04 COVID Link Gelles 508

Effectiveness of COVID -19 vaccines
Ruth Link -Gelles, PhD, MPH
CDR, US Public Health Service
Vaccine Effectiveness Program LeadCoronavirus and Other Respiratory Viruses DivisionCenters for Disease Control and Prevention October 23, 2024National Center for Immunization and Respiratory Diseases

•VE data to inform need for:
-Additional doses in immunocompromised
•What’s known about VE in immunocompromised vs. non-
immunocompromised adults, including waning by time since dose
-Additional dose for adults ≥65 years
•What’s known about waning of a single dose in healthy adults ≥65 years, including against more severe outcomes
•Benefits of an additional dose in past seasonsAgenda – COVID -19 vaccine effectiveness (VE)
1. Time since dose impacts protection
-How much and over what time period?
2. SARS -CoV-2 variants change over time
-Variant/vaccine match may impact effectiveness
3. Surges in disease, seroprevalence, and time since last SARS -CoV-2
infection impact measured VE
Difficult to disentangle time since dose (true “waning”) vs. impact of
changes in variants vs. impact of time since prior infectionSome key issues in COVID- 19 vaccine effectiveness (VE)
•High rates of SARS -CoV-2 infection -induced immunity by July – August 2023.*Context for interpreting COVID -19 VE across age groups: SARS -CoV-2
seroprevalence before 2023 -2024 respiratory virus season
* Internal CDC data. Data on persons aged ≥16 years is from a longitudinal, national cohort of >35,000 blood donors.
Methods and prior data available at: https://covid.cdc.gov/covid- data- tracker/#nationwide -blood -donor -seroprevalence- 202289%
89%
84%
72%16-29 years
30-49 years
50-64 years
≥65 years
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Percent with infection- induced immunityPercent of persons with infection -induced immunity,
based on anti -nucleocapsid results from blood donors
VE findings should be interpreted as the added benefit  provided by COVID -19 vaccination in a
population with a high prevalence of vaccine - and infection -induced immunity.
Measuring COVID- 19 VE
Measure Definition Example
vaccinated
groupExample comparison group
Absolute VE Compares frequency of health
outcomes in vaccinated and unvaccinated people Received
original
monovalent
COVID -19
vaccineReceived no COVID -19 vaccines ever
Relative VE Compares frequency of health outcomes in people who received one type of vaccine to people who received a different vaccineReceived
bivalent
COVID -19
vaccineEligible for, but did not receive, bivalent COVID -19 vaccine , but received
original monovalent COVID -19
vaccine
VE of 2023 -2024 COVID -
19 vaccinesCompares people who received 2023 -2024  COVID -19 vaccine to
people who did not, regardless of past vaccinationReceived
updated
(2023 -24)
doseEligible for, but did not receive, an
updated (2023 -24) dose , regardless of
past vaccination history
Methods
VISION Multi -Site Network of Electronic Health Records
>300 emergency departments and urgent cares and >200 hospitals
Design: Test-negative design
Population: Adults visiting a participating
emergency department or urgent care (ED/UC) or
hospitalized with COVID -19-like illness (CLI) with a
SARS -CoV-2 NAAT test result within 10 days before
or 72 hours after encounter
−Cases: CLI with positive  NAAT for SARS -CoV-2 and no
positive NAAT for RSV or influenza
–Controls: CLI with negative  NAAT for SARS -CoV-2 and
no positive NAAT for influenza
Vaccination data: Documented by electronic health records and state and
city registries
IVY Network — 26 hospitals, 20 U.S. States
•Design : Test-negative, case -control design
•Population: Adults  aged  ≥18 years  hospitalized with COVID -
like illness (CLI)* and SARS -CoV-2 test results within 10 days of
illness onset and 3 days of admission
–Cases: CLI and test  positive  for SARS -CoV-2 by NAAT or antigen
–Controls: CLI and test negative  for SARS -CoV-2 and influenza by
RT-PCR
•Vaccination data: Electronic medical records (EMR), state and
city registries, and plausible self -report
•Specimens: Nasal swabs  obtained on all patients for central
RT-PCR testing and whole genome sequencing
*CLI is defined as presence of any one of the following: fever, cough, shortness of breath, chest imaging consistent with pneumoni a, or hypoxemia

*Data sources included Medicare Enrollment Database (EDB) and Common Medicare Environment (CME), Common Working File (CWF) and S hared System Data (SSD) Medicare Parts A/B claims data, Minimum Data Set (MDS), and CDC/ATSDR
Social Vulnerability Index (SVI). Events identified from Medicare claims data using International Classification of Diseases,  Tenth Revision, Clinical Modification (ICD -10 CM) and common procedural terminology (CPT) codes. Medicare data
• Design: Retrospective cohort
• Data source:  Medicare fee- for-service claims data*
• Population:  Persons aged ≥65
• Censoring events:
– COVID -19-related thromboembolic event
– Death
– Disenrollment in Medicare Parts A/B
– Enrollment in Medicare Part C
– Nursing home stay lasting ≥100 days
– Admission to hospice facility
– Dialysis encounter
– Receipt of multiple bivalent booster doses
– Bivalent booster dose < 60 days from the last COVID -19 vaccine
dose
– End of study period
• VE = (1 - adjusted hazard ratio) x 100%
where adjusted hazard ratio = 𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟  𝑜𝑜𝑜𝑜 𝑅𝑅𝑅𝑅𝑅𝑅  ℎ𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑟𝑟𝑟𝑟𝑜𝑜𝑜𝑜𝑜𝑜𝑟𝑟𝑟𝑟𝑜𝑜𝑜𝑜𝑜𝑜𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣
𝑟𝑟𝑟𝑟𝑟𝑟𝑟𝑟  𝑜𝑜𝑜𝑜 𝑅𝑅𝑅𝑅𝑅𝑅  ℎ𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑜𝑟𝑟𝑟𝑟𝑜𝑜𝑜𝑜𝑜𝑜𝑟𝑟𝑟𝑟𝑜𝑜𝑜𝑜𝑜𝑜𝑢𝑢𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣𝑣COVID -19 hospitalizationOther Censoring Event
Unvaccinated person- time
Vaccinated person- time
COVID -19 VE data to inform need for
additional doses in persons with
immunocompromise
Adjusted VE% (95% CI)
Vaccination
status/days since doseImmunocompromised Not immunocompromised
2 doses
14-59 days 38 (-25-71) 81 (70- 88)
60-119 days 27 (-7-51) 74 (66- 80)
120-179 days 33 (6- 52) 64 (56- 71)
180-239 days 35 (13- 51) 60 (53- 61)
240-299 days 39 (27- 50) 57 (53- 61)
300+ days 42 (29- 52) 66 (62- 69)
3 doses
14-59 days 81 (75- 85) 93 (91- 94)
60-119 days 74 (68- 78) 91 (90- 92)
120-179 days 49 (37- 58) 84 (81- 87)VISION: Original monovalent vs. unvaccinated  mRNA VE for COVID -19-associated hospitalization  by
number of doses and time since last dose receipt for adults ≥50 years, Dec 2021– Mar 2022, by
immunocompromised status
Adapted from Britton et al. MMWR: https://www.cdc.gov/mmwr/volumes/71/wr/mm7142a4.htm . Individuals with prior infections excluded. Logistic regression conditioned on calendar
week and geographic area, and adjusted for age, sex, race, ethnicity, local virus circulation, respiratory or nonrespiratory  underlying medical conditions, and propensity to be vaccinated 11-40 -20 0 20 40 60 80 100
Vaccine  E ff ectiveness (%)   Immunocompromised     Not immunocompromised
VE of original mRNA doses vs. unvaccinated persons during Delta and early Omicron was higher among non -immunocompromised adults.  An
additional dose restored/increased protection in immunocompromise and non -immunocompromised, with some waning apparent.
Adjusted VE% (95% CI)
Vaccination
status/days since doseImmunocompromised Not immunocompromised
2 doses
14-59 days 38 (-25-71) 81 (70- 88)
60-119 days 27 (-7-51) 74 (66- 80)
120-179 days 33 (6- 52) 64 (56- 71)
180-239 days 35 (13- 51) 60 (53- 61)
240-299 days 39 (27- 50) 57 (53- 61)
300+ days 42 (29- 52) 66 (62- 69)
3 doses
14-59 days 81 (75- 85) 93 (91- 94)
60-119 days 74 (68- 78) 91 (90- 92)
120-179 days 49 (37- 58) 84 (81- 87)VISION: Original monovalent vs. unvaccinated  mRNA VE for COVID -19-associated hospitalization  by
number of doses and time since last dose receipt for adults ≥50 years, Dec 2021– Mar 2022, by
immunocompromised status
Adapted from Britton et al. MMWR: https://www.cdc.gov/mmwr/volumes/71/wr/mm7142a4.htm . Individuals with prior infections excluded. Logistic regression conditioned on calendar
week and geographic area, and adjusted for age, sex, race, ethnicity, local virus circulation, respiratory or nonrespiratory  underlying medical conditions, and propensity to be vaccinated 12-40 -20 0 20 40 60 80 100
Vaccine  E ff ectiveness (%)   Immunocompromised     Not immunocompromised
VE of original mRNA doses vs. unvaccinated persons during Delta and early Omicron was higher among non -immunocompromised adults.  An
additional dose restored/increased protection in immunocompromise and non -immunocompromised, with some waning apparent.
IVY: Original monovalent and bivalent vs. unvaccinated mRNA VE against COVID -19-associated
hospitalization by time since last dose receipt for adults ≥18 years, September 2022 –August
2023, by immunocompromised status
DeCuir J. medRxiv 2024.01.07.24300910; doi:https://doi.org/10.1101/2024.01.07.24300910
A dose of bivalent vaccine added protection among those >1 year from their last original monovalent dose during Omicron predo minance.
IVY: Original monovalent and bivalent vs. unvaccinated mRNA VE against COVID -19-associated
hospitalization by time since last dose receipt for adults ≥18 years, September 2022 –August
2023, by immunocompromised status
DeCuir J. medRxiv 2024.01.07.24300910; doi:https://doi.org/10.1101/2024.01.07.24300910
A dose of bivalent vaccine added protection among those >1 year from their last original monovalent dose during Omicron predo minance.
IVY: Original monovalent and bivalent vs. unvaccinated mRNA VE against COVID -19-associated
hospitalization by time since last dose receipt for adults ≥18 years, September 2022 –August
2023, by immunocompromised status
DeCuir J. medRxiv 2024.01.07.24300910; doi:https://doi.org/10.1101/2024.01.07.24300910
A dose of bivalent vaccine added protection among those >1 year from their last original monovalent dose during Omicron predo minance.
VISION: VE of 2023 -2024 vs. no 2023 -2024  COVID -19 vaccine against COVID -19-associated
hospitalization among adults aged ≥18 years, by immunocompromise status
September 2023 – August 2024
16Adjusted VE% (95% CI)
Days since
vaccinationImmunocompromised Not immunocompromised
7-59 days 36 (22- 48) 51 (45- 56)
60-119 days 23 (6- 36) 42 (35- 48)
120-179 days 1 (-28-23)* 15 (3- 26)
-40 -20 0 20 40 60 80 100
Vaccine  E ff ectiveness (%)   Immunocompromised     Not immunocompromised
During the 2023- 2024 season, VE appeared somewhat lower in immunocompromised individuals, though waning
patterns were similar to those in non- immunocompromised individuals.
CDC, preliminary unpublished data. Individuals with prior infections excluded. Logistic regression conditioned on calendar we ek and geographic area, and adjusted for age,
sex, race, ethnicity, local virus circulation, respiratory or nonrespiratory underlying medical conditions, and propensity to  be vaccinated
Conclusions: VE among those with
immunocompromising conditions
•COVID -19 vaccines provided protection for both persons with and without
immunocompromise.
•Patterns of COVID -19 VE in immunocompromised were different season- to-season, with
generally lower VE compared to non- immunocompromised, but inconsistent waning
patterns.
-During 2023- 2024, VE against hospitalization in immunocompromised waned to 0 by ~4 -6
months.
•This inconsistency is likely multifactorial, including:
-Heterogeneity among those classified as immunocompromised
-Variation in underlying immunity and response to prior  infection
-Differing health behav iors (e.g., masking, social distancing) over time and by immunocompromise status
17
COVID -19 VE data to inform need for an
additional COVID -19 vaccine dose for
adults aged ≥65 years
COVID -19 VE against COVID- 19-associated hospitalization  wanes over time, but is more
sustained against COVID -19-associated critical illness , though some waning is evident
Data from VISION and IVY showing VE by vaccine formulation of most recent dose.
-20020406080100
7-59 or 14-59 60-119 120-179 180-239* 240-299* 300-364* 365+Vaccine effectiveness (%)
Days since last dose
Recipients of bivalent and 2023 -2024 doses included in this analysis received a single dose of the most recent formulation.
Sources: DeCuir, et al., MMWR 2023/  Lin k-Gelles, ACIP Slides, April 20, 2022 ; CDC unpublished data updated from Link -Gelles, ACIP Slides, June 23, 2023 ; CDC unpublished data updated from: Link -Gelles, ACIP Slides, June 27, 2024
* For original monovalent doses, VE for hospitalization was for 180 -364 days from last dose combined. For 2023- 2024 doses, VE fo r hospitalization was for ≥180 days combined, with a median of 228 days (IQR: 202 -259).Hosp italization Critical illness
Original monovalent (adults aged 50+; ref: unvaccinated)
Bivalent (adults aged 18+; ref: unvaccinated)
2023- 2024 (adults aged 18+; ref: no 2023- 2024 dose)
SARS -CoV-2 variant period/
mRNA dosage pattern/
days since doseMedian (IQR) days
from last doseVaccinated
case-patients
 no./total no. (%)Vaccinated
control -patients,
no./total no. (%)Adjusted VE (95% CI)   s
BA.1/BA.2 period
2 original monovalent doses
14-150 days 111 (87 –130) 62/771 (8) 79/514 (15) 63 (46 –75)
>150 days 290 (241 –351) 471/1,180 (40) 404/839 (48) 34 (20 –46)
3 original monovalent doses
7-120 days 80 (55 –100) 167/876 (19) 393/828 (47) 79 (74 –84)
>120 days 180 (154 –208) 265/974 (27) 301/736 (41) 41 (23 –55)
BA.4/BA.5 period
2 original monovalent doses
14-150 days 102 (77 –123) 3/189 (2) 13/168 (8) 83 (35 –96)
>150 days 430 (329 –471) 128/314 (41) 168/323 (52) 37 (12 –55)
3 original monovalent doses
7-120 days 74 (33 –110) 13/199 (7) 24/179 (13) 60 (12 –81)
>120 days 237 (204 –269) 219/405 (54) 208/363 (57) 29 (3 –48)IVY: Original monovalent vs. unvaccinated VE against COVID -19-associated hospitalization
among immunocompetent adults ≥18 years, by Omicron sublineage period
December 2021- August 2022
Surie and Bonnell, et al. MMWR, https://www.cdc.gov/mmwr/volumes/71/wr/mm7142a3.htm  200 20 40 60 80 100
VE of an additional original monovalent dose provided increased protection during Omicron with similar waning patterns for 2 and 3 doses.
SARS -CoV-2 variant period/
mRNA dosage pattern/
days since doseTotalSARS -CoV-2-
test-positive,
N (%)Median interval
since last dose,
days (IQR)Adjusted VE (95% CI)
BA.4/BA.5 period
Unvaccinated (ref) 2,971 743 (25) --
2 original monovalent doses
14-149 days 77 14 (18) 80 (57- 105) --
≥150 days 2828 556 (20) 473 (422- 503) 31 (21- 39)
3 original monovalent doses
7-119 days 289 26 (9) 72 (42- 98) 73 (55 -84)
≥120 days 4838 913 (19) 240 (211- 266) 38 (30- 46)
4 original monovalent doses
7-59 days 765 89 (12) 38 (23- 50) 66 (53 -75)
≥60 days 1549 210 (14) 88 (75- 105) 57 (44 -66)VISION: Original monovalent vs. unvaccinated VE against COVID- 19-
associated hospitalization  among immunocompetent adults ≥65 years
June -August 2022
Link-Gelles, et al. JAMA Network Open, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2802473 , 2023 210 20 40 60 80 100
VE of an additional original monovalent dose provided increased protection during Omicron with similar waning patterns for 2 and 3 doses.
IVY: Original monovalent and bivalent vs. unvaccinated  VE against COVID -19-
associated severe in -hospital outcomes among adults aged ≥18 years without
immunocompromising conditions
DeCuir et al., 2024, under reviewVE of COVID -19 vaccines was most durable against the most severe outcomes.
mRNA Dosage Pattern/time since doseNo. of
beneficiariesNo. of
COVID -19
related TETotal no. of
person -daysMedian follow-
up days
contributed to
categoryAdjusted VE (95% CI)
Original monovalent vaccine dose (ref) 7,022,968 17,746 1,505,533,898 181 Ref
Bivalent dose 5,683,208 4,255 694,184,995 130 47 (45– 49)
Bivalent dose 7 -59 days earlier 350,021 1,492 294,516,234 53 54 (51– 56)
Bivalent dose ≥60 days earlier 5,333,187 2,763 399,668,761 77 42 (39– 45)
0 20 40 60 80 100
Vaccine  Effectiveness (%)Medicare: VE of bivalent  vs. original monovalent COVID -19 vaccine
against COVID- 19-related thromboembolic events  among
immuno competent  Medicare beneficiaries aged ≥65 years
September 2022 – March 2023
VE estimates adjusted for age, sex, race and ethnicity, geographic region, and calendar time. Updated from: Link -Gelles et al., MMWR,
https://www.cdc.gov/mmwr/volumes/72/wr/mm7221a3.htm
TE = thromboembolic event*A COVID -19–related thromboembolic event was defined as presence of an International Classification of Disease, 10th
Edition  (ICD -10) or common procedural terminology (CPT) code indicating ischemic stroke, venous thromboembolism, or
myocardial infarction from 7 days before through 30 days after a medical claim indicating a COVID –19 diagnosis.
VISION: VE of 2 vs. 1 bivalent  doses against COVID- 19-associated
hospitalization  among immuno competent  adults aged ≥65 years
September 2022 – September 2023
• VE estimates adjusted for age, sex, race and ethnicity, geographic region, and calendar time. Updated from: Link -Gelles et al., MMWR, https://www.cdc.gov/mmwr/volumes/72/wr/mm7221a3.htm
CDC unpublished datamRNA Dosage PatternTotal
encountersSARS -CoV-2-
test-positive,
N (%)Median interval
since last dose,
days (IQR)Adjusted VE
(95% CI)
Hospitalization,  2 vs. 1 bivalent doses (at least 4 months apart)
1 bivalent dose (ref) 21,825 1,894 (8) -- Ref
2 bivalent doses 599 50 (8) 50 (26- 76) 20 (-9 to 41)
-20 0 20 40 60 80 100
Vaccine  Effectiveness (%)
VE of an additional bivalent dose at least 4 months after the original bivalent dose appeared to provide some
protection, though the confidence interval was wide and crossed 0.
Age group/2023 -2024 COVID -19 vaccination
status/days since doseTotal
encountersSARS -CoV-2-
test-positive,
N (%)Median interval since
last dose among
vaccinated, days (IQR) Adjusted VE (95% CI)
≥18 years
No 2023 -2024 COVID -19 dose (ref) 266,148 29,492 (11) 750 (534 -912) Ref
2023 -2024 COVID -19 dose , 7-299 days earlier 59,366 5,079 (9) 115 (60 -185) 25 (22 to 28)
2023 -2024 COVID -19 dose , 7-59 days earlier 14,801 1,112 (8) 34 (21 -47) 48 (45 to 52)
2023 -2024 COVID -19 dose , 60-119 days earlier 16,101 1,338 (8) 88 (73 -103) 28 (23 to 32)
2023 -2024 COVID -19 dose , 120 -179 days earlier 12,636 766 (6) 147 (133 -163) 17 (10 to 23)
2023 -2024 COVID -19 dose , 180-299 days earlier 15,828 1,863 (12) 229 (203 -258) -5 (-11 to 1)
18-64 years
No 2023- 2024 COV I D -19 dose (ref) 189,980 19,809 (10) 783 (617 -928) Ref
2023 -2024 COVID -19 dose , 7-299 days earlier 20,563 1,545 (8) 112 (58 -182) 25 (21 to 29)
2023 -2024 COVID -19 dose , 7-59 days earlier 5,341 318 (6) 34 (20 -47) 54 (49 to 59)
2023 -2024 COVID -19 dose , 60-119 days earlier 5,566 366 (7) 88 (74 -104) 32 (25 to 39)
2023 -2024 COVID -19 dose , 120 -179 days earlier 4,387 227 (5) 147 (133 -163) 16 (4 to 27)
2023 -2024 COVID -19 dose , 180-299 days earlier 5,269 634 (12) 228 (202 -256) -19 (-30 to -8)
≥65 years
No 2023- 2024 COV I D -19 dose (ref) 76,168 9,683 (13) 661 (431 -860) Ref
2023 -2024 COVID -19 dose , 7-299 days earlier 38,803 3,534 (9) 116 (61 -187) 25 (22 to 28)
2023 -2024 COVID -19 dose , 7-59 days earlier 9,460 794 (8) 34 (21 -47) 45 (40 to 49)
2023 -2024 COVID -19 dose , 60-119 days earlier 10,535 972 (9) 88 (73 -103) 25 (20 to 31)
2023 -2024 COVID -19 dose , 120 -179 days earlier 8,249 539 (7) 148 (133 -163) 20 (11 to 27)
2023 -2024 COVID -19 dose , 180-299 days earlier 10,559 1,229 (12) 230 (203 -259) 1 (-7 to 8)VISION: VE of 2023 -2024 COVID -19 vaccine against COVID -19-associated ED/UC
encounters among immunocompetent adults aged ≥18 years, by age group
September 2023 – August 2024
https://www.cdc.gov/mmwr/volumes/73/wr/mm7308a5.htm  (Results updated with additional data since publication.) VE was calculated as (1 − odds ratio) x 100%, estimated using a tes t-negative case- control
design, with the odds ratio adjusted for age, sex, race and ethnicity, geographic region, and calendar time. -40 -20 0 20 40 60 80 100
VISION: VE of 2023- 2024 COVID -19 vaccine against COVID -19-associated
hospitalization among immunocompetent adults aged ≥18 years, by age group
September 2023 – August 2024
*Some estimates are imprecise, which might be due to a relatively small number of persons in each level of vaccination or case  status. This imprecision indicates that the actual VE could be substantially different from the point estimate shown, and estim ates
should therefore be interpreted with caution. Additional data accrual could increase precision and allow more precise interpr etation.
https://www.cdc.gov/mmwr/volumes/73/wr/mm7308a5.htm  (Results updated with additional data since publication.) VE was calculated as (1 − odds ratio) x 100%, estimated using a tes t-negative case -control design, adjusted for age, sex, race and ethnicity,
geographic region, and calendar time.Age group/2023 -2024 COVID -19 vaccination
status/days since doseTotal
encountersSARS -CoV-2-
test-positive,
N (%)Median interval since
last dose among
vaccinated, days (IQR) Adjusted VE (95% CI)
≥18 years
No 2023 -2024 COVID -19 dose (ref) 83,596 8,025 (10) 728 (499 -911) Ref
2023 -2024 COVID -19 dose , 7-299 days earlier 21,468 1,664 (8) 120 (62 -189) 30 (25 to 34)
2023 -2024 COVID -19 dose , 7-59 days earlier 5,095 382 (8) 34 (21 -47) 50 (44 to 55)
2023 -2024 COVID -19 dose , 60-119 days earlier 5,623 431 (8) 88 (74 -104) 38 (31 to 44)
2023 -2024 COVID -19 dose , 120 -179 days earlier 4,754 268 (6) 148 (134 -164) 21 (10 to 31)
2023 -2024 COVID -19 dose , 180-299 days earlier 5,996 583 (10) 227 (202 -257) -8 (-19 to 3)
18-64 years
No 2023 -2024 COVID -19 dose (ref) 33,335 2,076 (6) 783 (600 -934) Ref
2023 -2024 COVID -19 dose , 7-299 days earlier 3,694 201 (5) 116 (61 -182) 16 (1 to 28)
2023 -2024 COVID -19 dose , 7-59 days earlier 903 57 (6) 33 (21 -45) 26 (3 to 44)
2023 -2024 COVID -19 dose , 60-119 days earlier 999 47 (5) 89 (75 -104) 34 (11 to 51)
2023 -2024 COVID -19 dose , 120 -179 days earlier 834 26 (3) 148 (135 -164) 28 (-8 to 51)*
2023 -2024 COVID -19 dose , 180-299 days earlier 958 71 (7) 226 (199 -254) -35 (-76 to -4)*
≥65 years
No 2023 -2024 COVID -19 dose (ref) 50,261 5,949 (12) 692 (460 -890) Ref
2023 -2024 COVID -19 dose , 7-299 days earlier 17,774 1463 (8) 121 (63 -190) 31 (27 to 36)
2023 -2024 COVID -19 dose , 7-59 days earlier 4,192 325 (8) 34 (21 -47) 53 (47 to 59)
2023 -2024 COVID -19 dose , 60-119 days earlier 4,624 384 (8) 88 (74 -104) 38 (30 to 44)
2023 -2024 COVID -19 dose , 120 -179 days earlier 3,920 242 (6) 148 (134 -164) 19 (7 to 30)
2023 -2024 COVID -19 dose , 180-299 days earlier 5,038 512 (10) 228 (202 -257) -4 (-16 to 7)
-80 -60 -40 -20 020 40 60 80 100
VISION: VE of 2023- 2024 COVID -19 vaccine against COVID -19-associated
hospitalization and critical illness among adults aged ≥18 years
September 2023 – August 2024
Additional methods, including definition of immunocompromised available: https://www.cdc.gov/mmwr/volumes/73/wr/mm7308a5.htm  (Results updated with additional data since publication.) VE was
calculated as (1 − odds ratio) x 100%, estimated using a test -negative case- control design, with odds ratios adjusted for age, s ex, race and ethnicity, geographic region, and calendar time.
* Some estimates are imprecise, which might be due to a relatively small number of persons in each level of vaccination or ca se status. This imprecision indicates that the actual VE could be substantially
different from the point estimate shown, and estimates should therefore be interpreted with caution. Additional data accrual could increase precision and allow more precise interpretation. Age group/2023 -2024 COVID -19 vaccination
status/days since doseTotal
encountersSARS -CoV-2-
test-positive,
N (%)Median interval since
last dose among
vaccinated, days (IQR) Adjusted VE (95% CI)
≥18 years, hospitalization
No 2023 -2024 COVID -19 dose (ref) 83,596 8,025 (10) 728 (499 -911) Ref
2023 -2024 COVID -19 dose , 7-299 days earlier 21,468 1,664 (8) 120 (62 -189) 30 (25 to 34)
2023 -2024 COVID -19 dose , 7-59 days earlier 5,095 382 (8) 34 (21 -47) 50 (44 to 55)
2023 -2024 COVID -19 dose , 60-119 days earlier 5,623 431 (8) 88 (74 -104) 38 (31 to 44)
2023 -2024 COVID -19 dose , 120 -179 days earlier 4,754 268 (6) 148 (134 -164) 21 (10 to 31)
2023 -2024 COVID -19 dose , 180-299 days earlier 5,996 583 (10) 227 (202 -257) -8 (-19 to 3)
≥18 years, critical illness
No 2023 -2024 COVID -19 dose (ref) 76,965 1,394 (2) 730 (503 -913) Ref
2023 -2024 COVID -19 dose , 7-299 days earlier 20,010 206 (1) 119 (62 -187) 50 (42 -58)
2023 -2024 COVID -19 dose , 7-59 days earlier 4,758 45 (1) 34 (21 -46) 67 (55 -75)
2023 -2024 COVID -19 dose , 60-119 days earlier 5,248 56 (1) 89 (74 -104) 56 (42 -67)
2023 -2024 COVID -19 dose , 120 -179 days earlier 4,523 37 (1) 149 (134 -164) 40 (16 -58)
2023 -2024 COVID -19 dose , 180-299 days earlier 5,481 68 (1) 226 (201 -256) 21 (-3-40)
-80 -60 -40 -20 020 40 60 80 100
Outcome Analysis Vaccine effectiveness, % (95% CI)
Thromboembolic events* Medicare, ESKD adults ≥65y, 2023- 2024 vaccine, median follow -up days=74 53 (23 -71)
Death Medicare, E SK D adults ≥65y , 2023- 2024 vaccine, med ian follow -up days=104 47 (15 -67)
ICU admission/deathV ISION, adults ≥65y, 2023- 2024 vaccine, med ian follow -up days=34 69 (57 -78)
V ISION, adults ≥65y, 2023- 2024 vaccine, med ian follow -up days=89 56 (42 -68)
V ISION, adults ≥65y, 2023- 2024 vaccine, med ian follow -up days=149 43 (18 -60)Effectiveness of 2023- 2024 COVID -19 vaccines against COVID -19-associated critical
outcomes in immunocompetent adults ≥65 years, Medicare and VISION data
CDC unpublished data. Medicare analysis includes only Medicare fee -for-service beneficiaries.0 20 40 60 80 100 Abbreviations: ESKD = end stage kidney disease; y = years; IMV = invasive mechanical ventilation; ICU = intensive care unit
*A COVID -19–related thromboembolic event was defined as presence of an International Classification of Disease, 10th
Edition  (ICD -10) or common procedural terminology (CPT) code indicating ischemic stroke, venous thromboembolism, or
myocardial infarction from 7 days before through 30 days after a medical claim indicating a COVID –19 diagnosis.
•VE findings should be interpreted as the added benefit provided by COVID -19 vaccination in a population with a
high prevalence of vaccine - and infection- induced immunity at the start of the 2023- 2024 respiratory virus season.
•2023- 2024 COVID -19 vaccination provided increased protection against COVID -19-associated ED/UC visits and
hospitalizations compared to no 2023- 2024 vaccine dose.
-Protection waned to 0 against COVID -19-associated ED/UC visits and hospitalization by ~4 -6 months.
•Waning patterns of 2023- 2024 COVID -19 vaccines appeared similar to previous COVID -19 vaccine formulations;
most durable protection appeared to be for critical illness
-VE against critical illness remained above 40% at 5 months after vaccination among those ≥65 years
•As with previous COVID -19 vaccine formulations, effectiveness was similar across age groups
•Data from prior seasons show that an additional dose of the same formula appeared to provide additional
protection.  Conclusions: COVID- 19 VE in adults ≥65 years
Acknowledgements
CDC
Amanda B. Payne
Katherine E. Fleming -Dutra
Lakshmi PanagiotakopoulosLauren Roper
Amadea Britton
Allison CieslaFatimah Dawood
Jennifer DeCuir
Monica Dickerson
Sascha Ellington
Shikha GargAmber Kautz
Nathaniel M. Lewis
Kevin Ma
Josephine Mak
Joe MillerMorgan Najdowski
Zach Smith
Diya Surie
Caitlin Ray
Ryan WiegandVISION Collaborators
WestatSarah Ball
Angela Cheung
Margaret Dunne
Patrick Mitchell
Sarah ReeseElizabeth Rowley
Janet Watts
Zack Weber
Intermountain Health
Kristin Dascomb
Kaiser Permanente Center for Health Research
Stephanie A. Irving
Kaiser Permanente Northern California
Nicola P. Klein
Regenstrief
Shaun J. Grannis
University of Colorado
Toan C. Ong
HealthPartners
Malini B. DeSilva
Columbia University
Karthik NatarajanIVY Collaborators
Cristie  Columbus
Laurence W. Busse
Steven Y. Chang
Abhijit Duggal
Matthew C. Exline
Manjusha GaglaniKevin W. Gibbs
Adit A. Ginde
David N. HagerEstelle S. Harris
Cassandra JohnsonNicholas J. Johnson
Akram Khan
Jennie H. KwonAdam S. Lauring
Christopher MallowEmily MartinAmira MohamedNicholas M. Mohr
Jarrod M. Mosier
Ithan  D. Peltan
Matthew Prekker
Basmah  Safdar
Wesley H. SelfNathan I. Shapiro
Jay S. Steingrub
Ivana A. Vaughn
Jennifer G. Wilson
Yuwei Zhu
CMS Collaborators
CMS
Alia Bayatti
AcumenHeng -Ming Sung
Ivy Zhang
Carla Gomez Victor
Yenlin  Lai
Bradley LufkinYoganand Chillarige
+ many more!

Summary: Effectiveness of COVID -19 vaccines  Ruth Link -Gelles, PhD, MPH CDR, US Public Health Service Vaccine Effectiveness Program LeadCoronavirus and Other Respiratory Viruses DivisionCenters for Disease Control and Prevention October 23, 2024National Center for Immunization and Respiratory Diseases   •VE data to inform need for: -Additional doses in immunocompromised •What’s known about VE in immunocompromised vs. non- immunocompromised adults, including waning by time since dose -Additional dose…


05 COVID Prosser 508

Economic analysis of an
additional dose of the
2024 -2025 COVID -19 vaccine
University of Michigan
COVID -19 Vaccination Modeling Team
Presentation to the Advisory Committee on Immunization Practices
October 23, 2024
1
Study team
University of Michigan
•Lisa A. Prosser, PhD, Principal Investigator
•David W. Hutton, PhD, Co -Investigator
•Acham Gebremariam, MS, Programmer/Analyst
•Angela Rose, MS, MPH, Project Manager
•Kerra Mercon, MS, Research Assistant
Wake Forest University
•Cara Janusz, PhDCenters for Disease Control and Prevention
•Jamie Pike, PhD, Health Economist, Project officer
•Megan Wallace, DrPH, Epidemiologist
•Ismael Ortega -Sanchez, PhD, Senior Economist
•Andrew Leidner, PhD, Economist
•Fangjun Zhou, PhD, Health Scientist
•Melisa Shah, MD, MPH, Medical Epidemiologist
•Danielle Moulia, MPH, Health Scientist
•Ruth Link -Gelles, PhD, Epidemiologist
•Sharon Saydah, PhD, Epidemiologist
2
Conflict of interest statement
3Authors have no known conflicts of interest.
Objectives
•Original aims*:
oEstimate annual disease burden and healthcare utilization associated with COVID -19
illness and COVID- 19 booster vaccination, including cases of symptomatic illness,
hospitalizations, deaths, adverse events, costs, and quality- adjusted life years
oProject cost- effectiveness of an updated mRNA booster against COVID -19-associated
illness in persons ages ≥18 years
•Update s to the current version of the model (Phase 3B):
o2-dose strategy (an additional mid- year dose)
o2023- 2024 hospitalization rates (COVID- NET data)
oVaccine dose costs reflect CDC -negotiated 2024- 2025 prices
oAll cost inputs adjusted to 2024$
4* Earlier analyses from this model were presented to ACIP in September 2023, February 2024, and June 2024: Prosser, Lisa A. (2023). Economic Analysis of Vaccination
with mRNA Booster Dose against COVID -19 Among Adults; Prosser, Lisa A (2024). Economic analysis of an additional dose of COVID -19 vaccine; Prosser, Lisa A (2024).
Economic Analysis of COVID -19 Vaccination.
Weekly rates of
COVID -19
associated
hospitalizations
by season, all
ages
52021- 2022
2020- 2021
2019- 2020
2023- 20242022- 2023Hospitalization rate per 100,000
Oct       Nov       Dec      Jan        Feb      Mar       Apr      May      Jun       Jul      Aug      Sep
40
30
20
10
0Input data for Phase 3b model
Source: COVID -NET
Probability of hospitalization due to COVID -19 illness
Age groups 2023- 2024 2022- 2023 % change
5-11 years 0.000105 0.000133 -21%
12-17 years 0.000139 0.000181 -23%
18-49 years 0.000299 0.000443 -33%
50-64 years 0.001184 0.001551 -24%
>65 years 0.006778 0.007901 -14%
6Source: COVID -NET
Updated seasonality -adjusted vaccine impact*
Health outcomes AgeSeasonality -adjusted vaccine impact
1-dose strategy 2-dose strategy
Base case Low High Base case Low High
•Symptomatic illness (non -
hospitalized)
•Hospitalization,
uncomplicated5-11 y 0.375 0.112 0.705 0.512 0.158 0.716
12-17 y 0.379 0.110 0.704 0.501 0.143 0.711
18-49 y 0.295 0.106 0.442 0.404 0.144 0.482
50-64 y 0.310 0.118 0.453 0.416 0.157 0.492
>65 y 0.315 0.121 0.455 0.422 0.163 0.498
•Critical illness**
•Death5-11 y 0.375 0.112 0.705 0.512 0.158 0.716
12-17 y 0.379 0.110 0.704 0.501 0.143 0.711
18-49 y 0.391 0.221 0.662 0.527 0.355 0.666
50-64 y 0.402 0.234 0.665 0.534 0.366 0.670
>65 y 0.410 0.238 0.665 0.536 0.369 0.671
Source: COVID -NET, VISION, and IVY* Updated hospitalization rates Oct 23 - Sept 24
**Hospitalization requiring ICU and/or ventilator assistance7
Seasonality -adjusted vaccine impact,
2023 -2024 v. 2024 -2025
Age group 1-dose 2-dose
Seasonality -adjusted vaccine impact against symptomatic illness or hospitalization
5-11 years -11% -1%
12-17 years -10% -6%
18-49 years -18% -6%
50-64 years -13% -5%
65+ years -9% -3%
Seasonality -adjusted vaccine impact against critical care (hospitalization with ICU stay or death)
5-11 years -11% -1%
12-17 years -10% -6%
18-49 years -15% -3%
50-64 years -12% -3%
65+ years -9% -2%
8
Vaccine dose cost, 2023 -2024 v. 2024 -2025
92023 2024
%
change CDCPrivate
sector % VFC or
BridgeBase
caseCDC  Private
sector% VFC or
BridgeBase
case
5-11 y
Pfizer $65.45 $77.0050% $89.09$65.45 $77.0054% $88.25 -1%Moderna $85.91 $128.00 $85.91 $129.00
12-17 y
Pfizer $97.75 $115.0050% $102.44$99.71 $136.7554% $114.18 10%Moderna $85.91 $128.00 $85.91 $141.80
18+ y
Pfizer $97.75 $115.0012.8% $118.73$99.71 $136.75NA $139.28 15%Moderna $85.91 $128.00 $85.91 $141.80
Source: CDC Vaccine Price List
Additional assumptions: 2 -dose strategy
•Adverse events: Twice the number of the 1 -dose strategy
•Costs of vaccination: Twice the cost of the 1 -dose strategy
•See additional slides
10
Analysis Plan
•Conduct base case and uncertainty analyses (one -way sensitivity and scenario
analyses) comparing no vaccination, 1 -dose, and 2 -dose strategies
•Project disaggregated outcomes stratified by intervention strategy and by age
subgroups (5 -11y, 12- 17y, 18- 49y, 50- 64y, >65y) – supplemental slides
oCases
oHospitalizations
oICU
oLong COVID
oDeaths
oCosts
oQALYs
oAdverse events
***This presentation reports preliminary results from the fourth phase of an ongoing analysis***
11
•Multi -way sensitivity analyses/parameter sets
oVaccination -related costs
oVaccination settings
oHospitalization and critical illness
•Scenario analyses
oSeasonality adjusted vaccine impact
oAlternative seasonality scenarios
oProbability of hospitalization - proxy for lower and higher risk cohorts
oProbability of critical care - proxy for higher risk cohorts
oProbability of symptomatic illness
oVaccine dose cost
•One-way sensitivity analyses
12Analysis Plan cont.: Uncertainty analyses
Results
13
Disaggregated results, per 100,000, societal perspective,
2024 -2025 vaccination, preliminary results
1405,00010,00015,00020,00025,00030,00035,00040,000
5-11 y 12-17 y 18-49 y 50-64 y ≥65 y# Events
0100200300400500600
5-11 y 12-17 y 18-49 y 50-64 y ≥65 y# Long COVID
0100200300400500600700800
5-11 y 12-17 y 18-49 y 50-64 y ≥65 y# Hospitalizations
0102030405060708090100
5-11 y 12-17 y 18-49 y 50-64 y ≥65 y# ICU stays
0510152025303540
5-11 y 12-17 y 18-49 y 50-64 y ≥65 y# Deaths
Note: Height of bars represents total outcomes without vaccination

Disaggregated results, per 100,000, societal perspective, 2024 -2025
vaccination, preliminary results
Age Intervention strategyOutcomes Outcomes Averted
CasesLong
COVIDHosp. ICU Deaths CasesLong
COVIDHosp. ICU Deaths
5-11 yNo vaccination 31,450 70.6 10.5 2.2 0.1 - - - - -
Vaccination, 1 -dose 19,656 44.1 6.6 1.3 0.1 11,794 26.5 3.9 0.8 0.0
Vaccination, 2 -dose 15,348 34.4 5.1 1.1 0.0 4,309 9.7 1.4 0.3 0.0
12-17 yNo vaccination 31,450 71.5 13.9 2.9 0.1 - - - - -
Vaccination, 1 -dose 19,530 44.4 8.6 1.8 0.1 11,919 27.1 5.3 1.1 0.0
Vaccination, 2 -dose 15,694 35.7 6.9 1.4 0.1 3,837 8.7 1.7 0.4 0.0
18-49 yNo vaccination 31,450 413.0 29.9 3.9 0.4 - - - - -
Vaccination, 1 -dose 22,172 299.1 21.1 2.4 0.2 9,278 121.8 8.8 1.5 0.2
Vaccination, 2 -dose 18,744 246.1 17.8 1.8 0.2 3,428 45.0 3.3 0.5 0.1
50-64 yNo vaccination 28,410 395.4 118.0 22.8 3.8 - - - - -
Vaccination, 1 -dose 19,603 272.8 81.4 13.6 2.3 8,807 122.6 36.6 9.2 1.5
Vaccination, 2 -dose 16,591 230.9 68.9 10.6 1.9 3,011 41.9 12.5 3.0 0.5
>65 yNo vaccination 33,390 498.2 678.0 90.9 34.4 - - - - -
Vaccination, 1 -dose 22,872 341.3 464.4 53.6 21.4 10,518 156.9 213.6 37.3 12.9
Vaccination, 2 -dose 19,299 288.0 391.9 42.2 17.3 3,573 53.3 72.6 11.5 4.1
15
Incremental cost -effectiveness ratios (ICERs), per 1000,
societal perspective, 2024 -2025 vaccination, preliminary results
Age group Intervention strategy Projected costsIncremental
costsProjected
QALYsIncremental
QALYsICER
($/QALY)
5-11 yNo vaccination $39,723 - 26,788 - -
Vaccination, 1 -dose $191,776 $152,053 26,789 0.6566 $231,570
Vaccination, 2 -dose $353,283 $161,507 26,789 0.2129 $758,268
12-17 yNo vaccination $46,010 - 24,638 - -
Vaccination, 1 -dose $214 ,115 $168,105 24,639 0.6733 $249,670
Vaccination, 2 -dose $394,045 $179,930 24,639 0.1942 $926,390
18-49 yNo vaccination $128,351 - 20,208 - -
Vaccination, 1 -dose $289,206 $160,855 20,209 0.4802 $335,010
Vaccination, 2 -dose $474,497 $185,290 20,209 0.1633 $1,134,840
50-64 yNo vaccination $218,703 - 12,278 - -
Vaccination, 1 -dose $347,499 $128,796 12,279 0.6197 $207,834
Vaccination, 2 -dose $523,448 $175,949 12,279 0.1957 $898,653
>65 yNo vaccination $336,230 - 6,525 - -
Vaccination, 1 -dose $419,404 $83,174 6,527 1.4132 $58,855
Vaccination, 2 -dose $577,132 $157,729 6,528 0.4424 $356,534
16 ICER = incremental cost effectiveness ratio; QALY = quality- adjusted life year
Incremental cost -effectiveness ratios (ICERs), adding a 2 -dose
strategy, societal perspective, 2024 -2025 vaccination,
preliminary results
Age group Intervention strategy ICER ($/QALY)
5-11 yNo vaccination -
Vaccination, 1 -dose $231,570
Vaccination, 2 -dose $758,268
12-17 yNo vaccination -
Vaccination, 1 -dose $249,670
Vaccination, 2 -dose $926,390
18-49 yNo vaccination -
Vaccination, 1 -dose $335,010
Vaccination, 2 -dose $1,134,840
50-64yNo vaccination -
Vaccination, 1 -dose $207,834
Vaccination, 2 -dose $898,653
>65 yNo vaccination -
Vaccination, 1 -dose $58,855
Vaccination, 2 -dose $356,534
17 QALY = quality -adjusted life year
$0 $50,000 $100,000 $150,000 $200,000 $250,000Productivity loss due to Long COVID (0.25, 1)Cost of nirmatrelvir-r ($0, $1494)Probability of outpatient visit given symptomatic COVID-19 (0.1996, 0.3088)Time spent to receive vaccine, physician office setting (0.17, 2)Lifetime productivity loss ($189191, $378382)(Quality adjustment for symptomatic COVID-19 (0.0018, 0.0074)Probability of symptomatic COVID-19 (0.2312, 0.451)Cost of vaccine dose ($30, $140)Probability of hospitalization (0.00235, 0.0209)SAVI*
$/QALY1-way sensitivity analyses, 1 -dose strategy, >65 y
18Note: Numbers in parenthesis indicate range of input values
* Seasonality adjusted vaccine impact (SAVI) against hospitalization 1 -dose: 0.121, 0.455; SAVI against critical illness 1- dose:  0.238, 0.665
QALY = quality -adjusted life year; ICER = incremental cost effectiveness ratio; SAVI = seasonality -adjusted vaccine impact; CS =  cost-saving
CS
CS
Base case: $58,855
1-way sensitivity analyses, 2 -dose strategy, >65 y
19Note: Numbers in parenthesis indicate range of input values
* Seasonality adjusted vaccine impact (SAVI) against hospitalization 2 -dose: 0.163, 0.498; SAVI against critical illness 2- dose:  0.369, 0.671
QALY = quality -adjusted life year; ICER = incremental cost effectiveness ratio; SAVI = seasonality -adjusted vaccine impact
Base case: $356,534 $0 $500,000 $1,000,000 $1,500,000 $2,000,000Probability of death given ICU, no ventilator (0.105, 0.162)Probability of death given ICU with ventilator (0.466, 0.599)Probability of systemic reaction (0.107, 0.171)Quality adjustment for systemic reaction (0.0001, 0.0004)Time spent to receive vaccine, physician office setting (0.17, 2)Probability of symptomatic COVID-19 illness (0.2312, 0.451)Quality adjustment for symptomatic COVID-19 (0.0018, 0.0074)Cost of vaccine dose ($30, $140)Probability of hospitalization given symptomatic COVID-19 (0.00235, 0.0209)SAVI *
$/QALY
ICERs, 1 -way sensitivity analysis, probability of
hospitalization, societal perspective, 2024 -2025 vaccination,
preliminary results
*Probability of hospitalization inputs, base case (range):  5-11 y: 0.000105 (0.0000168 - 0.000336); 12-  17 y: 0.000139 (0.0000252 - 0.000456);
18-49 y: 0.000299 (0.0000799 - 0.00204); 50-64 y: 0.00118 (0.000348 - 0.00479); >65 y  0.00678 (0.00235 - 0.02090)
ICER = incremental cost -effectiveness ratio; QALY = quality- adjusted life yearAge group Intervention strategyICER ($/QALY)
Base case Lower bound Upper bound
5-11 yVaccination, 1 -dose $231,570 $237,799 $216,062
Vaccination, 2 -dose $758,268 $773,808 $719,816
12-17 yVaccination, 1 -dose $249,670 $256,907 $230,464
Vaccination, 2 -dose $926,390 $944,391 $878,879
18-49 yVaccination, 1 -dose $335,010 $363,084 $183,058
Vaccination, 2 -dose $1,134,840 $1,207,451 $746,171
50-64 yVaccination, 1 -dose $207,834 $309,213 $29,782
Vaccination, 2 -dose $898,653 $1,208,636 $373,246
>65 yVaccination, 1 -dose $58,855 $163,421 Cost saving
Vaccination, 2 -dose $356,534 $682,429 $99,455
20
ICER, scenario analysis varying probability of hospitalization,
societal perspective, 2024 -2025 vaccination,
preliminary results
21Age
groupIntervention strategyICER ($/QALY)
¼ base case ½ base case Base case 2x base case 3x base case 4x base case
5-11 yVaccination, 1 -dose $237,123 $235,256 $231,570 $224,381 $217,426 $210,693
Vaccination, 2 -dose $772,119 $767,458 $758,268 $740,400 $723,184 $706,585
12-17 yVaccination, 1 -dose $256,292 $254,067 $249,670 $241,081 $232,755 $224,680
Vaccination, 2 -dose $942,860 $937,321 $926,390 $905,095 $884,525 $864,645
18-49 yVaccination, 1 -dose $363,779 $353,853 $335,010 $300,917 $270,898 $244,263
Vaccination, 2 -dose $1,209,252 $1,183,547 $1,134,840 $1,046,999 $969,960 $901,847
50-64 yVaccination, 1 -dose $317,597 $274,393 $207,834 $121,533 $68,015 $31,582
Vaccination, 2 -dose $1,234,636 $1,101,255 $898,653 $641,036 $484,085 $378,439
>65 yVaccination, 1 -dose $192,897 $127,480 $58,855 $1,483 Cost saving Cost saving
Vaccination, 2 -dose $775,607 $569,600 $356,534 $180,751 $103,912 $60,824
Adjusted risk of hospitalization by underlying condition: hypertension: 2.8, coronary artery disease: 1.3, history of stroke:  0.9, diabetes: 3.2, obesity: 2.9,
severe obesity: 4.4, chronic kidney disease: 4.0, asthma: 1.4, chronic obstructive pulmonary disease: 0.9 . Ko et al 2021.
ICER = incremental cost effectiveness ratio; QALY = quality- adjusted life year
ICER, scenario analysis varying probability of hospitalization*,
age >65, societal perspective, 2024 -2025 vaccination,
preliminary results
22Age
groupIntervention strategyICER ($/QALY)
¼ base case
(169 per
100,000)½ base case
(339 per
100,000)Base case
(678 per
100,000)2x base case
(1356 per
100,000)3x base case
(2033 per
100,000)4x base case
(2711 per
100,000)
>65 yVaccination, 1 -dose $192,897 $127,480 $58,855 $1,483 Cost saving Cost saving
Vaccination, 2 -dose $775,607 $569,600 $356,534 $180,751 $103,912 $60,824
*Adjusted risk of hospitalization by underlying condition: chronic obstructive pulmonary disease: 0.9, history of stroke: 0.9 , coronary artery
disease: 1.3, asthma: 1.4, hypertension: 2.8, obesity: 2.9, diabetes: 3.2, chronic kidney disease: 4.0, severe obesity: 4.4. Ko et al 2021.
ICER = incremental cost -effectiveness ratio; QALY = quality- adjusted life year
ICER, scenario analysis varying probability of critical care,
societal perspective, 2024 -2025 vaccination,
preliminary results
23Age group Intervention strategyICER ($/QALY)
Base case* 2x 3x 4x
5-11 yVaccination, 1 -dose $231,570 $226,638 $221,839 $217,169
Vaccination, 2 -dose $758,268 $744,568 $731,285 $718,401
12-17 yVaccination, 1 -dose $249,670 $245,073 $240,586 $236,205
Vaccination, 2 -dose $926,390 $912,162 $898,312 $884,826
18-49 yVaccination, 1 -dose $335,010 $310,742 $288,947 $269,266
Vaccination, 2 -dose $1,134,840 $1,066,161 $1,004,627 $949,177
50-64 yVaccination, 1 -dose $207,834 $146,192 $105,154 $75,870
Vaccination, 2 -dose $898,653 $692,143 $556,444 $460,466
>65 yVaccination, 1 -dose $58,855 $28,898 $12,731 $2,614
Vaccination, 2 -dose $356,534 $239,110 $175,202 $135,015
*Base case probability of  ICU given hospitalization: 5 -11 y - 0.205; 12- 17 y - 0.208; 18- 49 y -  0.130; 50- 64 y - 0.193, >65 y - 0.134
Adjusted risk ratios for ICU: 1 condition: 1.32, 2- 5 conditions: 1.60, 6- 10 conditions: 1.84, >10 conditions: 1.96. Underlying c onditions: Essential hypertension,
Disorders of lipid metabolism, Obesity, Diabetes with complication, Coronary atherosclerosis and other heart disease, Esophag eal disorders, Chronic kidney disease,
Anxiety and fear -related disorders, COPD and bronchiectasis, Thyroid disorders, Depressive disorders, Implant device or graft -related encounter, Sleep -wake
disorders, Neurocognitive disorders, Osteoarthritis, Aplastic anemia, Diabetes without complication, Asthma. Source: Kompaniyets  et al 2021.
ICER = incremental cost effectiveness ratio; QALY = quality -adjusted life year
Scenario analysis: vaccination -related costs, societal
perspective, 2024 -2025 vaccination, preliminary results
Age group Intervention strategyICER ($/QALY)
Base case All lower All upper
5-11 yVaccination, 1 -dose $231,570 $103,396 $353,999
Vaccination, 2 -dose $758,268 $363,134 $1,135,689
12-17 yVaccination, 1 -dose $249,670 $92,955 $325,103
Vaccination, 2 -dose $926,390 $383,118 $1,187,889
18-49 yVaccination, 1 -dose $335,010 $71,945 $382,665
Vaccination, 2 -dose $1,134,840 $361,230 $1,274,981
50-64 yVaccination, 1 -dose $207,834 $4,019 $244,737
Vaccination, 2 -dose $898,653 $253,551 $1,015,457
>65 yVaccination, 1 -dose $58,855 Cost saving $75,585
Vaccination, 2 -dose $356,534 $70,458 $409,976
ICER = incremental cost effectiveness ratio; QALY = quality- adjusted life year
ICER, scenario analyses varying vaccination costs,
age >65, societal perspective, 2024 -2025 vaccination,
preliminary results
Age
groupIntervention strategyICER ($/QALY)
$20 $60 $80 $100Base case
$133
>65 yVaccination, 1 -dose Cost saving $2,755 $16,908 $31,060 $58,855
Vaccination, 2 -dose $86,910 $177,327 $222,536 $267,744 $356,534Age group Intervention strategyICER ($/QALY)
All lower Base case All upper
>65 yVaccination, 1 -dose Cost saving $58,855 $75,585
Vaccination, 2 -dose $70,458 $356,534 $409,976
Varying vaccine dose cost onlyVarying all vaccination -related costs*
25*Multi -way sensitivity analysis varying vaccine dose cost, vaccine administration cost, time costs of vaccination, and cost of
vaccine -associated adverse events to lower and upper bounds. See supplementary slide 44 for input data.
ICER = i ncremental  cost-effectiveness ratio; QALY = quality- adjusted life year
Scenario analysis: vaccine dose cost, 2024 -2025
vaccination, preliminary results
$0$200,000$400,000$600,000$800,000$1,000,000$1,200,000
$20 $30 $40 $50 $60 $70 $80 $90 $100 $110 $120 $130 $140$114$88
$0$200,000$400,000$600,000$800,000$1,000,000$1,200,000
$20 $30 $40 $50 $60 $70 $80 $90 $100 $110 $120 $130 $140$114$881-dose 2-dose
$139
Cost per dose Cost per dose$/QALY
$/QALY
Note: arrows indicate base case vaccine dose cost by age group
QALY= quality -adjusted life year$139$139$139
$139
$139
Limitations
•Unpublished data used to derive key parameters in the model: vaccine effectiveness,
symptomatic illness, probabilities of hospitalization and critical illness
•Data sources vary in representativeness, generalizability
•VE estimates derived from single prior season data
•Few seasons to date to estimate seasonality
•MarketScan  data for ages >65 only includes those with supplemental insurance
•Evidence base for long covid is especially scarce
•Model does not include reduced transmission (conservative approach)
27
Summary
2024- 2025 COVID -19 vaccination, 2 -dose strategy
•ICERs for age groups <65 y were less favorable than for those > 65 y across
plausible parameter ranges
•For >65 years, ICERs are sensitive to seasonality -adjusted vaccine impact,
probability of hospitalization, and costs of vaccination
•ICERs are more favorable in scenarios with higher risk of hospitalization and
lower costs of vaccination
28

Summary: Economic analysis of an  additional dose of the  2024 -2025 COVID -19 vaccine University of Michigan  COVID -19 Vaccination Modeling Team Presentation to the Advisory Committee on Immunization Practices October 23, 2024 1 Study team University of Michigan •Lisa A. Prosser, PhD, Principal Investigator •David W. Hutton, PhD, Co -Investigator •Acham Gebremariam, MS, Programmer/Analyst •Angela Rose, MS, MPH, Project Manager •Kerra Mercon, MS, Research Assistant Wake Forest University •Cara Janusz,…