02 Stoecker Pneumococcal 508

1Economic Analysis and Public Health Impact of PCV
use for Adults Aged ≥50 Years
Charles Stoecker
Tulane University
Celia Scott Weatherhead School of Public Health and Tropical
Medicine
ACIP
October 23, 2024

2Conflicts of Interest
❑Dr. Stoecker has no conflicts of interest to declare.
3Acronyms
❑ PCV: pneumococcal conjugate vaccine
❑ PCV20: 20 valent PCV
❑ PCV21: 21 valent PCV
❑ VE: vaccine effectiveness
❑ VT: vaccine type
❑ ST: serotype
❑ NBP: non -bacteremic pneumonia
❑ IPD: invasive pneumococcal disease
❑ IPT: inpatient
❑ OPT: outpatient
❑ QALY: quality adjusted life year
❑ IC: immunocompromised
❑ CMC: chronic medical conditions, but not IC
❑ NIS: National Immunization Survey
❑ ABCs: Active Bacterial Core Surveillance System
4Methods:  Study Question
❑Evaluate cost effectiveness of an age -based
recommendation for PCV20 or PCV21 in adults younger
than age 65
▪Motivation is to get higher coverage among risk -based adults
•Additionally get coverage among general population
❑Evaluate
▪Program cost/savings
▪Changes in disease, medical costs, nonmedical costs, and work
productivity costs
•Limited societal perspective
▪Population
•Cohort of 4,051,078 50 -year -olds
•Separate model buckets for:
oImmunocompromised (IC) –HIV, Cancer, Organ Transplants,
Dialysis
oChronic medical conditions (CMC) –Diabetes, Heart Disease, Lung
Disease, Liver Disease, Alcoholism
oOthers –”General”
5Two Modeling Strategies
❑Moving Strategies
▪Moving age -based recommendation from 65 to age 50
▪Shifts disease burden from younger to older adults
▪Moving strategy will overcount benefits
•Overstates savings from not vaccinating at age 65 years
•Overstates unprotected time if waning is longer than 15 years
•If the future policy considerations will add a later age -based vaccination
after reevaluation in the future
oReevaluations could be motivated by waning evaluation or higher
valency vaccinations
❑Adding Strategies
▪Adding vaccination at 50 in addition to 65
▪In the future, clinicians may prefer to administer a booster dose at age
65 years in the "moving strategy" to ensure protection for older adults
▪Maintains protective benefits for older adults from current age -based
recommendation
6Specific Strategies to Evaluate
❑Moving Strategies
❑Adding Strategies
❑Repeat with PCV21Intervention Comparator
PCV20 at age 50 PCV20 at CMC/IC & PCV20 at age 65
PCV20 at age 60 PCV20 at CMC/IC & PCV20 at age 65
Intervention Comparator
PCV20 at ages 50 & 65 PCV20 at CMC/IC & PCV20 at age 65
PCV20 at ages 60 & 75 PCV20 at CMC/IC & PCV20 at age 65
7Conceptual Model
NBP
Background mortality from non -pneumococcus related illness is included in all branches, but not displayed in the model for brevi ty.
Abbreviations: IPT -inpatient case, OPT -outpatient case, IPD -invasive pneumococcal disease, NBP -non -bacteremic  pneumoniaIPT Case
IPT Case
OPT Case
8Model Inputs
❑IPD rates, all -cause IPT and OPT NBP rates, IPD cases resulting in
fatality were estimated by age - and risk group (general/CMC/IC).
❑Age -group specific IPT NBP case fatality rates were applied to the 3
risk groups
❑Vaccine effectiveness (VE) was estimated by risk group and
outcome (IPD/NBP)
▪VE against serotype 3 was lower than other VT
▪Vaccine serotype effectiveness was the same across PCV20 and PCV21
❑Vaccine coverage was estimated separately by age group (50 –64,
65+) and for existing risk -based recommendations (age 50 -64)
▪Updated from June 2024 presentation with more granular data
See supplemental slides for the specific estimates used in the model.  Additional details are also available in the earlier v ersion
of the model that was presented at ACIP in June 2024 (Stoecker 2024 "Economic Assessment of PCV21 in US Adults")
9Vaccine Price
❑PCV20 $288.66a
❑PCV21 $319.43b
❑Administration 50 -64 years: $30.49c
❑Administration 65+ years:  $21.07d
❑Travel + patient time cost: $44.46e
a Payment Allowance Limits for Medicare Part B for PCV20.
b Applied ratio of PCV21 to PCV20 price from manufacturer model and applied to PCV20 Medicare price. Sensitivity analysis uses upper bound of manufacturer
PCV21 price range.
c Tsai et al. AJPM 2019. Updated to 2023 dollars.
d Average Medicare maximum allowable reimbursement for immunization administration (HCPCS code 90471) across all Medicare Admin istrative Contractors,
2023.
e Travel cost from Maciosek  et al. Am J Prev Med 2006. Updated to 2023 dollars.
10Waning Immunity Assumptions
❑No decline in effectiveness for first five years a
❑Wane to zero over next 10 or 15 years b
aPatterson  S, Webber C, Patton M, Drews  W, Huijts  SM, Bolkenbaas  M, et al. A post hoc assessment of duration of protection in CAPiTA  (Community
Acquired Pneumonia immunization Trial in Adults). Trials in Vaccinology. 2016;5.:92 -96.
b van Werkhoven  CH, Huijts  SM, Bolkenbaas  M, Grobbee  DE, Bonten  MJ. The Impact of Age on the Efficacy of 13 -valent Pneumococcal Conjugate
Vaccine in Elderly. Clin Infect Dis 2015;61(12):1835 -8.00.10.20.30.40.50.60.70.80.91
01234567891011121314151617181920% Initial Effectiveness
Years Since Initial Vaccination
Wane by 15 Wane by 20
11Herd Effects from PCV20 in Children
❑Apply serotype group -specific declines observed in
PCV13 types (+6C, -3, -19F) in adults after PCV13
introduction in children
❑Apply to additional types in PCV20 but not in PCV13
❑Run versions of the model with and without these herd
effects to assess importance
Year Remaining Proportion of Disease
1 0.755161
2 0.496227
3 0.339094
4 0.244074
5 0.187125
6 0.156599
7+ No further declines
Source: Kobayashi et al. Poster presented at: 13th Meeting of the International Society of Pneumonia & Pneumococcal Diseases,  March 2024
12Moving Strategies
1315 Y ear Waning, With Herd Effects
PCV20 PCV20 PCV21 PCV21
50 vs. 65 60 vs. 65 50 vs. 65 60 vs. 65
IPD Cases 44 32 458 464
Hospitalized Pneumonia Cases 871 808 1,925 1,977
Non -hospitalized Pneumonia Cases
722 590 1,498 2,017
Deaths due to IPD 12 9 69 66
Deaths due to Hospitalized Pneumonia 37 35 83 83
QALYs 66 -102 -210 -671
Total Cost (million$) -$76 -$206 -$121 -$218
$ Saved / QALY Lost Cost -Saving 2,023,745 575,614 324,164
Undiscounted Cases 50 -64 -4,031 -3,217 -9,338 -6,265
Undiscounted Cases 65+ 9,681 6,374 22,261 14,735
Undiscounted Deaths 50 -64 -69 -54 -154 -106
Undiscounted Deaths 65+ 203 136 530 356
Note: Undiscounted cases include invasive pneumococcal disease cases as well as non -bacteremic  pneumonia cases (both inpatient and outpatient).
14Adding Strategies
1515 Y ear Waning, With Herd Effects
PCV21 at Age
50 and 65PCV21 at Age
60 and 75PCV20 at Age
50 and 65PCV20 at Age
60 and 75
IPD Cases -932 -941 -434 -354
Hospitalized Pneumonia Cases -1,367 -4,117 -600 -1,868
Non -hospitalized Pneumonia Cases -6,000 -7,233 -2,635 -3,467
Deaths due to IPD -100 -133 -46 -46
Deaths due to Hospitalized Pneumonia -38 -171 -17 -77
QALYs 2,070 1,581 956 741
Life-years
2,633 2,407 1,214 1,092
Costs (million $)
Total Cost $444 $189 $523 $270
Medical Costs -$141 -$177 -$64 -$82
Vaccine Costs $689 $403 $635 $372
Work Loss -$103 -$37 -$48 -$20
Cost Ratios ($)
Cost/QALY 214,430 119,665 546,811 364,497
Cost/Life -year 168,533 78,612 430,913 247,411
Note: All strategies are compared to current recommendations; risk -based use between ages 50 -64 and age -based use at age 65.
1620 Y ear Waning, With Herd Effects
PCV21 at Age
50 and 65PCV21 at Age
60 and 75PCV20 at Age
50 and 65PCV20 at Age
60 and 75
IPD Cases -989 -949 -449 -355
Hospitalized Pneumonia Cases -1,455 -3,595 -618 -1,649
Non -hospitalized Pneumonia Cases -6,386 -7,075 -2,710 -3,389
Deaths due to IPD -106 -153 -48 -51
Deaths due to Hospitalized Pneumonia -40 -155 -17 -70
QALYs 2,144 1,445 967 676
Life-years
2,747 2,199 1,234 992
Costs (million $)
Total Cost $433 $206 $521 $278
Medical Costs -$150 -$162 -$66 -$75
Vaccine Costs $689 $403 $635 $372
Work Loss -$105 -$35 -$48 -$19
Cost Ratios ($)
Cost/QALY 202,019 142,373 539,097 411,202
Cost/Life -year 157,728 93,531 422,657 280,039
1715 Y ear Waning, No Herd Effects
PCV21 at Age
50 and 65PCV21 at Age
60 and 75PCV20 at Age
50 and 65PCV20 at Age
60 and 75
IPD Cases -1,283 -1,275 -795 -704
Hospitalized Pneumonia Cases -1,781 -6,587 -1,115 -5,139
Non -hospitalized Pneumonia Cases -7,819 -10,216 -4,892 -7,346
Deaths due to IPD -137 -184 -84 -100
Deaths due to Hospitalized Pneumonia -49 -281 -31 -223
QALYs 2,778 2,177 1,725 1,480
Life-years
3,541 3,390 2,193 2,310
Costs (million $)
Total Cost $364 $109 $433 $170
Medical Costs -$189 -$253 -$118 -$178
Vaccine Costs $689 $403 $635 $372
Work Loss -$136 -$41 -$84 -$25
Cost Ratios ($)
Cost/QALY 131,028 50,122 251,037 114,909
Cost/Life -year 102,804 32,186 197,417 73,619
18Limitations
❑Uncertainty around waning & herd effects
❑Sequelae from IPD not modeled explicitly
❑Uncertainties about the pneumococcal disease trends due to
pneumococcal serotypes that are no longer included in PCV21
(e.g., serotype 4, 19F)
❑Disruption from changing pneumococcal schedule not modeled
19Moving Strategy Summary
❑Moving age -based vaccination from age 65 to lower ages:
▪All scenarios result in increased net cases
•Lowers cases and deaths in ages 50 -64
•Increases cases and deaths in ages 65+
▪Lower cost
▪Also true under longer vaccine waning scenarios and scenarios without herd
immunity from childhood program (Appendix)
20Adding Strategy Summary
❑Adding a second age -based vaccination results in increased QAL Ys
and costs  compared with the current recommendation
▪ICERs range from $50k/QALY to $500k/QALY
▪ICERs are always lower for PCV21 recommendations than PCV20 recommendations
❑Assuming no herd effects improves economic  efficiency of both
PCV20 & PCV21
▪Change in $/QALY is greater in PCV20 than PCV21
▪But this change is not large enough to make PCV20 more efficient than PCV21
❑Assumptions surrounding vaccine waning are minimally impactful
on ICERs
▪Waning is extended  in both the intervention and comparison strategies
❑Vaccination at later ages is more economically efficient
▪Vaccination at 60 & 75 is lower $/QALY than vaccination at 50 & 65 (or 55 & 70)
21Thank you!
Please send comments to:
cfstoecker@tulane.edu
Contributors:
Andrew Leidner
Miwako Kobayashi
Bo-Hyun Cho
Yin Wang
Cheryl Ward
National Center for Immunization & Respiratory Diseases
HSREB – Econ Team

22Serotype Group18-49
Years50-64
Years65-74
Years75-84
Years85+
Years
% PCV20 only -4-19F
   (1, 5, 6B, 9V, 14, 18C, 23F, 15B, including
isolates reported as 15BC)1.99% 1.52% 3.09% 1.01% 1.08%
% PCV20 & PCV21 -3
(6A, 7F, 19A, 22F, 33F, 8, 10A, 11A, 12F) +6C 34.44% 41.95% 32.72% 32.32% 33.33%
% PCV21 only -35B
   (9N, 17F, 20, 15A, 15C, 16F, 23A, 23B, 24F, 31)30.13% 30.70% 31.48% 29.29% 35.48%
% serotype 3 13.91% 12.46% 17.28% 21.21% 14.25%
% serotype 4 4.97% 2.43% 1.23% 0.00% 0.00%
% serotype 19F 4.97% 4.56% 3.70% 3.03% 3.01%
% serotype 35B 2.65% 0.91% 4.32% 5.05% 3.23%
Ratio PCV21 only:PCV20 only serotypes 2.75 3.71 4.46 8.50 9.46
Source: Active Bacterial Core Surveillance 2018 -2019. For multivariate sensitivity analyses distributions are beta -pert with -/+20% for low and high.IPD Serotype Distributions, General
23Serotype Group18-49
Years50-64
Years65-74
Years75-84
Years85+
Years
% PCV20 only -4-19F
   (1, 5, 6B, 9V, 14, 18C, 23F, 15B, including
isolates reported as 15BC)0.49% 0.71% 1.88% 2.17% 1.81%
% PCV20 & PCV21 -3
(6A, 7F, 19A, 22F, 33F, 8, 10A, 11A, 12F) +6C 36.99% 33.62% 30.36% 32.79% 28.62%
% PCV21 only -35B
   (9N, 17F, 20, 15A, 15C, 16F, 23A, 23B, 24F, 31)30.33% 32.67% 30.83% 32.52% 33.70%
% serotype 3 11.34% 17.96% 21.91% 17.07% 17.39%
% serotype 4 9.99% 4.35% 1.25% 0.27% 0.72%
% serotype 19F 3.08% 2.45% 2.66% 2.44% 2.17%
% serotype 35B 2.59% 3.01% 4.23% 5.15% 6.88%
Ratio PCV21 only:PCV20 only serotypes 2.43 4.75 6.06 7.72 8.63IPD Serotype Distributions, CMC
Source: Active Bacterial Core Surveillance 2018 -2019. For multivariate sensitivity analyses distributions are beta -pert with -/+20% for low and high.
24IPD Serotype Distributions, IC
Serotype Group18-49
Years50-64
Years65-74
Years75-84
Years85+
Years
% PCV20 only -4-19F
   (1, 5, 6B, 9V, 14, 18C, 23F, 15B, including
isolates reported as 15BC)6.02% 3.92% 3.30% 2.88% 0.00%
% PCV20 & PCV21 -3
(6A, 7F, 19A, 22F, 33F, 8, 10A, 11A, 12F) +6C 28.92% 31.63% 30.03% 37.50% 48.31%
% PCV21 only -35B
   (9N, 17F, 20, 15A, 15C, 16F, 23A, 23B, 24F, 31)31.33% 33.73% 33.99% 26.44% 25.84%
% serotype 3 15.66% 8.43% 11.55% 10.10% 4.49%
% serotype 4 1.20% 1.20% 1.32% 0.00% 0.00%
% serotype 19F 3.61% 3.61% 3.30% 1.44% 5.62%
% serotype 35B 6.02% 6.63% 8.91% 9.62% 5.62%
Ratio PCV21 only:PCV20 only serotypes 3.45 4.62 5.42 8.35 5.60
Source: Active Bacterial Core Surveillance 2018 -2019. For multivariate sensitivity analyses distributions are beta -pert with -/+20% for low and high.
25NBP Serotype Distributions
Serotype Group18-49
Years50-64
Years65+
Years
% PCV20 only -4-19F
   (1, 5, 6B, 9V, 14, 18C, 23F, 15B)0.6% 0.7% 1.1%
% PCV20 & PCV21 -3
(6A, 7F, 19A, 22F, 33F, 8, 10A, 11A, 12F) +6C 3.0% 4.5% 3.9%
% PCV21 only -35B
   (9N, 17F, 20, 15A, 15C, 16F, 23A, 23B, 24F, 31)3.2% 4.2% 2.4%
% serotype 3 1.1% 2.0% 1.4%
% serotype 4 0.0% 0.2% 0.2%
% serotype 19F 0.1% 0.9% 0.7%
% serotype 35B 0.8% 0.6% 0.7%
Ratio PCV21 only:PCV20 only serotypes 5.7 2.7 1.6
Source: Merck adjusted SSUAD serotype distribution data.
Note that the serotype distribution is among all community -acquired pneumonia, not limited to pneumococcal pneumonia.
 For multivariate sensitivity analyses distributions are beta -pert with -/+20% for low and high.
26IPD Rates per 100k
Source: Active Bacterial Core Surveillance System, 2017 -2018; NHIS 2017 –2018. For multivariate sensitivity analyses distributio ns are beta -pert with -/+20% for
low and high. Risk Group19-49
Years50-64
Years65-74
Years75-84
Years85+
Years
General 2.09 6.09 8.25 13.90 33.06
CMC 8.09 24.04 25.89 33.34 58.57
IC 16.22 37.28 35.10 36.81 46.38
27NBP Hospitalization Rates per 100k
Source: MarketScan  & Optum databases. 2013 -2015 data. (Pelton et al. CID 2019) (95% CIs in parenthesis)Risk
Group19-49
Years50-64
Years65-74
Years75+
Years
General 35 (35, 36) 88 (87, 90) 191 (185, 197) 957 (938, 975)
CMC 207 (202, 212) 429 (423, 425) 941 (925, 957) 2745 (2717, 2774)
IC 701 (681, 721) 1226 (1207, 1244) 2124 (2087, 2162) 3992 (3944, 4040)
28NBP Outpatient  Rates per 100k
Source: Tong et al. 2014 data. BMC Health Serv Res 2018. For multivariate sensitivity analyses distributions are beta -pert with -/+20% f or low and high.Risk Group19-49
Years50-64
Years65-74
Years75-84
Years85+
Years
General 322.92 385.04 491.98 1366.22 2378.97
CMC 1872.91 1886.72 2410.70 3962.03 6899.00
IC 6361.40 5352.10 5461.00 5738.10 9991.70
29IPD Cases Resulting in Fatality
Source: Active Bacterial Core Surveillance System, 2017 -2018. For multivariate sensitivity analyses distributions are beta -pert with -/+20% for low and high.Risk Group19-49
Years50-64
Years65-74
Years75-84
Years85+
Years
General 5.54% 8.73% 7.93% 11.25% 17.30%
CMC 7.24% 11.06% 12.22% 12.82% 22.97%
IC 10.04% 14.27% 13.97% 11.33% 17.62%
30IPT NBP Cases Resulting in Fatality
Base Low High
18-49 Years 1.6 0.4 2.9
50-64 Years 2.8 1.1 4.4
65-74 Years 3.5 1.5 5.5
75-84 Years 4.1 2.2 6.0
85+ Years 5.3 3.3 7.2
Source: NIS2018 (lower bound: ICD -10 code J13 or J181 for primary diagnosis; upper bound: ICD -10 code J13 or J181 in ANY locatio n; base: mean of LB and UB).
Low and High parameters used in beta -pert distribution
31Vaccine Effectiveness
a. Bonten  NEJM 2015 (per protocol)
b. Point estimate from Pilishvili et al. ISPPD2018 abstract, lower bound set to 0, upper bound from Lewis 2020 ISPPD poster
c. Suaya  Vaccine 2018; 1477 -1483.
d. Applied the ratio of IPD VE/Pneumonia VE for all PCV13 types to the point estimate for ST3 IPD VE.  General CMC IC
PCV vs VT ( -ST3) IPDa 75.0 (41.4, 90.8) 75.0 (41.4, 90.8) 25.0 (13.8, 30.3)
PCV vs ST3 IPDb 26.0 (0, 53.4) 26.0 (0, 53.4) 8.7 (0, 17.8)
PCV vs VT ( -ST3) NBPc 66.7 (11.8, 89.3) 40.3 (11.4, 60.2) 15.0 (4.7, 21.8)
PCV vs ST3 NBPd 15.6 (0, 32.0) 15.6 (0, 32.0) 5.2 (0, 10.7)
32Coverage Rates
June 2024
Inputs Updated
PCV Age -based 50 -64 39.65b 47.6e
PCV Age -based 65+ 56c 70f
Risk -based (50 -64) 22.2a 37.5f
a. NHIS 2021 data https://www.cdc.gov/vaccines/imz -managers/coverage/adultvaxview/pubs -resources/vaccination -coverage -adults -2021.html ;
b. Mean of  NHIS 2021 for Zoster Vaccine in adults 60 -64 years; and estimate for PCV15/PCV20 coverage in adults 65 years and older
c. Mean of NHIS 2021 any pneumococcal coverage; and any PCV13 coverage data in Medicare beneficiaries aged ≥65 years, 2019
e.     Applied the ratio of vaccine coverage among ages 50 -64/65+ for Influenza and COVID -19 vaccines to age -based pneumococcal vaccine coverage in
adults aged 65+years
f.       BRFSS 2022, any pneumococcal vaccine coverage
33Utility Decrements
Variable QAL Y DecrementsaImplied Healthy Days
Lostb
IPD0.0709
(0.0509, 0.0909)25.9
IPT NBP0.0709
(0.0509, 0.0909)25.9
OPT NBP0.0045
(0.00399, 0.00501)1.6
a QALY values from Mangen  et al. 2015 Eur Respir J (95% CIs in parenthesis)
b Health days lost were include on this slide to illustrate in relatable terms the magnitude of health loss associated with QAL Y decrements. Healthy days lost
calculated by multiplying QALY decrement by 365.
c Alternate values are inverse variance weighted values from Tang et al. 2021 J Pub Health. Source material places higher decre ment on outpatient disease
than inpatient disease for age 65+.Pneumococcal Disease
Treatment Intensity, AgeQALY
Decrement
Outpatient, 19 -64 0.0094
Inpatient, 19 -64 0.0396
Outpatient, 65+ 0.0586
Inpatient, 65+ 0.0087Alternate Utility Decrementsc
34Baseline QAL Y Values
Age General CMC/IC
50-55 0.83 (0.78,0.88) 0.72 (0.67,0.77)
56-60 0.81 (0.76,0.86) 0.69 (0.64,0.74)
61-65 0.77 (0.72,0.82) 0.63 (0.58,0.68)
66-70 0.76 (0.71,0.81) 0.57 (0.52,0.62)
71-75 0.74 (0.69,0.79) 0.54 (0.49,0.59)
76-80 0.7 (0.65,0.75) 0.52 (0.47,0.57)
81-85 0.63 (0.58,0.68) 0.51 (0.46,0.56)
86+ 0.51 (0.46,0.56) 0.51 (0.46,0.56)
Sisk, 2003.
35Disease Cost (2023$)
Data for ages 19 -64 from MarketScan  2019 -2022. Data for 65+ from CMS Medicare claims 2019 -2022.  95% CI from bootstrapping mean values with 1,000
iterations. All costs converted to 2023$ using CPI Medical Care before bootstrapping. See appendix slide for ICD -10 codes.Disease Setting Cost 95% CI
19-64 YearsIPD IPT $64,018.10 $61,559.31 $66,424.61
NBP IPT $58,423.99 $55,923.53 $60,908.13
NBP OPT $362.38 $339.44 $385.24
65+ YearsIPD IPT $27,564.22 $27,039.18 $28,149.20
NBP IPT $21,300.64 $20,825.64 $21,800.98
NBP OPT $318.22 $308.06 $328.70
36ICD -10 Codes for Medical Cost Extraction
Disease ICD-10 Codes
IPD A40.3, A40.9+B95.3, A41.9+B95.3, R78.81+B95.3, G00.1, G00.2+B95.3,
G00.9+B95.3, G03.9+B95.3, J86.x+B95.3, J85.1+B95.3, A40.3 + at least one code
from "All -cause", A40.9+B95.3 + at least one code from "All -cause",
A41.9+B95.3 + at least one code from "All -cause", R78.81+B95.3 + at least one
code from "All -cause", A40.9 & J13, A41.9 & J13, R78.81 & J13, M00.1x,
K65.8+B95.3, I30.1+B95.3, I33.0+B95.3, I33.9 +B95.3, K65.2+B95.3,
M86.1x/M86.2x/M86.9+B95.3, M00.0x, M00.2x, M00.8x, M00.9 + B95.3
NBP J13, J15.9+B95.3, J18.0/J18.1+B95.3, J18.8/J18.9+B95.3
All-cause (for
satisfying some
definitions of
IPD)J12.x (J12.0, J12.1, J12.2, J12.3, J12.81, J12.89, J12.9), J13, J18.1, A48.1, J14, J15.0,
J15.1, J15.2x (J15.20, J15.211, J15.212, J15.29), J15.3, J15.4, J15.5, J15.6, J15.8,
J15.9, J15.7, J16.x (J16.0, J16.8), A22.1, A37.X1, B25.0, B44.0, J17, J18.0, J18.2,
J18.8, J18.9, J09.X1, J10.0x (J10.00, J10.01, J10.08), J11.0x (J11.00, J11.08)
37Work Loss
AgeLabor Force
Participation
Rate (%)aMedian Daily
Wage ($)b
19 to 24 71 99.71
25 to 34 83.2 148.86
35 to 44 83 175.57
45 to 54 81.1 176.14
55 to 64 65.2 169.43
65 to 74 26.6 157.29
75+ 8.2 157.29
a US Bureau of Labor Statistics.
b Current Population Survey, 2023.
c Altawalbeh  SM, Wateska  AR, Nowalk  MP, Lin CJ, Harrison LH, Schaffner W, Zimmerman RK, Smith KJ. Societal cost of racial pneumococcal disease disparities in
US adults aged 50 years or older. Applied Health Economics and Health Policy. 2024 Jan;22(1):61 -71.
d Used ratio of days of work loss from outpatient (14) to inpatient pneumonia (18) allowed by Marine Corps policy and applied t o inpatient durations of illness
from Altawalbeh  2024. Vold  Pepper P, Owens DK. Cost -effectiveness of the pneumococcal vaccine in the United States Navy and Marine Corps. Clinical
infectious diseases. 2000 Jan 1;30(1):157 -64.Base High Low
Inpatientc 34 17 51
Outpatientd 26.4 13.2 39.7Labor Force Participation and Daily Wage Duration of Work Loss
3815 Y ear Waning, With Herd Effects (Moving)
PCV20 PCV20 PCV20 PCV21 PCV21 PCV21
50 vs. 65 55 vs. 65 60 vs. 65 50 vs. 65 55 vs. 65 60 vs. 65
IPD Cases 44 34 32 458 459 464
Hospitalized Pneumonia Cases 871 897 808 1,925 2,032 1,977
Non -hospitalized Pneumonia Cases
722 647 590 1,498 1,529 2,017
Deaths due to IPD 12 10 9 69 69 66
Deaths due to Pneumonia 37 39 35 83 88 83
QALYs 66 -9 -102 -210 -419 -671
Total Cost (million$) -$76 -$133 -$206 -$121 -$171 -$218
$ Saved / QALY Lost Cost -Saving 14,014,611 2,023,745 575,614 407,176 324,164
Undiscounted Cases 50 -64 -4,031 -4,269 -3,217 -9,338 -9,579 -6,265
Undiscounted Cases 65+ 9,681 8,757 6,374 22,261 20,177 14,735
Undiscounted Deaths 50 -64 -69 -72 -54 -154 -160 -106
Undiscounted Deaths 65+ 203 184 136 530 482 356
3920 Y ear Waning, With Herd Effects (Moving)
PCV20 PCV20 PCV20 PCV21 PCV21 PCV21
50 vs. 65 55 vs. 65 60 vs. 65 50 vs. 65 55 vs. 65 60 vs. 65
IPD Cases 71 59 65 560 559 571
Hospitalized Pneumonia Cases 1,269 1,299 1,129 2,742 2,890 2,655
Non -hospitalized Pneumonia Cases
1,193 1,131 1,042 2,283 2,479 2,915
Deaths due to IPD 16 14 13 84 83 80
Deaths due to Pneumonia 54 56 48 118 124 111
QALYs -20 -96 -184 -376 -606 -848
Total Cost (million$) -$67 -$121 -$194 -$106 -$145 -$194
$ Saved / QALY Lost 3,325,061 1,252,046 1,056,802 283,008 239,889 228,155
Undiscounted Cases 50 -64 -4,263 -4,095 -2,999 -10,237 -9,311 -5,866
Undiscounted Cases 65+ 12,226 10,605 7,643 27,976 24,322 17,557
Undiscounted Deaths 50 -64 -73 -70 -51 -168 -155 -99
Undiscounted Deaths 65+ 261 228 165 678 594 432
4015 Y ear Waning, No Herd Effects (Moving)
PCV20 PCV20 PCV20 PCV21 PCV21 PCV21
50 vs. 65 55 vs. 65 60 vs. 65 50 vs. 65 55 vs. 65 60 vs. 65
IPD Cases 418 438 482 796 825 881
Hospitalized Pneumonia Cases 3,598 3,747 3,432 3,941 4,134 3,928
Non -hospitalized Pneumonia Cases
5,861 5,917 5,638 5,226 5,327 5,730
Deaths due to IPD 63 64 66 116 118 120
Deaths due to Pneumonia 141 148 135 160 169 158
QALYs -830 -1,038 -1,185 -876 -1,203 -1,537
Total Cost (million$) -$40 -$86 -$136 -$101 -$141 -$165
$ Saved / QALY Lost 48,348 82,895 114,542 114,808 116,909 107,388
Undiscounted Cases 50 -64 -7,694 -8,032 -4,831 -12,353 -12,711 -7,613
Undiscounted Cases 65+ 30,465 27,551 20,002 38,099 34,498 25,117
Undiscounted Deaths 50 -64 -130 -134 -80 -211 -217 -131
Undiscounted Deaths 65+ 586 534 396 847 771 571
4120 Y ear Waning, No Herd Effects (Moving)
PCV20 PCV20 PCV20 PCV21 PCV21 PCV21
50 vs. 65 55 vs. 65 60 vs. 65 50 vs. 65 55 vs. 65 60 vs. 65
IPD Cases 489 514 567 938 974 1,038
Hospitalized Pneumonia Cases 4,845 4,991 4,408 5,391 5,625 5,100
Non -hospitalized Pneumonia Cases
7,221 7,246 6,845 6,659 6,921 7,202
Deaths due to IPD 74 75 77 137 139 140
Deaths due to Pneumonia 194 201 176 222 232 207
QALYs -1,059 -1,280 -1,402 -1,143 -1,508 -1,819
Total Cost (million$) -$18 -$54 -$107 -$77 -$100 -$128
$ Saved / QALY Lost 16,782 42,282 76,328 67,272 66,407 70,122
Undiscounted Cases 50 -64 -8,627 -7,815 -4,503 -13,830 -12,398 -7,117
Undiscounted Cases 65+ 38,671 33,563 24,125 48,108 41,795 30,100
Undiscounted Deaths 50 -64 -146 -131 -75 -236 -212 -122
Undiscounted Deaths 65+ 770 677 493 1,096 962 700
4215 Y ear Waning, With Herd Effects (Adding)
PCV21 at Age
50 and 65PCV21 at Age
55 and 70PCV21 at Age
60 and 75PCV20 at Age
50 and 65PCV20 at Age
55 and 70PCV20 at Age
60 and 75
IPD Cases -932 -930 -941 -434 -402 -354
Hospitalized Pneumonia Cases -1,367 -2,584 -4,117 -600 -1,141 -1,868
Non -hospitalized Pneumonia Cases -6,000 -6,699 -7,233 -2,635 -2,990 -3,467
Deaths due to IPD -100 -104 -133 -46 -44 -46
Deaths due to Pneumonia -38 -93 -171 -17 -41 -77
QALYs 2,070 1,768 1,581 956 829 741
Life-years
2,633 2,420 2,407 1,214 1,116 1,092
Costs (million $)
Total Cost $444 $330 $189 $523 $416 $270
Medical Costs -$141 -$171 -$177 -$64 -$77 -$82
Vaccine Costs $689 $570 $403 $635 $526 $372
Work Loss -$103 -$69 -$37 -$48 -$33 -$20
Cost Ratios ($)
Cost/QALY 214,430 186,838 119,665 546,811 501,851 364,497
Cost/Life -year 168,533 136,496 78,612 430,913 372,691 247,411
4320 Y ear Waning, With Herd Effects (Adding)
PCV21 at Age
50 and 65PCV21 at Age
55 and 70PCV21 at Age
60 and 75PCV20 at Age
50 and 65PCV20 at Age
55 and 70PCV20 at Age
60 and 75
IPD Cases -989 -995 -949 -449 -419 -355
Hospitalized Pneumonia Cases -1,455 -2,522 -3,595 -618 -1,115 -1,649
Non -hospitalized Pneumonia Cases -6,386 -6,966 -7,075 -2,710 -3,083 -3,389
Deaths due to IPD -106 -123 -153 -48 -49 -51
Deaths due to Pneumonia -40 -93 -155 -17 -41 -70
QALYs 2,144 1,798 1,445 967 827 676
Life-years
2,747 2,480 2,199 1,234 1,120 992
Costs (million $)
Total Cost $433 $333 $206 $521 $418 $278
Medical Costs -$150 -$169 -$162 -$66 -$75 -$75
Vaccine Costs $689 $570 $403 $635 $526 $372
Work Loss -$105 -$69 -$35 -$48 -$33 -$19
Cost Ratios ($)
Cost/QALY 202,019 184,959 142,373 539,097 505,534 411,202
Cost/Life -year 157,728 134,122 93,531 422,657 373,616 280,039
4415 Y ear Waning, No Herd Effects (Adding)
PCV21 at Age
50 and 65PCV21 at Age
55 and 70PCV21 at Age
60 and 75PCV20 at Age
50 and 65PCV20 at Age
55 and 70PCV20 at Age
60 and 75
IPD Cases -1,283 -1,284 -1,275 -795 -765 -704
Hospitalized Pneumonia Cases -1,781 -3,846 -6,587 -1,115 -2,776 -5,139
Non -hospitalized Pneumonia Cases -7,819 -8,896 -10,216 -4,892 -5,715 -7,346
Deaths due to IPD -137 -145 -184 -84 -85 -100
Deaths due to Pneumonia -49 -143 -281 -31 -106 -223
QALYs 2,778 2,357 2,177 1,725 1,490 1,480
Life-years
3,541 3,285 3,390 2,193 2,096 2,310
Costs (million $)
Total Cost $364 $247 $109 $433 $318 $170
Medical Costs -$189 -$237 -$253 -$118 -$155 -$178
Vaccine Costs $689 $570 $403 $635 $526 $372
Work Loss -$136 -$86 -$41 -$84 -$52 -$25
Cost Ratios ($)
Cost/QALY 131,028 104,656 50,122 251,037 213,705 114,909
Cost/Life -year 102,804 75,085 32,186 197,417 151,924 73,619
4520 Y ear Waning, No Herd Effects (Adding)
PCV21 at Age
50 and 65PCV21 at Age
55 and 70PCV21 at Age
60 and 75PCV20 at Age
50 and 65PCV20 at Age
55 and 70PCV20 at Age
60 and 75
IPD Cases -1,389 -1,382 -1,278 -860 -818 -699
Hospitalized Pneumonia Cases -1,931 -3,780 -5,748 -1,209 -2,749 -4,499
Non -hospitalized Pneumonia Cases -8,476 -9,491 -10,120 -5,305 -6,258 -7,363
Deaths due to IPD -148 -173 -212 -91 -100 -113
Deaths due to Pneumonia -53 -145 -256 -33 -109 -204
QALYs 2,928 2,422 1,958 1,817 1,526 1,305
Life-years
3,761 3,394 3,046 2,328 2,150 2,028
Costs (million $)
Total Cost $344 $247 $133 $421 $319 $188
Medical Costs -$205 -$235 -$230 -$127 -$154 -$161
Vaccine Costs $689 $570 $403 $635 $526 $372
Work Loss -$140 -$87 -$39 -$87 -$53 -$23
Cost Ratios ($)
Cost/QALY 117,514 102,083 68,174 231,438 208,701 144,205
Cost/Life -year 91,491 72,848 43,822 180,616 148,188 92,771

Summary: 1Economic Analysis and Public Health Impact of PCV  use for Adults Aged ≥50 Years Charles Stoecker Tulane University Celia Scott Weatherhead School of Public Health and Tropical  Medicine ACIP October 23, 2024  2Conflicts of Interest ❑Dr. Stoecker has no conflicts of interest to declare. 3Acronyms ❑ PCV: pneumococcal conjugate vaccine ❑ PCV20: 20 valent PCV ❑ PCV21: 21 valent PCV ❑ VE: vaccine effectiveness ❑ VT: vaccine type ❑ ST: serotype ❑ NBP: non -bacteremic pneumonia ❑ IPD: invasive…


03 Leidner Pneumococcal 508

Summary of three economic analyses on the use of
PCVs among 50-64 year old  adults in the United States
Andrew J. Leidner, Sofia Bletnitsky
Applied Research, Implementation Science and Evaluation (ARISE) Branch
Immunization Services Division (ISD)
NCIRD
ACIP Meeting
October 23, 2024NCIRD/ISD/ARISE
Disclaimer: Views and opinions expressed in this presentation are the authors and do not necessarily represent the views and opinions of the
Centers for Disease Control and Prevention .1
•This presentation summarizes work conducted by three modeling teams
-Tulane -CDC team
•Charles Stoecker (Tulane University), Yin Wang (Tulane University), Miwako Kobayashi (CDC), Andrew
Leidner (CDC), Bo -Hyun Cho (CDC), Cheryl Ward (CDC)
-Merck team
•Kwame Owusu -Edusei , Zinan  Yi , Muloongo  Simuzingili , Elamin  Elbasha , Elmira Flem , Thomas Weiss,
Heather Platt, Kristen Feemster, Kelly Johnson, Ulrike Bushwald , Craig Roberts, Don Yin
-Pfizer team
•Ahuva  Averin , Jeffrey Vietri, Mark Atwood, Dhwani Hariharan, Mark Rozenbaum, Alejandro Cane, Paul
Balmer, Jelena Vojicic , Paula Peyrani , Ray FarkouhAcknowledgements
2Disclaimer: Views and opinions expressed in this presentation are the authors and do not necessarily represent the views and opinions of the
Centers for Disease Control and Prevention.
•Andrew Leidner, Sofia Bletnitsky: None
•Tulane -CDC team: None
•Merck team:
-Merck manufactures the PCV21, PCV15 and PPSV23 vaccines
•Pfizer team:
-Pfizer manufactures the PCV20 and PCV13 vaccinesConflicts of interest statement
3
Terminology
4Abbreviation Full term/Meaning
CER Cost -effectiveness ratio
CFR Case -fatality rate
CMC Chronic medical conditions but not immunocompromised
CR Current recommendations ( Risk-based use of PCV at ages 50 -64 and age -based use of PCV at age 65 )
IC Immunocompromising conditions
ICER Incremental cost -effectiveness ratio
IPD Invasive pneumococcal disease
NBP Non -bacteremic  pneumonia
PCV15 15-valent pneumococcal conjugate vaccine
PCV20 20-valent pneumococcal conjugate vaccine
PCV21 21-valent pneumococcal conjugate vaccine
QALYs Quality -adjusted life years
SA Sensitivity analyses
•Background on cost -effectiveness analysis
•Model overview
•Main results
•Sensitivity analyses
•Discussion of other models
•Limitations
•SummaryOutline
5
•Cost -effectiveness analyses compare the costs and outcomes of two or more strategies by
estimating an incremental cost -effectiveness ratio (ICER)
-An ICER is an estimated cost per unit of health outcome gained
•Outcomes: averted cases, averted hospitalizations, quality -adjusted life years (QALYs)
•Cost per QALY gained  ($/QALY)
-ICERs always compare 2 potential strategies
•Strategies are referred to as the “intervention” and “comparator”
•E.g., vaccination vs. no vaccination, vaccine schedule A vs. vaccine schedule B, new
vaccination vs. status quoWhat is cost -effectiveness analysis (CEA)?
6CostsPCV@50 -64 – CostsCR         Change in costs
   =                         = $/Outcome
OutcomesPCV@50 -64 – OutcomesCR                Change in outcomes
ICER= Incremental cost -effectiveness ratio; CR= Current recommendations
What is cost -effectiveness analysis (CEA)?
7  CostsPCV@50 -64 – CostsCR              Change in costs
                          =                            =
$/Outcome
 OutcomesPCV@50 -64 – OutcomesCR     Change in outcomes
Economic model inputs
  Vaccine characteristics
     Efficacy
     Safety
     Cost per dose
          …
  Disease burden inputs
     Incidence rates
     Health care costs
     Mortality rates
          …Economic model estimated  outputs
   Costs
      Vaccination program costs
      Disease -related costs
   Health outcomes
      Prevented episodes of disease
      QALYs gainedEconomic
model
CR= Current recommendations
Interpreting an incremental cost -effectiveness ratio
(ICER)  Change in costs
                          = $/Outcome
  Change in outcomes
DominatedHigher costs &
higher health
Lower costs &
lower healthCost -savingBetter health outcomes
(Change in outcomes > 0)Worse health outcomes
(Change in outcomes < 0)Higher costs
(Change in costs > 0)
Lower costs
(Change in costs < 0)
CR
8CR= Current recommendations
Interpreting an incremental cost -effectiveness ratio
(ICER)  Change in costs
                          = $/Outcome
  Change in outcomes
DominatedHigher costs &
higher health
Lower costs &
lower healthCost -savingBetter health outcomes
(Change in outcomes > 0)Worse health outcomes
(Change in outcomes < 0)Higher costs
(Change in costs > 0)
Lower costs
(Change in costs < 0)
CR
9 CR= Current recommendations$1,000,000
                            = $125,000/QALY
    8 QALYs
$500,000
                              = $62,500/QALY
    8 QALYs
Estimate BEstimate A
•Should a single dose of pneumococcal conjugate vaccine (PCV) be
recommended for all PCV -naïve adults aged 50 –64 years?Policy question
10
•Comparator (current recommendations): Risk-based vaccination with PCV at ages
50-64 years and age -based vaccination with PCV at age 65 yearsa
•Intervention (younger age -based vaccination): Age-based vaccination with PCV at
age 50 years“Moving” comparisons in the models
Alternate comparisons
11CMC = chronic medical conditions; IC = immunocompromised; PCV =  pneumococcal conjugate vaccine.
a.In the main results, all three models include some form of vaccination at age 65, but the coverage rates at age 65 varied across  models and vary within specific scenarios. Some scenarios presented later did not include age -based
vaccination at 65.
b.This table shows coverage assumptions from the Tulane -CDC model. The other models have different vaccination coverage rate assumptio ns, and the coverage rate assumptions can vary across different scenarios within each of the
models. Age group Risk groupPCV coverage by strategybModeled impact
of policy change Comparator Intervention
50-64CMC/IC 38% 48%PCV use
increases by 10%
General 0% 48%PCV use
increases by 48%
65+ General and CMC/IC 70% 0%PCV use
decreases by 70%
•Comparator (current recommendations): Risk-based vaccination with PCV at ages
50-64 years and age -based vaccination with PCV at age 65 yearsa
•Intervention (younger age -based vaccination): Age-based vaccination with PCV at
age 50 years and age 65 yearsa“Adding” comparisons in the models
Main comparisons
12CMC = chronic medical conditions; IC = immunocompromised; PCV =  pneumococcal conjugate vaccine.
a.In the main results, all three models include some form of vaccination at age 65, but the coverage rates at age 65 varied across  models and vary within specific scenarios. Some scenarios presented later did not include age -based
vaccination at 65.
b.This table shows coverage assumptions from the Tulane -CDC model. The other models have different vaccination coverage rate assumptio ns, and the coverage rate assumptions can vary across different scenarios within each of the
models. Age group Risk groupPCV coverage by strategybModeled impact
of policy change Comparator Intervention
50-64CMC/IC 38% 48%PCV use
increases by 10%
General 0% 48%PCV use
increases by 48%
65+ General and CMC/IC 70% 70%No change
in PCV use
•Comparator (current recommendations): Risk-based vaccination with PCV at ages
50-64 years and age -based vaccination with PCV at age 65 yearsa
•Intervention (younger age -based vaccination): Age-based vaccination with PCV at
age 50 years and age 65 yearsa
-These comparisons can more directly estimate the impacts of expanding coverage among
50-64 year olds
-Older adult groups (i.e., 65+) would receive some protection from disease during a time
in life with high incidence, disease severity, and costs due to pneumococcal disease
•Some vaccine -naïve individuals may not receive a PCV until age 65, even with an age -
based recommendation at age 50+
•Vaccine duration of protection assumed to last 10 -20 years; there is limited available data
on duration of protection after 5 years
•In the future, new vaccines may be available for adults who have received PCV“Adding” comparisons in the models
Main comparisons
13a. In the main results, all three models include some form of vaccination at age 65, but the coverage rates at age 65 varied acr oss models and vary within specific scenarios. Some scenarios presented later did not include age -based
vaccination at 65.
Model overview
14Model characteristics Tulane -CDC Merck Pfizer
Cohort type Single cohortMulti -cohort
(Single -cohort in SA)Multi -cohort
(Single -cohort in SA)
Analytic model time frame Lifetime Lifetime Lifetime
Base case perspective Limited societalaSocietalSocietal
(Healthcare in SA)
Currency year 2023 $ US 2023 $ US 2023 $ US
Vaccine cost per doseb PCV20: $289
PCV21: $319PCV20: $261
PCV21: $287PCV20: $262
Other vaccine -associated costs per
doseAdmin: $30 (50 -64); $21 (65+)
Travel: $44Admin: $31 (50 -64); $25 (65+)
Travel: $45Admin: $31
Vaccine coverage change in the
intervention among 50 -64 year oldsGeneral: +48%
CMC/IC: +10%General: +39%
CMC/IC: 0% (+8% in SA )General: +21%
CMC/IC: +15 to 17%
(+20 to +32% in SA)
Serotype coverage ratio:
PCV21:PCV20c3.7 to 9.5
(vaccine -unique types)4.3 to 6.3
(vaccine -unique types)NA
SA=sensitivity analyses; CMC/IC= chronic medical conditions/immunocompromised.
a. The limited societal perspective does not include non -market production as part of productivity losses.
b. Private sector list prices were $262 for PCV20  and $288 for PCV21 on October 1, 2024. The Tulane -CDC model cost per dose inclu des an additional cost of reimbursement from health system payers, which is typically higher than
the list price.
c. This is the ratio of PCV21 -only type IPD disease to PCV20 -only type IPD disease among 50+ year olds, the ranges come from diffe rent age stratifications used in the models.
Model overview, cont.
15Model characteristics Tulane -CDC Merck Pfizer
Years until PCV protection wanes to 0%15 yearsa
(20 years in SA)15 yearsa
(20 years, varied waning
rates in SA)16 yearsa
VE vs IPD in year 15, general population 0% (30% in SA) 0% (75% in SA) 36%
VE vs NBP based on all -cause pneumonia in alternative
VE approachNo No Yes
Include indirect effectsb Yes
(None in SA)Yes
(Higher and none in SA)Yes
(Reduced in SA)
Indirect effects magnitude (PCV20 non -PCV13 types),
when included81% reduction
by year 533% reduction by year 4
(64% by year 5 in SA)70% reduction
by year 5
Include long -term post -IPD sequalae (e.g., disability) No Yes No
Include age -adjusted and risk -stratified incidence Yes Yes Yes
Productivity loss for disease -related deaths at age 60c$331,732 $684,301 $330,654 to $333,623
SA=sensitivity analyses; VE= vaccine effectiveness; IPD= invasive pneumococcal disease; NBP= non -bacteremic  pneumonia;
a.The duration of protection assumptions were similar in the base case of Tulane -CDC and Merck, constant VE for the first 5 years fol lowed by a linear decline to VE=0 at year 15. The Pfizer model assumed a slower decline in VE from
years 5 to 15, resulting in about 30% more vaccine protection than the Tulane -CDC and Merck models.
b. In these models, indirect effects refer to the reduced pneumococcal disease among adults from the use of PCVs in pediatric po pulations.
c. Productivity losses for a death at age 60 for each model were calculated by the economics review team. These include lost pro ductivity due to a premature death at age 60, assuming average life expectancy of 80 years, with total
losses discounted to present values.
Main results
Cost -effectiveness estimates ($/QALY)
16Intervention ComparatorICER ($/QALY)
Tulane -CDCa Merck Pfizerd
Age-based vaccination
at 50 and 65 with PCV21Current recommendations
with PCV21131,023 to
214,430251,048 to
425,455b NA
Age-based vaccination
at 50 and 65 with PCV20Current recommendations
with PCV20251,037 to
546,811548,114 to
879,117c56,376* to
133,524
Current recommendations= Age-based vaccination at 65 and risk -based vaccination at 50 -64; ICER= incremental cost -effectiveness ratio; QALY= quality -adjus ted life year.
a.Ranges  are from different assumptions about indirect effects from PCV20 use in children. The lower value assumes no indirect effects , the higher value assumes base case inputs for indirect effects.
b.The results are single -cohort estimates and the range is from scenarios that use different assumptions about vaccination coverage a nd indirect effects. The lower value assumes no indirect effects and CMC/IC individuals aged 50
experience an increase in vaccination coverage due to the age -based recommendation at age 50; higher value assumes higher indire ct effects and that CMC/IC individuals are not affected by the age -based recommendation at age 50.
c.The results are single -cohort estimates and the range is from scenarios that include different population groups. The lower values do not include indirect effects, the higher values have higher indirect effects. These scenarios did not
include increase vaccination coverage among CMC/IC individuals aged 50 -64.
d.The range in the Pfizer estimates is from scenarios that use different assumptions about vaccine effectiveness and indirect effec ts. The lower value is based on vaccine effectiveness estimates from studies with all -cause pneumonia
as the primary outcome and assumes higher indirect effects from PCV15 -non-PCV13 type disease; the higher value is based on estim ates that rely on quantifying the amount of circulating vaccine -type disease with base case indirect
effect assumptions.
* The Pfizer model did not include vaccination at age 65+ in either the intervention or the comparator for this scenario.•Tulane -CDC model ICERs for PCV20 and PCV21 were lower than Merck, higher than Pfizer
•In the models that assessed both PCV20 and PCV21, PCV21 use had lower ICERs
Scenario results: Higher VE and duration of protection
Cost -effectiveness estimates ($/QALY)
17Intervention ComparatorICER ($/QALY)
Tulane -CDCa Merckb Pfizerc
Age-based vaccination
at 50 and 65 with PCV21Current recommendations
with PCV21117,514 to
202,019146,089 NA
Age-based vaccination
at 50 and 65 with PCV20Current recommendations
with PCV20231,438 to
422,657342,26362,264 to
99,632
Current recommendations= Age-based vaccination at 65 and risk -based vaccination at 50 -64. ICER= incremental cost -effectiveness ratio; QALY= quality -adjus ted life year.
a.In this scenario in the Tulane -CDC model, the duration of protection waned to 0% at year 20. The ranges are from different assumpt ions about indirect effects from PCV20 use in children. The lower value assumes no indirect effects,
the higher value assumes base case inputs for indirect effects.
b.In this scenario in the Merck model, the duration of protection scenario assumed initial VE was constant (no waning) for 20 year s and declined to 0% VE at year 21. The results in this table are from single -cohort estimates.
c.In this scenario in the Pfizer model, the VE against NBP was set to the high value in the input range, VE against IPD and durati on of protection remained at base case levels.•Scenarios with higher VE and longer duration of protection (longer than 15 years) had lower
ICERs
Scenario results: Reduced or no indirect effectsa
Cost -effectiveness estimates ($/QALY)
18Intervention ComparatorICER ($/QALY)
Tulane -CDC Merck Pfizerb
Age-based vaccination
at 50 and 65 with PCV21Current recommendations
with PCV21131,028251,048 to
306,396cNA
Age-based vaccination
at 50 and 65 with PCV20Current recommendations
with PCV20251,037 548,11456,376 to
93,127*
Current recommendations= Age-based vaccination at 65 and risk -based vaccination at 50 -64. ICER= incremental cost -effectiveness ratio; QALY= quality -adjus ted life year.
a. In these models, indirect effects refer to the reduced pneumococcal disease among adults from the use of PCV20 in pediatric p opulations.
b. The range in the Pfizer estimates is from scenarios that use different assumptions about vaccine effectiveness. The lower val ue is based on vaccine effectiveness estimates from studies with all -cause pneumonia as the primary
outcome, the higher value is based on estimates that rely on quantifying the amount of circulating vaccine -type disease.
c.These  results are single -cohort estimates and the range is from scenarios that use different assumptions about vaccination coverage. The lower value assumes CMC/IC individuals aged 50 experience an increase in vaccination
coverage due to the age -based recommendation at age 50, the higher value assumes CMC/IC individuals are not affected by the age -based recommendation at age 50.
* The Pfizer model did not include vaccination at age 65+ in either the intervention or the comparator for these scenarios.•Scenarios with reduced or lower indirect effects from pediatric PCV20 use yielded lower
ICERs, particularly for PCV20 strategies
•Merck health equity model
-The Merck model team submitted a separate report that estimated the impact of 50 -64
year old PCV use on health equity
-This report used the Atkinson indexa to quantify the inequality with and without 50 -64
year old PCV vaccination
-Health inequality was found to be reduced with a lower age -based recommendation
•Pittsburgh modelb
-Summarized in the June 2024 ACIP meetingc
-Estimated health equity benefits were associated with 50 -64 year old PCV vaccination
-Estimated lower ICERs than the other models presented todayDiscussion, other models
19a. Yang et al. 2020. Impact of Socioeconomic Differences on Distributional Cost -effectiveness Analysis . Atkinson 1970.  On the measurement of inequality .
b. Altawalbeh  et al. 2024. Cost-effectiveness of an in -development adult -formulated 21 -valent pneumococcal conjugate vaccine in US adults aged 50 years or older .
c. Leidner et al. 2024. Summary of three economic analyses on the use of 21 -valent pneumococcal conjugate vaccine (PCV21) among adults in the United Sta tes.
•Substantial uncertainty and limited data available for several key model inputs
-Vaccine effectiveness and duration of protection
-Indirect effects from pediatric PCV20 use
-Vaccination coverage impacts in a younger age -based recommendation policy
•Additional uncertainties about several model assumptions
-Future epidemiology of pneumococcal serotypes that are not included in PCV21 (e.g., serotype 4, 19F)
-Impact of supplemental doses with PCVs and new higher -valency vaccines
•Impacts on vaccination implementation due to changing the pneumococcal vaccine schedule
were not includedLimitations
20
Summary of model findings ($/QALY)
21•From the “adding” comparisons, all strategies improved health, but none were cost -saving
•Cost per QALY gained estimates for PCV20 had a wider range, more uncertainty than PCV21
•In two of three models, PCV21 had lower costs per QALY gained than PCV20
Current recommendations= Age-based vaccination at 65 and risk -based vaccination at 50 -64; QALY= quality adjusted life year.0 100,000 200,000 300,000 400,000 500,000 600,000 700,000 800,000 900,000 1,000,000
Incermental cost -effectiveness ratio (ICER) ($/QALY)Cost -effectiveness estimates for PCV21 and PCV20 vaccination
at age 50 and 65 years vs. current recommendations
PCV21
PCV21PCV20
PCV20
PCV20Tulane -CDC
model
Merck
model
Pfizer
model
For more information, contact CDC
1-800-CDC-INFO (232 -4636)
TTY:  1 -888-232-6348    www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position
of the Centers for Disease Control and Prevention.
Thank you for your attention and thank you to those that contributed to this presentation
22Tulane -CDC team
Charles Stoecker (Tulane University)
Yin Wang (Tulane University)
Miwako Kobayashi (CDC)
Andrew Leidner (CDC)
Bo-Hyun Cho (CDC)
Cheryl Ward (CDC)Merck team
Kwame Owusu -Edusei
Zinan  Yi
Elamin  Elbasha
Elmira Flem
Thomas Weiss
Heather Platt
Kristen Feemster
Kelly Johnson
Ulrike Bushwald
Craig Roberts
Don YinPfizer team
Ahuva  Averin
Jeffrey Vietri
Mark Atwood
Dhwani Hariharan
Mark Rozenbaum
Alejandro Cane
Paul Balmer
Jelena Vojicic
Paula Peyrani
Ray FarkouhACIP economics review team
Fangjun Zhou
Bo-Hyun Cho
Jamie Pike
Reni Kaul
Xiaoyu Dong
Sofia Bletnitsky
Andrew Leidner
Tursynbek Nurmagambetov
1. Altawalbeh  SM, Wateska AR, Nowalk  MP, Lin CJ, Harrison LH, Schaffner W, Zimmerman RK, Smith KJ. 2024. Cost -effectiveness of
an in -development adult -formulated 21 -valent pneumococcal conjugate vaccine in US adults aged 50 years or older. Vaccine . Apr
30;42(12):3024 -32.
2. Atkinson AB. 1970.  On the measurement of inequality. Journal of Economic Theory . Sep 2;2(3):244 -63.
3. Leidner AJ. 2024. Summary of three economic analyses on the use of 21 -valent pneumococcal conjugate vaccine (PCV21) among
adults in the United States. Meeting of the Advisory Committee on Immunization Practices (ACIP),  June 26 -28, 2024.
4. Yang F, Angus C, Duarte A, Gillespie D, Walker S, Griffin S. 2020. Impact of socioeconomic differences on distributional cost -
effectiveness analysis. Medical Decision Making . Jul;40(5):606 -18.References
23

Summary: Summary of three economic analyses on the use of  PCVs among 50-64 year old  adults in the United States Andrew J. Leidner, Sofia Bletnitsky Applied Research, Implementation Science and Evaluation (ARISE) Branch Immunization Services Division (ISD) NCIRD ACIP Meeting October 23, 2024NCIRD/ISD/ARISE Disclaimer: Views and opinions expressed in this presentation are the authors and do not necessarily represent the views and opinions of the  Centers for Disease Control and Prevention .1 •This…


04 Kobayashi Pneumococcal 508

Summary of Work Group Interpretation of EtR and
Policy Options
PCV Use in Adults aged ≥50 years
October 23, 2024
Miwako Kobayashi, MD, MPHNational Center for Immunization and Respiratory Diseases
1
PICO for WG discussion through October 2024
CMC=chronic medical conditions (i.e., alcoholism; chronic heart disease, including congestive heart failure and cardiomyopath ies; chronic liver disease; chronic lung disease, including
chronic obstructive pulmonary disease, emphysema, and asthma; cigarette smoking; or diabetes mellitus); IC=immunocompromising  condition(i.e., chronic renal failure, nephrotic
syndrome, immunodeficiency, iatrogenic immunosuppression, generalized malignancy, HIV infection, Hodgkin disease, leukemia, l ymp homa, multiple myeloma, solid organ transplant,
congenital or acquired asplenia, or sickle cell disease or other hemoglobinopathies). Those with a cerebrospinal fluid leak a nd a cochlear implant are also included among those with a
risk-based vaccine indication. Policy 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 PCV15*, PCV20, or PCV21
*In series with PPSV23
Comparison Current risk -based vaccine recommendation (CMC or IC)
Outcomes Vaccine type (VT) -IPD, VT -non-bacteremic  pneumococcal pneumonia, VT -
pneumococcal mortality, serious adverse events
Evidence to Recommendations ( EtR) framework
3EtR Domain Question
Public Health Problem • Is the problem of public health importance?
Equity • What would be the impact of the intervention on health equity?
Benefits and Harms • How substantial are the desirable anticipated effects?
• How substantial are the undesirable anticipated effects?
• Do the desirable effects outweigh the undesirable effects?
• What is the overall certainty of this evidence for the critical outcomes?
Values • Does the target population feel the desirable effects are large relative to the
undesirable effects?
• Is there important variability in how patients value the outcomes?
Acceptability • Is the intervention acceptable to key stakeholders?
Resource Use • Is the intervention a reasonable and efficient allocation of resources?
Feasibility • Is the intervention feasible to implement?
Public Health Problem
Is pneumococcal disease of public health importance for adults aged 50 –64 years?
4
051015202530354045
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022Cases per 100,000 population
YearAge <5 Age ≥65Invasive pneumococcal disease (IPD) incidence rates, by age
group, 2007 –2022
Source: CDC’s Active Bacterial Core surveillancePCV13:
children
5 Adapted from Gierke Feb 2024 ACIP meeting presentationPost -COVID
051015202530354045
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022Cases per 100,000 population
YearAge <5 Age 50-64 Age ≥65Invasive pneumococcal disease (IPD) incidence rates, by age
group, 2007 –2022
Source: CDC’s Active Bacterial Core surveillancePCV13:
children
6 Adapted from Gierke Feb 2024 ACIP meeting presentationPost -COVID
051015202530354045
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022Cases per 100,000 population
YearAge <5 Age ≥65Invasive pneumococcal disease (IPD) incidence rates, by age
group, 2007 –2022
SCDM: shared clinical decision -making
Source: CDC’s Active Bacterial Core surveillancePCV13: adults
65+PCV13:
children
7PCV13: adults 65+
based on SCDM
Adapted from Gierke Feb 2024 ACIP meeting presentationPost -COVID
IPD mortality rate* in adults  aged ≥65 years has
become closer to that in adults aged 50 –64 years
ABCs Bact  Facts Interactive Data Dashboard | ABCs | CDC . *deaths from IPD per 100,000 population 8

Adults aged 50 –64 years at increased risk of
pneumococcal disease
•Among adults aged 50 –64 years with pneumococcal disease (IPD1,
hospitalized pneumococcal pneumonia2), a high proportion (88%) of adults
had ≥1 condition with a risk -based pneumococcal vaccine indication (risk
condition)
1. CDC ABCs 2018 –2021 data
2. Self et al. PNEUMO study unpublished data 9
Is pneumococcal disease of public health importance?
•Success of pediatric PCV program
increased the relative burden of
pneumococcal disease in adults aged 50 –
64 years, especially in those with risk
conditions*.
•Additional Work Group comment:
-Should consider the absolute rate of disease
(rather than relative burden compared with
other age groups). IPD rates have come
down significantly compared with pre -PCV
era rates.
*Adults with certain underlying medical conditions or other risk factors 10□ No
□ Probably no
□ Probably yes
□ Yes
□ Varies
□ Don’t know
Equity
What would be the impact of recommending PCV for all PCV -naïve adults
aged 50 –64 years on health equity?
11
About 32–54% of adults aged 50 –64 years have underlying
conditions with risk -based pneumococcal vaccine indication*
Source: NHIS 2020 data
*chronic heart disease, chronic lung disease, chronic liver disease, diabetes, smoking, alcoholism, weakened immune system du e 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 120%10%20%30%40%50%60%70%80%90%100%
Age 50-64 years Age 65+ yearsHispanic
White, non-Hispanic
Black, non-Hispanic
Asian, non-Hispanic
Disparities in pneumococcal vaccine coverage by race/ethnicity exist
for both age -based and risk -based indications
Source: BRFSS 2022; AI/AN=American Indian and Alaska Native 130102030405060708090100
50-64 years, risk-based 65+ yearsPercentHispanic
White, non-Hispanic
Black, non-Hispanic
Asian, non-Hispanic
AI/AN, non-Hispanic
05101520253035
40-44 45-49 50-54 55-59 60-64 65+ 40-44 45-49 50-54 55-59 60-64 65+
Black Black Black Black Black Black Non
BlackNon
BlackNon
BlackNon
BlackNon
BlackNon
BlackIPD rates (any pneumococcal serotype) in Black adults peak
at a younger age compared with Non -Black adults
ABCs 2018 –2019 unpublished data 14IPD rate for adults aged ≥65 years across all
race/ethnicity (24/100,000)
Impact of hypothetical PCV20/PCV21 vaccination scenarios on
non-PCV13 -type IPD rates in adults aged ≥19 years
CDC ABCs 2014 –2019 unpublished data. 15
2 3
Vaccination Scenarios•For simplicity, assumes vaccine
protects against 100% of vaccine -
type disease
•Vaccine coverage is applied to
adults who developed non -
PCV13 -type IPD in 2014 –2019 (American Indian and Alaska Native)

Impact of hypothetical PCV20/PCV21 vaccination scenarios on
non-PCV13 -type IPD rates in adults aged ≥19 years
CDC ABCs 2014 –2019 unpublished data. 16
2 3
Vaccination Scenarios(American Indian and Alaska Native)
Vaccination Scenarios:
1.Current risk -based (19 –64 years)
and age -based (≥65 years)
recommendations with observed
vaccine coverage by race
• For simplicity, assumes vaccine protects
against 100% of vaccine -type disease
• Vaccine coverage is applied to adults who
developed non -PCV13 -type IPD in 2014 –2019 1 1Population
average
Impact of hypothetical PCV20/PCV21 vaccination scenarios on
non-PCV13 -type IPD rates in adults aged ≥19 years
CDC ABCs 2014 –2019 unpublished data. 17
2 3
Vaccination Scenarios(American Indian and Alaska Native)
1 1Vaccination Scenarios:
1.Current risk -based and age -based
recs with observed vaccine
coverage by race
2.Lower age -based recs to ≥50 years
using current coverage for adults
aged ≥65 years; risk -based for 19 –
49 years2 2
What would be the impact of recommending PCV for all PCV -
naïve adults aged 50 –64 years on health equity?
18□ Reduced
□ Probably reduced
□ Probably no impact
□ Probably increased
□ Increased
□ Varies
□ Don’t know
Work Group comments
•The intervention could help improve health equity by:
-Improving vaccine coverage for those with known or unknown risk conditions
-Providing protection at an earlier age when certain populations (e.g., Black
adults, AI adults) are already experiencing elevated disease rates
-Simplifying the recommendation, which could improve implementation across all
populations
•Acknowledged that the overall impact on health equity is complex and
would depend on how the recommendation is implemented and any
underlying disparities in healthcare access.
19
Benefits and Harms
20
Outcomes considered were specified in PICO
*Rated on a 1 to 9 scale, where 7 –9 are critical, 4 –6 are important, 1 –3 are of limited importance 21Outcome (Benefits) Importance* Data sources
VT-IPD Critical
PCV clinical trial data (immunogenicity)VT-non-bacteremic
pneumococcal pneumoniaCritical
VT-pneumococcal deaths Critical
Serious adverse events
(SAE)Critical PCV clinical trial data; post -licensure
safety data (PCV20)
Updated targeted literature search
•Previously conducted systematic review of literature and presented
summary of findings and GRADE for PCV151, PCV202, PCV213
•Updated literature search (August and September, 2024) based on current
PICO question
•6 PCV15 trials, 3 PCV20 trials, and 7 PCV21 trials included in the updated
review (list of studies available in supplemental slides)
1. Presented summary of literature search through February 18, 2021
2. Presented summary of literature search through March 31, 2022
3. Presented summary of literature search through October 17, 202322
PCV clinical trial data (immunogenicity)
Conclusions remain unchanged
•PCV15: Noninferior1 to PCV13 for all shared serotypes; had statistically significantly
greater response2 for non -PCV13 serotypes 22F and 33F vs. PCV13
•PCV20: Noninferior3 to PCV13 for all shared serotypes; noninferior3 to PPSV23 for
6/7 non -PCV13 serotypes (not met for serotype 8)
•PCV21: Noninferior4 to PCV20 for 10/10 shared serotypes; had statistically
significantly greater response5 for 10/11 PCV21 -unique serotypes (except serotype
15C)
1. Noninferiority defined as the lower bound of the 2 -sided 95% CI of the OPA GMT ratio (PCV15/PCV13) to be >0.5.
2. Statistically significantly greater response for unique serotypes (22F and 33F) defined as the lower bound of the 2 -sided 95% CI of the OPA GMT ratio (PCV15/PCV13) to be >2.0 and the lower bound of
the 2 -sided 95% CI of the differences (PCV15 -PCV13) between the proportions of participants with a ≥4 -fold rise to be >0.1 (or 1 0 percentage points)
3. Noninferiority for a serotype was declared if the lower bound of the 2 -sided 95% CI for the OPA GMT ratio (PCV20/comparator vacci ne) for that serotype was greater than 0.5 (2 -fold criterion).
4. Noninferiority for GMT ratio was defined as the lower bound of the 2 -sided 95% CI of the OPA GMT ratio [PCV21 / (Comparator Vacc ine)] to be >0.5.
5. Statistically significantly greater response for GMT ratio was defined as the lower bound of the 2 -sided 95% CI of the OPA GMT r atio [PCV21 / (Comparator Vaccine)] to be >2.0. Statistically significantly
greater response for difference in proportions of participants with a ≥4 -fold rise in serotype -specific OPA responses from basel ine to 30 days postvaccination was defined as the lower bound of the 2 -
sided 95% CI of the differences [PCV21 – (Comparator Vaccine)] between the proportions of participants with a ≥4 -fold rise from baseline to 30 days postvaccination to be >0.1. 23
1. How substantial are the desirable  anticipated
effects* of PCV vaccination?
Intervention: Recommending PCV for all PCV -naïve adults aged 50 –64 years
Comparator: Risk-based recommendation for adults with CMC/IC
CMC: chronic medical conditions, IC=immunocompromising conditions 24□ Minimal
□ Small
□ Moderate
□ Large
□ Varies
□ Don’t know   *Desirable anticipated effects for the following outcomes
as specified in the PICO:
Vaccine -type (VT) IPD, VT non -bacteremic  pneumococcal
pneumonia, VT pneumococcal mortality
Certainty of evidence (February 2024 ACIP meeting):
Moderate
PCV clinical trial data (safety)
Conclusions remain unchanged
•No vaccine -related serious adverse events reported for PCV15 and PCV20
•Two vaccine -related serious adverse events reported among PCV21
recipients (previously presented)
-Bronchospasm (V116 -005): 50 -year -old female in the sequential group with
bronchospasm within 30 minutes after the 2nd vaccination (V116); duration 23
hours; resolved
-Injection site cellulitis (V116 -006): 67 -year -old female in Cohort 1 (prior PPSV23)
with injection site cellulitis on Day 6; duration 1.57 weeks; resolved
25
Post -licensure PCV20 safety data
What we presented during the February 2024 ACIP meeting
•October 2021 –December 2023: 1,976 VAERS reports after PCV20 in adults*
•Most reports were classified as non -serious
•Data mining alert for disproportional reporting of Guillain -Barré Syndrome (GBS)
after PCV20 vaccine
•11 reports  for GBS after PCV20 vaccine, verified by chart review
•The reporting rate for GBS after PCV20 vaccine was  0.5 cases  per million doses distributed
•FDA also presented preliminary FDA -CMS partnership data at the meeting
•Near real -time monitoring in Medicare beneficiaries aged ≥65 years had not identified a
safety signal for GBS
*adults defined as individuals aged ≥19 years 26
Post -licensure PCV20 safety data
Updated data
•October 2021 –August 2024 : 2,767 VAERS reports after PCV20 in adults*
•18 reports for Guillain -Barré Syndrome (GBS) after PCV20 vaccine, verified by chart
review
•The reporting rate for GBS after PCV20 vaccine was  0.7 cases per million doses
distributed
•Updated  data findings from FDA-CMS partnership ( data through May 31, 2024 )
•A statistically significant signal (IRR>1†) for GBS following PCV20 vaccination in Medicare
beneficiaries aged ≥65 years identified when using the primary GBS definition
•GBS events were not chart confirmed (based on claims)
•Findings were not statistically significant when using a different GBS definition or
adjusting for positive predictive value
•Incidence was low (<10 GBS cases per 100K person -years), resulting in wide
credible intervals
*adults defined as individuals aged ≥19 years
†Bayesian Poisson Regression was used to estimate the posterior distribution of incidence rate ratio (IRR) between pre -specified risk and comparison windows 27
Summary: Post -licensure PCV20 safety data
•Potential Guillain -Barré Syndrome (GBS) signal for PCV20 in VAERS
•GBS signal in Medicare sequential monitoring for primary definition, but
not for alternate definition or when adjusted for positive predictive value
•Significant uncertainty because of the small number of GBS cases
observed
•CDC and FDA will continue to monitor post -licensure PCV safety
28
2. How substantial are the undesirable  anticipated
effects* of PCV vaccination?
Intervention: Recommending PCV for all PCV -naïve adults aged 50 –64 years
Comparator: Risk-based recommendation for adults with CMC/IC
CMC: chronic medical conditions, IC=immunocompromising conditions 29□ Minimal
□ Small
□ Moderate
□ Large
□ Varies
□ Don’t know   *Desirable unanticipated effects for the following
outcome as specified in the PICO: Serious adverse events
Certainty of evidence (February 2024 ACIP meeting):
Moderate
3. Do the desirable  effects of PCV vaccination outweigh the
undesirable  anticipated effects?
Intervention: Recommending PCV for all PCV -naïve adults aged 50 –64 years
Comparator: Risk-based recommendation for adults with CMC/IC
CMC: chronic medical conditions, IC=immunocompromising conditions 30□ Favors intervention
□ Favors current (risk -based for CMC/IC only)
□ Favors both
□ Favors neither
□ Varies
□ Don’t know   Additional Work Group comment:
•Some members believed that
the interpretation would vary
by the PCV product
Values and Preferences
31
1. Does the target population feel that the desirable
effects are large relative to undesirable effects?
32□ No
□ Probably no
□ Probably yes
□ Yes
□ Varies
□ Don’t know
Work Group comments
•Members with experience serving underserved populations, with many
underinsured or self -pay individuals, noted that these groups can be comfortable
with pneumococcal vaccines if benefits are clearly explained.
•The effectiveness of communication about benefits depends significantly on who
delivers the message and how much time is spent explaining it.
•There was discomfort in asserting what the target population thinks without more
evidence.
•Average populations may prioritize concerns about undesirable effects over
perceived benefits.
•Increased vaccine hesitancy observed in recent times makes the interpretation
challenging.
33
2. Is there important uncertainty about or variability
in how much people value the main outcomes*?
*Vaccine -type (VT) IPD, VT -non -bacteremic  pneumococcal pneumonia, VT -pneumococcal deaths, serious adverse events 34□ Important uncertainty or variability
□ Probably important uncertainty or variability
□ Probably not important uncertainty or variability
□ No important uncertainty or variability
□ No known undesirable outcomes
Acceptability
Is the intervention acceptable to key stakeholders?
35
Is it acceptable to recommend PCV for all PCV -naïve
adults aged 50 –64 years?
•At the June ACIP meeting, presented
findings from Merck -funded healthcare
provider surveys1,2:
-challenges with implementing risk -based
vaccine recommendations (e.g., time
constraints, difficulties in identifying
vaccination history or underlying health
condition of the patient)
-support for lowering the age threshold of
the current age -based recommendation
1. Online survey conducted in February 2024 by ZS, funded by Merck. 502 HCPs (physicians, NP/PAs, pharmacists who vaccinate) par ticipated; majority (70%) physicians
2. Online survey conducted from March –May 2024 by OPEN Health, funded by Merck. Included a total of 340 HCPs consisting of physicia ns, nurse practitioners, physician assistants,
and pharmacists36□ No
□ Probably no
□ Probably yes
□ Yes
□ Varies
□ Don’t know
Resource Use
Is the intervention a reasonable and efficient allocation of resources?
37
Summary of model findings, “adding” strategies
38•From the “adding” comparisons, all strategies improved health, but none were cost -saving
•Cost per QALY gained estimates for PCV20 had a wider range, more uncertainty than PCV21
•In two of three models, PCV21 had lower costs per QALY gained than PCV20
Leidner October 2024 ACIP meeting presentation 0 100,000 200,000 300,000 400,000 500,000 600,000 700,000 800,000 900,000 1,000,000
Incermental cost -effectiveness ratio (ICER) ($/QALY)Cost -effectiveness estimates for PCV21 and PCV20 vaccination at age 50
and 65 years vs. current recommendations
PCV21
PCV21PCV20
PCV20
PCV20Tulane -CDC
Merck
model
Pfizer
model
Is PCV use for PCV -naïve adults aged 50 –64 years a reasonable
and efficient allocation of resources?
39□ No
□ Probably no
□ Probably yes
□ Yes
□ Varies
□ Don’t know   •Probably yes/yes:
-Despite the higher economic costs,
members valued the opportunity to
prevent more disease, particularly among
racial and ethnic groups who currently have
higher disease burden
Work Group comments
Probably No/Varies:
•Some Work Group members expressed concerns about the less favorable
economic analysis for PCV20 compared to PCV21 .
•Improved vaccination coverage among those with risk -based pneumococcal
vaccine indications could diminish the need for broader age -based
vaccination, while acknowledging that there has been insufficient success
•The decision varies when considering projections over the next 15 years,
e.g., indirect effects of pediatric vaccination, availability of new higher -
valency vaccines, data on duration of protection from vaccination, and
considerations of whether or not to give booster doses.
40
Feasibility
Is the intervention feasible to implement?
41
Is it feasible to implement PCV for all PCV -naïve adults
aged 50 –64 years?
42□ No
□ Probably no
□ Probably yes
□ Yes
□ Varies
□ Don’t know
Vaccine coverage tends to be lower in younger adults
even with an age -based recommendation
1.Week ending May 11, 2024. Vaccine coverage with the updated 2023 -2024 COVID -19 vaccine, defined as receipt of at least one vacci nation since September 2023.
2.Week ending May 11, 2024. Vaccine coverage for the 2023 -2024 influenza season
3.Vaccination Coverage among Adults in the United States, National Health Interview Survey, 2021 | CDC , % represents those who received at least 2 doses
4.BRFSS 2022 data, % represents receipt of any pneumococcal vaccine dose 4350–64 yrs ≥65 yrs
COVID -19125.2% 40.6%
Influenza251.5% 73.8%
Recombinant
Zoster Vaccine312.2% (50 –59) 20.1% (60 –64) 22.8%
Pneumococcal437.3%* 69.7%
*Receipt of any pneumococcal vaccine dose among those with risk -based indications
Compared with vaccine coverage in adults aged ≥65 years,
pneumococcal vaccine coverage in adults aged 50 –64 years
with risk -based indication was disproportionately lower
1.Week ending May 11, 2024. Vaccine coverage with the updated 2023 -2024 COVID -19 vaccine, defined as receipt of at least one vacci nation since September 2023.
2.Week ending May 11, 2024. Vaccine coverage for the 2023 -2024 influenza season
3.Vaccination Coverage among Adults in the United States, National Health Interview Survey, 2021 | CDC , % represents those who received at least 2 doses
4.BRFSS 2022 data, % represents receipt of any pneumococcal vaccine dose 4450–64 yrs ≥65 yrs (50–64 yrs)/
(≥65 yrs)
COVID -19125.2% 40.6% 0.62
Influenza251.5% 73.8% 0.70
Recombinant
Zoster Vaccine312.2% (50 –59) 20.1% (60 –64) 22.8%
Pneumococcal437.3%* 69.7% 0.54
*Receipt of any pneumococcal vaccine dose among those with risk -based indications
Work Group comments
•Age-based recommendations are generally easier to implement than risk -
based recommendations
•Lower vaccine coverage in younger adults is likely due to multiple factors,
such as healthcare access, perceived risk of disease or benefits from
vaccination.
-There is a larger proportion of adults aged 50 –64 years without health insurance
compared with adults aged ≥65 years1.
•Having a different age -based recommendation by vaccine product (e.g.,
PCV20, PCV21) will be more challenging to implement.
•Variability in health insurance coverage might keep PCV20 as the only
practical option for some individuals in the short term since PCV21 is new.
1. Health Insurance Coverage in the United States: 2022 (census.gov) 45
46EtR Domains Work Group Interpretation
Public Health Problem Yes
Equity Probably increased
Benefits and Harms
a. Benefits Moderate
b. Harms Minimal
c. Benefit>Harm? Favors intervention
Values and Preferences
a. Desirable>Undesirable? Probably yes/yes
b. Uncertainty? Probably not important uncertainty or variability
Acceptability Yes
Resource Use Probably yes/Yes
Feasibility Probably yes/YesSummary of Work Group Interpretations of EtR Domains
Key considerations: factors supporting lowering the
PCV age -based recommendation to age ≥50 years
1.The relatively high burden of pneumococcal disease in adults aged 50 –64 years,
particularly among those with risk conditions
2.Potential for improved vaccine uptake through an age -based recommendation,
which is easier to implement compared with the current risk -based
recommendation
3.Potential to reduce pneumococcal disease incidence  in demographic groups
experiencing the highest burden
4.Projected health benefits from economic models* despite increased net costs
*Note that these are models that assumed that another vaccine dose is given later in life to ensure older adults are protecte d from disease 47
Key considerations: potential implications
1.Economic concerns: While our models showed health benefits, there were
significant concerns about the cost of lowering the age recommendation for both
PCV20 and PCV21 when considering overall health benefits to society
2.Market availability and insurance coverage: Concerns were raised that variability
in health insurance coverage might keep PCV20 as the only practical option for
some individuals in the short term, given that PCV21 is a newer vaccine
3.Ease of implementation: The Work Group agreed that having different age -based
recommendations by vaccine would be challenging to implement
48
Key considerations: uncertainties
1.How long is the duration of protection from a dose of PCV in adults?

2.What is the magnitude of indirect effects from pediatric PCV15/20 vaccination?
3.What might be the impact of higher -valency vaccines under development?
49
Summary: Work Group Interpretation
•Should a single dose of pneumococcal conjugate vaccine be
recommended for all PCV -naïve adults aged 50 –64 years?
50Balance of
consequencesUndesirable
consequences
clearly
outweigh
desirable
consequences
in most
settingsUndesirable
consequences
probably
outweigh
desirable
consequences
in most
settingsThe balance
between
desirable and
undesirable
consequences
is closely
balanced or
uncertainDesirable
consequences
probably
outweigh
undesirable
consequences
in most
settingsDesirable
consequences
clearly
outweigh
undesirable
consequences
in most
settingsThere is
insufficient
evidence to
determine the
balance of
consequences
Should a single dose of pneumococcal conjugate vaccine be
recommended for all PCV -naïve adults aged 50 –64 years?
Is there sufficient information to move forward with a recommendation
Yes
•Policy options for ACIP consideration
-The majority recommended, but about a quarter said “do not recommend the
intervention”
•The higher cost/QALY gained for PCV20 compared to PCV21 in economic
analyses
•Uncertainties around key assumptions like the impact of pediatric PCV use
and duration of protection
•Concerns about the implications of a broad recommendation given the
differences in serotype coverage between PCV20 and PCV21
51
Should a single dose of pneumococcal conjugate vaccine be
recommended for all PCV -naïve adults aged 50 –64 years?
•Is there sufficient information to move forward with a recommendation
-Yes
•Policy options for ACIP consideration
-Recommend the intervention
52
Proposed policy option
•ACIP recommends a pneumococcal conjugate vaccine (PCV) for all PCV -
naïve adults aged ≥50 years
53
Clinical considerations
Proposed language
54
PCV-naïve adults* (or adults with unknown history)
•A single dose of PCV (PCV15, PCV20, or PCV21) is recommended for all
adults aged ≥50 years and for adults aged 19 –49 years with certain
underlying conditions or risk factors†who have not received a PCV or
whose vaccination history is unknown.
•If PCV15 is administered, a single dose of PPSV23§ should be
administered ≥1 year after the PCV15 dose. A minimum interval of 8
weeks can be considered if PCV15 is used in adults with an
immunocompromising condition¶, cochlear implant, or CSF leak.
*Includes adults who received PCV7 only
†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.
§For adults who have received PCV15 but have not completed their recommended pneumococcal vaccine series with PPSV23, 1 dose o f PCV21 or PCV20 may be used if PPSV23 is not
available.
¶Chronic renal failure, nephrotic syndrome, immunodeficiency, iatrogenic immunosuppression, generalized malignancy, HIV infect ion, Hodgkin disease, leukemia, lymphoma, multiple
myeloma, solid organ transplant, congenital or acquired asplenia, or sickle cell disease or other hemoglobinopathies .55DRAFT
Underlying
conditionsPrevious
vaccination
historyAge 19 –49 years Age ≥50 years
None None No vaccine recommendation
Chronic
medical
conditionsNone
CSF leak,
cochlear
implantNone
Immuno -
compromisedNonePCV15 PPSV23*OR
≥1yr
Use of 21 -Valent Pneumococcal Conjugate Vaccine Among U.S. Adults: Recommendations of the Advisory Committee on Immunization Pra ctices — United States, 2024 | MMWR 56*If adults previously received PPSV23 before receiving a dose of PCV15, it need not be followed by another dose of PPSV23
†A minimum interval of 8 weeks can be considered for adults with an immunocompromising condition, cochlear implant, or cerebro spinal fluid
leakPCV20ORPCV21
PCV15 PPSV23*ORPCV20ORPCV21
≥1yr≥8wks†PCV-naïve adults (or adults with unknown history) DRAFT
PCV13 -experienced adults who completed  the
recommended vaccine series
•Shared clinical decision -making is recommended regarding use of a
supplemental PCV20 or PCV21 dose for adults aged ≥65 years who have
completed their recommended vaccine series with both PCV13 and
PPSV23.
Rationale:
•No change is proposed to the age threshold. Under the previous
recommendation, PCV13 -vaccinated adults were only considered to have
“completed” their recommended vaccine doses after receiving one and
final dose of PPSV23 at or after age 65 years . Therefore, this scenario only
applies to adults aged ≥65 years who received both PCV13 and PPSV23 at
or after age 65 years. 57DRAFT (no change from current)
Underlying conditions Age ≥65 years
None
Chronic medical
conditions
CSF leak, cochlear
implant
Immuno -compromisedPCV13 -experienced adults who completed  the
recommended vaccine series
Use of 21 -Valent Pneumococcal Conjugate Vaccine Among U.S. Adults: Recommendations of the Advisory Committee on Immunization Pra ctices — United States, 2024 | MMWR58PCV13 PPSV23
≥1yr≥8wks*
PCV20ORPCV21
Shared clinical
decision -makingDRAFT (no change from current)
≥5yrs
*A minimum interval of 8 weeks can be considered for adults with an immunocompromising condition, cochlear implant, or cerebr ospinal fluid leak
PCV13 -experienced adults who have not completed
the recommended vaccine series
•A single dose of either PCV20 or PCV21 is recommended for adults aged
≥19 years who have started their pneumococcal vaccine series with PCV13
but have not received all recommended pneumococcal vaccine doses.
Change:
•Removed the option to complete vaccine series with PPSV23 for PCV13 -
experienced adults
Rationale:
•The potential need for repeated PPSV23 doses in adults who received
PCV13 was one of the reasons for the complexity of the recommendation.
59DRAFT
Underlying
conditionsAge 19 –64 years Age ≥65 years
None
Chronic
medical
conditions
CSF leak,
cochlear
implant
Immuno -
compromised≥8wksPCV13 -experienced adults who have not completed the
recommended vaccine series (current recommendation)
60≥5yrs≥5yrs≥1yr
OR
PCV13PCV13
PCV13PCV13
PPSV23
PPSV23 PPSV23PPSV23≥1yr PCV20PCV21
OR
OR
PCV20PCV21
OR
PPSV23PCV20PCV21
OR
OR≥8wksOR
Underlying
conditionsAge 19 –64 years Age ≥65 years
None
Chronic
medical
conditions
CSF leak,
cochlear
implant
Immuno -
compromised≥8wksPCV13 -experienced adults who have not completed
the recommended vaccine series (proposed)
61≥5yrs≥5yrs≥1yr
OR
PCV13PCV13
PCV13PCV13
PPSV23
PPSV23 PPSV23PPSV23≥1yr PCV20PCV21
OR
OR
PCV20PCV21
OR
PPSV23PCV20PCV21
OR
OR≥8wksOR
Acknowledgements
•ACIP and the Pneumococcal Vaccines Work Group
•Active Bacterial Core surveillance sites and program
•Charles Stoecker, Yin Wang (Tulane University)
•Wesley Self, Jackson Resser (Vanderbilt University Medical Center)
•CDC contributors and consultants: Ryan Gierke, Jennifer Farrar, Andrew Leidner,
Sofia Bletnitsky, Kristin Andrejko, Emma Accorsi, Wei Xing, Adam Cohen, Alison
Albert, Shelby Miller, Noele Nelson, Kimberly Fox, Pedro Moro, Bo -Hyun Cho,
Elizabeth Velazquez, Janelle King, Fangjun Zhou, Peng -Jun Lu, Anup Srivastav, Carla
Black, Marc Fischer, Laurie Orell, Cheryl Ward, Rebecca Morgan, Doug Campos -
Outcalt
62
Supplementary Slides
63
Search strategy
64Database Strategy Run Date Records
PubMed (PCV15 OR PCV20 OR "15 -valent pneumococcal
conjugate vaccine" OR "20 -valent pneumococcal
conjugate vaccine") AND adult; Filters applied: English,
Humans, from 2021/2/19 - Present. August 3, 2024 94
PubMed (PCV21 OR V116 OR "pneumococcal conjugate vaccine
21" OR "pneumococcal conjugate vaccine 21 -valent")
AND ("2023/09/19"[Date - Publication] : "3000"[Date -
Publication])September 8,
202466
Clinicaltrials.gov V114, Filter: "Adult (18 -64)", "Phase 3" August 17, 2024 8
Clinicaltrials.gov 20vPnc, PCV20, 20 -valent PCV, 20 -valent pneumococcal
conjugate vaccine; Filter: "Adult (18 -64)", "Phase 3" August 17, 2024 18
Clinicaltrials.gov 1. Intervention: “V116”, filter: “Adult (18 –64)”, “Phase
3”
2. “PCV21”, filter: “Adult (18 –64)”, “Phase 3”
3. “21 valent pneumococcal conjugate vaccine”, filter:
“Adult (18 –64)”, “Phase 3”September 8,
20241. 7
2. 0
3. 7 (all duplicate
with 1)
Study Study designCountry (or
more detail, if
needed)Age (rangeTotal
populationN Intervention N comparison OutcomesFunding
source
Song 2021Phase III randomized
controlled trial US, Korea,
Spain, TaiwanAdults ≥50 years of
age, PCV followed by
PPSV23 12 months
later627 325 302Immunogenicity,
SafetyMerck
Mohapi  2022Phase III randomized
controlled trial USAdults ≥18 years of
age with HIV, PCV
followed by PPSV23 8
weeks later298 150 148Immunogenicity,
SafetyMerck
Platt 2022Phase III randomized
controlled trialUS, Japan,
Spain, Canada,
TaiwanAdults ≥50 years of
age1202 602 600Immunogenicity,
SafetyMerck
Simon 2022Phase III randomized
controlled trialUS, Australia,
Chile, Denmark,
Finland, UKAdults ≥50 years of
age2340 2107 233 Immunogenicity,  Safety Merck
Severance 2022Phase III randomized
controlled trialUSAdults ≥50 years of
age1200600 (concomitant
with QIV)600 (sequential QIV
administration)Immunogenicity, Safety Merck
V110 -911Phase III randomized
controlled trialUS, Puerto RicoAdults ≥50 years of
age850 (includes 426
who received
PPSV23 214 (concomitant
with mRNA -1273)210 (sequential mRNA -
1273 administration)Immunogenicity and
safetyMerckPCV15 studies included in the review of evidence
65
Study Study designCountry (or
more detail, if
needed)Age (rangeTotal
populationN Intervention N comparison OutcomesFunding
source
Essink , 2022Phase III
randomized
controlled
trial US and
SwedenAdults ≥ 18 -49
years (34.0, SD
8.8)448 336 (PCV20) 112 (PCV13)
Immunogenicity,
SafetyPfizerAdults ≥ 50 -59
years (54.9, SD
2.8)445 334 (PCV20) 111 (PCV13)
Adults ≥ 60
years (64.6, SD
4.8)2997 1507 (PCV20)1490
(PCV13+PPSV23)
Hurley, 2021    Phase II
randomized
controlled
trial  USAdults 60 - 64
years (62.0, SD
1.4)444 222 222Immunogenicity,
SafetyPfizer
Haranaka , 2024Phase III
randomized
controlled
trialJapan,
South
Korea, and
TaiwanAdults aged
≥60 years (66.1,
SD 4.7)1421 711 (PCV20)710
(PCV13+PPSV23)Immunogenicity,
SafetyPfizerPCV20 studies included in the review of evidence
66
PCV21 studies included in the review of evidence
*participants who received at least one dose of study intervention67Study Study design Country Age Total population N Intervention* N comparison OutcomesFunding
source
Platt, 2023 RCT (Phase II) US Adults ≥50 years 508 254 PPSV23: 254 Immunogenicity and SafetyMerck
Platt, 2024RCT (Phase III);
pivotal studyUS, Australia, Belgium,
Chile, Germany, Korea,
New Zealand, Puerto
Rico, Sweden, Taiwan,
TurkeyHealthy adults ≥50 years,
pneumococcal vaccine – naïve
2,6631,179 PCV20: 1,177
Immunogenicity and Safety Merck
Healthy adults 18 - 49 years,
pneumococcal vaccine – naïve200 PCV20:  100
V116 -005RCT (Phase III)US Adults ≥50 years 1,080(V116 + QIV,
coadministered): 536(QIV followed by V116):
536Immunogenicity and
SafetyMerck
Scott, 2024RCT (Phase III)US, Canada, Israel,
France, Italy, Japan,
Korea, Spain, TaiwanAdults ≥50 years, previous PPSV23
≥1 year prior to enrollment350 229 PCV15, n=117
Immunogenicity
and
SafetyMerckAdults ≥50 years, previous PCV13 ≥1
year prior to enrollment261 174PPSV23
N=85
Adults ≥50 years, PCV13+PPSV23,
PCV15+PPSV23, PCV15, PCV20, or
PPSV23+PCV13 ≥1 year prior to
enrollment106 105 None
V116 -007 RCT (Phase III)Belgium,  Chile,  France,
South Africa,
Thailand,
United StatesAdults ≥18 years living with HIV; 36%
prior PCV13 or PPSV23*313 155 PCV15+PPSV23, n=156 Immunogenicity and Safety Merck
V116 -008 RCT (Phase III)United States, Australia,
Canada, Chile, Japan,
South Korea, New
Zealand, Poland,  Adults aged 18 –64 years with
increased risk for pneumococcal
disease†518 386 PCV15+PPSV23, n=130 Immunogenicity and Safety Merck
V116 -010 RCT (Phase III)Argentina, Australia,
Colombia, Germany,
Israel, South Korea, New
Zealand, Spain, Taiwan,
Turkey, United KingdomAdults aged ≥50 years,
pneumococcal vaccine -naïve 1,484 739 PPSV23: 741 Immunogenicity and Safety Merck

Summary: Summary of Work Group Interpretation of EtR and  Policy Options PCV Use in Adults aged ≥50 years October 23, 2024 Miwako Kobayashi, MD, MPHNational Center for Immunization and Respiratory Diseases 1 PICO for WG discussion through October 2024 CMC=chronic medical conditions (i.e., alcoholism; chronic heart disease, including congestive heart failure and cardiomyopath ies; chronic liver disease; chronic lung disease, including  chronic obstructive pulmonary disease, emphysema, and asthma;…


01 influenza Loehr 508

National Center for Immunization & Respiratory Diseases
Influenza Work Group —Introduction
Dr. Jamie Loehr (Work Group Chair)
Advisory Committee on Immunization Practices
October 23, 2024
Influenza Work Group
ACIP Members
•Jamie Loehr (Chair)
•Robert Schechter
•Albert Shaw
•Keipp Talbot
Ex Officio
•Timothy Brennan (FDA)
•Uzo Chukwuma (IHS)
•Michael Ison (NIH)
•Cynthia Nolletti (FDA)
•Jo Resnick (FDA)
•Chris Roberts (NIH)Liaison Representatives and Consultants
•Robert Atmar
•Kevin Ault
•Ed Belongia
•Hank Bernstein
•Kris Bryant
•Doug Campos -Outcalt
•Sarah Coles
•Frances Ferguson
•Sandra Fryhofer
•Robert Hopkins
•Wendy Keitel
•Camille Kotton
•Marie -Michèle Léger
•Susan Lett
•Krissy Moehling•Zackary Moore
•Rebecca Morgan
•Flor Munoz
•Caitlin Newhouse
•Jesse Papenburg
•William Schaffner
•Ken Schmader
•Tamara Sheffield
•Angela Sinilaite
•Peter Szilagyi
•Matthew Zahn
CDC Lead
•Lisa Grohskopf
2
CDC Participants
•Lenee Blanton
•Karen Broder
•Alicia Budd
•Jessie Chung
•Jennifer DeCuir
•Sascha Ellington
•Tarayn Fairlie
•Jill Ferdinands
•Brendan Flannery
•Andrew Kroger
•Samantha Olson
•David Shay
•Tom Shimabukuro
•Naomi Tepper
3
Brief Note
Update concerning FluMist (Live Attenuated Influenza Vaccine, Trivalent; LAIV3)
•On September 20, 2024, FDA approved FluMist for self or caregiver administration.
•For the current 2024 -25 influenza season, FluMist is available for administration by
a healthcare provider only.
•It is anticipated that FluMist will be available for self or caregiver administration for
the 2025 -26 influenza season.
4https://www.fda.gov/vaccines -blood -
biologics/vaccines /flumist
2023 -24 Season Influenza Vaccine Effectiveness (VE)
Updates:
•2023–24 End of Season Influenza Vaccine Effectiveness – United States
⁻Dr. Sascha Ellington, Influenza Division, CDC/NCIRD
•This topic is presented for information and discussion. Issue:
•Influenza vaccine effectiveness (VE) varies and is assessed annually through several
CDC platforms focusing on laboratory -confirmed influenza outpatient visits and
hospitalizations in adult and pediatric populations.
•Preliminary 2023 -24 season VE estimates were presented at the February 2024
ACIP meeting.
5
Avian Influenza A(H5N1) Update
Updates:
•Highly Pathogenic Avian Influenza A(H5N1 ) Update
⁻Dr. Tom Shimabukuro; Deputy Director, Influenza Division, CDC/NCIRD
•This topic is presented for information and discussion. Issue:
•Influenza A(H5N1) has been detected in U.S. dairy herds in 14 U.S. states
•27 human cases have been reported during 2024 .
6https://www.cdc.gov/bird -flu/situation -summary/index.html
Vaccines for Children (VFC) Vote
Vote:
•A VFC resolution is proposed to add options for vaccination of 18 -year -olds who are
solid organ transplant recipients.
⁻Dr. Jeanne Santoli, CDC/NCIRDIssue:
•High -dose inactivated (HD -IIV3) and adjuvanted inactivated (aIIV3) influenza
vaccines are approved in the United States for ages ≥65 years.
•An evidence review of HD -IIV3 and aIIV3 for solid organ transplant (SOT) recipients
ages ≥6 months was presented at the June 2024 ACIP meeting.
•ACIP voted to recommend that HD -IIV3 and aIIV3 are acceptable options for SOT
recipients aged 18 through 64 years who are receiving immunosuppressive
medication regimens, without a preference over other age -appropriate inactivated
or recombinant vaccines.
7
For more information, contact CDC
1-800-CDC-INFO (232 -4636)
TTY:  1 -888-232-6348    www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the
official position of the Centers for Disease Control and Prevention.

Summary: National Center for Immunization & Respiratory Diseases Influenza Work Group —Introduction Dr. Jamie Loehr (Work Group Chair) Advisory Committee on Immunization Practices October 23, 2024 Influenza Work Group ACIP Members •Jamie Loehr (Chair) •Robert Schechter •Albert Shaw •Keipp Talbot Ex Officio •Timothy Brennan (FDA) •Uzo Chukwuma (IHS) •Michael Ison (NIH) •Cynthia Nolletti (FDA) •Jo Resnick (FDA) •Chris Roberts (NIH)Liaison Representatives and Consultants •Robert Atmar •Kevin Ault •Ed…


02 influenza Ellington 508

National Center for Immunization & Respiratory Diseases
2023 –24 End of Season Influenza Vaccine Effectiveness – United
States
Sascha Ellington, PhD, MSPH
Influenza Division
U.S. Centers for Disease Control and Prevention
2023 –2024 Influenza Season
•A(H1N1)pdm09 predominant
•Lower levels of A(H3N2) and
B/Victoria circulation
•Peak activity 2023 week 52
•Vaccines were quadrivalent and
included A(H1N1)pdm09,
A(H3N2), and B components
H1N1
H3N2B
3CDC Influenza Vaccine Effectiveness Networks
Investigating Respiratory Viruses in the Acutely Ill (IVY)
New Vaccine Surveillance Network (NVSN)
US Flu Vaccine Effectiveness Network (US Flu VE)
Virtual SARS -CoV-2, Influenza, and Other respiratory viruses Network (VISION)

VISION
IVYNVSN
4These networks include all ages across settings
AgeSettingOutpatient
clinic
HospitalizationEmergency
department/
urgent careUS Flu VE
Adults
(≥18 years)Children and adolescents
(6 months – 17 years)Outpatient
NVSN
5NVSN: all settings
AgeSettingOutpatient
clinic
HospitalizationEmergency
department/
urgent care
Adults
(≥18 years)Children and adolescents
(6 months – 17 years)Outpatient
NVSN
6US Flu VE: Outpatient clinic and ED/UC
AgeSettingOutpatient
clinic
HospitalizationEmergency
department/
urgent careUS Flu VE
Adults
(≥18 years)Children and adolescents
(6 months – 17 years)Outpatient
NVSN
7VISION: ED/UC & hospitalization
AgeSettingOutpatient
clinic
HospitalizationEmergency
department/
urgent careUS Flu VE
Adults
(≥18 years)Children and adolescents
(6 months – 17 years)VISIONOutpatient
IVY
8IVY: hospitalization
AgeSettingOutpatient
clinic
HospitalizationEmergency
department/
urgent care
Adults
(≥18 years)Children and adolescents
(6 months – 17 years)Outpatient
IVY
9US Flu VE: Outpatient clinic and ED/UC
AgeSettingOutpatient
clinic
HospitalizationEmergency
department/
urgent care
Adults
(≥18 years)Children and adolescents
(6 months – 17 years)US Flu VE Outpatient
IVY
10VISION: ED/UC & hospitalization
AgeSettingOutpatient
clinic
HospitalizationEmergency
department/
urgent care
Adults
(≥18 years)Children and adolescents
(6 months – 17 years)US Flu VE
VISIONOutpatient
VISION
IVYNVSN
11These networks include all ages across settings
AgeSettingOutpatient
clinic
HospitalizationEmergency
department/
urgent careUS Flu VE
Adults
(≥18 years)Children and adolescents
(6 months – 17 years)Outpatient
12CDC influenza VE networks include patients from 23 states
13
?
142023 –2024 Influenza VE Methods
Enrollees: Have acute respiratory illness and present for medical care
Dates of enrollment: Fall 2023 –April/May 2024
Design: Test-negative design
›Comparing vaccination odds among case patients with influenza confirmed by
molecular assay versus control patients testing negative for influenza and SARS -CoV-2
›Vaccination status: receipt of any 2023 –24 seasonal flu vaccine according to medical
records, immunization registries, claims data, and/or self -report
152023 –2024 Influenza VE Methods
Analysis : VE = (1 – adjusted OR) x 100%
›Adjusted for geographic region, age, calendar time of illness
•IVY , US Flu VE, and VISION also adjusted for sex and race and ethnicity
•US Flu VE also adjusted for days between illness onset and enrollment and self -reported
general health status
VE among children and adolescents aged 6 months – 17 years
17Pediatric VE against any influenza
February 2024

18Pediatric VE against any influenza
February 2024
19Pediatric VE against influenza A
February 2024

20Pediatric VE against influenza A
February 2024

21Pediatric VE against influenza B
February 2024

22Pediatric VE against influenza B
February 2024
VE among adults ages 18 –49 years
24Adult (aged 18 –49 years) VE against any influenza

25Adult (aged 18 –49 years) against VE influenza A

26Adult (aged 18 –49 years) VE against influenza B

VE among adults aged 50 –64 years
28Adult (aged 50 –64 years) VE against any influenza
February 2024, 18–64 years combined

29Adult (aged 50 –64 years) VE against any influenza
February 2024, 18–64 years combined

30Adult (aged 50 –64 years) VE against influenza A
February 2024, 18–64 years combined

31Adult (aged 50 –64 years) VE against influenza A
February 2024, 18–64 years combined

32Adult (aged 50 –64 years) VE against influenza B
February 2024, 18–64 years combined

33Adult (aged 50 –64 years) VE against influenza B
February 2024, 18–64 years combined

VE among adults aged ≥65 years
35Adult (aged ≥65) VE against any influenza
February 2024

36Adult (aged ≥65) VE against any influenza
February 2024

37Adult (aged ≥65) VE against influenza A
February 2024

38Adult (aged ≥65) VE against influenza A
February 2024
39Adult (aged ≥65) VE against influenza B
February 2024

40Adult (aged ≥65) VE against influenza B
February 2024
VE by A subtype
42VE against influenza A(H1N1)pdm09

VE against influenza A(H3N2)
43

Discussion
45Summary of four CDC influenza VE networks
Vaccination with a 2023 –2024 influenza vaccine reduced the risk  of medically
attended influenza outpatient visits and hospitalizations  among children,
adolescents, adults, and the elderly .
Results were consistent across 4 networks in 23 states.
Preliminary end-of-season  estimates are similar to interim estimates from
February.
For more information, contact CDC
1-800-CDC-INFO (232 -4636)
TTY:  1 -888-232-6348    www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the
official position of the Centers for Disease Control and Prevention.
We’d like to thank our many collaborators from CDC, IVY , NVSN, US Flu VE, and VISIONThank you

Summary: National Center for Immunization & Respiratory Diseases 2023 –24 End of Season Influenza Vaccine Effectiveness – United  States Sascha Ellington, PhD, MSPH Influenza Division  U.S. Centers for Disease Control and Prevention  2023 –2024 Influenza Season •A(H1N1)pdm09 predominant •Lower levels of A(H3N2) and  B/Victoria circulation •Peak activity 2023 week 52 •Vaccines were quadrivalent and  included A(H1N1)pdm09,  A(H3N2), and B components H1N1 H3N2B 3CDC Influenza Vaccine Effectiveness…