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Risk-Benefit Analysis of RSV
Vaccination in Older Adults
David W. Hutton, PhD, MS
Associate Professor, Health Management and Policy, School of Public Health
Associate Professor of Global Public Health, School of Public Health
Associate Professor, Industrial and Operations Engineering, College of Engineering
University of Michigan
1This presentation has been corrected. See slides 13, 20, and 21 for corrected slides. The original slides are included at the end of the presentation.
Disclaimer
•An error in the market productivity calculation for adults aged 50 –6 4
years has been identified in this presentation.
•Correction of this error and additional updates have been
inc
orporated into a more recent analysis.
•Please refer to the ACIP agenda on Ap ril 16, 2025 and the
presentation titled, “Economic Analysis of Adult RSV Vaccination, including benefits and risk discussion” by Dr. Ismael Ortega -Sanchez
for the most updated version of this analysis.
2
Research Team
University of Michigan
•David Hutton, PhD
•Lisa Prosser, PhD
•Angela Rose, MPH
•Christina Nyamuswa , M SCDC
•Michael Melgar , M D
•Amadea Britton, MD
•Lauren Roper, MPH
•Mila P rill, M SPH
•Jamison Pike, PhD
•Ismael Ortega- Sa nchez, PhD
•Andrew Leidner, PhD
•Fiona Havers, MD
•Michael Whitaker, MPH
•Rebecca Woodruff, PhD
•Huong Pham, MPH
3
Conflicts of interest statements
•No known conflict of interests.
4
Objective:
•Compare the es timated benefits of RSV vaccination with the potential risk of Guillain -
Barre syndrome (GBS) after RSV vaccination in adults aged 50 -59 years with chronic
medical conditions, 60 -74 years with chronic medical conditions, and among all adults
aged 75 years and older.
•To do this, used the same mathematical models presented in previous presentation. In
ad
dition to cost effectiveness, these models estimate the burden of RSV disease,
including RSV -associated hospitalization, ICU admissions, and deaths, that might be
averted through vaccination.
•Will summarize estimated benefit outputs from those models and add information on
pot
ential rates of GBS experienced after RSV vaccination.
•This is an update to the presentation on benefits and risks from the February 2024 ACIP
mee
ting. Here, we add information on observational (“real -world”) vaccine effectiveness
against hospitalization and expand the analysis to evaluate benefits and risks specifically among adults with chronic medical conditions, including adults aged 50 -59 years.
•Focus only on the Pr
otein subunit RSV vaccines (manufactured by Pfizer and GSK). To date,
there are no pre -licensure or observational data indicating risk of GBS after Moderna RSV
vaccination (mRESVIA). 5
Methods: Study question
•Compare the es timated benefits of RSV vaccination and the
potential risk of Guillain -Barre syndrome (GBS) after Protein
subunit RSV vaccination (Pfizer/GSK).
6
Methods: Intervention(s)
•Target population: US adults aged ≥50 years, stratified by age,
chronic medical conditions
•Adults aged ≥75 years
•Adults aged 60 -74 years with at least one chronic medical condition*
•Adults aged 50 -59 years with at least one chronic medical condition*
•Interventions: Pro tein subunit RSV vaccines
•Pfizer’s ABRYSVO
•GSK’s AREXVY
•Comparator: Ea ch compared to No Vaccination
7*At least one of: chronic obstructive pulmonary disease (COPD), asthma, coronary artery disease, chronic kidney disease,
diabetes mellitus, severe obesity (BMI ≥40)
Methods: Scenario analyses
•Adults in each age group (50 -59, 60 -74, ≥75) without chronic medical
conditions*
•Adults in each age group with sp ecific chronic medical conditions:
•Chronic obstructive pulmonary disease (COPD)
•Asthma
•Coronary artery disease
•Chronic kidney disease
•Diabetes mellitus
•Severe obesity (BMI ≥40 )
•Heart failure
•Immune Compromise
•Lung Transplant
•Hematopoietic cell transplant, allogeneic
•Hematopoietic cell transplant, autologous
8Assumed that vaccine effectiveness was
reduced by half in immune compromised
populations, compared with all others
*None of: COPD, asthma, coronary artery disease, chronic kidney disease, diabetes mellitus, severe obesity (BMI ≥40)
Heart failure and immune compromise are considered separately because RSV epidemiologic parameters were derived from differen t
published sources and cannot be combined with RSV -NET hospitalization rate estimates under “at least one” condition.
Methods: Decision Tree Model
9No
Vaccination
VaccinationInfection Hospitalization
ED
None of the aboveOutpatientAlive
DeadRSV Infection
Adverse
EventsGuillain Barre Syndrome
No Guillain Barre SyndromeInfection RSV Infection
•GBS risk attributable to RSV vaccination is based on FDA active surveillance
using CMS data.
•The FDA analysis was a self -controlled case series based on inpatient claims
data.
Study population: Medicare beneficiaries ages ≥65 years1 who had received either Pfizer or
GSK RSV vaccine, from May 2023 (date of FDA approval) to October 8, 2023
Used administrative inpatient claims data to identify GBS cases occurring within a 1– 42-day
risk interval after RSV vaccination, compared with a 43 –90-day control interval
Incidence rate ratios and attributable risk were adjusted for outcome-dependent observation time, positive predictive value of inpatient claims in identifying chart -confirmed GBS, and
seasonality
10Methods: Attributable Risk of Guillain Barre Syndrome (GBS) from
RSV vaccination
Abbreviations: CMS = Centers for Medicare & Medicaid Services, FDA = U.S. Food and Drug Administration, GBS = Guillain -Barre syndrome
1. Must have been enrolled in Medicare Parts A, B and D. Must not have had a diagnostic code for GBS in the 365 days preceding v accination.
Reference (Dr. Patricia Lloyd, FDA, June 2024 ACIP meeting)
•Attributable risk of GBS:
Pfizer ABRYSVO : 16 GBS cases (95% CI: 3, 29) per 1 million doses administered
GSK AREXVY : 3 GBS cases (95% CI: 0, 10) per 1 million doses administered*
•These risk estimates are in excess of background rate of GBS. I.e., they
represent excess GBS cases beyond those that would occur in this
population without vaccination.
•This analysis remains preliminary. GBS cases identified using diagnostic coding must still undergo chart verification, and the analysis must be updated to include RSV vaccinations occurring after October 8, 2023.
•In the interim, we are using the available estimates, recognizing the associated uncertainty. We are also extrapolating from the study population (age ≥65 years) to adults aged 50 –64 years.
11Methods: Attributable Risk of Guillain Barre Syndrome (GBS) from
RSV vaccination
Abbreviations: CI = confidence interval, CMS = Centers for Medicare & Medicaid Services, FDA = U.S. Food and Drug Administrat ion, GBS = Guillain -Barre syndrome
* At tributable risk for GSK’s AREXVY was estimated to be 3 GBS cases (95% CI: -3, 10) per 1 million doses. For this analysis, the lo wer end of the 95% CI was
truncated at 0 to evaluate potential risk of GBS. Potential protective effects were not evaluated.
•Results are presented as R SV outcomes avertable over 2 RSV seasons
per 1 million single- dose RSV vaccinations , and attributable GBS risk
per 1 million single- dose RSV vaccinations .
12Results: Estimated Benefits and Potential Risk
3 GBS cases
(95% CI 0– 10) Estimated RSV- associated outcomes avertable over 2
RSV seasons vs. potential cases of GBS per 1 million
vaccine doses in adults ≥75 years (general population)
16 GBS cases
(95% CI 3– 29) 4,283
13630 605
01,0002,
0003,0004,0005,0006,0007,0008,000Events AvertedGSK All Adults Age ≥75
Hospitalization ICU Stays Death3,817
561 539
08,0
7,000ed6,000t er5,000v A s4,000t en3,000v E2,0001,000Pfizer All Adults Age ≥75
00
Hospitalization ICU Stays Death202 329 190 283 Lower Bound:This slide contains corrections. To see the slide as originally presented, without corrections, please see slide 32.
Estimated RSV- associated outcomes avertable over 2 RSV
seasons vs. potential cases of GBS per 1 million vaccine
doses in adults 60 -74 years with ≥1 chronic condition*
14*At least one of: chronic obstructive pulmonary disease, asthma, coronary artery disease, diabetes mellitus, chronic kidney
disease, severe obesity (BMI ≥40) 3 GBS cases
(95% CI 0– 10) 16 GBS cases (95% CI 3– 29)
2,839
647246
02,0004,0006,0008,000Events AvertedGSK At least one condition Age
60-74 years
Hospitalization ICU Stays Death2,530
577219
02,0004,0006,0008,000Events AvertedPfizer At least one condition Age
60-74 years
Hospitalization ICU Stays Death83 337 74 311 Lower Bound:
Estimated RSV- associated outcomes avertable over 2 RSV
seasons vs. potential cases of GBS per 1 million vaccine
doses in adults 50 -59 years with ≥1 chronic condition*
15*At least one of: chronic obstructive pulmonary disease, asthma, coronary artery disease, diabetes mellitus, chronic kidney
disease, severe obesity (BMI ≥40) 3 GBS cases
(95% CI 0– 10)
1,520
33183
02,0004,0006,0008,000Events AvertedGSK At least one condition Age
50-59 years
Hospitalization ICU Stays Death26 130Lower Bound:
16*At least one of: chronic obstructive pulmonary disease, asthma, coronary artery disease, diabetes mellitus, chronic kidney
disease, severe obesity (BMI ≥40) 3 GBS cases
(95% CI 0– 10)
Zoomed In1,520
331
83
05001,0001,5002,000Events AvertedGSK At least one condition Age
50-59 years
Hospitalization ICU Stays DeathEstimated RSV- associated outcomes avertable over 2 RSV
seasons vs. potential cases of GBS per 1 million vaccine
doses in adults 50 -59 years with ≥1 chronic condition*
Range
199 -26
26130
Lower Bound:
Scenarios
17
Scenario 1: Estimated RSV-associated outcomes
avertable among adults without chronic medical
conditions*
18*None of: COPD, asthma, coronary artery disease, chronic kidney disease, diabetes mellitus, severe obesity
(BMI ≥40)
Estimated RSV- associated outcomes avertable over 2 RSV
seasons vs. potential cases of GBS per 1 million vaccine
doses in adults ≥75 years with none of these conditions *
19*None of: COPD, asthma, coronary artery disease, chronic kidney disease, diabetes mellitus, severe obesity (BMI ≥40).
Persons may have other chronic medical conditions (e.g., heart failure, non- severe obesity, immune compromise).3 GBS cases
(95% CI 0– 10) 16 GBS cases (95% CI 3– 29)
1,732
189 245
02,0004,0006,000Events AvertedGSK None of these conditions
Age ≥75
8,000
Hospitalization ICU Stays Death1,544
168 218
02,0004,0006,0008,000Events AvertedPfizer None of these conditions
Age ≥75
Hospitalization ICU Stays Death84 89 73 80 Lower Bound:
40664 35
02,0004,0006,0008,000Events AvertedPfizer None of these conditions
Age 60 -74 years
Hospitalization ICU Stays DeathEstimated RSV- associated outcomes avertable over 2 RSV
seasons vs. potential cases of GBS per 1 million vaccine
doses in adults 60 -74 years with none of these conditions *
20*None of: COPD, asthma, coronary artery disease, chronic kidney disease, diabetes mellitus, severe obesity (BMI ≥40).
Persons may have other chronic medical conditions (e.g., heart failure, non- severe obesity, immune compromise).3 GBS cases
(95% CI 0– 10) 16 GBS cases (95% CI 3– 29)
45672 39
02,0004,0006,0008,000Events AvertedGSK None of these conditions
Age 60 -74 years
Hospitalization ICU Stays DeathLower
Bound 14
16 14 39 34 Lower Bound:Lower
Bound 16This slide contains corrections. To see the slide as originally presented, without corrections, please see slide 34.
406
6435
0100200300400500Events AvertedPfizer None of these conditions
Age 60 -74 years
Hospitalization ICU Stays Death
21*None of: COPD, asthma, coronary artery disease, chronic kidney disease, diabetes mellitus, severe obesity (BMI ≥40).
Persons may have other chronic medical conditions (e.g., heart failure, non- severe obesity, immune compromise).3 GBS cases
(95% CI 0– 10) 16 GBS cases (95% CI 3– 29)
Lower
Bound 14Zoomed InEstimated RSV- associated outcomes avertable over 2 RSV
seasons vs. potential cases of GBS per 1 million vaccine
doses in adults 60 -74 years with none of these conditions*
456
7239
0100200300400500Events AvertedGSK None of these conditions
Age 60 -74 years
Hospitalization ICU Stays Death1639 1434
Lower Bound:Lower
Bound 16This slide contains corrections. To see the slide as originally presented, without corrections, please see slide 36.
Scenario 2: RSV-attributable deaths avertable
among adults by age and presence of specific
chronic conditions
22
1,0441,6431,472
890 8041,6612,468
4491,146
443
01,0002,0003,0004,0005,0006,0007,0008,000
Age 60-74 years
Age ≥75
Age 60-74 years
Age ≥75
Age 60-74 years
Age ≥75
Age 60-74 years
Age ≥75
Age 60-74 years
Age ≥75
Age 60-74 years
Age ≥75
Age 60-74 years
Age ≥75
Lung Transplant
Allogenic HCT
Autologous HCT
Heart Failure COPD Asthma CAD Diabetes obesity BMI >40 CKD Immune CompromiseDeahts AvertedEstimated RSV -associated deaths avertable over 2 RSV seasons vs.
potential cases of GBS per 1 million Pfizer ABRYSVO doses in adults 75
years and older with specific chronic conditions
2316 GBS cases
(95% CI 3– 29) Immune Compromise is not age -stratifiedHCT: hematopoietic cell transplant
Lower bound is labeled if <50
544384 306 260 2153915854491,146
443
01,0002,0003,0004,0005,0006,0007,0008,000
Age 60-74 years
Age ≥75
Age 60-74 years
Age ≥75
Age 60-74 years
Age ≥75
Age 60-74 years
Age ≥75
Age 60-74 years
Age ≥75
Age 60-74 years
Age ≥75
Age 60-74 years
Age ≥75
Lung Transplant
Allogenic HCT
Autologous HCT
Heart Failure COPD Asthma CAD Diabetes obesity BMI >40 CKD Immune CompromiseDeaths AvertedEstimated RSV -associated deaths avertable over 2 RSV seasons
vs. potential cases of GBS per 1 million Pfizer ABRYSVO doses in
adults 60-74 years with specific chronic conditions
2416 GBS cases
(95% CI 3– 29) Immune Compromise is not age -stratifiedHCT: hematopoietic cell transplant
Lower bound is labeled if <50
1,1711,8431,652
999 902
1334391,8642,769
5031,286
497
01,0002,0003,0004,0005,0006,0007,0008,000
Age 50-59 years
Age 60-74 years
Age ≥75
Age 50-59 years
Age 60-74 years
Age ≥75
Age 50-59 years
Age 60-74 years
Age ≥75
Age 50-59 years
Age 60-74 years
Age ≥75
Age 50-59 years
Age 60-74 years
Age ≥75
Age 50-59 years
Age 60-74 years
Age ≥75
Age 50-59 years
Age 60-74 years
Age ≥75
Lung Transplant
Allogenic HCT
Autologous HCT
Heart Failure COPD Asthma CAD Diabetes obesity BMI >40 CKD Immune
CompromiseDeaths AvertedEstimated RSV -associated deaths avertable over 2 RSV seasons
vs. potential cases of GBS per 1 million GSK AREXVY doses in
adults 75 years and older with specific chronic conditions
253 GBS cases
(95% CI 0– 10) Immune Compromise is not age -stratifiedHCT: hematopoietic cell transplant
Lower bound is labeled if <50
610431 344 292 241 1334391,864
6575031,286
497
01,0002,0003,0004,0005,0006,0007,0008,000
Age 50-59 years
Age 60-74 years
Age ≥75
Age 50-59 years
Age 60-74 years
Age ≥75
Age 50-59 years
Age 60-74 years
Age ≥75
Age 50-59 years
Age 60-74 years
Age ≥75
Age 50-59 years
Age 60-74 years
Age ≥75
Age 50-59 years
Age 60-74 years
Age ≥75
Age 50-59 years
Age 60-74 years
Age ≥75
Lung Transplant
Allogenic HCT
Autologous HCT
Heart Failure COPD Asthma CAD Diabetes obesity BMI >40 CKD Immune
CompromiseDeaths AvertedEstimated RSV -associated deaths avertable over 2 RSV seasons
vs. potential cases of GBS per 1 million GSK AREXVY doses in
adults 60-74 years with specific chronic conditions
263 GBS cases
(95% CI 0– 10) Immune Compromise is not age -stratifiedHCT: hematopoietic cell transplant
Lower bound is labeled if <50
278133 95 98 75 1334391,864
2305031,286
497
01,0002,0003,0004,0005,0006,0007,0008,000
Age 50-59 years
Age 60-74 years
Age ≥75
Age 50-59 years
Age 60-74 years
Age ≥75
Age 50-59 years
Age 60-74 years
Age ≥75
Age 50-59 years
Age 60-74 years
Age ≥75
Age 50-59 years
Age 60-74 years
Age ≥75
Age 50-59 years
Age 60-74 years
Age ≥75
Age 50-59 years
Age 60-74 years
Age ≥75
Lung Transplant
Allogenic HCT
Autologous HCT
Heart Failure COPD Asthma CAD Diabetes obesity BMI >40 CKD Immune
CompromiseDeaths AvertedEstimated RSV -associated deaths avertable over 2 RSV seasons
vs. potential cases of GBS per 1 million GSK AREXVY doses in
adults 50-59 years with specific chronic conditions
273 GBS cases
(95% CI 0– 10) Immune Compromise is not age -stratifiedHCT: hematopoietic cell transplant
Lower bound is labeled if <5042 31 30 25 38Lower Bound:
Summary
•Estimated numbers of avertable deaths are much larger than
p
otential GBS cases for:
•Adults 75 and older
•Adults 60 -7 4 with at least one chronic condition
•Estimated numbers of avertable hospitalizations and ICU admissions a
re much larger than potential GBS cases for all age groups, for both
GSK’s AREXVY and Pfizer’s ABRYSVO.
•Estimated numbers of avertable deaths are larger, but more similar in m
agnitude, than potential GBS cases for:
•Adults 50 -5 9 with at least one chronic condition
•Adults 60 -7 4 without chronic conditions, particularly for the Pfizer ABRYSVO
vaccine
28
Limitations
•Uncertain Inputs
•RSV hospitalization incidence by age and condition
•RSV-NET represents ~9% of the United States and hospitalization rates observed in RSV -N ET may
not be generalizable to the U.S.
•Could not include all conditions that may increase risk of severe RSV disease in this analysis
•Vaccine effectiveness (VE)
•Observational VE data only available for first few months after vaccination —p rotection over time
was extrapolated from waning in efficacy against symptomatic illness observed in clinical trials
•Risk of Guillain-Barre Syndrome
•GBS risk estimates were calculated using a small number of events observed after RSV
va
ccination, resulting in high uncertainty.
•GBS was identified by diagnostic codes in administrative data and may be subject to coding er
rors. Not all cases of GBS occurring after RSV vaccination may have received a diagnostic code.
•Attributable risk of GBS may be different among adults 50 -59 than among adults 60 and older.
29
Thank You
•Please send comments to:
•[email protected]
30
Original slides
•The following slides contain errata. They are being shared here for
arec
ord of what was presented at the June 26, 2024, ACIP meeting.
•Corrected slides are available in the main presentation.
•Corrected slides with changes highlighted are included in th
efollowing slides.
31
3 GBS cases
(95% CI 0– 10) Estimated RSV- associated outcomes avertable over 2
RSV seasons vs. potential cases of GBS per 1 million
vaccine doses in adults ≥75 years (general population)
3216 GBS cases
(95% CI 3– 29) 4,283
630 605
01,0002,0003,0004,0005,0006,0007,0008,000Events AvertedGSK All Adults Age ≥75
Hospitalization ICU Stays Death3,817
561 539
01,0002,0003,0004,0005,0006,0007,0008,000Events AvertedPfizer All Adults Age ≥75
Hospitalization ICU Stays Death254 311 232 295 Lower Bound:This slide was presented at ACIP on June 26, 2024 and contains errata (highlighted in purple). To see the corrected slide, pl ease see slide 13 ; to see the corrected slide with changes highlighted see slide 33.
3 GBS cases
(95% CI 0– 10) Estimated RSV- associated outcomes avertable over 2
RSV seasons vs. potential cases of GBS per 1 million
vaccine doses in adults ≥75 years (general population)
3316 GBS cases
(95% CI 3– 29) 4,283
630 605
01,0002,0003,0004,0005,0006,0007,0008,000Events AvertedGSK All Adults Age ≥75
Hospitalization ICU Stays Death3,817
561 539
01,0002,0003,0004,0005,0006,0007,0008,000Events AvertedPfizer All Adults Age ≥75
Hospitalization ICU Stays Death202 329 190 283 Lower Bound:This slide has been corrected (highlighted). To see the slide as originally presented at the June 26, 2024 meeting, please se e slide 32; to see a corrected, unhighlighted version, see slide 13 .
45672 39
02,0004,0006,0008,000Events AvertedGSK None of these conditions
Age 60 -74 years
Hospitalization ICU Stays DeathLower
Bound 14Lower
Bound 15
40664 35
02,0004,0006,0008,000Events AvertedPfizer None of these conditions
Age 60 -74 years
Hospitalization ICU Stays DeathEstimated RSV- associated outcomes avertable over 2 RSV
seasons vs. potential cases of GBS per 1 million vaccine
doses in adults 60 -74 years with none of these conditions *
34*None of: COPD, asthma, coronary artery disease, chronic kidney disease, diabetes mellitus, severe obesity (BMI ≥40).
Persons may have other chronic medical conditions (e.g., heart failure, non- severe obesity, immune compromise).3 GBS cases
(95% CI 0– 10) 16 GBS cases (95% CI 3– 29)
15 14 39 34 Lower Bound:This slide was presented at ACIP on June 26, 2024 and contains errata (highlighted in purple). To see the corrected slide, pl ease see slide 20 ; to see the corrected slide with changes highlighted see slide 35.
45672 39
02,0004,0006,0008,000Events AvertedGSK None of these conditions
Age 60 -74 years
Hospitalization ICU Stays DeathLower
Bound 16
40664 35
02,0004,0006,0008,000Events AvertedPfizer None of these conditions
Age 60 -74 years
Hospitalization ICU Stays DeathEstimated RSV- associated outcomes avertable over 2 RSV
seasons vs. potential cases of GBS per 1 million vaccine
doses in adults 60 -74 years with none of these conditions *
35*None of: COPD, asthma, coronary artery disease, chronic kidney disease, diabetes mellitus, severe obesity (BMI ≥40).
Persons may have other chronic medical conditions (e.g., heart failure, non- severe obesity, immune compromise).3 GBS cases
(95% CI 0– 10) 16 GBS cases (95% CI 3– 29)
Lower
Bound 14
16 14 39 34 Lower Bound:This slide has been corrected (highlighted). To see the slide as originally presented at the June 26, 2024 meeting, please se e slide 34; to see a corrected, unhighlighted version, see slide 20.
Lower
Bound 15456
7239
0100200300400500Events AvertedGSK None of these conditions
Age 60 -74 years
Hospitalization ICU Stays Death406
6435
0100200300400500Events AvertedPfizer None of these conditions
Age 60 -74 years
Hospitalization ICU Stays Death
36*None of: COPD, asthma, coronary artery disease, chronic kidney disease, diabetes mellitus, severe obesity (BMI ≥40).
Persons may have other chronic medical conditions (e.g., heart failure, non- severe obesity, immune compromise).3 GBS cases
(95% CI 0– 10) 16 GBS cases (95% CI 3– 29)
Lower
Bound 14Zoomed InEstimated RSV- associated outcomes avertable over 2 RSV
seasons vs. potential cases of GBS per 1 million vaccine
doses in adults 60 -74 years with none of these conditions*
1539 1434
Lower Bound:This slide was presented at ACIP on June 26, 2024 and contains errata (highlighted in purple). To see the corrected slide, pl ease see slide 21 ; to see the corrected slide with changes highlighted see 37.
Lower
Bound 16406
6435
0100200300400500Events AvertedPfizer None of these conditions
Age 60 -74 years
Hospitalization ICU Stays Death
37*None of: COPD, asthma, coronary artery disease, chronic kidney disease, diabetes mellitus, severe obesity (BMI ≥40).
Persons may have other chronic medical conditions (e.g., heart failure, non- severe obesity, immune compromise).3 GBS cases
(95% CI 0– 10) 16 GBS cases (95% CI 3– 29)
Lower
Bound 14Zoomed InEstimated RSV- associated outcomes avertable over 2 RSV
seasons vs. potential cases of GBS per 1 million vaccine
doses in adults 60 -74 years with none of these conditions*
456
7239
0100200300400500Events AvertedGSK None of these conditions
Age 60 -74 years
Hospitalization ICU Stays Death1639 1434
Lower Bound:This slide has been corrected (highlighted). To see the slide as originally presented at the June 26, 2024 meeting, please se e slide 36; to see a corrected, unhighlighted version, see slide 21.