of the intervention.
    • The assessment on indirectness was downgraded to “serious” since only immunogenicity studies were available and there are no established correlates of protection for PCV21 against some of the critical outcomes (vaccine-type non-invasive non-bacteremic pneumococcal pneumonia, vaccine-type pneumococcal disease mortality).
  • Overall certainty of evidence was moderate for the safety of the intervention.
    • The assessment on imprecision was downgraded to “serious” because few vaccine-related serious adverse events were reported in studies with small sample sizes.
 Previous GRADE summary tables for PCV15, PCV20 and PCV21 are available through the following links:

PCV15:

https://www.cdc.gov/acip/grade/pneumo-PCV15-PPSV23-age-based.html

https://www.cdc.gov/acip/grade/pneumo-PCV15-PPSV23-risk-based.html

PCV20:

https://www.cdc.gov/acip/grade/pneumo-PCV20-age-based.html

https://www.cdc.gov/acip/grade/pneumo-PCV20-risk-based.html

https://www.cdc.gov/acip/grade/PCV20-prev-vax-adults-19-64-risk-based.html

https://www.cdc.gov/acip/grade/PCV20-prev-vax-older-adults.html

PCV21:

https://www.cdc.gov/acip/grade/pcv21-non-risk-based-adults-19-49.html

https://www.cdc.gov/acip/grade/pcv21-non-risk-based-adults-50-64.html

https://www.cdc.gov/acip/grade/pcv21-adults-19-and-older.html

Values

Criteria Work Group Judgements Evidence Additional Considerations
Does the target population feel that the desirable effects are large relative to undesirable effects? Probably yes/Yes
Minority opinion: Don’t know
 There was no evidence identified to support the discussion of this question. Interpretation of this EtR domain was informed by Work Group discussions based on their expert opinions.
  • Work Group members who work with underserved communities, including many underinsured or self-pay individuals, noted that they are generally receptive to pneumococcal vaccines when benefits are clearly communicated.
  • The success of conveying the advantages of pneumococcal vaccination is greatly influenced by the person delivering the information, as well as the amount of time they dedicate to discussing it with patients.
  • There was some hesitancy among some Work Group members to assert specific beliefs or attitudes toward pneumococcal vaccines in target populations without more concrete data or evidence.
  • On average, people may be more focused on potential side effects than on the benefits of vaccination, which can affect their willingness to receive pneumococcal vaccines.
  • Some acknowledged an increase in vaccine hesitancy overall in recent times, complicating efforts to understand and address people's perceptions and acceptance of vaccines.
Is there important uncertainty about or variability in how much people value the main outcomes? Probably no important uncertainty or variability There was no evidence identified to support the discussion of this question.

Acceptability

Criteria Work Group Judgements Evidence Additional Considerations
Is the intervention acceptable to key stakeholders? Yes No new evidence was identified to inform the Work Group discussions of this EtR domain. At the June 2024 ACIP meeting, a summary of findings from Merck-supported cross-sectional online surveys was presented, which highlighted that healthcare providers face challenges with implementing risk-based vaccine recommendations.6 These challenges include time constraints during patient visits and difficulties in determining patients' vaccination history or underlying health conditions. Surveyed providers supported lowering the age threshold for the age-based PCV recommendation to 50 years.

Resource Use

Criteria Work Group Judgements Evidence Additional Considerations
Is the intervention a reasonable and efficient allocation of resources? Probably yes/Yes
Minority opinion: Probably no
 “Probably yes” and “yes” were selected by the majority of Work Group members. However, “probably no” was the second most common response.
Three economic models (Tulane-CDC, Merck, and Pfizer models) assessed the cost-effectiveness of the use of PCV20 and PCV21 among PCV-naïve adults who are aged 50–64 years. For each of the models, the primary health outcome that was used to assess cost-effectiveness was the quality-adjusted life-year (QALY). Across the three models, base case estimates of the value of using PCV20 and PCV21 in adults aged 50–64 years ranged from $56,376 to $879,117 per QALY gained.30 Estimated costs varied across vaccines and across models.
In the Tulane-CDC model, age-based use of PCV21 at ages 50 and 65 was compared to risk-based use of PCV21 between ages 50–64 years and age-based use of PCV21 at age 65. This base case estimate was $214,430 per QALY gained, with a range from $131,023 to $214,430 per QALY gained where the higher value assumes base case inputs for indirect effects; and the lower value assumes no indirect effects from childhood vaccination.31 In the Tulane-CDC model age-based use of PCV20 at ages 50 and 65 was compared to risk-based use of PCV20 between ages 50 and 64 and age-based use of PCV20 at age 65. This base case estimate was $546,811 per QALY gained, with a range from $251,037 to $546,811 per QALY gained where the higher value assumes base case inputs for indirect effects; and the lower value assumes no indirect effects from childhood vaccination.31
For both PCV21 and PCV20, the Merck model assessed age-based use of PCV at age 50 and 65, as compared to risk-based use of PCV between ages 50 and 64 and age-based use of PCV at age 65. For PCV21, the estimates from the Merck model ranged from $251,048 to $425,455 per QALY gained, where the higher value comes from a scenario with indirect effects from PCV20 use in children; and the lower value comes from a scenario without indirect effects from PCV20 use in children. For PCV20, the Merck model estimates ranged from $548,114 to $879,117 per QALY gained, where the higher value comes from a scenario with indirect effects from PCV20 use in children; and the lower value comes from a scenario without indirect effects from PCV20 use in children; and both scenarios included no increase in vaccination coverage among adults aged 50-64 years with risk conditions.30
The Pfizer model assessed PCV20 only, evaluating the use of PCV20 at ages 50 and 65 as compared to PCV20 risk-based use from 50-64 and age-based use at age 65. In this comparison, the Pfizer model found cost-effectiveness estimates that ranged from $56,376 per QALY gained to $133,524 per QALY gained, where the higher value is based on vaccine effectiveness estimates that rely on quantifying the amount of circulating vaccine-type disease and base case assumptions about indirect effects from childhood use of PCVs; and the lower value is based on vaccine effectiveness estimates that rely on vaccine effectiveness studies looking at all-cause pneumonia and higher indirect effects from PCV15-non-PCV13 type disease.30
 Several key assumptions varied across models and had an impact on estimated results. The most important inputs from the review appeared to be the magnitude of indirect effects from PCV use among pediatric populations, initial vaccine effectiveness and the duration of vaccine effectiveness over time, and the assumed changes in vaccination coverage rates among the 50–64-year-old population. Lower incremental cost-effectiveness ratios (ICERs) were associated with lower magnitudes of indirect effects from PCV use in children, higher vaccine effectiveness and longer duration of protection assumptions, and relatively more vaccination coverage in populations at ages 50–64 years with risk conditions. Additional assumptions that were also varied across models included vaccine and vaccination-related costs, sequelae following acute pneumococcal disease states, case-fatality rates following inpatient non-bacteremic pneumonia, and productivity loss assumptions. The cost per dose of PCV21 varied across models from $287 in the Merck model, to $319 in the Tulane-CDC model. The cost per dose of PCV20 varied across models as well from $261 in the Merck model, to $262 in the Pfizer model, to $289 in the Tulane-CDC model. These variations in inputs and assumptions contributed to variations observed across the main results estimated by the models. Several limitations applied to all models, including limited available data on vaccine efficacy and duration of protection, the magnitude of indirect effects from PCV use, the magnitude of vaccination coverage changes that would occur in 50–64-year-olds with a younger age-based recommendation, the future epidemiology of pneumococcal serotypes that are not included in PCV21 (e.g., serotype 4, 19F), and the impact of supplemental doses or re-vaccinations.30
In addition to the Tulane-CDC, Merck, and Pfizer models, another economic model called the Pittsburgh model was published in Vaccine in early 2024. This publication included an assessment of 50-64 year old PCV vaccination, which was summarized at the June 2024 ACIP meeting and was briefly discussed at the October 2024 ACIP meeting.30,32 In the Pittsburgh model, age-based use of PCV at age 50 and 65, as compared to risk-based use of PCV between ages 50 and 64 and age-based use of PCV at age 65, was found to cost $2,713 to $114,645 for PCV21 and $36,854 to $149,269 for PCV20. The higher estimates for each vaccine were calculated using the healthcare sector perspective, and the lower values were calculated using the societal perspective.30

Equity

Criteria Work Group Judgements Evidence Additional Considerations
What would be the impact on health equity? Probably increased Proportion of adults with an underlying condition with a risk-based vaccine recommendation
According to NHIS 2020 data, 32.1% (Asian, non-Hispanic adults) to 54.1% (Black, non-Hispanic adults) of adults aged 50–64 years had ≥1 risk condition[1] that qualifies for a risk-based pneumococcal vaccine recommendation. Racial disparities exist in the prevalence of undiagnosed underlying conditions.33,34
Pneumococcal vaccine coverage by recommendation strategy
According to 2022 BRFSS data, the percentage of adults aged 50–64 years with risk-based vaccine recommendation who have received any pneumococcal vaccine dose was 37.3%, compared with 69.7% for adults aged ≥65 years with age-based pneumococcal vaccine recommendation.2 Racial disparities in vaccine coverage existed in both adults with risk-based and age-based vaccine coverage, ranging from 27.9% (Hispanic adults) to 39.3% (White, non-Hispanic adults) for adults 50–64 years with risk-based vaccine recommendation to 53.5% (Hispanic adults) to 63.4% (Black, non-Hispanic adults) for adults aged ≥65 years with age-based pneumococcal vaccine recommendation.2
Racial disparities in pneumococcal disease incidence
Racial disparities in pneumococcal disease incidence have existed, with disproportionately higher disease burden among Black adults compared with non-Black adults, resulting in high U.S. societal costs.35–37 Introduction of PCV13 among U.S. children reduced disparities that existed in PCV13-type IPD incidence, likely due to indirect effects from PCV13 vaccination in children, and remaining disparities are primarily due to non-PCV13 serotypes.38
According to CDC’s ABCs data from 2018–2019, IPD rates in Black adults peaked at a younger age (i.e., aged 55–59 years) compared with non-Black adults whose IPD rates increased with increasing age. While these disparities may be driven by multiple factors, higher prevalence of conditions that increase the risk of pneumococcal disease in Black vs non-Black adults aged <65 years may be one contributing factor.35
Racial disparities in the proportion of vaccine serotype coverage
The remaining disparities are driven by non-PCV13 type disease.38 Based on 2014–2019 ABCs data, PCV20-non-PCV13 serotypes caused 46% of non-PCV13 IPD cases in adults aged 19–49 years (range: 39% in Black adults to 59% in Asian adults), 43% in adults aged 50–64 years (range: 37% in Black adults to 55% in American Indian/Alaska Native [AI/AN]  adults), and 38% in adults aged ≥65 years (range: 32% in Black adults to 49% in AI/AN adults). PCV21-non-PCV13 serotypes caused 89% of non-PCV13 IPD cases in adults aged 19–49 years (range: 68% in Asian adults to 94% in AI/AN adults), 90% in adults aged 50–64 years (range: 85% in Asian adults to 91% in White adults), and 86% in adults aged ≥65 years (range: 78% in Asian adults to 90% in AI/AN adults).
[1]chronic heart disease, chronic lung disease, chronic liver disease, diabetes, smoking, alcoholism, weakened immune system due to prescriptions, weakened immune system due to health condition, solid cancer (not including non-melanoma skin cancer or unknown type of skin cancer) and blood cancer

Feasibility

Criteria Work Group Judgements Evidence Additional Considerations
Is the intervention feasible to implement? Probably yes, Yes Since there are age-based vaccine recommendations for adults in this age group (e.g., influenza, COVID-19, recombinant zoster vaccines), the Work Group believed that it is feasible to implement PCV for all PCV-naïve adults aged 50–64 years. Some Work Group members believed that achieving high vaccine uptake in younger adults presents challenges due to a combination of issues such as limited healthcare access and a lower perception of disease risk or vaccination benefits. The disparity in health insurance coverage was highlighted, especially since adults aged 50–64 years are less likely to have health insurance than those aged ≥65 years (according to 2022 US census data, 8.6% of adults aged 45–64 years vs 1.1% of adults aged ≥65 years were uninsured).39 Some expressed that the variability in insurance coverage may result in PCV20 being the only practical option for certain individuals until there is broader acceptance and availability of PCV21. The Work Group agreed that having a different age-based recommendation by vaccine product (e.g., PCV20, PCV21) will pose implementation challenges.

Balance of consequences

Desirable consequences probably outweigh undesirable consequences in most settings

Is there sufficient information to move forward with a recommendation: Yes

Policy options for ACIP consideration

ACIP recommends the intervention

Draft recommendation

ACIP recommends a pneumococcal conjugate vaccine (PCV) for all PCV-naïve adults aged ≥50 years

Additional considerations

Most Work Group members concluded that “Desirable consequences probably outweigh undesirable consequences in most settings.” However, approximately one-quarter of members opposed recommending the intervention, primarily due to three concerns: 1) economic analyses showing higher cost/QALY gained for PCV20 compared to PCV21; 2) uncertainties around key assumptions, particularly the impact of pediatric PCV use in reducing adult disease burden through indirect effects and duration of protection from PCV vaccination; and 3) implications of a broad recommendation given the differences in serotype coverage between PCV20 and PCV21. Despite these concerns, Work Group members recognized important potential benefits of lowering the age-based recommendation to ≥50 years for all PCVs. These benefits included reducing pneumococcal disease burden in adults aged 50–64 years, particularly among demographic groups experiencing higher disease rates in this age range. Members also noted that age-based recommendations are generally easier to implement than risk-based recommendations. Additionally, having different age-based recommendations for different vaccine products could create implementation challenges.

Final ACIP recommendation

ACIP recommends the intervention

References

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