03 RSV Adults Woodruff 508

Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation
use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences.
Chronic Conditions as Risk Factors for RSV -Associated
Hospitalization
Rebecca C. Woodruff, PhD, MPH
Epidemiologist, Centers for Disease Control and Prevention
February 29, 2024Advisory Committee on Immunization Practices Meeting

Information is needed about which chronic conditions
increase the risk of hospitalization for RSV infection.
2
Research Questions
Which chronic medical conditions are associated with higher rates of
RSV-associated hospitalization among community -dwelling adults
aged ≥50 years?
What are the rate ratios comparing RSV hospitalization rates among
community -dwelling adults aged ≥50 years  with and without
chronic medical conditions?
How do the rates and rate ratios comparing RSV hospitalization rates
among community -dwelling adults aged ≥50 years with and without
chronic medical conditions vary by age group ?
3
Methods
We leveraged multiple data sources to calculate RSV -
associated hospitalization rates during the 2017 -2018 RSV
season by chronic condition and age group.
Numerator
 Denominator
•RSV-Associated Hospitalization
Surveillance Network (RSV -NET)•Behavioral Risk Factor Surveillance
System (BRFSS)
•Census population counts
Methods adapted from Ko JY , Danielson ML, Town M, Derado  G, Greenlund  KJ, Daily Kirley  P , Alden NB, Yousey -Hindes  K, Anderson EJ, Ryan PA, Kim S, Lynfield  R, Torres SM, Barney GR, Bennett NM, Sutton M, Talbot HK, Hill M, Hall AJ, Fry AM, Garg S, Kim L. Risk Factors for Coronaviru s
Disease 2019 (COVID -19)-Associated Hospitalization: COVID -19-Associated Hospitalization Surveillance Network and Behavioral Risk  Factor Surveillance System. Clin Infect Dis. 2021 Jun 1; 72(11):e695 -e703. https://doi.org/10.1093/cid/ciaa1419  5
▪RESP -NET: a population -based hospitalization
surveillance platform
▪Active, population -based surveillance of
laboratory -confirmed RSV -associated
hospitalizations
–>300 acute -care hospitals, 58 counties in 12 states
–~8.6% of U.S. population
▪Tests positive for RSV within 14 days prior to
or during hospitalization
–Clinician -driven testingRSV -Associated Hospitalization Surveillance Network
(RSV -NET)
California
Oregon
Utah
Colorado
New
MexicoMichigan
MarylandNew York
Connecticut
Tennessee
Georgia
RSV-NET surveillance areas
with percentage of state
population represented by
participating RSV -NET
counties
Minnesota
6
Behavioral Risk Factor Surveillance System
(BRFSS) Overview
•Annual telephone -based survey in the US, DC, and
select territories
•Self-reported history of select chronic conditions
•Representative of the state population
•Eligible participants:
•Civilian, community -dwelling residents
•Aged  ≥18 years
7
▪Asthma
▪Chronic kidney disease (CKD)
▪Chronic obstructive pulmonary disease (COPD)
▪Coronary artery disease (CAD)
▪Current smoking
▪Diabetes mellitus
▪Obesity (body mass index 30 -39 kg/m2)
▪Severe obesity (body mass index ≥40 kg/m2)
▪StrokeWe evaluated 9 chronic medical conditions as potential risk
factors for RSV -associated hospitalization.
8
We calculated RSV -associated hospitalization rates using
the following methods.
Obtained counts of RSV -associated hospitalizations among community -dwelling
adults aged ≥50 years with and without chronic medical conditions during the 2017 -
2018 surveillance season (RSV -NET)
Obtained estimated counts of community -dwelling adults aged ≥50 years with and
without chronic medical conditions in 2018 for the 38 -county RSV -NET catchment
area
Calculated RSV-associated hospitalization rates (per 100,000 population) among
adults with and without chronic medical conditions stratified by age group (50 -64,
65-74, ≥75 years)
Applied burden multipliers to the rates to account for frequency of RSV testing
among adults hospitalized with respiratory illness and sensitivity of diagnostic tests
9
We calculated RSV -associated hospitalization rate ratios
using the following methods.
Divided the RSV -associated hospitalization rates in adults with vs. without
chronic medical conditions (ages 50 -64, 65 -74, ≥75 years)
Used Monte Carlo simulation and generalized Poisson models to estimate rate
ratios adjusted for sex and race or ethnicity group and 95% Monte Carlo
(confidence) intervals
10
Preliminary Results
Adults Aged 50 -64 Years
0100200300400500
≥40 30-39 <30
All Chronic
Kidney
DiseaseCOPD Body Mass Index
(kg/m2)Coronary
Artery
DiseaseAsthma Diabetes Current
smokerStrokeRSV-associated hospitalization rate
(per 100,000)RSV-associated hospitalization rates among community -dwelling adults aged 50-64 years with and without
chronic medical conditions, 2017 -2018 surveillance season
COPD: Chronic Obstructive Pulmonary Disease. Data are preliminary and unpublished. Rates of laboratory -confirmed RSV -associated hospitalization account for under -detection of RSV infection among hospitalized adults and sensitivity of diagnostic tests;
rates exclude residents of nursing homes and long -term care facilities and are not adjusted for sex or race/ethnicity group. Adj usted rate ratios are derived from generalized Poisson models using Monte Carlo simulation methods and adjust for sex and rac e
and ethnicity group. 7.9
(4.7–13.8)
5.8
(3.7–9.3)
3.3
(2.1–5.1)3.7
(2.4–5.7) 2.8
(1.9–4.1)2.4
(1.4–4.0)4.2
(2.5–7.1)
1.5
(1.0–2.3)1.4
(0.7–2.8)Adjusted rate ratio:
12
Adults Aged 50 -64 Years
0100200300400500
≥40 30-39 <30
All Chronic
Kidney
DiseaseCOPD Body Mass Index
(kg/m2)Coronary
Artery
DiseaseAsthma Diabetes Current
smokerStrokeRSV-associated hospitalization rate
(per 100,000)RSV-associated hospitalization rates among community -dwelling adults aged 50-64 years with and without
chronic medical conditions, 2017 -2018 surveillance season
COPD: Chronic Obstructive Pulmonary Disease. Data are preliminary and unpublished. Rates of laboratory -confirmed RSV -associated hospitalization account for under -detection of RSV infection among hospitalized adults and sensitivity of diagnostic tests;
rates exclude residents of nursing homes and long -term care facilities and are not adjusted for sex or race/ethnicity group. All adults
≥75 years
13
Adults Aged 65 -74 Years
0100200300400500600700800
≥40 30-39 <30
All Chronic
Kidney
DiseaseBody Mass Index
(kg/m2)COPD Asthma Current
smokerCoronary
Artery
DiseaseDiabetes StrokeRSV-associated hospitalization rate
(per 100,000)RSV-associated hospitalization rates among community -dwelling adults aged 6 5-74 years with and without
chronic medical conditions, 2017 -2018 surveillance season
6.1
(3.7–10.7)
4.2
(2.7–6.7)3.3
(2.0–5.9)2.5
(1.6–4.2)2.2
(1.5–3.3)4.5
(2.3–8.8)
1.5
(1.0–2.4)2.3
(1.4–3.8) 1.6
(0.8–3.0)Adjusted rate ratio:
COPD: Chronic Obstructive Pulmonary Disease. Data are preliminary and unpublished. Rates of laboratory -confirmed RSV -associated hospitalization account for under -detection of RSV infection among hospitalized adults and sensitivity of diagnostic tests;
rates exclude residents of nursing homes and long -term care facilities and are not adjusted for sex or race/ethnicity group. Adj usted rate ratios are derived from generalized Poisson models using Monte Carlo simulation methods and adjust for sex and rac e
and ethnicity group.
14
Adults Aged 65 -74 Years
0100200300400500600700800
≥40 30-39 <30
All Chronic
Kidney
DiseaseBody Mass Index
(kg/m2)COPD Asthma Current
smokerCoronary
Artery
DiseaseDiabetes StrokeRSV-associated hospitalization rate
(per 100,000)RSV-associated hospitalization rates among community -dwelling adults aged 6 5-74 years with and without
chronic medical conditions, 2017 -2018 surveillance season
COPD: Chronic Obstructive Pulmonary Disease. Data are preliminary and unpublished. Rates of laboratory -confirmed RSV -associated hospitalization account for under -detection of RSV infection among hospitalized adults and sensitivity of diagnostic tests;
rates exclude residents of nursing homes and long -term care facilities and are not adjusted for sex or race/ethnicity group. All adults
≥75 years
15
Adults Aged ≥75 Years
0200400600800100012001400160018002000
≥40 30-39 <30
All Chronic
Kidney
DiseaseBody Mass Index
(kg/m2)COPD Asthma Coronary
Artery
DiseaseDiabetes Stroke Current
smokerRSV-associated hospitalization rate
(per 100,000)0.9
(0.4–2.2)1.9
(1.2–2.9)RSV-associated hospitalization rates among community -dwelling adults aged ≥75 years with and without
chronic medical conditions, 2017 -2018 surveillance season
6.1
(3.6–12.6)
4.2
(2.7–6.6) 2.9
(1.5–6.2)2.9
(1.3–6.7)
1.1
(0.7–1.7)1.6
(1.0–2.6)1.5
(0.8–3.1)Adjusted rate ratio:
COPD: Chronic Obstructive Pulmonary Disease. Data are preliminary and unpublished. Rates of laboratory -confirmed RSV -associated hospitalization account for under -detection of RSV infection among hospitalized adults and sensitivity of diagnostic tests;
rates exclude residents of nursing homes and long -term care facilities and are not adjusted for sex or race/ethnicity group. Adj usted rate ratios are derived from generalized Poisson models using Monte Carlo simulation methods and adjust for sex and rac e
and ethnicity group.
16
RSV -Associated Hospitalization Rates by Chronic Condition
and Age Group
02004006008001000120014001600
50-64
65-74
≥75
50-64
65-74
≥75
50-64
65-74
≥75
50-64
65-74
≥75
50-64
65-74
≥75
50-64
65-74
≥75
50-64
65-74
≥75
50-64
65-74
≥75
50-64
65-74
≥75
50-64
65-74
≥75
All adults Chronic
Kidney
DiseaseCOPD Severe
obesity
(BMI ≥40)Asthma Coronary
Artery
DiseaseDiabetes
mellitusStroke Obesity
(BMI 30-
39)Current
smokerRSV-associated hospitalization rate
(per 100,000)RSV-associated hospitalization rates among community -dwelling adults aged ≥50 years with chronic medical
conditions, 2017 -2018 season
COPD: Chronic Obstructive Pulmonary Disease. Data are preliminary and unpublished. Rates of laboratory -confirmed RSV -associated hospitalization account for under -detection of RSV infection among hospitalized adults and sensitivity of diagnostic tests;
rates exclude residents of nursing homes and long -term care facilities and are not adjusted for sex or race/ethnicity group.
17
Adjusted Rate Ratios for RSV -Associated Hospitalization
by Chronic Condition among Adults Aged ≥50 Years
6.5
4.6
3.12.8
2.42.0 1.91.51.1
0.11.010.0100.0
Chronic
Kidney
DiseaseCOPD Asthma Severe
obesityCoronary
Artery
DiseaseDiabetes
mellitusCurrent
smokerStroke ObesityaRR
COPD: Chronic Obstructive Pulmonary Disease. Data are preliminary and unpublished. Adjusted rate ratios are derived from gene ralized Poisson models using Monte Carlo simulation methods and adjust for sex and race and ethnicity group. 18
RSV -Associated Hospitalization Rates by
Combinations of Chronic Conditions
By Number of Chronic Conditions
02004006008001000
50-64
years65-74
years≥75
yearsRSV-associated hospitalization rate
(per 100,000)RSV-associated hospitalization rates* among community -dwelling adults aged ≥50 years by
number of chronic conditions and age group, 2017 -2018 season
10.6
(6.3–18.6)6.4
(3.7–11.2)
2.9
(1.7–5.1)2.6
(1.4–4.9)2.6
(1.4–4.7)12.4
(7.8–20.2)Adjusted rate ratio:
* Data are preliminary and unpublished. Rates of laboratory -confirmed RSV -associated hospitalization account for under -detection o f RSV infection among hospitalized adults and sensitivity of diagnostic tests; rates exclude residents of nursing homes and
long -term care facilities and are not adjusted for sex or race/ethnicity group. Adjusted rate ratios are derived from generalize d Poisson models using Monte Carlo simulation methods and adjust for sex and race and ethnicity group.
20
By Chronic Kidney Disease & Coronary Artery Disease
0200400600800100012001400160018002000
50-64
years65-74
years≥75
yearsRSV-associated hospitalization rate
(per 100,000)RSV-associated hospitalization rates* among community -dwelling adults aged ≥50 years by
chronic kidney disease (CKD), coronary artery disease (CAD), and age group, 2017 -2018 season
15.7
(6.8–37.7)
7.3
(3.8–13.9)
3.1
(1.6–5.5)10.5
(4.8–23.3)
5.7
(3.0–11.2)
2.1
(1.1–4.0)7.9
(3.5–17.6)
6.3
(3.4–13.4)
1.7
(0.9–3.2)Adjusted rate ratio:
* Data are preliminary and unpublished. Rates of laboratory -confirmed RSV -associated hospitalization account for under -detection o f RSV infection among hospitalized adults and sensitivity of diagnostic tests; rates exclude residents of nursing homes and
long -term care facilities and are not adjusted for sex or race/ethnicity group. Adjusted rate ratios are derived from generalize d Poisson models using Monte Carlo simulation methods and adjust for sex and race and ethnicity group.
21
By Chronic Kidney Disease & Diabetes
0200400600800100012001400160018002000
50-64
years65-74
years≥75
yearsRSV-associated hospitalization rate
(per 100,000)RSV-associated hospitalization rates* among community -dwelling adults aged ≥50 years by
chronic kidney disease (CKD), diabetes, and age group, 2017 -2018 season
12.8
(6.1–27.7)
7.3
(3.4–16.4)
2.3
(1.3–3.8)9.0
(4.6–18.7)
6.0
(2.6–13.7)
1.7
(1.0–3.0)5.8
(2.7–13.1)
7.4
(4.0–14.9)
1.4
(0.8–2.7)Adjusted rate ratio:
* Data are preliminary and unpublished. Rates of laboratory -confirmed RSV -associated hospitalization account for under -detection of RSV infection among hospitalized adults and sensitivity of diagnostic tests; rates exclude residents of n ursing homes and
long -term care facilities and are not adjusted for sex or race/ethnicity group. Adjusted rate ratios are derived from generalize d Poisson models using Monte Carlo simulation methods and adjust for sex and race and ethnicity group.
22
▪Denominator data were created based on self -reported history of chronic conditions
from BRFSS
–~49.9% response rate in 2018
–Subject to recall & social desirability biases
▪BRFSS might underestimate true prevalence of select chronic medical conditions, which
would drive the rates and rate ratios upwards
▪Could not assess all chronic medical conditions or potential risk factors of interest
–Heart failure
–End-stage renal disease
–Immunocompromise
▪Results do not necessarily generalize to non -community -dwelling adults (e.g., residents
of nursing homes, long -term care facilities, shelters, treatment facilities, or correctional
institutions)Limitations
23
Select chronic medical
conditions were associated
with higher rates of RSV -
associated hospitalization
among community -dwelling
adults, which varied by
condition and age group.
24
Acknowledgements
Centers for Disease Control and Prevention
Coronavirus and Other Respiratory Viruses Division
•Gordana Derado, PhD
•Sarah Hamid, PhD
•Fiona P . Havers, MD
•Michael Melgar, MD
•Huong Pham, MPH
•Christopher A. Taylor, PhD
Division for Heart Disease and Stroke Prevention
•Fleetwood V. Loustalot, PhD
•Elizabeth Lundeen, PhD
•Ahlia Sekkarie, PhD
RSV-Associated Hospitalization Surveillance Network (RSV -NET) Site
Investigators, Surveillance Officers, and Staff 25
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.
Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation
use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences.

Summary: Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation  use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences. Chronic Conditions as Risk Factors for RSV -Associated  Hospitalization Rebecca C. Woodruff, PhD, MPH Epidemiologist, Centers for Disease Control and Prevention February…


04 RSV Adults Black 508

Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
RSV Vaccination Implementation Update
Carla Black, PhD
Surveillance and Epidemiology Branch
Immunization Services Division, NCIRD, CDC
Advisory Committee on Immunization Practices
February 29, 2024
Data reported by jurisdiction Immunization Information Systems
Vaccination coverage estimates by demographic characteristics and high risk
conditions, National Immunization Survey
Doses administered in pharmacies and physician offices, by product type, IQVIA
Vaccination attitudes and concerns, CDC Omnibus Surveys
RSV vaccine implementation considerationsPresentation Outline
2
Data Reported by Jurisdiction Immunization
Information Systems (IIS)
Percent of Adults 60 Years and Older Who Have Received ≥1 Dose RSV Vaccine
Reported by Jurisdiction Immunization Information Systems, Through December 2023
•Among the currently reporting 37 state and city IIS jurisdictions, RSV vaccination coverage among adults 60 years and older ranged from 4.6% to 17.9%
4
National Immunization Survey (NIS) Data
Update
National Immunization Survey -Adult COVID Module (NIS -ACM) Methods
•The NIS- ACM is a random- digit -dial cellular telephone survey of adults age ≥18 years in the U.S.
•Respondents are sampled within all 50 states, District of Columbia, five local jurisdictions (Bexar County TX,
Chicago IL, Houston TX, New York City NY , and Philadelphia County PA), Puerto Rico and the U.S. Virgin Islands (sampled in 2023 only).
•Data are weighted to represent the non- institutionalized U.S. population.
oEstimates from the NIS -ACM may differ from estimates based on other data sources, and are subject to errors resulting
from incomplete sample frame (exclusion of households without cell phones), selection bias (survey respondents may
be more likely to be vaccinated than non -respondents), and errors in self -reported vaccination status. Estimates are
weighted to selected sociodemographic characteristics of the U.S. population to reduce possible bias from incomplete
sample frame and selection bias.
•All responses are self- reported.
•Enhanced weekly estimates:
oCoverage estimates are based on all interviews through the current week and represent approximately the cumulative
percent vaccinated by mid -week. Each week, estimates for prior weeks are recalculated using the additional interviews
conducted that week (combined with all previous interviews).
oEstimates for vaccination intent are based on interviews conducted that week and are adjusted to the cumulative vaccination coverage estimate for that week.
•Kaplan -Meier estimates:
oBased on interviews conducted September 24, 2023 –January 27, 2024
oKaplan -Meier estimation procedure used to estimate RSV vaccination coverage through end of December 2023
•Additional information available at: About the National Immunization Surveys6
4.8 5.2 6.5 8.2 9.1 11.4 12.6 13.5 13.9 15.9 16.7 17.0 17.3 17.4 20.2 20.6 20.9 21.4 22.420.9 21.8 20.0 19.6 17.516.917.8 16.6 14.415.6 14.2 12.214.8 16.815.8 14.4 15.4 11.713.350.4 50.345.547.842.742.843.5 45.042.640.4 38.8 39.238.041.6 37.5 38.8 35.1 39.438.324.0 22.728.124.430.7 28.8 26.1 24.829.1 28.1 30.3 31.6 29.824.2 26.5 26.1 28.6 27.5 26.1
0255075100Weighted %• Among adults aged ≥60 years responding to the National Immunization Survey through February  3, 22.4%  (95% CI: 21.1- 23.6)  reported having received an RSV vaccine.
• 13.3% (95% CI: 11.5- 15.1) of adults  ≥60 years  said they definitely will get vaccinated, and 26.1% (95% CI: 23.7 -28.4) said they probably or definitely will not get
vaccinated.
Probably or definitely will not get RSV vaccine
Probably will get RSV vaccine or unsureDefinitely will get RSV vaccineReceived RSV vaccineRSV Vaccination Status and Intent Among Adults 60 Years and Older
National Immunization Survey-Adult COVID Module (NIS -ACM)
Weekly RSV Vaccination Status and Intent Among
Adults Age ≥60 Years, NIS -ACM (n = 97,574)
7
12.4*22.53.2*14.0*12.9*16.714.5*24.4*29.1*24.9*19.4*24.0*11.11.7*19.720.414.220.0
0 20 40 60 80 100Multi/Other, non-HispanicWhite, non-Hispanic (Ref)NH/OPI, non-HispanicHispanicBlack, non-HispanicAsian, non-HispanicAI/AN, non-Hispanic80+75-7970-7465-6965+60-64 (Ref)50-59**MaleFemale (Ref)Overall 50+**Overall 60+
Weighted % (95% CI)RSV vaccination coverage  among adults 60 years and older, by end of December 2023
National Immunization Survey-Adult COVID Module  (NIS -ACM)
(N = 91,680)
AI/AN: American Indian or Alaska Native; NH/OPI: Native Hawaiian or Other Pacific
Islander; CI: 95% confidence interval; Ref: Referent category .
*Statistically significant at p<0.05 compared to the referent category.**This bar only among age 50+, all other bars age 60+ only.•20.0% (95% CI: 19.1- 20.9) of adults ≥60
years reported having received an RSV
vaccine by the end of December 2023.
•Vaccination was highest among older
adults and white non- Hispanic adults.
8
2.6*11.7*38.52.5*30.517.918.3*20.4*23.2
0 20 40 60 80 100No COVID vaccinations1+ (not updated)Updated COVID vaccine (Ref)Did notReceived flu vaccine (Ref)Smoker (current/former)SVI: HighSVI: ModerateSVI: Low (Ref)
Weighted % (95% CI)17.88.1*32.722.228.423.5*23.0*29.3*24.527.7*25.1*
0 20 40 60 80 100None of the above (Ref)NeurologicalLiver diseaseImmunocompromisedHIV infectionHeart conditionsDiabetesChronic lung diseasesChronic kidney diseaseCancer1+ chronic conditions
Weighted % (95% CI)RSV vaccination coverage  among adults 60 years and older, by end of December 2023
National Immunization Survey -Adult COVID Module  (NIS -ACM)
Immunocompromised includes immunocompromised state, solid organ or blood stem cell
transplant, sickle cell disease or thalassemia; Neurological includes stroke or cerebrovascular hemorrhage, dementia or other neurological, Down syndrome.SVI: Social Vulnerability Index; CI: 95% confidence interval; Ref: Referent category .
*Statistically significant at p<0.05 compared to the referent category.•Adults ≥60 years with 1+ chronic conditions had significantly higher RSV vaccination coverage (25.1%) than those with no chronic conditions (17.8%).
•RSV vaccination coverage was higher among those who have received a flu vaccine or who have received the updated 2023- 24 COVID -19
vaccine.
9
30.0*23.9*20.0*14.318.4*24.0*18.6*14.04.1*20.614.720.9*21.0*28.220.423.820.017.9*21.718.2*20.914.9*24.1
0 20 40 60 80 100Advanced degreeCollege graduateSome collegeHigh school or less (Ref)Income unknownAbove poverty, >=$75KAbove poverty, <$75KBelow poverty (Ref)UninsuredInsured (Ref)Rural (Ref)SuburbanUrbanHHS Region 10HHS Region 9HHS Region 8HHS Region 7HHS Region 6HHS Region 5HHS Region 4HHS Region 3HHS Region 2HHS Region 1 (Ref)
Weighted % (95% CI)RSV vaccination coverage  among adults 60 years and older, by end of December 2023
National Immunization Survey-Adult COVID Module  (NIS -ACM)
(N = 91,680)
•RSV vaccination coverage was highest
in HHS regions 10 (28.2%; AK,ID,OR,WA ) and
1 (24.1; CT,ME,MA,NH,RI,VT ).
•Adults in rural areas had lower vaccination coverage (14.7%).
•Adults with health insurance had significantly higher vaccination
coverage (20.6%) than adults without
insurance (4.1%).
•RSV vaccination increased with increasing household income and
education.
HHS Regions
1: CT,ME,MA,NH,RI,VT  6: AR,LA,NM,OK,TX
2: NJ,NY,PR,VI   7: IA,KS,MO,NE
3: DE,DC,MD,PA,VA,WV  8: CO,MT,ND,SD,UT,WY
4: AL,FL,GA,KY,MS,NC,SC,TN  9: AZ,CA,HI,NV,GU
5: IL,IN,MI,MN,OH,WI  10: AK,ID,OR,WAAI/AN: American Indian or Alaska Native; NH/OPI: Native Hawaiian or Other Pacific Islander; CI: 95% confidence interval; Ref: Referent category .
*Statistically significant at p<0.05 compared to the referent category. 10
19.8 8.5 14.7 57.1
0.0 20.0 40.0 60.0 80.0 100.060+ years
Weighted %RSV vaccine received with flu vaccine RSV vaccine received with COVID vaccine RSV vaccine received with flu + COVID vaccines None of the aboveCoadministration among adults 60 years and older who received an RSV vaccine, January 2024
National Immunization Survey -Adult COVID Module (NIS -ACM)
•Among adults ≥60 years who received an RSV vaccine,
•19.8% received RSV + Flu vaccines at the same visit
•8.5% received RSV + COVID vaccines at the same visit
•14.7% received RSV + Flu + COVID vaccines at the same visit
11
84.288.883.9 84.387.7 85.8 84.788.584.6 83.3 82.0 84.411.07.713.4 14.812.111.6 12.510.415.2 15.4 17.6 13.64.8 3.4 2.7 0.9 0.2 2.6 2.9 1.0 0.2 1.3 0.4 2.0
0%20%40%60%80%100%Weighted %Other non-medical
Medical
Pharmacy
Medical: includes doctor's office, health department, clinic or health center, hospital, mass vaccination site, or "other" me dically -related place .
Other non -medical: includes workplace, high school/college/university, or "other" nonmedically -related place.Place of RSV Vaccination Among Vaccinated Adults Age ≥60 Years, NIS -
ACM, November 2023 -February 2024Place of RSV vaccination among vaccinated adults 60 years  and older
National Immunization Survey -Adult COVID Module (NIS -ACM)
12
IQVIA Data Update
RSV vaccine doses administered in retail pharmacies, long -term care pharmacies, and
American Medical Association (AMA) physicians’ medical offices* based on claims
submitted to insurers and cash payments (pharmacies only).
IQVIA data include raw (actual) number of doses administered at a sample of
pharmacies and medical offices of a sample of AMA physicians.
oIQVIA uses a proprietary projection methodology to estimate the projected number of vaccinations administered
inallpharmacies and medical offices of all AMA physicians.
National medical offices projected estimates are based on 2,866 (48%) of the 5,979
AMA physicians that IQVIA monitors who  provide RSV vaccinations.
oRange for states is 0% – 73%
oProjected estimates are updated monthly and do not mature until about two months. This results in an increase or
decrease in the initial or subsequent estimates for a given week (up to ~10% based on initial evaluations)IQVIA Methodology
IQVIA data products used: Custom Longitudinal Prescription Claims ( LRx) for retail pharmacies, Custom Medical Claims (Dx) for physician medical offices, SMART National Prescription
Audit (NPA)*Physicians are a sample of AMA’s proprietary list of physicians. 14
National retail pharmacy projected estimates are based on a sample of 40,469 (97%)
of the 41,583 pharmacies that IQVIA monitors that provide RSV vaccinations.
oRange for states is 94% – 100%
oHigher confidence in the accuracy of national estimates for pharmacy data compared with physician office
data
Data are notavailable for vaccinations administered in:
oOther medical settings ( e.g. public health clinics, hospitals)
oNon -medical, non -pharmacy settings ( e.g. workplace, community settings)IQVIA methodology (cont )
15
Weekly Cumulative Projected RSV Vaccinations Administered in Retail Pharmacies and
Physician Medical Offices, Adults 60 years and older, August 12, 2023 – February 3,  2024.
Data Source: IQVIA*
*Data Source: IQVIA Custom Weekly LRx and Custom Weekly Dx . Data are available Respiratory Syncytial Virus (RSV) Adult Vaccinations Administered | CDC
**IQVIA SMART NPA; Data pulled 2/12/24. This is a subset of vaccinations administered in long -term care settings .
 •As of February 3 , 2024, a combined total of 9.65 million RSV vaccinations were administered in retail pharmacies  (9.36
million) and physician medical offices (291,599).
•An additional 164,254 RSV vaccinations were administered in long -term care pharmacies.**
16
Weekly and Cumulative Projected RSV Vaccinations Administered in Retail Pharmacies by Product,
Adults 60 years and older, August 12, 2024 – February 2, 2024. Data Source: IQVIA*
•Of the total 9,360,148 RSV vaccinations administered, 2,933,112 (31%)  were Abrysvo  (Pfizer) and 6,427,035
(69%) were Arexvy  (GSK).
*IQVIA Custom Weekly LRx; File delivery date 2/8/24 .17
Cumulative Projected RSV Vaccinations Administered in Pharmacies, by Age Group and
Product, August 4, 2023 – February 2, 2024. Data Source: IQVIA*
*Data Source: IQVIA SMART National Prescription Audit (NPA) Weekly Extended Insights. Information about these sources is availab le via IQVIA.
**An additional 1,543 ABRYSVO and 2,860 AREXVY doses were administered to unspecified ages.•As with all persons 60 years and older, for each age group, about 30% received Abrysvo  (Pfizer) and 70% received Arexvy  (GSK).
18
Weekly and Cumulative Projected RSV Vaccinations Administered in Physicians’ Medical
Offices by Product, Adults 60 years and older, August 12, 2024 - February 3, 2024
•Of the total 291,598 RSV vaccinations administered, 130,720 (45%) were Abrysvo  (Pfizer) and 160,877 (55%)
were Arexvy  (GSK) .
*IQVIA Custom Weekly Dx ; File delivery date 2/20/24 .
19
Cumulative Projected RSV Vaccinations Administered in Physicians’ Medical Offices, by Age
Group and Product, U.S., August 4, 2023– February 3, 2024. Data Source: IQVIA*
*IQVIA Custom Weekly Dx ; File delivery date 2/20/24 .•Of the 291,598 doses administered, Arexvy  was administered in 53% of adults 60 -64 years and 56% among 65
and older
20
Cumulative Raw (Actual)* RSV Vaccinations Administered Alone or On the Same Day with
Influenza and/or COVID Vaccinations, in Retail Pharmacies and Physicians’ Medical Offices Combined, Adults 60 years and older, August 2023 –  December 2023
*Raw estimates are based on actual sample of pharmacies and medical offices and thus will be different than projected estimat es
presented elsewhere. IQVIA was unable to provide projected estimates due to complexity of analysis. Vaccination(s) received Number (%) of persons
receiving vaccinations
RSV only (without flu and/or COVID) 3,635,795 (52.0%)
RSV and flu 1,557,403 (22.3%)
RSV and COVID 852,591 (12.2%)
RSV, flu, and COVID 943,676 (13.5%)
Total 6,989,465•Of the  ~7 million doses of RSV administered through end of December, 52% were administered alone
and 48% with either flu or COVID vaccination or all three vaccine on the same day.
21
Comparison of NIS and IQVIA Projected Doses Administered by Setting
•Number of doses reported from the NIS projected by applying the vaccination coverage estimates and reported place of
vaccination to the 2022 U.S. Census population of persons 60 years and older
•IQVIA data do not capture all medical settings and settings other than medical and pharm.acy .
•NIS-based estimate for number of doses administered in pharmacies is 14.9 million compared with 9.4 million doses based on
IQVIA’s projected estimate. NIS-based estimate for all medical settings is 2.4 million compared with 0.29 million in physicians’
medical offices .
*Data Source: IQVIA SMART NPA and Custom Weekly Dx . NIS ACM Weekly enhanced coverage estimates by week ending February 3, 2024, and
reported place of vaccination for persons interviewed during the week ending February 3, 2024. 22
Comparison of NIS and IQVIA Projected Estimates to Determine Possible Range of
Vaccination Coverage and Persons Vaccinated
*Data Source: IQVIA SMART NPA and Custom Weekly Dx . NIS ACM Weekly enhanced coverage estimates by week ending February 3, 2024, and
reported place of vaccination for persons interviewed during the week ending February 3, 2024.•The IQVIA projected total for physicians’ medical offices and pharmacies combined is 9.7 million (cover age 12.2%).
•Based on adjusting IQVIA pharmacy estimates by the proportion of people vaccinated in pharmacies reported from the NIS , 11.1
million doses were administered in all settings (coverage 14.1%).
•Based on  applying NIS vaccination coverage estimates to the 2022 U.S. Census population of persons 60 years and older , 17.7
million doses of RSV vaccine were administered in all settings (coverage 22.4%).
•Using data from both sources, estimated range of persons vaccinated is approximately 11 –18 million and estimated percent of
persons vaccinated is 14% –22% .
Cumulative number of RSV vaccine doses administered (left bars) and cumulative RSV vaccination coverage (right bars), among persons 60 years and older, as of week ending February 3, 2024.
23
RSV Vaccination Attitudes, Omnibus Surveys,
January 2024
Data for this analysis were collected through the IPSOS KnowledgePanel  and NORC
AmeriSpeak  Omnibus Surveys, which use probability -based panels to survey a
nationally representative sample of U.S. adults aged 18 years and older.
CDC fields questions about vaccination status, intent, knowledge, attitudes, beliefs, and
behaviors on each survey for 2 waves each month, for a combined sample size of ~4,000 respondents.
Data were weighted to represent the non -institutionalized U.S. population and mitigate
possible non- response bias. All responses are self -reported.Omnibus Survey Methods
25
4.6%
2.6%
2.5%
2.4%
2.3%
1.9%
1.5%
1.0%
0 25 50 75 100Side
effects
Don't know enough
about RSV or vaccine
Haven't
had time
Not worried
about RSV
Too close to
COVID vaccine
Vaccine
fatigue
No HCP
recommendation
Other
reason
Weighted % (95% confidence interval)Received/definitely will get
(N=391)
84.0% reported "No concerns or issues"25.8%
23.0%
11.8%
7.7%
7.5%
6.2%
6.1%
5.9%
0 25 50 75 100No HCP
recommendation
Don't know enough
about RSV or vaccine
Vaccine is
too new
Unsure if need
or eligible
Haven't
had time
Too close to
COVID vaccine
Side
effects
Vaccine
fatigue
Weighted % (95% confidence interval)Probably will get/unsure
(N=490)
34.5% reported "No concerns or issues"28.2%
23.0%
21.2%
20.7%
15.7%
15.6%
11.9%
10.6%
0 25 50 75 100Do not trust
gov. or pharma
Don't know enough
about RSV or vaccine
Vaccine is
too new
Not worried
about RSV
Side
effects
No HCP
recommendation
Vaccine is not
effective
Do not
need it*
Weighted % (95% confidence interval)Probably/definitely will NOT get
(N=445)
26.4% reported "No concerns or issues"Top RSV Vaccination Concerns and Issues Among Adults ≥60 Years of Age, by
Status/Intent, Omnibus Surveys, January 5 -29, 2024 (N=1,326)
Other response options included: "Cost/insurance issues ," "Already had RSV*," "HCP recommended against," "Medical reasons*," "Afraid of needles," "Vaccine not available."
*Option not offered to those who already received the vaccine.26
Implementation Considerations
Takes time to integrate into systems, gain wide access, increase awareness
among healthcare providers, and normalize among the population.
RSV is recommended based on SCDM.
SCDM recommendations are difficult to implement.
Coadministration messaging is complex and may result in missed opportunities for
vaccination.
Insurance plans have a year to cover the vaccine and not all plans may cover RSV
vaccine in its first year.
Vaccines are costly, meaning a costly upfront investment to carry the vaccine.
RSV vaccine is billed under Medicare Part D.
Residents of long -term care have additional, specific challenges.Potential factors contributing to relatively low vaccination
coverage among people ages 60 years and older
28
Frequent speaking engagements with healthcare providers to provide education on
recommendations and answer questions
Social media and other consumer resources to promote vaccination
Resources to increase clinician knowledge of RSV vaccination recommendations and coadministration recommendations
Regular communication with CMS to communicate challenges with billing
Regular collaboration and communication with long -term care partners
Planning analysis on shared clinical decision makingWhat is CDC doing to increase coverage or RSV vaccination
in people ages 60+?
29
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 o f the Centers for Disease Control and Prevention.
Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation use. No rights  are implied or extended for use in printing or
any use by other CDC CIOs or any external audiences.Thank you!

Summary: Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases RSV Vaccination Implementation Update Carla Black, PhD Surveillance and Epidemiology Branch…


05 RSV Adults Shimabukuro 508

Centers for Disease Control and Prevention
National Center for Emerging and Zoonotic Infectious Diseases
Post -licensure safety monitoring of respiratory
syncytial virus (RSV) vaccines in adults aged ≥60 years
Tom Shimabukuro, MD, MPH, MBA
On behalf of the Immunization Safety Office, CDC
Advisory Committee on Immunization Practices (ACIP)
February 29, 2024
Topics
▪Background
▪CDC vaccine safety monitoring for RSV vaccines in adults aged ≥60 years
•V-safe
•Vaccine Adverse Event Reporting System (VAERS) (co -managed with FDA)
•Vaccine Safety Datalink (VSD)
▪Summary
2
Background
▪In May 2023, the U.S. Food and Drug Administration licensed two RSV vaccines
with approvals for use in adults aged ≥60 years
•GSK RSV vaccine (trade name Arexvy )*
•Pfizer RSV vaccine (trade name Abrysvo )†
▪In June 2023, the Advisory Committee on Immunization Practices (ACIP) voted to
recommend that adults aged ≥60 years may receive a single dose of an RSV
vaccine using shared clinical decision -making‡
*Package Insert - AREXVY (fda.gov)
†Package Insert - ABRYSVO (STN 125769/26) (fda.gov) ; Abrysvo was also authorized on August 21, 2023, for use in pregnant people to prevent lower respiratory tract disease caused by
RSV in infants from birth through six months of age.
‡ Melgar et al. Use of Respiratory Syncytial Virus Vaccines in Older Adults: Recommendations of the Advisory Committee on Immun ization Practices - United States, 2023. MMWR Morb
Mortal Wkly  Rep. 2023;72(29):793 -801. 3
Background, cont.
▪The most common reactions in prelicensure studies among adults aged ≥60
years receiving RSV vaccine were:
•GSK ( Arexvy )* RSV vaccine: pain at the injection site (61%), fatigue (34%), and
myalgia (29%)
•Pfizer ( Abrysvo )† RSV vaccine: fatigue (16%), headache (13%), and pain at the
injection site (11%)
▪In prelicensure studies‡ of Pfizer ( Abrysvo ) RSV vaccine among 20,255 vaccine
recipients aged ≥60 years, 2 cases of Guillain -Barré syndrome (GBS) were
observed within 42 days of vaccination
▪In prelicensure studies‡,¶of GSK ( Arexvy ) RSV vaccine among 18,304 vaccine
recipients aged ≥60 years, 1 case of GBS was observed within 42 days
ofvaccination
*Package Insert - AREXVY (fda.gov)
†Package Insert - ABRYSVO (STN 125769/26) (fda.gov)
‡ Melgar et al. Use of Respiratory Syncytial Virus Vaccines in Older Adults: Recommendations of the Advisory Committee on Immun ization Practices - United States, 2023. MMWR Morb
Mortal Wkly  Rep. 2023;72(29):793 -801
¶Gerber S. ACIP presentation slides, October 25, 2023 ( 1 - GSK RSV - ACIP Core Presentation_CO  (cdc.gov) )4
Background, cont.
▪Clinical trials generally are too small to assess risk for rare adverse events
▪Due to the small number of GBS cases and size of the prelicensure studies , it is
not known at this time whether these GBS cases or other neuroinflammatory
events occurred due to random chance, or whether RSV vaccination might
increase the risk of these events
▪Post -licensure safety monitoring* of the RSV vaccines is currently ongoing in:
•V-safe
•Vaccine Adverse Reporting System (VAERS)†
•Vaccine Safety Datalink (VSD)
•Non -CDC systems
* Vaccine Safety Monitoring | Vaccine Safety | CDC
† Clinical Immunization Safety Assessment (CISA) Project contributing expertise to VAERS report reviews 5
6V-safe
New version of V -safe is now available
▪System requires both previous and
new users to create an account
▪Includes both email and text
messaging functionality
▪Vaccines currently monitored:
•RSV vaccines for older adults and
pregnant persons
•COVID -19 vaccines for persons aged 6
months and older
7
V-safe sends health surveys after vaccination
▪After vaccinations, surveys are sent daily during the first week, then weekly
through 6 weeks
▪Daily surveys solicit adverse events and health impacts after vaccination
•Local reactions (e.g., pain, redness, swelling)
•Systemic reactions (e.g., fatigue, headache, muscle pain)
•Health impacts (e.g., unable to perform normal daily activities, missed
school or work, or received medical care)
•Additional questions for persons who reported immunocompromise at
vaccination
▪Weekly surveys solicit new symptoms or conditions after vaccination
▪Participants reporting medically attended health impacts are
encouraged tocomplete a VAERS report
8
Characteristic Vaccine manufacturer (%)
GSK ( Arexvy )
N=6,227Pfizer ( Abrysvo )
N=3,746Manuf  not known
N=5,772Total
N=15,745
Female sex assigned at birth 59.5 58.0 61.1 59.7
Median age (min, max), years 70 (60, 93) 70 (60, 94) 70 (60, 94) 70 (60, 94)
Ethnicity
Hispanic, Latino, or Spanish 2.7 3.8 3.0 3.1
Race
American Indian or Alaska Native 0.2 0.2 0.3 0.3
Asian 2.9 2.7 2.2 2.6
Black or African American 4.4 7.2 4.6 5.2
Native Hawaiian or Pacific Islander 0.2 0.1 0.1 0.1
White 89.2 85.9 88.7 88.2
Other 0.7 1.2 1.0 1.0
Unknown/prefer not to answer 1.0 1.4 1.5 1.3
Multiracial 1.3 1.2 1.6 1.4
* For 15,745 V -safe participants who enrolled in the RSV 60+ years old protocol and completed ≥1 daily survey during October 20,  2023 -January 28, 2024Demographic characteristics of adults aged ≥60 years
who reported RSV vaccination*
9
Additional characteristics of adults aged ≥60 years who
reported RSV vaccination*
Characteristic Vaccine manufacturer (%)
GSK ( Arexvy )
N=6,227Pfizer ( Abrysvo )
N=3,746Manuf  not known
N=5,772Total
N=15,745
Immunocompromised 6.8 6.6 6.4 6.6
State of health
Excellent 22.7 22.6 21.5 22.2
Very good 46.9 46.0 46.1 46.4
Good 25.1 25.8 26.5 25.8
Fair 4.9 5.3 5.6 5.3
Poor 0.3 0.2 0.4 0.3
Vaccine(s) co -administered 24.6 33.8 35.6 30.8
COVID -19 16.0 22.8 23.5 20.4
Influenza 12.6 17.4 20.0 16.5
COVID -19 and influenza 7.3 10.1 11.4 9.5
COVID -19, influenza, and other 0.7 1.1 1.2 1.0
Other 4.9 6.0 5.8 5.5
* For 15,745 V -safe participants who enrolled in the RSV 60+ years old protocol and completed ≥1 daily survey during October 20,  2023 -January 28, 2024 10
Reactions and health impacts reported for adults aged ≥60 years at
least once in days 0 -7 following RSV vaccination, by manufacturer*
1.80.4 1.3 0.51.70.3
0102030405060708090100
Any symptoms Injection site reaction Systemic reaction Unable to complete daily
activitiesUnable to work Got medical care
GSK Pfizer Don't know
* For 15,745 V -safe participants who enrolled in the RSV 60+ protocol and completed ≥1 daily survey during October 20, 2023 -Janu ary 28, 2024 11
Promoting V -safe – We need your help
▪Ensure vaccination partners are aware of V -safe
•Information sheets
•Social media posts
•Communications to vaccine recipients
Materials and more information available at:
https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/v -safe/index.html
12
VAERS is the nation’s early warning system for vaccine safety
+
Vaccine Adverse Event
Reporting System
http://vaers.hhs.gov
13
Vaccine Adverse Event Reporting System (VAERS)
Strengths
▪National data
▪Accepts reports from anyone
▪Rapidly detects safety signals
▪Can detect rare adverse events
▪Data available to publicLimitations
▪Reporting bias
▪Inconsistent data quality and completeness
▪Lack of unvaccinated comparison group
▪Not designed to assess causality
•VAERS accepts all reports from all reporters without making judgments on causality or judging
clinical seriousness of the event
•As a hypothesis generating system, VAERS identifies potential vaccine safety concerns that can
be studied in more robust data systems14
VAERS methods
▪Signs and symptoms of adverse events are coded using Medical Dictionary for
Regulatory Activities (MedDRA)* Preferred Terms (PTs)
•MedDRA PTs are not mutually exclusive
•A single report may be assigned more than 1 MedDRA PT
▪Individual report review of serious† reports and medical records, if available
▪Brighton Collaboration case definitions applied for the neuroinflammatory
conditions, Guillain -Barré syndrome and acute disseminated encephalomyelitis‡
▪Reporting rate calculations use doses of vaccine administered for each type of
RSV vaccine
▪Empirical Bayesian datamining used to detect disproportional reporting for the
entire post marketing period for each product¶
* Welcome to MedDRA | MedDRA
† Based on the Code of Federal Regulations if one of the following is reported: death, life -threatening illness, hospitalization o r prolongation of hospitalization, permanent disability, congenital anomaly or birth defect
‡ Sejvar et al. Brighton Collaboration GBS Working Group. Guillain -Barré syndrome and Fisher syndrome: case definitions and guidel ines for collection, analysis, and presentation of immunization safety data. Vaccine.
2011;29(3):599 -612. Sejvar et al. Encephalitis, myelitis, and acute disseminated encephalomyelitis (ADEM): case definitions and guidelines for coll ection, analysis, and presentation of immunization safety data.
Vaccine. 2007 Aug 1;25(31):5771 -92.
¶ DuMouchel  W. Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. Am Statistici an 1999;53:177 –90.15
Surveillance of Adverse Events of Special Interest (AESI)
after RSV vaccination
▪Primary AESIs
•Selected for historical, theoretical, or observed safety concerns (i.e., observed in clinical trials)
•Attempts are made to obtain medical records for all primary AESI reports (serious* and non -serious)
•CDC reviews records and abstracts clinically important information
•AESIs may be added to or removed from the list as appropriate
▪Secondary AESIs
•Monitored via periodic (e.g., weekly) automated data tables
•Can be added to primary AESI list if safety concerns identified
* Based on the Code of Federal Regulations if one of the following is reported: death, life -threatening illness, hospitalization o r prolongation of hospitalization,
permanent disability, congenital anomaly or birth defect16
AESI after RSV vaccination
▪Outcomes of general interest
•Death
▪Neurologic/neuroinflammatory conditions
•Guillain -Barré syndrome (GBS), including Miller Fisher variant
•Acute disseminated encephalomyelitis (ADEM)
•Transverse myelitis (TM)
•Chronic inflammatory demyelinating polyneuropathy (CIDP)
▪Allergic reactions
•Anaphylaxis
▪Cardiac conditions
•Atrial fibrillation
•Other supraventricular tachycardias (SVT)▪Neurologic/neuroinflammatory conditions
•Optic neuritis
•Multiple sclerosis
•Bell’s palsy
•Encephalitis/Encephalomyelitis
•Meningitis/Meningoencephalitis
•Myelitis
▪Other conditions
•Vaccination errors
•AEs following simultaneous administration with
COVID -19, inactivated influenza, or other adult
vaccinesPrimary AESI Secondary AESI
17
8 participating medical
research centers with
vaccine safety experts*More information about clinical consults available at: : Clinical Immunization Safety
Assessment (CISA) Project | CISA | Monitoring | Ensuring Safety | Vaccine Safety | CDCCISA
Clinical
Immunization
Safety
Assessment
(CISA) Project
▪clinical consult services*
▪clinical expertise for surveillance
▪clinical research
18
U.S. reports to VAERS following respiratory syncytial virus (RSV)
vaccination among adults ages ≥60 years  (as of February 16, 2024)
VaccineDoses administered
(as of Feb 2 –3, 2004)*Median age
(IQR†), yearsFemale
N (%)Non -serious
N (%)Serious‡
N (%)Total
Reports
GSK (Arexvy) 6,587,912 72 (67 –77) 1,674 (67) 2,347 (93) 169 (7) 2,516
Pfizer ( Abrysvo ) 3,063,832 73 (68 –78) 618 (59) 954 (91) 91 (9) 1,045
Vaccine brand
unknownNot applicable 73.5 (67 -78) 70 (55) 109 (85) 19 (15) 128
 Total 9,651,744 72 (67 –77) 2,362 (64) 3,410 (92) 279 (8) 3,689
* Doses administered during August 4, 2023, through February 3, 2024, at medical offices from AMA’s list of physicians [Data source: Custom IQVIA Custom Medical Claims (Dx)] and during August 12, 2023, through
February 2, 2024, at retail pharmacies [Data source: Custom Longitudinal Prescription Claims ( LRx)]. IQVIA data do not include vaccinations administered at other medical settings such as public health clinics and
other settings including workplaces and community locations. These represent projected doses. Based on a sample of retail pha rmacies and medical offices of a sample of AMA physicians, IQVIA projects doses
administered in all retail pharmacies and medical offices of all AMA physicians.
† Interquartile range
‡ Based on the Code of Federal Regulations if one of the following is reported: death, life -threatening illness, hospitalization or prolongation of hospitalization, permanent disability, congenital anomaly or birth defect
19
Most frequently reported MedDRA Preferred Terms* among reports to VAERS
following RSV vaccination among adults ages ≥60 years, by manufacturer
(as of February 16, 2024 )
RankAll Reports
(N=3,689)†,‡ n (%)Pfizer (Abrysvo)
(N=1,045)† n (%)GSK (Arexvy)
(N=2,516)† n (%)
1 Pain in extremity 439 (12) Fatigue 120 (12) Pain in extremity 327 (13)
2 Fatigue 432 (12) Headache 114 (11) Injection site pain 320 (13)
3 Pain 414 (11) Pain in extremity 99 (10) Pain 305 (12)
4 Injection site pain 408 (11) Pain 97 (9) Fatigue 290 (12)
5 Headache 404 (11) Fever 95 (9) Headache 277 (11)
6 Fever 353 (10) Arthralgia 86 (8) Injection site erythema 267 (11)
7 Injection site erythema 338 (9) Injection site pain 81 (8) Fever 249 (10)
8 Arthralgia 304 (8) Chills 75 (7) Arthralgia 210 (8)
9 Erythema 255 (7) Nausea 71 (7) Erythema 193 (8)
10 Injection site swelling 247 (7) Dizziness 70 (7) Injection site swelling 191 (8)
* Medical Dictionary for Regulatory Activities Preferred Terms ( MedDRA Hierarchy | MedDRA )
†Signs and symptoms are not mutually exclusive
‡ Includes 128 reports with unknown RSV vaccine brand20
Most frequently reported MedDRA Preferred Terms* among reports to VAERS
following RSV vaccination among adults ages ≥60 years (as of February 16, 2024 )
Rank MedDRA PT (not mutually exclusive) n (%)
1 Dyspnoea 48 (17)
2 Asthenia 47 (17)
3 Fatigue 38 (14)
4 Gait disturbance 35 (13)
5 Fever 34 (12)
6 Muscular weakness 33 (12)
7 Nausea 31 (11)
8 Guillain -Barré syndrome 30 (11)
9 Intensive care 29 (10)
10 Paraesthesia 29 (10)Serious reports†,‡ (N=279) Non -serious reports† (N=3,410)
Rank MedDRA PT (not mutually exclusive) n (%)
1 Pain in extremity 416 (12)
2 Injection site pain 395 (12)
3 Fatigue 394 (12)
4 Pain 388 (11)
5 Headache 384 (11)
6 Injection site erythema 333 (10)
7 Fever 319 (9)
8 Arthralgia 284 (8)
9 Erythema 252 (7)
10 Injection site swelling 245 (7)
* Medical Dictionary for Regulatory Activities Preferred Terms ( MedDRA Hierarchy | MedDRA )
†Includes 128  reports with unknown  RSV vaccine brand (109 non -serious and 19 serious)
‡ Based on the Code of Federal Regulations if one of the following is reported: death, life -threatening illness, hospitalization o r prolongation of hospitalization, permanent disability, congenital anomaly or birth defect21
Reports* to VAERS of selected AESIs after RSV vaccination among adults
ages ≥60 years (as of February 16, 2024)
ConditionPfizer
(Abrysvo )GSK
(Arexvy )No brand
name Total
Death 9 22 3 34
Guillain -Barré syndrome (GBS) 18 16 1 35
Acute disseminated
encephalomyelitis (ADEM)1 0 1 2
Transverse myelitis (TM) 1 2 0 3
Chronic inflammatory demyelinating
polyneuropathy (CIDP)0 1 0 1
Anaphylaxis 1 1 0 2
Atrial fibrillation 15 38 5 58
Supraventricular tachycardia (SVT) 1 2 0 3
Total 46 82 10 138▪On January 19, 2024, a data
mining alert for
disproportional reporting was
detected in FDA Empirical
Bayesian (EB) data mining for
Pfizer ( Abrysvo ) RSV vaccine
and GBS
▪No data mining alert for GSK
(Arexvy ) RSV vaccine and GBS
has been detected to date
▪EB data mining is product -
specific and analyzes product -
specific vaccine -adverse event
pairings compared to the
overall VAERS database
*Reports in this table include verified,
unverified, ruled out and duplicate reports
22
Reports to VAERS of Guillain -Barré syndrome (GBS) after respiratory
syncytial virus (RSV) vaccination among adults (as of February 16, 2024)
▪23 verified* reports of GBS with symptom onset within
42 days (all within 22 days) of RSV vaccination:
•Pfizer ( Abrysvo ) (n=15), GSK ( Arexvy ) (n=8)
•Median age: 71 years (IQR: 63,75 years)
•1 report in a non -pregnant female patient aged 50s
years, received Pfizer ( Abyrsvo )
•Median time to onset: 9 days (range 1,22 days**)
•14 males, 9 females
•None were pregnant
•1 death; patient aged 70s years, male, received GSK ( Arexvy )Preliminary reports† of GBS
(N=37)
Under review‡
(n=6)
Excluded based upon
medical record review
(n=7)¶
Verified GBS by medical record review (n=23)* Based on VAERS report and medical record review and application of GBS definition in: Sejvar et al. Brighton
Collaboration GBS Working Group. Guillain -Barré syndrome and Fisher syndrome: case definitions and guidelines
for collection, analysis, and presentation of immunization safety data. Vaccine. 2011;29(3):599 -612.
† Includes reports identified through automated search and clinical review; all vaccinated Aug 29, 2023, through
Jan 5, 2024
‡ Awaiting medical records
¶ Includes one report in a pregnant person who received Pfizer ( Abyrsvo ) RSV vaccine; patient did not meet clinical
criteria for Guillain -Barr é syndrome following review by independent experts in CISA, including neurologists
** Includes one report after GSK ( Arexvy ) RSV vaccine with onset at 22 daysPfizer ( Abrysvo )
(n=15)GSK ( Arexvy )
(n=8)Verified GBS but
excluded due to onset
>42 days (n=1)
23
Reports to VAERS of Guillain -Barré syndrome after respiratory
syncytial virus (RSV) vaccination among adults (as of February 16, 2024)
▪All 23 verified reports met Brighton Collaboration criteria for GBS*:
•3 were Brighton level 1, 12 were Brighton level 2, and 8 were Brighton level 3
•21 of 23 were also classified as GBS cases (Brighton level 1 -3) by at least one CISA neurologist†
▪4 reports involving Pfizer ( Abrysvo ) RSV vaccine had respiratory symptoms within 4 weeks prior to GBS onset
▪Other vaccines were given during same visit in 14 of the 23 GBS reports‡:
Pfizer ( Abrysvo ) RSV vaccine n=9
Other vaccine N
 Bivalent mRNA COVID -19 (Pfizer -BioNTech) 3
 Bivalent mRNA COVID -19 (Moderna)
 13-valent pneumococcal conjugate vaccine1
 aIIV4 (Fluad) 1
 Imovax rabies 1
 Tdap (Boostrix) 1
 Zoster (Shingrix) 1
 RIV4 (Flublok) 1GSK ( Arexvy ) RSV vaccine n=5
Other vaccine N
 HD-IIV4 (Fluzone high -dose influenza)
 Bivalent mRNA COVID -19 (Pfizer -BioNTech)
 20-valent pneumococcal conjugate vaccine1
 aIIV4 (Fluad) 1
 Covid -19 Moderna 2
 Covid -19 Moderna
 HD-IIV4 (Fluzone high -dose influenza)1
* Sejvar et al. Guillain -Barré syndrome and Fisher syndrome: case definitions and guidelines for collection, analysis, and presentation of immun ization safety data. Vaccine . 2011;29(3):599 -612.
† One GSK report (death report) (Brighton level 4 per CISA) and 1 Pfizer report aged ≥60 years (Brighton level 4 and 5 per CISA) were not classified as GBS by at least one CISA neurologist after review
‡ Other vaccines were given within 4 weeks of symptom onset and not during same visit in 4 of the 23 reports. 1 Pfizer report, Biv alent mRNA COVID -19 vaccine; 1 GSK report, adjuvanted influenza vaccine;
1 GSK report, unspecified influenza vaccine; 1 GSK report, inactivated influenza vaccine and 20 -valent pneumococcal conjugate va ccine24
Reports to VAERS of other non -GBS neuroinflammatory conditions
after respiratory syncytial virus (RSV) vaccination* (as of February 16, 2024)
▪Transverse myelitis (n=2)
•1 report each after Pfizer ( Abrysvo )† and GSK ( Arexvy )‡
▪Acute Disseminated Encephalomyelitis (n=3)
•1 report after Pfizer ( Abrysvo )‡ and 2 reports after GSK ( Arexvy )¶
▪Posterior reversible encephalopathy syndrome (n=1)
•1 report after Pfizer ( Abrysvo )‡
▪Acute encephalitis (n=1)
•1 report after Pfizer ( Abrysvo ) †
* Sejvar et al. E ncephalitis, myelitis, and acute disseminated encephalomyelitis (ADEM): case definitions and guidelines for collection, analy sis, and presentation of immunization safety data.
Vaccine. 2007;25(31):5771 -92.
† Pending medical records
‡ Case  classified as listed diagnosis by at least one CISA neurologist
¶ One case  classified as insufficient information to verify diagnosis by CISA neurologists; another case pending review of medical recor ds 25
Observed VAERS reports and reporting rates of verified Guillain -Barré
syndrome (GBS) after respiratory syncytial virus (RSV) vaccination
among adults ages ≥60 years
* Based on VAERS report and medical record review and application of GBS definition in: Sejvar et al. Brighton Collaboration GBS Working Group. Guillain -Barré syndrome and Fisher syndrome: case
definitions and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2011;29(3):599 -612.
† Doses administered during August 4, 2023, through February 3, 2024, at medical offices from AMA’s list of physicians [Data source: Custom IQVIA Custom Medical Claims (Dx)] and during August 12, 2023,
through February 2, 2024, at retail pharmacies [Data source: Custom Longitudinal Prescription Claims ( LRx)]. IQVIA data do not include vaccinations administered at other medical settings such as public
health clinics and other settings including workplaces and community locations. These represent projected doses. Based on a s amp le of retail pharmacies and medical offices of a sample of AMA physicians,
IQVIA projects doses administered in all retail pharmacies and medical offices of all AMA physicians.
‡ Assumes complete person -time follow -up
¶ Reporting rate  for Pfizer ( Abrysvo ) increases to 4.9if patient aged 50s years is included26Age group
(years)Risk
windowRSV vaccineObserved verified
GBS reports*
(as of Feb 16, 2024)Doses
administered†
(as of Feb 2 –3, 2024)Observed VAERS
reporting rate
(per million
doses admin)‡
≥60 21-daysPfizer ( Abrysvo ) 14 3,063,832 4.6¶
GSK ( Arexvy ) 7 6,587,912 1.1
≥60 42-daysPfizer ( Abrysvo ) 14 3,063,832 4.6¶
GSK ( Arexvy ) 8 6,587,912 1.2
Using estimated rate of chart confirmed GBS after mRNA COVID -19 vaccination
in the Vaccine Safety Datalink (VSD) as a proxy for background rate*
▪Safety monitoring of mRNA COVID -19 vaccines in the VSD did NOT  detect an increased risk of
GBS associated with either of the mRNA COVID -19 vaccines
•Therefore, the rate of GBS following mRNA COVID -19 vaccination can be used as a proxy for the
background rate of GBS in a ‘vaccine -accepting’ population
•This rate is appropriate because it is relatively current and all GBS cases were a priori chart reviewed
•However, there are limitations (e.g., different populations, different time periods, different age groups)
▪Estimated rate of confirmed cases of GBS in those 65+ years of age following mRNA COVID -19
primary series vaccination in VSD
•21-day risk interval : 3.4 (95% CI 1.2 –7.3) per 100,000 person -years
•42-day risk interval : 4.5 (95% CI 2.4 –7.7) per 100,000 person -years
▪Expected cases per 1 million RSV doses administered, assuming complete person -time
follow -up
•21-day risk interval : 2.0 cases per million doses admin (range from 95% CI 0.7 –4.2)
•42-day risk interval : 5.2 cases per million doses admin (range from 95% CI 2.8 –8.9)
*Hanson et al. Incidence of Guillain -Barré Syndrome After COVID -19 Vaccination in the Vaccine Safety Datalink. JAMA Netw  Open. 2022;5(4):e228879 and VSD unpublished data.27
Observed VAERS reports and reporting rates of verified Guillain -Barré
syndrome (GBS) after respiratory syncytial virus (RSV) vaccination among
adults ages ≥60 years and estimated background rates
Age group
(years)Risk
windowRSV vaccineObserved verified
GBS reports*
(as of Feb 16,
2024)Doses
Admin
(as of Feb 2 –3,
2024)†Observed VAERS
Reporting rate
(per million
doses admin)‡Estimated
expected rate
(per million
doses admin)
based on VSD
data¶
≥60 21-daysPfizer ( Abrysvo ) 14 3,063,832 4.6 2.0
(95% CI 0.7 –4.2)GSK ( Arexvy ) 7 6,587,912 1.1
≥60 42-daysPfizer ( Abrysvo ) 14 3,063,832 4.65.2
(95% CI 2.8 –8.9)GSK ( Arexvy ) 8 6,587,912 1.2
* Based on VAERS report and medical record review and application of GBS definition in: Sejvar et al. Brighton Collaboration GBS Working Group. Guillain -Barré syndrome and Fisher syndrome: case definitions
and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2011;29(3):599 -612.
† Doses administered during August 4, 2023, through February 3, 2024, at medical offices from AMA’s list of physicians [Data source: Custom IQVIA Custom Medical Claims (Dx)] and during August 12, 2023,
through February 2, 2024, at retail pharmacies [Data source: Custom Longitudinal Prescription Claims ( LRx)]. IQVIA data do not include vaccinations administered at other medical settings such as public health
clinics and other settings including workplaces and community locations. These represent projected doses. Based on a sample o f retail pharmacies and medical offices of a sample of AMA physicians, IQVIA
projects doses administered in all retail pharmacies and medical offices of all AMA physicians.
‡ Assumes complete person -time follow -up
¶ Background data (21 -day and 42 -day risk windows) on Guillain -Barré syndrome after COVID -19 vaccines from the vaccine safety data link (cases per million doses); estimate of background rate in a vaccine -
accepting population and used as proxy because data from VSD did not detect an increased risk of GBS after mRNA COVID -19 vaccines (Source: Hanson et al. Incidence of Guillain -Barré syndrome After COVID -
19 Vaccination in the Vaccine Safety Datalink. JAMA Netw  Open. 2022;5(4):e228879.) and VSD unpublished data28
Observed VAERS reports and reporting rates of verified Guillain -Barré syndrome
(GBS) after respiratory syncytial virus (RSV) vaccination among adults ages ≥60
years compared to the VAERS reporting rate for COVID -19 vaccines
Age group
(years)RSV vaccineGBS reporting
rate in VAERS
(verified cases)
per million
doses admin*
≥60 Pfizer ( Abrysvo ) 4.6
≥60 GSK ( Arexvy ) 1.1
* Assumes complete person -time follow -up
† Reporting rate for GBS (21 -day risk window) after mRNA Covid -19 vaccines from VAERS in persons aged ≥65 years during December 20 20-January 2022. Source: Abara  et al. Reports of
Guillain -Barré syndrome After COVID -19 Vaccination in the United States. JAMA Netw  Open. 2023;6(2):e2253845.
‡ An association between Ad26 and GBS was observed but not between GBS and mRNA COVID -19 vaccines
21-day risk interval
21-day risk interval†,‡
29
Vaccine Safety Datalink (VSD)
▪Established in 1990
▪Collaborative project
between CDC and 13
integrated healthcare
organizations
▪Includes electronic health
data annually on ~13.5
million individuals across
all sites which includes ~2.8
million adults aged 60
years or older
30
Observed VSD GBS rates following RSV vaccination in adults
aged ≥60 years through December 30, 2023
▪The VSD has identified 4 GBS cases within 1 -84 days of GSK ( Arexvy ) RSV vaccination; all 4 cases have
undergone medical record review and have been adjudicated according to Brighton Criteria*

GSK ( Arexvy ) Chart Confirmed Results – Brighton Levels 1, 2, or 3

▪The 4th case, absent from the table above, was classified as Brighton Level 4 and is pending
additional medical record review
▪Currently no cases of GBS have been observed within 1 –42 days after Pfizer ( Abrysvo ) RSV vaccination
in VSD, but only ~10% of all RSV vaccinations in VSD have been with the Pfizer product
▪VSD will continue to monitor the safety of RSV vaccines in adults aged ≥60 years and formal sequential
safety analysis will begin in March 2024 using a vaccinated concurrent comparison group (similar to
COVID -19 vaccine safety monitoring)
31
* Sejvar et al. Guillain -Barré syndrome and Fisher syndrome: case definitions and guidelines for collection, analysis, and prese ntation of immunization safety data. Vaccine . 2011;29(3):599 -612.Vaccine Risk window# GBS
cases# vaccine
dosesRate per million
doses admin
(95% CI)Rate per 100,000
person years
(95% CI)
GSK ( Arexvy ) 1-21 days 2 209,653 9.5 (1.2 –34.5) 16.6 (2.0 –59.9)
GSK ( Arexvy ) 1-42 days 3 209,653 14.3 (3.0 –41.8) 12.4 (2.6 –36.4)
Summary: Early post -licensure safety monitoring of
RSV vaccines in adults aged ≥60 years
▪Local and systemic symptoms (e.g., fatigue) were the most commonly reported adverse
events following either of the RSV vaccines
▪Monitoring in VAERS indicates a higher -than -expected number of GBS reports following
Pfizer ( Abrysvo ) RSV vaccine, but VAERS is subject to the limitations of passive surveillance
•GBS cases were observed in the pre -licensure clinical trials for both the Pfizer ( Abrysvo ) and GSK
(Arexvy ) RSV vaccines and GBS is included as an adverse event in the labels of both vaccines
▪Early data from VSD suggest the potential for an increased rate for GBS after GSK ( Arexvy )
RSV vaccine, but additional analyses are needed to further assess this potential risk;
insufficient doses of Pfizer ( Abrysvo ) RSV vaccine used in VSD to inform risk
▪Monitoring  for GBS following RSV vaccines in FDA and CDC (VSD) population -based active
surveillance systems is in progress
▪CDC and FDA will continue to monitor RSV vaccine safety in VAERS and CDC will continue to
monitor in V -safe
32
Acknowledgements
▪CDC Immunization Safety Office
•VAERS Team
•V-safe Team
•Clinical Immunization Safety Assessment (CISA) Project
•Vaccine Safety Datalink (VSD)
▪Food and Drug Administration
•Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation
and Research
▪National Center for Immunization and Respiratory Diseases
•Coronavirus and Other Respiratory Viruses Division
33
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: Centers for Disease Control and Prevention National Center for Emerging and Zoonotic Infectious Diseases Post -licensure safety monitoring of respiratory  syncytial virus (RSV) vaccines in adults aged ≥60 years Tom Shimabukuro, MD, MPH, MBA On behalf of the Immunization Safety Office, CDC Advisory Committee on Immunization Practices (ACIP) February 29, 2024 Topics ▪Background ▪CDC vaccine safety monitoring for RSV vaccines in adults aged ≥60 years •V-safe •Vaccine Adverse Event Reporting…


06 RSV Adults Lloyd  508

1
Preliminary Analysis of Guillain-Barré Syndrome
(GBS) following RSV Vaccination among adults 65 years and older

Dr. Patricia Lloyd, ScM PhD
Health Statistician
Office of Biostatistics and Pharmacovigilance
Center for Biologics Evaluation and Research
U. S. Food & Drug Administration
MEETING OF THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP)
Respiratory Syncytial Virus (RSV) Vaccines, Adults
February 29, 2024
2
Outline
•Study Methods
•Statistical Analysis
•Study Results
•Limitations
•Conclusion
•Appendix
3
Study Methods
Study ObjectiveTo evaluate preliminary rates of Guillain- Barré Syndrome (GBS) following one dose of either
RSVPreF3+AS01 (AREXVY) or RSVPreF  (ABRYSVO) vaccine and to compare the observed
rates of GBS to the historical control (expected) rates
Study Design Retrospective cohort analysis with a historical comparator group
Data SourcesCenters for Medicare & Medicaid Services (CMS) administrative claims and enrollment
information derived from CMS Medicare Shared Systems Data (SSD) (Medicare Parts A, B, and D)
Study PopulationCMS Medicare Beneficiaries ages 65 years and older, enrolled in Medicare Fee- for-Service
(FFS) (Parts A and B) and Medicare Part D on the date of the first observed RSV vaccination
Study Period•RSVPreF : May 31, 2023 – Dec 2, 2023
•RSVPreF3+AS01: May 3, 2023 – Dec 2, 2023
ExposuresOne dose of either RSVPreF  or RSVPreF3+AS01 that occurred after RSV vaccine
authorization and prior to the data through date, i.e., Dec 2, 2023
Health Outcome GBS (Risk Window: 1- 42 days; Care Setting: Inpatient – primary position only)
4
•The expected number of outcomes are standardized by age and sex
•The analyses are adjusted for observational delay based on estimates from
historical data
•Incidence Rate Ratios (IRRs) are calculated by dividing observed rates by expected rates; corresponding 95% confidence intervals (CIs) are provided
•Estimation of GBS positive -predictive value (PPV) -adjusted rates is based on
multiple imputed datasets
•Chart review, PPV for GBS: 71% (95% CI: 63%, 79%)*Statistical Analyses
*Arya,D.P ., et al. Surveillance for Guillain -Barré syndrome after 2015- 2016 and 2016- 2017 influenza vaccination of Medicare
beneficiaries. Vaccine, 2019. 37(43): p. 6543- 6549.
5
020,00040,00060,00080,000100,000120,000140,000160,000Number of RSV Vaccinations
Calendar WeekRSVPreF RSVPreF3+AS01RSV Vaccinations by Calendar Week and Vaccine Brand
Claims delay
Data through date 02DEC2023.
6
Results
Incidence Rate Ratio (IRR) and 95% Confidence Interval (CI) of GBS Following an RSV
vaccination, stratified by age group and sex
Red font indicates statistically significant elevation in GBS risk. Summary
•A total of 2,061,602 RSV vaccine doses were
observed
•RSVPreF : 682,267 doses
•RSVPreF3+AS01 : 1,379,335 doses
•GBS was observed for both vaccines post- RSV
vaccination
•RSVPreF : 13 cases
•RSVPreF3+AS01: <11 cases
•An elevated IRR was observed for GBS
following RSV vaccination
•RSVPreF : 6.9 (95% CI: 3.7, 11.9)
•RSVPreF3+AS01: 2.8 (95% CI: 1.3, 5.1)
•Also observed was elevated risk by age groups and sex, but the number of cases were small by
subgroups (<5)RSV Vaccine
ExposureAge
Group
(years)SexEligible
VaccinesObserved
EventsIncidence Rate
Ratio
(IRR)IRR
95% Confidence
Interval (CI)
RSVPreF Overall Overall 682,267 13 6.9 (3.7, 11.9)
RSVPreF 65-74 Male 141,269 <11 5.8 (1.2, 17.0)
RSVPreF 75-84 Male 121,913 <11 8.5 (2.3, 21.8)
RSVPreF 85+ Male 28,091 <11 13.3 (0.3, 74.2)
RSVPreF 65-74 Female 191,409 <11 4.9 (0.6, 17.8)
RSVPreF 75-84 Female 154,152 <11 8.5 (1.8, 24.7)
RSVPreF 85+ Female 45,433 <11 - --
RSVPreF3+AS01 Overall Overall 1,379,335 <11 2.8 (1.3, 5.1)
RSVPreF3+AS01 65-74 Male 287,780 <11 2.0 (0.2, 7.2)
RSVPreF3+AS01 75-84 Male 246,852 <11 3.3 (0.7, 9.6)
RSVPreF3+AS01 85+ Male 55,292 <11 - --
RSVPreF3+AS01 65-74 Female 394,413 <11 3.8 (0.8, 11.0)
RSVPreF3+AS01 75-84 Female 310,546 <11 2.9 (0.4, 10.6)
RSVPreF3+AS01 85+ Female 84,452 <11 - --
7
Results – PPV-adjusted Analyses
Adjusted IRR and 95% CI of GBS Following an RSV vaccination
Red font indicates statistically significant elevation in GBS risk.
*Adjusted estimate based on multiple imputation.**Accounts for claims delay and 1- 42 day risk window for GBS. The GBS rate per 1 million doses assuming a 1- 21 risk window:
RSVPreF  12.5 (95% CI 3.4, 21.7); RSVPreF3+AS01, 5.0 (95% CI 0.8, 9.2).Summary
•An elevated IRR was observed for GBS following
RSVPreF  vaccination
•6.9 (95% CI: 1.9, 12.0)
•A non- statistically significant elevated IRR was
observed for GBS following RSVPreF3+AS01 vaccination
•2.8 (95% CI: 0.5, 5.0)RSV Vaccine ExposureEligible
Vaccines IRRIRR*
95% Confidence
Interval (CI)GBS  Rate**
per 1 million
doses95% CI**
RSVPreF 682,267 6.9 (1.9, 12.0) 25.1 (6.7, 43.4)
RSVPreF3+AS01 1,379,335 2.8 (0.5, 5.0) 10.0 (1.7, 18.3)
•Adjusted GBS rates per 1 million doses:
•RSVPreF : 25.1 ( 95% CI: 6.7, 43.4)
•RSVPreF3+AS01: 10.0 ( 95% CI: 1.7, 18.3)
•Multiple imputation was not successful in estimating IRR for age and sex subgroups due to the small
number of cases
•Medical charts for observed cases have been
requested and will be reviewed
8
•The observed vs. expected analysis utilizes aggregate historical rates rather
than individual historical persons as comparators, increasing the potential for
confounding and bias
•Health outcomes are identified by International Classification of Disease – 10th
Revision – Clinical Modification (ICD- 10-CM) diagnosis codes in administrative
claims databases, hence are subject to outcome misclassification
•GBS is a rare outcome, the number of cases are small, the uncertainty is high, therefore it poses a challenge for verification of a potential signalLimitations
9
•An elevated risk of GBS was observed
following both RSV vaccines
•RSVPreF  (n=13 cases) and
RSVPreF3+AS01 (n<11 cases)
•Results did not remain statistically significant for RSVPreF3+AS01 when adjusting for the PPV
•Safety monitoring following RSV vaccination using a self -controlled case
series design is planned and will provide more conclusive evidence of the potential risks following RSV vaccinationConclusions
https://bestinitiative.org/wp -content/uploads/2023/12/BEST_RSV_Safety_Older_Adults_2023- 2024.pdf
10
Acknowledgments
•Steven Anderson
•Richard Forshee
•Henry Zhang
•Joann Gruber
•Carla Zelaya
•Tainya Clarke
•FDA BEST Partners:
–Acumen, CMS
www.bestinitiative.org
Questions?
11

Summary: 1 Preliminary Analysis of Guillain-Barré Syndrome  (GBS) following RSV Vaccination among adults 65 years and older   Dr. Patricia Lloyd, ScM PhD Health Statistician Office of Biostatistics and Pharmacovigilance Center for Biologics Evaluation and Research U. S. Food & Drug Administration MEETING OF THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) Respiratory Syncytial Virus (RSV) Vaccines, Adults  February 29, 2024 2 Outline •Study Methods •Statistical Analysis •Study Results…