EtR Framework for Adults Aged ≥19 Years Who Currently Have a Recommendation to Receive a Pneumococcal Conjugate Vaccine

About

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

Summary

Question: Should 21-valent pneumococcal conjugate vaccine (PCV21) be recommended for U.S. adults aged ≥19 years who currently have a recommendation to receive a pneumococcal conjugate vaccine (PCV)?

Population: U.S. adults aged ≥19 years who currently have a recommendation to receive a PCV.

Intervention: One dose of PCV21

Comparison: Current pneumococcal vaccine recommendations

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

Setting: U.S. adults aged ≥19 years who currently have a pneumococcal vaccine recommendation. These include:

  • adults aged ≥65 years who have never received a PCV
  • adults aged 19–64 years with a risk condition*, who have never received a PCV
  • adults aged ≥19 year who have received a PCV (i.e., PCV7, PCV13, or PCV15), but have not completed the recommended series

*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.
  • 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 PCV21 in adults and identified policy options that maximize pneumococcal disease prevention among adults, reduce disparity, and simplify recommendations to improve vaccine uptake.

Public Health Importance

References in this table:1234567

Criteria Work Group Judgements Evidence Additional Information
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, respectively1. In 2020, IPD rates decreased in all age groups, likely due to COVID-19 non-pharmaceutical interventions that resulted in cessation of transmission of non-SARS-CoV-2 respiratory pathogens2. However, relaxation of COVID-19-related interventions resulted in an increase in transmission of these pathogens in more recent years3,4. Data from 2022 show that IPD rates have been nearing pre-COVID-19 baseline. Based on serotype distribution of IDP cases reported in 2018–2022, PCV20 and PCV21 covered 54% and 84% of IPD cases, respectively, in adults aged ≥65 years. In adults aged 19–64 years who currently have risk-based pneumococcal vaccine recommendations, the proportions were 58% (PCV20) and 81% (PCV21), respectively.
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, respectively5. In adults aged <65 years, the rate ratios of all-cause pneumonia in adults with ≥1 chronic medical condition vs. healthy adults were 2.9 and 3.2 in adults aged 18–49 years and 50–64 years, respectively; in adults with ≥1 immunocompromising condition, the rate ratios vs. healthy adults were 4.2 and 5.8 in adults aged 18–49 years and 50–64 years, respectively5.
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)6. 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 old); and 8.7%, 6.9%, and 5.8% (≥65 years).
In 2021, new pneumococcal conjugate vaccines (PCVs), PCV15 and PCV20, were recommended for use among PCV-naive adults aged 19–64 years with risk-based indications, and all adults aged ≥65 years7. Unpublished data from Medicare Part A/B beneficiaries show that coverage of these vaccines among adults aged ≥65 years as of end of 2023 were estimated to be <1% and 12% for PCV15 and PCV20, respectively1. These vaccines were recommended for children in 2022 (PCV15) and 2023 (PCV20).

Benefits and Harms

References in this table:89101112131415

Criteria Work Group Judgements Evidence Additional Information
How substantial are the desirable anticipated effects? Moderate

Large

 Findings from one Phase II8 and three Phase III clinical trials9–11 randomized controlled trials (RCT) compared the immunogenicity of PCV21 to that of comparator vaccines (23-valent pneumococcal polysaccharide vaccine [PPSV23], PCV20, PCV15). One study assessed the safety and immunogenicity of PCV21 with concomitant or sequential administration of the quadrivalent influenza vaccine12.

In the Phase II clinical trial conducted among non-immunocompromised pneumococcal vaccine-naive U.S. adults aged ≥50 years with or without stable chronic medical conditions8, PCV21 met non-inferiority criteria for 9/9 shared serotypes (defined as the lower bound of the 95% confidence interval [CI] of the estimated opsonophagocytic activity geometric mean titer (OPA GMT) ratio [PCV21/PPSV23] to be >0.33) and superiority criteria (lower bound of the 95% CI of the estimated GMT ratio to be >1.0) for 12/12 serotypes unique to PCV21 (unique serotypes) when compared with PPSV23.

In the pivotal Phase III clinical trial conducted among non-immunocompromised, pneumococcal vaccine naive adults aged ≥18 years11, those who received PCV21 had a numerically higher OPA GMT for 6/10 shared serotypes compared with those who received PCV20; for 4/6, the 95% CI of the OPA GMT ratios (PCV21/PPSV23) did not cross 1. PCV21 met non-inferiority criteria (defined as the lower bound of the 2-sided 95% CI of the OPA GMT ratio [PCV21/PCV20] to be >0.5) for 10/10 shared serotypes. For the serotypes unique to PCV21, both OPA GMT and % seroresponders were higher among those who received PCV21 compared with PCV20; PCV21 met superiority criteria for 10/11 unique serotypes (not serotype 15C) for both endpoints (GMT ratio: defined as lower bound of the 2-sided 95% CI of the OPA GMT ratio [PCV21/PCV20] to be >2.0; difference in proportions of participants with ≥4-fold rise in serotype-specific OPA responses from baseline to 30 days: lower bound of the 2-sided 95% CI of the differences [PCV21/PCV20] between the proportion of participants with ≥4-fold rise from baseline to 30 days postvaccination to be >0.1).

In a Phase III clinical trial among non-immunocompromised adults aged ≥50 years who previously received a pneumococcal vaccine (PCV13 or PPSV23) ≥1 year prior to enrollment, receipt of PCV21 was compared with a comparator vaccine (PCV15 if previously received PPSV23; PPSV23 if previously received PCV13). In addition, adults who previously received both PCV13 and PPSV23 ≥1 year prior received PCV21 without a comparator group9. Among PPSV23-vaccinated adults, OPA GMT was numerically higher in 4/6 shared serotypes and for 15/15 unique serotypes among PCV21 vs PCV15 recipients. % seroresponders were numerically higher for 1/6 shared serotypes and for 15/15 unique serotypes among PCV21 vs PCV15 recipients. Among PCV13-vaccinated adults, OPA GMT was numerically higher in 7/12 shared serotypes and for 9/9 unique serotypes among PCV21 vs PPSV23 recipients. % seroresponders were numerically higher for 6/12 shared serotypes and for 9/9 unique serotypes among PCV21 vs PPSV23 recipients.
In a Phase III clinical trial among adults aged ≥18 years living with HIV10 (36% of the participants had previously received PCV13 or PPSV23), OPA GMT was numerically higher for 7/13 shared serotypes among PCV21 recipients (PCV21 followed by placebo 8 weeks later) compared with PCV15+PPSV23 recipients (PCV15 followed by PPSV23 8 weeks later) and was higher for 8/8 unique serotypes. % seroresponders were numerically higher for 8/13 shared serotypes and for 8/8 unique serotypes among PCV21 recipients.
Lastly, in a Phase III study among non-immunocompromised adults aged ≥50 years12 (29% previously received PCV13 or PPSV23) who received PCV21 and quadrivalent influenza vaccine (QIV) concomitantly or sequentially (30 days after PCV21 administration), GMT ratio (concomitant group/sequential group) was <1 for all 21 serotypes among those who received PCV21 and QIV sequentially vs. concomitantly; non-inferiority criteria (lower bound of the 95% CI for the estimated GMT ratio >0.5) were met for 20/21 serotypes (not met for serotype 23B).
 There are no studies that have assessed the efficacy or effectiveness of PCV21 against clinical outcomes.
How substantial are the undesirable anticipated effects? Minimal PCV21 Clinical Trial Safety Data
Safety data from participants in four PCV21 Phase III clinical trials, i.e., pneumococcal vaccine-naive adults aged 18–49 years 11,13, pneumococcal vaccine naive adults aged ≥50 years 11,12, and pneumococcal vaccine-experienced adults aged ≥50 years 9,12, were pooled. Safety of PCV21 among 4,020 recipients was compared with that among 2,018 recipients of the comparator vaccine (PCV15, PCV20, or PPSV23). The proportion of participants who experienced at least one solicited adverse event was comparable among PCV21 (63.3%) and comparator vaccine (63.9%) recipients. Injection site pain was the most common solicited injection site event (55.6% among all PCV21 versus 54.5% among control vaccine recipients). Among solicited systemic adverse events, the following were more common among all PCV21 recipients than among comparator vaccine recipients: fatigue (27.1% versus 23.7%), headache (18.4% versus 15.5%), and myalgia (11.3% versus 7.5%). Most solicited adverse events were mild (Grade 1) or moderate (Grade 2). A total of four (0.1%) potentially life-threatening (Grade 4) solicited adverse events were reported (three in PCV21 group, one in the control group). All were fever, which resolved. No occurrences of Guillain-Barré syndrome were observed.
Across one Phase II clinical trial 8 and five Phase III clinical trials 11,9,10,12,13, serious adverse events were observed in 74 of 4,963 (1.5%) PCV21 recipients and 49 of 2,472 (2.0%) comparator vaccine recipients through six months postvaccination*. Two serious adverse events, bronchospasm 12 and injection site cellulitis 9, were deemed to be vaccine-related in the PCV21 recipients; both resolved.
Post-licensure PCV20 Safety Data
Analysis of reports to the Vaccine Adverse Event Reporting System (VAERS) showed that among 1,976 reports received after PCV20 vaccine in adults aged ≥19 years between October 2021 and December 2023, most reports were classified as non-serious and describe reactions consistent with pre-licensure PCV20 trials in adults14. There was a data mining alert for Guillain-Barré Syndrome (GBS) after PCV20 vaccination. An analysis of Centers for Medicare & Medicaid Services 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 outcomes15.
Do desirable effects outweigh undesirable effects? Favors Intervention
  • Based on available data, the Work Group believed that there are no concerns about the risks outweighing the benefits of PCV21 vaccination.
  • For adults who currently have a PCV recommendation, PCV21 provides broader pneumococcal serotype coverage than any of the currently recommended vaccines.
What is the overall certainty of the evidence of effects? Effectiveness of the intervention

Moderate

Safety of the intervention

Moderate

 GRADE analyses were completed to assess the certainty of evidence.
  • Overall evidence type was moderate for the effectiveness of the intervention.
    • 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 evidence type was moderate for the safety of the intervention.
    • Assessment on imprecision was downgraded to “serious” because few vaccine-related serious adverse events were reported in studies with small sample sizes.
 Refer to GRADE summary tables for details. This population is covered in GRADE tables for adults aged ≥19 years who currently have a recommendation to receive a pneumococcal conjugate vaccine.

* PCV21 recipient group includes participants who received PCV21 and concomitant influenza vaccine, and participants who received influenza vaccine followed by PCV21

Values

References in this table:16

Criteria Work Group Judgements Evidence Additional Information
Does the target population feel that the desirable effects are large relative to undesirable effects? Probably yes Evidence to support this discussion for this EtR domain was limited (see summary of surveys conducted among targeted adult population by the Healthcare and Public Perceptions of Immunizations [HaPPI] Survey Collaborative and by Merck in “Additional Considerations” column). The work group (WG) members found it difficult to understand how the target population would perceive the benefits vs. harms of PCV21; however, most WG members believed that adults who currently have PCV recommendations would feel that the desirable effects are large relative to undesirable effects.
  • An online survey targeting adults aged 19–64 years with underlying conditions with risk-based pneumococcal vaccine indications was conducted by the HaPPI Survey Collaborative in January 202416. Results showed that a higher proportion of participants who self-reported having received a pneumococcal vaccine vs. those who did not had heard of pneumococcal disease and believed they would get pneumococcal disease in the next year. Among those who reported not receiving a pneumococcal vaccine, the most common reasons selected were not knowing they needed to get a pneumococcal vaccine or not being recommended by a healthcare provider that they needed a vaccine. Regardless of self-reported vaccination status, >60% of participants stated that they would receive a pneumococcal vaccine if recommended by a healthcare provider (range: 64% among unvaccinated to 88% among vaccinated).
  • An online survey targeting healthcare consumers (HCC) was conducted by Merck in February 2024. The survey targeted adults aged ≥65 years who previously received a pneumococcal vaccine as an adult or vaccine-naive adults aged 50–64 years without immunocompromising conditions who were neutral or in favor of adult vaccinations.
    • 73% of the of the survey respondents aged 50–64 years and 90% of previously vaccinated adults aged ≥65 years showed a positive reaction (i.e., somewhat positive, very positive, and extremely positive combined) to a hypothetical vaccine that had the profiles of PCV21.
Is there important uncertainty about or variability in how much people value the main outcomes? Possibly important uncertainty or variability

Probably no important uncertainty or variability

 There was no evidence identified to support the discussion of this question and the WG interpretation was split between “possibly important uncertainty or variability” and “probably no important uncertainty or variability”.

Acceptability

References in this table:17

Criteria Work Group Judgements Evidence Additional Information
Is the intervention acceptable to key stakeholders? Yes A Merck-supported cross-sectional online survey was conducted among healthcare providers (HCPs, internal medicine physicians, family medicine physicians, nurse practitioners, physician assistances, pharmacists) March to May 202417. Participants were predominantly of White race (85.3%) and practiced in an urban location (82.9%). The most important vaccine attributes driving HCP decisions were related to disease coverage. The majority (95.9%) of survey respondents either strongly agreed or agreed to have more approved pneumococcal vaccine options for adults.

Resource Use

References in this table:1819

Criteria Work Group Judgements Evidence Additional Information
Is the intervention a reasonable and efficient allocation of resources? Yes “Yes” was selected by the majority of Work Group members.
Three economic models (Tulane-CDC, Merck, and Pittsburgh models) assessed the cost-effectiveness of the use of PCV21 among adults who are currently recommended for PCV. 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 PCV21 instead of PCV20 for adults who are currently recommended to receive a PCV ranged from being cost-saving to having a cost of $58,000 per QALY gained18. In the Tulane-CDC model, the use of PCV21 instead of PCV20 at age 65 was found to have cost of $4,000 in the base case with a 95% confidence range from cost-saving to $19,000 per QALY gained in probabilistic sensitivity analysis. Also in the Tulane-CDC model, the use of PCV21 instead of PCV20 among individuals with a risk-based indication for PCV was found to be cost-saving in the base case estimate and in the 95% confidence range in probabilistic sensitivity analysis19. The Merck model base case estimates for the use of PCV21 instead of PCV20 was $5,000 per QALY gained among individuals aged 65 and older and was cost-saving among individuals 19–64 who had a risk-based indication for PCV use. The Pittsburgh model estimated the cost-effectiveness ratio of both age-based and risk-based use of PCV21, as compared with PCV20, and found cost-savings in the societal perspective estimate and a cost of $58,000 in the health care sector perspective estimate18.
 Several key assumptions varied across the three models that were reviewed, including indirect effects from PCV20 use among pediatric populations, the modeling of sequalae following acute pneumococcal disease states, the case-fatality-rates following inpatient non-bacteremic pneumonia, and productivity loss assumptions18. The cost per dose of PCV21 varied across models from $287 in the Merck model, to $319 in the Tulane-CDC model, and to $333 in the Pittsburgh 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, and the future epidemiology of pneumococcal serotypes that are not included in PCV21 (e.g., serotype 4, 19F).

Equity

References in this table:420212223242526272829

Criteria Work Group Judgements Evidence Additional Information
What would be the impact on health equity? Probably increased Pneumococcal vaccine coverage
Adults aged 19–64 years with risk-based vaccine indication has had lower pneumococcal vaccine coverage compared with adults aged ≥65 years20. Among adults with risk-based indications, differences in vaccine coverage by underlying condition (highest among people living with HIV) and age (higher among older adults) have been reported21. Among those eligible to receive pneumococcal vaccines, racial disparities in pneumococcal vaccine coverage exist, with White adults having higher vaccine coverage compared with other race/ethnicity, especially among adults aged ≥65 years.
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 costs22–24. Introduction of 13-valent pneumococcal vaccine (PCV13) among U.S. children reduced disparities that existed in PCV13-type IPD incidence, likely due to indirect effects from PCV13 vaccination in children25.
Racial disparities in the proportion of vaccine serotype coverage
The remaining disparities are driven by non-PCV13 type disease25. 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 AI/AN adults), and 38% in adults aged ≥65 years (range: 32% in Black adults to 49% in American Indian/Alaska Native [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).
Emergence of serotype 4 disease in certain U.S. subpopulations
Clusters for IPD cases due to serotype 4 have been reported in certain populations, such as people experiencing homelessness4,26,27. Increase in IPD caused by pneumococcal serotype 4 has been reported through routine surveillance in recent years, especially post-2020 in the Western United States, such as adults in Alaska28, Navajo Nation29, and Western sites in CDC’s Active Bacterial Core surveillance. Serotype 4 is included in PCV7 and other licensed pneumococcal vaccines but not in PCV21 and had nearly been eliminated after PCV7 introduction in children. Affected adults are typically adults aged <65 years with underlying conditions with risk-based vaccine indications or with history of substance abuse.

Feasibility

Criteria Work Group Judgements Evidence Additional Information
Is the intervention feasible to implement? Yes The Work Group members believed that recommending PCV21 for adults who currently have a recommendation to receive a PCV is feasible to implement. In addition, economic analyses showed favorable results consistently.

Balance of consequences

Desirable consequences clearly outweigh undesirable consequences in most settings

Policy options for ACIP consideration

ACIP recommends the intervention

Draft recommendation

ACIP recommends PCV21 as an option for adults aged ≥19 years who currently have a recommendation to receive a dose of pneumococcal conjugate vaccine (PCV).

Final ACIP recommendation

ACIP recommends PCV21 as an option for adults aged ≥19 years who currently have a recommendation to receive a dose of pneumococcal conjugate vaccine (PCV).

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Content Source:
National Center for Immunization and Respiratory Diseases (NCIRD)
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  13. Merck Sharp & Dohme LLC. A Phase 3 Randomized, Double-Blind, Active Comparator-Controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults 18 to 49 Years of Age. clinicaltrials.gov; 2024. Accessed December 31, 2023. https://clinicaltrials.gov/study/NCT05464420
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  29. Navajo Epidemiology Center. Serotype 4 Invasive Pneumococcal Disease (IPD) Information for Providers. March 2024. Accessed May 28, 2024. https://nec.navajo-nsn.gov/Portals/0/Reports/ST4%20alert%20for%20NN%20providers_2024.0312.pdf