06 RSV Adults Melgar 508

Centers for Disease Control and Prevention
Evidence to Recommendations Framework
Respiratory Syncytial Virus (RSV) in Adults
Pfizer bivalent RSVpreF vaccine in older adults
GSK adjuvanted RSVPreF3 vaccine in older adults
Michael Melgar, MD
Amadea Britton, MD
Advisory Committee on Immunization Practices
June 21, 2023
2Evidence to Recommendations ( EtR) Framework
Policy Questions
▪Should a single dose of Pfizer bivalent RSVpreF vaccine (120µg antigen, 1 dose IM),
rather than no vaccine, be recommended in persons aged ≥65 years?
▪Should a single dose of Pfizer bivalent RSVpreF vaccine (120µg antigen, 1 dose IM),
rather than no vaccine, be recommended in persons aged 60 –64 years?
▪Should a single dose of GSK RSVPreF3 vaccine (120µg antigen + AS01Eadjuvant, 1
dose IM), rather than no vaccine, be recommended in persons aged ≥65 years?
▪Should a single dose of GSK RSVPreF3 vaccine (120µg antigen + AS01Eadjuvant, 1
dose IM), rather than no vaccine, be recommended in persons aged 60 –64 years?
3Evidence to Recommendations ( EtR) Framework
EtRDomain Question(s)
Public Health Problem ▪Is the problem of public health importance?
Benefits and Harms ▪How substantial are the desirable anticipated effects?
▪How substantial are the undesirable anticipated effects?
▪Do the desirable effects outweigh the undesirable effects?
Values ▪Does the target population feel the desirable effects are large relative
to the undesirable effects?
▪Is there important variability in how patients value the outcome?
Acceptability ▪Is the intervention acceptable to key stakeholders?
Feasibility ▪Is the intervention feasible to implement?
Resource Use ▪Is the intervention a reasonable and efficient allocation of resources?
Equity ▪What would be in the impact of the intervention on health equity?
4Evidence to Recommendations ( EtR) Framework
EtR Domain
Public Health Problem
Benefits and Harms
Values
Acceptability
Feasibility
Resource Use
Equity
5Evidence to Recommendations ( EtR) Framework
Manufacturer -specific data will be presentedEtRDomain
Public Health Problem
Benefits and Harms
Values
Acceptability
Feasibility
Resource Use
Equity
6Evidence to Recommendations ( EtR) Framework
Use of RSV vaccines broadly will be presentedEtRDomain
Public Health Problem
Benefits and Harms
Values
Acceptability
Feasibility
Resource Use
Equity
Benefits and Harms
-How substantial are the desirable anticipated effects?
-How substantial are the undesirable anticipated effects?
-Do the desirable effects outweigh the undesirable effects?
8Benefits and Harms
▪Pfizer bivalent RSVpreF vaccine
–Grading of Recommendations, Assessment, Development and
Evaluation ( GRADE ) Summary
–Modeling potential number of RSV -attributable illnesses prevented
▪GSK adjuvanted RSVPreF3 vaccine
–GRADE Summary
–Modeling potential number of RSV -attributable illnesses prevented
9GRADE Framework: PICO Question
▪Population Persons aged ≥60 years
Intervention Pfizer bivalent RSVpreF vaccine (120µg antigen, 1 dose IM)
-or-
GSK RSVPreF3 vaccine (120 μg antigen + AS01Eadjuvant, 1 dose IM)
Comparison No RSV vaccine
Outcomes ▪RSV lower respiratory tract illness/disease (LRTI/LRTD)
▪Medically attended RSV LRTI/LRTD
▪Hospitalization for RSV respiratory illness
▪Severe RSV respiratory illness requiring supplemental O2 or other
respiratory support
▪Death due to RSV respiratory illness
▪Serious Adverse Events (SAEs)
▪Inflammatory neurologic events (e.g., Guillain -Barré syndrome)
▪Reactogenicity (grade ≥3)
10GRADE Framework: PICO Question
▪Population Persons aged ≥60 years
Intervention Pfizer bivalent RSVpreF vaccine (120µg antigen, 1 dose IM)
-or-
GSK RSVPreF3 vaccine (120 μg antigen + AS01Eadjuvant, 1 dose IM)
Comparison No RSV vaccine
Outcomes ▪RSV lower respiratory tract illness/disease (LRTI/LRTD)
▪Medically attended RSV LRTI/LRTD
▪Hospitalization for RSV respiratory illness
▪Severe RSV respiratory illness requiring supplemental O2 or other
respiratory support
▪Death due to RSV respiratory illness
▪Serious Adverse Events (SAEs)
▪Inflammatory neurologic events (e.g., Guillain -Barré syndrome)
▪Reactogenicity (grade ≥3)
11Case definitions of lower respiratory tract
illness/disease were not aligned across clinical trials
▪Pfizer
▪RSV LRTI with ≥2 lower respiratory
signs/symptoms (co -primary outcome)
▪RSV LRTI with ≥3 lower respiratory
signs/symptoms (co -primary outcome)
▪Lower respiratory signs/symptoms:
–Sputum, cough, shortness of breath,
wheezing, tachypnea▪GSK
▪RSV LRTD (primary outcome)
–≥2 lower respiratory symptoms or
signs , including ≥1 sign, OR
–≥3 lower respiratory symptoms
▪Lower respiratory symptoms :
–Sputum, cough, dyspnea
▪Lower respiratory signs :
–Wheezing, crackles/rhonchi,
tachypnea, hypoxemia, O2
supplementation
12Case definitions of lower respiratory tract
illness/disease were not aligned across clinical trials
▪Pfizer
▪RSV LRTI with ≥2 lower respiratory
signs/symptoms (co -primary outcome)
▪RSV LRTI with ≥3 lower respiratory
signs/symptoms (co-primary outcome)
▪Lower respiratory signs/symptoms:
–Sputum, cough, shortness of breath,
wheezing, tachypnea▪GSK
▪RSV LRTD (primary outcome)
–≥2 lower respiratory symptoms or
signs , including ≥1 sign, OR
–≥3 lower respiratory symptoms
▪Lower respiratory symptoms :
–Sputum, cough, dyspnea
▪Lower respiratory signs :
–Wheezing, crackles/rhonchi,
tachypnea, hypoxemia, O2
supplementation
13GRADE: Pfizer bivalent RSVpreF
14Pfizer, Benefits: vaccine efficacy estimates
Outcome Importance Data sourcesVaccine efficacy (%)a
(95% confidence interval)Concerns in certainty
assessment
Benefits
RSV Lower Respiratory Tract Illness
(LRTI)bCritical
One phase 3 RCTc,
-10.6 months mean
follow up time
under surveillance,
including partial
season 2d
-31,986 person -
years under
surveillance84.4 (59.6, 95.2)
Vaccine: n=5, Placebo: n=32Indirectness (serious)e
Medically attended RSV LRTIbCritical81.0 (43.5, 95.2)
Vaccine: n=4, Placebo: n=21Indirectness (serious)e
Hospitalization for RSV respiratory
illnessImportant66.7 ( -315, 99.4)
Vaccine: n=1, Placebo: n=3Indirectness (serious)e
Imprecision (very
serious)f
Severe RSV respiratory illness
requiring O2/respiratory supportImportant0 (-7750, 98.7)
Vaccine: n=1, Placebo: n=1Indirectness (serious)e
Imprecision (very
serious)f
Death due to RSV respiratory illness ImportantVaccine: n=0/16,010 person -years
Placebo: n=0/15,976 person -yearsUnable to evaluateg
aEfficacy estimates were independently calculated using counts of events and total person -time available from the Pfizer pivotal phase 3 trial. Data provided by manufacturer.
Efficacy was calculated as 1 –incidence rate ratio. Events of each outcome were included if they occurred on or after day 15 af ter injection. Manufacturer used the same
methodology to calculate efficacy estimates.
bPfizer pivotal phase 3 trial included co -primary outcomes of LRTI with ≥2 lower respiratory signs or symptoms, and LRTI with ≥3 lower respiratory signs or symptoms. In GRADE,
the outcome of LRTI with ≥3 lower respiratory signs or symptoms was used.
c RCT = randomized controlled trial. Walsh EE, et al. Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adults . 2023. NEJM. https://doi.org/10.1056/nejmoa2213836
dMean time from vaccination to end of efficacy follow up, including a gap in RSV surveillance, was 12 months per participant. Among participants who contributed to partial
Season 2, this was 13.9 months per participant.
e Underrepresentation of adults aged ≥75 years and adults with congestive heart failure. Exclusion of adults with immune compro mise.
f95% confidence interval for measure of absolute risk included potential for both benefit and harm. Fragility of estimates.
gNo RSV -associated deaths were recorded.
15Pfizer, Benefits: vaccine efficacy estimates
Outcome Importance Data sourcesVaccine efficacy (%)a
(95% confidence interval)Concerns in certainty
assessment
Benefits
RSV Lower Respiratory Tract Illness
(LRTI)bCritical
One phase 3 RCTc,
-10.6 months mean
follow up time
under surveillance,
including partial
season 2d
-31,986 person -
years under
surveillance84.4 (59.6, 95.2)
Vaccine: n=5, Placebo: n=32Indirectness (serious)e
Medically attended RSV LRTIbCritical81.0 (43.5, 95.2)
Vaccine: n=4, Placebo: n=21Indirectness (serious)e
Hospitalization for RSV respiratory
illnessImportant66.7 ( -315, 99.4)
Vaccine: n=1, Placebo: n=3Indirectness (serious)e
Imprecision (very
serious)f
Severe RSV respiratory illness
requiring O2/respiratory supportImportant0 (-7750, 98.7)
Vaccine: n=1, Placebo: n=1Indirectness (serious)e
Imprecision (very
serious)f
Death due to RSV respiratory illness ImportantVaccine: n=0/16,010 person -years
Placebo: n=0/15,976 person -yearsUnable to evaluateg
aEfficacy estimates were independently calculated using counts of events and total person -time available from the Pfizer pivotal phase 3 trial. Data provided by manufacturer.
Efficacy was calculated as 1 –incidence rate ratio. Events of each outcome were included if they occurred on or after day 15 af ter injection. Manufacturer used the same
methodology to calculate efficacy estimates.
bPfizer pivotal phase 3 trial included co -primary outcomes of LRTI with ≥2 lower respiratory signs or symptoms, and LRTI with ≥3 lower respiratory signs or symptoms. In GRADE,
the outcome of LRTI with ≥3 lower respiratory signs or symptoms was used.
c RCT = randomized controlled trial. Walsh EE, et al. Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adults . 2023. NEJM. https://doi.org/10.1056/nejmoa2213836
dMean time from vaccination to end of efficacy follow up, including a gap in RSV surveillance, was 12 months per participant. Among participants who contributed to partial
Season 2, this was 13.9 months per participant.
e Underrepresentation of adults aged ≥75 years and adults with congestive heart failure. Exclusion of adults with immune compro mise.
f95% confidence interval for measure of absolute risk included potential for both benefit and harm. Fragility of estimates.
gNo RSV -associated deaths were recorded.
16Pfizer: RSV lower respiratory tract illness (LRTI),
defined by ≥3 lower respiratory signs or symptoms
PopulationCase split
(vaccine/placebo)aManufacturer -calculated
vaccine efficacy, % (95% CI)
All (age ≥60 years) 5/32 84.4 (59.6, 95.2)
Age ≥65 years 3/23 87.0 (56.8, 97.5)
Age ≥70 years 1/11 90.9 (37.5, 99.8)
Age ≥75 years 1/7 85.7 (-11.2, 99.7)b
Age ≥80 years 0/4 100.0 (-51.5, 100.0)b
a Pfizer pivotal phase 3 trial (Walsh EE, et al. NEJM 2023 https://doi.org/10.1056/nejmoa2213836 ). Events of each
outcome were included if they occurred on or after day 15 after injection. Average time, across participants, from
vaccination to end of efficacy follow up was 12 months, including unpublished data provided by manufacturer from
partial season 2. Total 36,127 participants (31,986 person -years) under surveillance.
bHighlighted text indicates that evidence of statistically significant efficacy is lacking.
17PopulationCase split
(vaccine/placebo)aManufacturer -calculated
vaccine efficacy, % (95% CI)
≥1 pre -existing comorbidity of
interestb 4/20 80.0 (40.3, 95.0)
≥1 pre -existing cardiorespiratory
comorbidityc 3/11 72.7 ( -3.2, 95.1)d
Adults who are frail Not assessedd
a Pfizer pivotal phase 3 trial (Walsh EE, et al. NEJM 2023 https://doi.org/10.1056/nejmoa2213836 ). Events of each outcome were
included if they occurred on or after day 15 after injection. Average time, across participants, from vaccination to end of e fficacy
follow up was 12 months, including unpublished data provided by manufacturer from partial season 2. Total 36,127 participants
(31,986 person -years) under surveillance.
b COPD, asthma, diabetes mellitus, congestive heart failure, liver or renal disease
cCOPD, asthma, congestive heart failure
dHighlighted text indicates that evidence of statistically significant efficacy is lacking.Pfizer: RSV lower respiratory tract illness (LRTI),
defined by ≥3 lower respiratory signs or symptoms
18Pfizer, Harms: relative risk
Outcome Importance Data sourcesRelative risk estimatea
(95% confidence interval)Concerns in certainty
assessment
Harms
Serious adverse events
(SAEs)CriticalOne phase 3 RCT,
one phase 1/2 RCTb1.04 (0.94, 1.15)
N=36,953 total participantsNone serious
Inflammatory neurologic
eventsImportantOne phase 3 RCTc
one phase 1/2 RCTcVaccine: n=3/18,622 participantsd
Placebo: n=0/18,335 participantseImprecision
(very serious)f,g
Reactogenicity (grade ≥3) ImportantOne phase 3 RCTh
one phase 1/2 RCTh1.43 (0.85, 2.39)
N=7,164 total participantsImprecision
(serious)f
aPooled relative risk estimates were independently calculated using counts of events and participants in the Pfizer pivotal ph ase 3 trial (Walsh EE et
al. NEJM 2023 https://doi.org/10.1056/nejmoa2213836 ), as well as from a placebo -controlled phase 1/2 dosing selection study ( Falsey AR, et al. J
Infect Dis. 2022 https://doi.org/10.1093/infdis/jiab611 ). Data provided by manufacturer.
bAfter dose 1, but before dose 2 (day 61). RCT = randomized controlled trial.
cWithin 42 days after injection. RCT = randomized controlled trial.
dIn the Pfizer pivotal phase 3 trial, 2 events of Guillain -Barré syndrome (GBS) and 1 event of motor -sensory axonal polyneuropat hy were reported
within 42 days after vaccination with RSVpreF , compared with zero in the placebo arm. One additional case of GBS was reported 8 months after
vaccination with RSVpreF and one additional case of GBS was reported 14 months after placebo receipt. No events were recorded in the phase 1/2
formulation selection study.
e Measures of relative and absolute risk were not calculated due to zero events within 42 days in placebo recipients.
f95% confidence interval for measure of absolute risk included potential for both benefit and harm.
g Fragility of estimate.
hWithin 7 days after vaccination. RCT = randomized controlled trial.
19aPooled relative risk estimates were independently calculated using counts of events and participants in the Pfizer pivotal ph ase 3 trial (Walsh EE et
al. NEJM 2023 https://doi.org/10.1056/nejmoa2213836 ), as well as from a placebo -controlled phase 1/2 dosing selection study ( Falsey AR, et al. J
Infect Dis. 2022 https://doi.org/10.1093/infdis/jiab611 ). Data provided by manufacturer.
bAfter dose 1, but before dose 2 (day 61). RCT = randomized controlled trial.
cWithin 42 days after injection. RCT = randomized controlled trial.
dIn the Pfizer pivotal phase 3 trial, 2 events of Guillain -Barré syndrome (GBS) and 1 event of motor -sensory axonal polyneuropat hy were reported
within 42 days after vaccination with RSVpreF , compared with zero in the placebo arm. One additional case of GBS was reported 8 months after
vaccination with RSVpreF and one additional case of GBS was reported 14 months after placebo receipt. No events were recorded in the phase 1/2
formulation selection study.
e Measures of relative and absolute risk were not calculated due to zero events within 42 days in placebo recipients.
f95% confidence interval for measure of absolute risk included potential for both benefit and harm.
g Fragility of estimate.
hWithin 7 days after vaccination. RCT = randomized controlled trial.Pfizer, Harms: relative risk
Outcome Importance Data sourcesRelative risk estimatea
(95% confidence interval)Concerns in certainty
assessment
Harms
Serious adverse events
(SAEs)CriticalOne phase 3 RCT,
one phase 1/2 RCTb1.04 (0.94, 1.15)
N=36,953 total participantsNone serious
Inflammatory neurologic
eventsImportantOne phase 3 RCTc
one phase 1/2 RCTcVaccine: n=3/18,622 participantsd
Placebo: n=0/18,335 participantseImprecision
(very serious)f,g
Reactogenicity (grade ≥3) ImportantOne phase 3 RCTh
one phase 1/2 RCTh1.43 (0.85, 2.39)
N=7,164 total participantsImprecision
(serious)f
Total of 3inflammatory neurologic events reported
within 42 days of vaccination with RSVpreF among
20,255 older adults across all clinical trials
20Pfizer: Total inflammatory neurologic events reported within 42
days of vaccination across all clinical trials
Participant
ageCountry Reported as Onset Trial Work group case
review
66 years United
StatesGBSa, Brighton
Collaborationblevel 114 days post -
vaccinationPivotal phase 3 trial,
randomized, blinded, placebo -
controlledClinical course more
consistent with CIDPc
66 years Japan GBSa, Miller -Fisher
variant, Brighton
Collaborationblevel 410 days post -
vaccinationPivotal phase 3 trial,
randomized, blinded, placebo -
controlledPossible GBS (Miller
Fisher syndrome)
though other causes
are also possible
68 years Argentina Motor -sensory
axonal
polyneuropathy*
*Site investigator reported
as not associated with
vaccination21 days post -
vaccination*
*Participant
reported some
symptoms preceded
vaccinationPivotal phase 3 trial,
randomized, blinded, placebo -
controlledUndifferentiated
motor -sensory axonal
polyneuropathy
aGBS = Guillain Barre syndrome
bhttps://brightoncollaboration.us/guillain -barre -and-miller -fisher -syndromes -case -definition -companion -guide/
cCIDP = chronic inflammatory demyelinating polyneuropathy
21Background incidence of Guillain -Barré syndrome
among older adults
aSejvar JJ, et al. Population incidence of Guillain -Barré syndrome: a systematic review and meta -analysis. Neuroepidemiology. 20 11;36(2):123 -33. https://doi.org/10.1159/000324710
bShui IM, et al. Guillain -Barré syndrome incidence in a large United States cohort (2000 -2009). Neuroepidemiology. 2012;39(2):10 9-15. https://doi.org/10.1159/000339248
Age group,
yearsAnnual rate per 100,000
population (95% CI)
0–9 0.62 (0.52 –0.75)
10–19 0.75 (0.60 –0.92)
20–29 0.90 (0.67 –1.19)
30–39 1.07 (0.74 –1.56)
40–49 1.29 (0.80 –2.06)
50–59 1.54 (0.87 –2.74)
60–69 1.85 (0.94 –3.64)
70–79 2.22 (1.01 –4.86)
80–89 2.66 (1.09 –6.48)Meta -analysisa, 13 studies, North America & Europe
Age group,
yearsAnnual rate per 100,000 population
(95% CI)
Female Male
0–4 0.51 (0.24 –0.78) 0.39 (0.16 –0.61)
5–17 0.43 (0.29 –0.57) 0.62 (0.46 –0.79)
18–24 0.64 (0.39 –0.89) 0.75 (0.47 –1.03)
25–49 1.00 (0.85 –1.15) 1.39 (1.20 –1.57)
50–64 2.19 (1.90 –2.50) 2.85 (2.49 –3.21)
≥65 4.68 (4.14 –5.21) 7.06 (6.31 –7.81)Vaccine Safety Datalink, United States, 2000 –2009b
22Estimated incidence of Guillain -Barre syndrome (GBS) following other
recommended vaccinations
▪Seasonal influenza vaccinesa: The data on the association between GBS and
seasonal flu vaccination are variable and inconsistent across flu seasons. If there is
an increased risk of GBS following flu vaccination it is small, on the order of 1–2
additional cases per million doses of flu vaccine administered.
▪Recombinant zoster vaccineb: 3 excess cases per million doses administered
–6 excess cases per million first doses administered, no increased risk following
the second dose
a https://www.cdc.gov/flu/prevent/guillainbarre.htm#how1
b https://www.fda.gov/vaccines -blood -biologics/safety -availability -biologics/fda -requires -warning -about -guillain -barre -syndrome -gbs-be-included -prescribing -information -
shingrix
23Summary of GRADE for Pfizer RSVpreF vaccine in older adults
Outcome Importance Design
(# of studies)Findings Evidence
type
Benefits
RSV Lower Respiratory Tract
Disease (LTRI)Critical RCT (1) Pfizer RSVpreF likely reduces RSV LRTI. Moderate
Medically attended RSV LRTI Critical RCT (1) Pfizer RSVpreF likely reduces medically attended RSV LRTI. Moderate
Hospitalization for RSV
respiratory illnessImportant RCT (1)Pfizer RSVpreF may reduce hospitalization for RSV respiratory
illness, but the effect is very uncertain.Very low
Severe RSV respiratory
illness requiring
O2/respiratory supportImportant RCT (1)Pfizer RSVpreF may not impact severe RSV respiratory illness
requiring supplemental oxygen or other respiratory support, but
the effect is very uncertain.Very low
Death due to RSV respiratory
illnessImportant RCT (1) No events observedUnable to
evaluate
Harms
Serious adverse events Critical RCT (2) Pfizer RSVpreF results in little to no differences in SAEs. High
Inflammatory neurologic
eventsImportant RCT (2) Pfizer RSVpreF may increase inflammatory neurologic events. Low
Reactogenicity (grade ≥3) Important RCT (2) Pfizer RSVpreF likely increases severe reactogenicity events. Moderate
24
Summary of GRADE for Pfizer RSVpreF vaccine in older adults
Overall evidence rating: Moderate certainty
25RSV-NET estimated annual hospitalizations per
100,000 adults: 2016 –2017 to 2019 –2020
050100150200250300350400450
18-49 yrs 50-59 yrs 60-64 yrs ≥65 yrs 65-69 yrs 70-74 yrs ≥75 yrsAnnual RSV -associated hospitalizations
per 100,000 population2016-17
2017-18
2018-19
2019-20
CDC RSV -NET unpublished data. Estimates are adjusted for under -testing and incomplete test sensitivity. https://www.cdc.gov/rsv/research/rsv -net/index.html
26Modeling potential RSV -attributable illnesses prevented:
Pfizer RSVpreF
▪Included in economic analysis performed by U. Michigan, using published incidence
estimates and RSV -NET estimated annual hospitalizations per 100,000 adults
▪Timeframe: 2 RSV seasons (assumed duration of vaccine protection)
Number prevented per 1
million vaccinations among:
Adults aged ≥65 yearsNumber prevented per 1
million vaccinations among:
Adults aged 60 –64 years
Outpatient visitsa25,000 19,000
Hospitalizationsb 2,500 960
Deathsc130 37
aIncidence rates of RSV illness requiring outpatient visit taken from McLaughlin et al, OFID (2022) . Vaccine efficacy (VE) against this outcome assumed to be equal to that against
medically attended acute respiratory illness (ARI) caused by RSV (Pfizer RENOIR trial, including unpublished data from partia l season 2 follow up).
bIncidence rates of RSV hospitalization taken from RSV -NET 2016 –2020 (unpublished). VE against RSV -associated hospitalization as sumed to be equal to that against medically attended
lower respiratory tract illness (LRTI) with ≥3 symptoms, caused by RSV (Pfizer RENOIR trial, unpublished).
cProbability of in -hospital death among adults hospitalized for RSV taken from RSV -NET 2016 –2020 (unpublished). VE against RSV -associated death assumed to be equal to that against
medically attended lower respiratory tract illness (LRTI) with ≥3 symptoms, caused by RSV (Pfizer RENOIR trial, unpublished).
27Pfizer, post -marketing safety requirements and commitments
Study Aim Design Final protocol submission to FDA Study completion date
C3671031aEvaluate risk of GBSRetrospective cohort,
claims -basedNovember 30, 2023 May 31, 2029
C3671037Evaluate risk of atrial
fibrillationbActive surveillance study November 30, 2023 February 28, 2027
C3671013 (main
phase 3 trial)Evaluate safety and
immunogenicity of
revaccinationClinical trial Submitted March 31, 2025
May 31, 2023 Approval Letter -ABRYSVO (fda.gov)aPost -marketing requirement under Section 505(o) of the Federal Food, Drug, and Cosmetic Act
bA numerical imbalance in events of atrial fibrillation was noted in the main phase 3 trial, with 10 events in the RSVpreF group and 4 events in the
placebo group, within 1 month following vaccination.
Vaccines and Related Biological Products Advisory Committee February 28 -March 1, 2023 Meeting Briefing Document -FDA: Applican t Pfizer
28Benefits and Harms Pfizer bivalent RSVpreF vaccine
▪How substantial are the desirable anticipated effects among adults
aged ≥65 years (relative to no RSV vaccine)?
–How substantial is the anticipated protective effect against:
•RSV lower respiratory tract disease (LRTD)
•Medically attended RSV LRTD
•Hospitalization for RSV respiratory illness
•Severe RSV respiratory illness requiring supplemental O2/respiratory
support
•Death due to RSV respiratory illness
Minimal Small Moderate Large Varies Don’t know
29Benefits and Harms Pfizer bivalent RSVpreF vaccine
▪How substantial are the undesirable anticipated effects among
adults aged ≥65 years (relative to no RSV vaccine)?
–How substantial is the anticipated effect on:
•Serious Adverse Events (SAEs)
•Inflammatory neuropathy (e.g., Guillain -Barré Syndrome)
•Reactogenicity (grade ≥3)
Minimal Small Moderate Large Varies Don’t know
30Benefits and Harms Pfizer bivalent RSVpreF vaccine
▪Do the desirable effects outweigh the undesirable effects among
adults aged ≥65 years ?
–What is the balance between the desirable effects relative to
the undesirable effects?
Favors intervention (Pfizer RSVpreF vaccine)
Favors comparison (no vaccine)
Favors both
Favors neither
Unclear
Minority opinion
31Benefits and Harms Pfizer bivalent RSVpreF vaccine
▪How substantial are the desirable anticipated effects among adults
aged 60–64 years (relative to no RSV vaccine)?
–How substantial is the anticipated protective effect against:
•RSV lower respiratory tract disease (LRTD)
•Medically attended RSV LRTD
•Hospitalization for RSV respiratory illness
•Severe RSV respiratory illness requiring supplemental O2/respiratory
support
•Death due to RSV respiratory illness
Minimal Small Moderate Large Varies Don’t know
32Benefits and Harms Pfizer bivalent RSVpreF vaccine
▪How substantial are the undesirable anticipated effects among
adults aged 60–64 years (relative to no RSV vaccine)?
–How substantial is the anticipated effect on:
•Serious Adverse Events (SAEs)
•Inflammatory neuropathy (e.g., Guillain -Barré Syndrome)
•Reactogenicity (grade ≥3)
Minimal Small Moderate Large Varies Don’t know
33Benefits and Harms Pfizer bivalent RSVpreF vaccine
▪Do the desirable effects outweigh the undesirable effects among
adults aged 60–64 years ?
–What is the balance between the desirable effects relative to
the undesirable effects?
Favors intervention (Pfizer RSVpreF vaccine)
Favors comparison (no vaccine)
Favors both
Favors neither
Unclear
Minority opinion
34GRADE: GSK adjuvanted RSVPreF3
35GSK, Benefits: vaccine efficacy estimates
Outcome Importance Data sourcesVaccine efficacy of a single dose (%)a
(95% confidence interval)Concerns in certainty
assessment
Benefits
RSV Lower Respiratory
Tract Disease (LTRD)Critical
One phase 3 RCTb,
-15.3 months mean
follow up time,
including season 2c
-31,932 –32,023
person -years under
surveillance, varied
by outcome74.6 (62.1, 83.5)
Vaccine: n=30, Placebo: n=139Indirectness (serious)d
Medically attended RSV
LRTDCritical77.5 (57.9, 89.0)
Vaccine: n=12, Placebo: n=63Indirectness (serious)d
Hospitalization for RSV
respiratory illnessImportant76.4 ( -111, 99.5)
Vaccine: n=1, Placebo: n=5Indirectness (serious)d
Imprecision (very serious)e
Severe RSV respiratory
illness requiring
O2/respiratory supportImportant76.4 ( -111, 99.5)
Vaccine: n=1, Placebo: n=5Indirectness (serious)d
Imprecision (very serious)e
Death due to RSV
respiratory illnessImportantVaccine: n=0/ 14,677 person -years
Placebo: n=0/17,346 person -yearsUnable to evaluatef
aEfficacy estimates were independently calculated using counts of events and total person -time available from the GSK pivotal ph ase 3 trial. Data provided by manufacturer.
Efficacy was calculated as 1 –incidence rate ratio. Events of each outcome were included if they occurred on or after day 15 af ter injection. Due to exclusion of follow up time after
RSVPreF3 dose 2 among participants randomized to annual re -vaccination, person -time in the placebo arm exceeded that in the inte rvention arm. CDC method of efficacy
estimation differed from manufacturer method (Poisson model adjusted by season, participant age, & region). Adjustment by sea sonresulted in substantially different estimates.
b RCT = randomized controlled trial. Papi A, et al. Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. 2023. NEJM. https://doi.org/10.1056/nejmoa2209604
cMean efficacy follow up time inclusive of person -time after dose 2 of RSVPreF3 was 16.6 months. Median time of efficacy follow up was 17.8 months.
dUnderrepresentation of adults aged ≥75 years, adults with congestive heart failure, and frail adults. Exclusion of adults wit h immune compromise.
e 95% confidence interval for measure of absolute risk included potential for both benefit and harm. Fragility of estimates.
fNo RSV -associated deaths were recorded.
36GSK, Benefits: vaccine efficacy estimates
Outcome Importance Data sourcesVaccine efficacy of a single dose (%)a
(95% confidence interval)Concerns in certainty
assessment
Benefits
RSV Lower Respiratory
Tract Disease (LTRD)Critical
One phase 3 RCTb,
-15.3 months mean
follow up time,
including season 2c
-31,932 –32,023
person -years under
surveillance, varied
by outcome74.6 (62.1, 83.5)
Vaccine: n=30, Placebo: n=139Indirectness (serious)d
Medically attended RSV
LRTDCritical77.5 (57.9, 89.0)
Vaccine: n=12, Placebo: n=63Indirectness (serious)d
Hospitalization for RSV
respiratory illnessImportant76.4 ( -111, 99.5)
Vaccine: n=1, Placebo: n=5Indirectness (serious)d
Imprecision (very serious)e
Severe RSV respiratory
illness requiring
O2/respiratory supportImportant76.4 ( -111, 99.5)
Vaccine: n=1, Placebo: n=5Indirectness (serious)d
Imprecision (very serious)e
Death due to RSV
respiratory illnessImportantVaccine: n=0/ 14,677 person -years
Placebo: n=0/17,346 person -yearsUnable to evaluatef
aEfficacy estimates were independently calculated using counts of events and total person -time available from the GSK pivotal ph ase 3 trial. Data provided by manufacturer.
Efficacy was calculated as 1 –incidence rate ratio. Events of each outcome were included if they occurred on or after day 15 af ter injection. Due to exclusion of follow up time after
RSVPreF3 dose 2 among participants randomized to annual re -vaccination, person -time in the placebo arm exceeded that in the inte rvention arm. CDC method of efficacy
estimation differed from manufacturer method (Poisson model adjusted by season, participant age, & region). Adjustment by sea sonresulted in substantially different estimates.
b RCT = randomized controlled trial. Papi A, et al. Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. 2023. NEJM. https://doi.org/10.1056/nejmoa2209604
cMean efficacy follow up time inclusive of person -time after dose 2 of RSVPreF3 was 16.6 months. Median time of efficacy follow up was 17.8 months.
dUnderrepresentation of adults aged ≥75 years, adults with congestive heart failure, and frail adults. Exclusion of adults wit h immune compromise.
e 95% confidence interval for measure of absolute risk included potential for both benefit and harm. Fragility of estimates.
fNo RSV -associated deaths were recorded.
37GSK: RSV lower respiratory tract disease (LRTD)
Age group
in yearsCase split
(vaccine/placebo)aManufacturer -calculated vaccine efficacyb, % (CI)
No adjustment by season Adjusted by season
≥60 (all) 30/139 74.5 (60.0, 84.5) 67.2 (48.2, 80.0)
≥65 25/100 70.3 (53.5, 81.6) 61.2 (39.0, 76.1)
≥70 13/65 76.4 (56.7, 88.1) 69.3 (43.4, 84.6)
≥75 8/24 Not sharedc49.3 ( -18.2, 80.6)c
≥80 4/10 52.6 ( -64.2, 89.2)c38.4 ( -118, 86.1)c
a GSK pivotal phase 3 trial ( Papi A, et al. NEJM 2023 https://doi.org/10.1056/nejmoa2209604 ). Events of each outcome were included if they
occurred on or after day 15 after injection. Median time, across participants, of efficacy follow up was 17.8 months, includi ng unpublished data
provided by manufacturer from season 2. Total 24,967 participants ( 31,932 person -years) under surveillance.
b Calculated using Poisson model, adjusted by season and participant age and region. Adjustment by season resulted in efficacy estimates
substantially different from those estimated by CDC. Due to exclusion of follow up time after dose 2 of RSVPreF3 among partic ipants
randomized to annual re -vaccination, person -time follow up in the placebo arm exceeded that in the intervention arm.
c Highlighted text indicates that evidence of statistically significant efficacy is lacking.
38GSK: RSV lower respiratory tract disease (LRTD)
PopulationCase split
(vaccine/
placebo)aManufacturer -calculated vaccine efficacyb, % (CI)
No adjustment by season Adjusted by season
≥1 pre -existing comorbidity of
interestc 16/72 74.5 (55.7, 86.1) 66.7 (41.8, 82.0)
≥1 pre -existing cardiorespiratory
comorbidityd 10/56 80.1 (60.6, 91.0) 73.8 (47.9, 88.2)
Gait speed ≥1.0 m/s ( fit) 20/89 73.4 (56.5, 84.5) 66.2 (44.3, 80.4)
Gait speed 0.4 –0.99 m/s ( pre-frail) 8/47 80.0 (57.3, 91.8) 73.3 (42.4, 89.2)
Gait speed <0.4 m/s or unable to
complete assessment ( frail)2/1 -116 ( -12,800, 88.9)e-148 ( -15,800, 88.2)e
a GSK pivotal phase 3 trial ( Papi A, et al. NEJM 2023 https://doi.org/10.1056/nejmoa2209604 ). Events of each outcome were included if they
occurred on or after day 15 after injection. Median time, across participants, of efficacy follow up was 17.8 months, includi ng unpublished data
provided by manufacturer from season 2. Total 24,967 participants ( 31,932 person -years) under surveillance.
b Calculated using Poisson model, adjusted by season and participant age and region. Adjustment by season resulted in efficacy estimates
substantially different from those estimated by CDC. Due to exclusion of follow up time after dose 2 of RSVPreF3 among partic ipants randomized to
annual re -vaccination, person -time follow up in the placebo arm exceeded that in the intervention arm.
c COPD, asthma, any chronic respiratory/pulmonary disease, diabetes mellitus, chronic heart failure, advanced liver or renal di sease
dCOPD, asthma, any chronic respiratory/pulmonary disease, chronic heart failure
e Highlighted text indicates that evidence of statistically significant efficacy is lacking.
39GSK, Harms: relative risk
Outcome Importance Data sourcesRelative risk estimatea
(95% confidence interval)Concerns in certainty
assessment
Harms
Serious adverse events (SAEs) CriticalOne phase 3 RCTb,
one phase 1/2 RCTc1.02 (0.91, 1.15)
N=25,174 total participantsNone serious
Inflammatory neurologic
eventsImportantOne phase 3 RCTd
one phase 1/2 RCTdVaccine: n=0/12,570 participants
Placebo: n=0/12,604 participantsUnable to evaluate
Reactogenicity (grade ≥3) ImportantOne phase 3 RCTf
one phase 1/2 RCTg4.06 (1.97, 8.36)
N=1,955 total participantsNone serious
aPooled relative risk estimates were independently calculated using counts of events and participants in the GSK pivotal phase 3trial ( Papi A, et al. NEJM 2023
https://doi.org/10.1056/nejmoa2209604 ), as well as from a placebo -controlled phase 1/2 dosing selection study (Leroux -Roels I, et al. J Infect Dis. 2022
https://doi.org/10.1093/infdis/jiac327 ). Data provided by manufacturer.
bUp to 6 months after injection
cAfter dose 1, but before dose 2 (day 61)
dWithin 42 days after injection
eNo events recorded in studies included in GRADE. One event of Guillain -Barré syndrome (GBS) reported within 42 days after vacci nation in a recipient of the
investigational vaccine in an open label trial without a placebo arm. This study was not included in GRADE assessment due to lack of an unvaccinated
comparator. Two events of acute disseminated encephalomyelitis (ADEM) reported in a co -administration study of the investigation al vaccine with standard
dose seasonal influenza vaccine. Both cases were reported in the co -administration arm within 42 days after the intervention; no ne in the sequential
administration control arm. This study was not included in GRADE assessment due to lack of an unvaccinated comparator.
fWithin 7 days after vaccination
gWithin 4 days after vaccinationRCT: Randomized control trial
40GSK, Harms: relative risk
Outcome Importance Data sourcesRelative risk estimatea
(95% confidence interval)Concerns in certainty
assessment
Harms
Serious adverse events (SAEs) CriticalOne phase 3 RCTb,
one phase 1/2 RCTc1.02 (0.91, 1.15)
N=25,174 total participantsNone serious
Inflammatory neurologic
eventsImportantOne phase 3 RCTd
one phase 1/2 RCTdVaccine: n=0/12,570 participants
Placebo: n=0/12,604 participantsUnable to evaluate
Reactogenicity (grade ≥3) ImportantOne phase 3 RCTf
one phase 1/2 RCTg4.06 (1.97, 8.36)
N=1,955 total participantsNone serious
aPooled relative risk estimates were independently calculated using counts of events and participants in the GSK pivotal phase 3trial ( Papi A, et al. NEJM 2023
https://doi.org/10.1056/nejmoa2209604 ), as well as from a placebo -controlled phase 1/2 dosing selection study (Leroux -Roels I, et al. J Infect Dis. 2022
https://doi.org/10.1093/infdis/jiac327 ). Data provided by manufacturer.
bUp to 6 months after injection
cAfter dose 1, but before dose 2 (day 61)
dWithin 42 days after injection
eNo events recorded in studies included in GRADE. One event of Guillain -Barré syndrome (GBS) reported within 42 days after vacci nation in a recipient of the
investigational vaccine in an open label trial without a placebo arm. This study was not included in GRADE assessment due to lack of an unvaccinated
comparator. Two events of acute disseminated encephalomyelitis (ADEM) reported in a co -administration study of the investigation al vaccine with standard
dose seasonal influenza vaccine. Both cases were reported in the co -administration arm within 42 days after the intervention; no ne in the sequential
administration control arm. This study was not included in GRADE assessment due to lack of an unvaccinated comparator.
fWithin 7 days after vaccination
gWithin 4 days after vaccinationRCT: Randomized control trial
Total of 3inflammatory neurologic events reported
within 42 days of vaccination with RSVpreF3 among
17,922 older adults across all clinical trials
41GSK: Total inflammatory neurologic events reported within 42
days of vaccination across all clinical trials
Participant
ageCountry Reported as Onset Trial Work group case
review
78 years Japan GBSa, Brighton
Collaborationb
level 39 days
post -
vaccination•Open -label phase 3 trial without a
placebo control, evaluating the
immunogenicity of different
revaccination intervalsLikely GBSa
71 years South
AfricaADEMc, fatal*
*Site investigator
updated diagnoses:
hypoglycemia &
dementia7 days
post -
vaccination•Randomized, blinded co -administration
study with standard dose seasonal
influenza vaccine
•Case occurred in the simultaneous
administration arm of the studyADEMccannot be
ruled out, however,
other diagnoses
appear more likely
71 years South
AfricaADEMc 22 days
post -
vaccination•Randomized, blinded co -administration
study with standard dose seasonal
influenza vaccine
•Case occurred in the simultaneous
administration arm of the studyADEMccannot be
ruled out, however,
other diagnoses
appear more likely
aGBS = Guillain Barre syndrome
bhttps://brightoncollaboration.us/guillain -barre -and-miller -fisher -syndromes -case -definition -companion -guide/
cADEM = acute disseminated encephalomyelitis
42Summary of GRADE for GSK RSVPreF3 vaccine in older adults
Outcome Importance Design
(# of studies)Findings Evidence
type
Benefits
RSV Lower Respiratory Tract
Disease (LTRD)Critical RCT (1) GSK RSVPreF3 likely reduces RSV LRTD. Moderate
Medically attended RSV
LRTDCritical RCT (1) GSK RSVPreF3 likely reduces medically attended RSV LRTD. Moderate
Hospitalization for RSV
respiratory illnessImportant RCT (1)GSK RSVPreF3 may reduce hospitalization for RSV respiratory
illness, but the effect is very uncertain.Very low
Severe RSV respiratory
illness requiring
O2/respiratory supportImportant RCT (1)GSK RSVPreF3 may reduce severe RSV respiratory illness requiring
oxygen supplementation or other respiratory support, but the
effect is very uncertain.Very low
Death due to RSV respiratory
illnessImportant RCT (1) No events observedUnable to
evaluate
Harms
Serious adverse events Critical RCT (2) GSK RSVPreF3 results in little to no differences in SAEs. High
Inflammatory neurologic
eventsImportant RCT (2)No events observed in placebo -controlled trials. Three cases
observed in clinical trials without placebo controls.Unable to
evaluate
Reactogenicity (grade ≥3) Important RCT (2) GSK RSVPreF3 increases severe reactogenicity events. High
43
Summary of GRADE for GSK RSV vaccine in older adults
Overall evidence rating: Moderate certainty
44Modeling potential RSV -attributable illnesses prevented:
GSK RSVPreF3
▪Included in economic analysis performed by U. Michigan, using published incidence
estimates and RSV -NET estimated annual hospitalizations per 100,000 adults
▪Timeframe: 2 RSV seasons (assumed duration of vaccine protection)
Number prevented per 1
million vaccinations among:
Adults aged ≥65 yearsNumber prevented per 1
million vaccinations among:
Adults aged 60 –64 years
Outpatient visitsa23,000 18,000
Hospitalizationsb 2,300 890
Deathsc 120 35
aIncidence rates of RSV illness requiring outpatient visit taken from McLaughlin et al, OFID (2022) . Vaccine efficacy (VE) against this outcome assumed to be equal to that against
medically attended acute respiratory illness (ARI) caused by RSV (GSK AReSVi -006 trial, including unpublished data from season 2 follow up).
bIncidence rates of RSV hospitalization taken from RSV -NET 2016 –2020 (unpublished). VE against RSV -associated hospitalization as sumed to be equal to that against medically attended
lower respiratory tract disease (LRTD) caused by RSV (GSK AReSVi -006 trial, unpublished).
cProbability of in -hospital death among adults hospitalized for RSV taken from RSV -NET 2016 –2020 (unpublished). VE against RSV -associated death assumed to be equal to that against
medically attended lower respiratory tract disease (LRTD) caused by RSV (GSK AReSVi -006 trial, unpublished).
45GSK, post -marketing safety requirements and commitments
Aim Design Final protocol submission to FDA Study completion date
Evaluate risk of GBS,
ADEMaSelf-controlled risk interval
designJune 30, 2024 June 30, 2030
Evaluate risk of atrial
fibrillationbSelf-controlled risk interval
designJune 30, 2024 June 30, 2030
May 23, 2023 Approval Letter -AREXVY (fda.gov)aPost -marketing requirement under Section 505(o) of the Federal Food, Drug, and Cosmetic Act
bA numerical imbalance in events of atrial fibrillation was noted in the main phase 3 trial, with 7 events in the RSVPreF3 gro upand 1 event in the
placebo group, within 1 month following vaccination (dose 1).
Vaccines and Related Biological Products Advisory Committee February 28 -March 1, 2023 Meeting Briefing Document -FDA: Applican t-GSK
46Benefits and Harms GSK adjuvanted RSVPreF3 vaccine
▪How substantial are the desirable anticipated effects among adults
aged ≥65 years (relative to no RSV vaccine)?
–How substantial is the anticipated protective effect against:
•RSV lower respiratory tract disease (LRTD)
•Medically attended RSV LRTD
•Hospitalization for RSV respiratory illness
•Severe RSV respiratory illness requiring supplemental O2/respiratory
support
•Death due to RSV respiratory illness
Minimal Small Moderate Large Varies Don’t know
47Benefits and Harms GSK adjuvanted RSVPreF3 vaccine
▪How substantial are the undesirable anticipated effects among
adults aged ≥65 years (relative to no RSV vaccine)?
–How substantial is the anticipated effect on:
•Serious Adverse Events (SAEs)
•Inflammatory neuropathy (e.g., Guillain -Barré Syndrome)
•Reactogenicity (grade ≥3)
Minimal Small Moderate Large Varies Don’t know
48Benefits and Harms GSK adjuvanted RSVPreF3 vaccine
▪Do the desirable effects outweigh the undesirable effects among
adults aged ≥65 years ?
–What is the balance between the desirable effects relative to
the undesirable effects?
Favors intervention (GSK RSVPreF3 vaccine)
Favors comparison (no vaccine)
Favors both
Favors neither
Unclear
Minority opinion
49Benefits and Harms GSK adjuvanted RSVPreF3 vaccine
▪How substantial are the desirable anticipated effects among adults
aged 60–64 years (relative to no RSV vaccine)?
–How substantial is the anticipated protective effect against:
•RSV lower respiratory tract disease (LRTD)
•Medically attended RSV LRTD
•Hospitalization for RSV respiratory illness
•Severe RSV respiratory illness requiring supplemental O2/respiratory
support
•Death due to RSV respiratory illness
Minimal Small Moderate Large Varies Don’t know
50Benefits and Harms GSK adjuvanted RSVPreF3 vaccine
▪How substantial are the undesirable anticipated effects among
adults aged 60–64 years (relative to no RSV vaccine)?
–How substantial is the anticipated effect on:
•Serious Adverse Events (SAEs)
•Inflammatory neuropathy (e.g., Guillain -Barré Syndrome)
•Reactogenicity (grade ≥3)
Minimal Small Moderate Large Varies Don’t know
51Benefits and Harms GSK adjuvanted RSVPreF3 vaccine
▪Do the desirable effects outweigh the undesirable effects among
adults aged 60–64 years ?
–What is the balance between the desirable effects relative to
the undesirable effects?
Favors intervention (GSK RSVPreF3 vaccine)
Favors comparison (no vaccine)
Favors both
Favors neither
Unclear
Minority opinion
Resource Use
Is an RSV vaccine program for older adults a reasonable and efficient
allocation of resources?
53Work group considerations
▪RSV vaccination for older adults could be a cost -effective intervention
▪There is substantial uncertainty in the net societal costs of an RSV
vaccination program for older adults, driven by:
–Uncertainty in vaccine acquisition cost
•Current assumptions: $200 Pfizer RSVpreF , $270 GSK RSVPreF3
–Uncertainty in incidence of RSV illness (e.g., hospitalization)
–Uncertainty in duration of protection from RSV vaccination
•Current assumption: 2 RSV seasons
▪Vaccination of older age groups would be more cost effective than
vaccination of younger age groups
54Resource Use
▪Is use of Pfizer bivalent RSVpreF vaccine among adults aged
≥65 years a reasonable and efficient allocation of resources,
compared with no RSV vaccine?
▪Is use of GSK adjuvanted RSVPreF3 vaccine among adults aged
≥65 years a reasonable and efficient allocation of resources,
compared with no RSV vaccine?
No Probably No Probably Yes Yes Varies Don’t know
55Resource Use
▪Is use of Pfizer bivalent RSVpreF vaccine among adults aged
60–64 years a reasonable and efficient allocation of resources,
compared with no RSV vaccine?
▪Is use of GSK adjuvanted RSVPreF3 vaccine among adults aged
60–64 years a reasonable and efficient allocation of resources,
compared with no RSV vaccine?
No Probably No Probably Yes Yes Varies Don’t know
Equity
What would be the impact on health equity of recommending RSV
vaccines in older adults?
57The Work Group discussed multiple equity concerns.
▪Not all persons experience the same risk of RSV disease.
▪An RSV vaccine might increase equity byprotecting those
disproportionately impacted by RSV.
▪However, if access or uptake of the vaccine is not equal, an
RSV vaccine might decrease equity.
▪The age groups in which the vaccine might be recommended
were felt to have important equity implications.
First the Work Group considered the impact on equity
of a recommendation for RSV vaccination in adults
aged 65 years and older .
Anticipated impact on equity of an age -based recommendation
for RSV vaccination in adults ≥65
RSV vaccination in adults aged ≥65 years might increase equity by decreasing RSV burden
among persons from racial and ethnic minority groups and in persons with lower income
levels.
Next the Work Group considered the impact on equity
of a recommendation for RSV vaccination in adults
aged 60 –64 years .
61Age of adults hospitalized with RSV, by race and
ethnicity, RSV -NET
N Median age, years
(interquartile range)
All 9,163 70 (58 –81)
Race and ethnicity
White, non -Hispanic 5,596 73 (62 –83)
Black, non -Hispanic 1,731 60 (50 –70)
Hispanic 713 65 (50 –77)
Asian or Pacific Islander, non -Hispanic 518 77 (64 –85)
American Indian or Alaska Native,
non-Hispanic56 57 (47 –71)
CDC RSV -NET data 2015 –2020 (unpublished). https://www.cdc.gov/rsv/research/rsv -net/index.html
62Age of adults hospitalized with RSV, by race and
ethnicity, RSV -NET
N Median age, years
(interquartile range)
All 9,163 70 (58 –81)
Race and ethnicity
White, non -Hispanic 5,596 73 (62 –83)
Black, non -Hispanic 1,731 60 (50 –70)
Hispanic 713 65 (50 –77)
Asian or Pacific Islander, non -Hispanic 518 77 (64 –85)
American Indian or Alaska Native,
non-Hispanic56 57 (47 –71)
CDC RSV -NET data 2015 –2020 (unpublished). https://www.cdc.gov/rsv/research/rsv -net/index.html
Number of chronic conditions by age among Asian, Black, Latino/Hispanic, and
White adults in the National Health Interview Survey (NHIS), 1999 to 2018
Source: Caraballo C, Herrin J, Mahajan S, et
al. Temporal Trends in Racial and Ethnic
Disparities in Multimorbidity Prevalence in
the United States, 1999 -2018. Am J Med .
2022;135(9):1083 -1092.e14.
doi:10.1016/j.amjmed.2022.04.010
Number of chronic conditions by age among Asian, Black, Latino/Hispanic, and
White adults in the National Health Interview Survey (NHIS), 1999 to 2018
Source: Caraballo C, Herrin J, Mahajan S, et
al. Temporal Trends in Racial and Ethnic
Disparities in Multimorbidity Prevalence in
the United States, 1999 -2018. Am J Med .
2022;135(9):1083 -1092.e14.
doi:10.1016/j.amjmed.2022.04.010
Number of chronic conditions by age among Asian, Black, Latino/Hispanic, and
White adults in the National Health Interview Survey (NHIS), 1999 to 2018
Source: Caraballo C, Herrin J, Mahajan S, et
al. Temporal Trends in Racial and Ethnic
Disparities in Multimorbidity Prevalence in
the United States, 1999 -2018. Am J Med .
2022;135(9):1083 -1092.e14.
doi:10.1016/j.amjmed.2022.04.010
▪Prevalence of multimorbidity
(≥2 concurrent conditions)
diverged between Black
individuals and White
individuals
▪Reached maximum difference
of 10% among those aged 60 -
64 years
Difference in prevalence of multiple chronic conditions by age and
race/ethnicity, National Health Interview Survey, 1999 to 2018
Source: Caraballo C, Herrin J, Mahajan S, et al. Temporal Trends in Racial and Ethnic Disparities in Multimorbidity Prevalence in the United States, 1999 -2018. Am J Med .
2022;135(9):1083 -1092.e14. doi:10.1016/j.amjmed.2022.04.010
RSV vaccination in adults aged ≥65 years might increase equity by decreasing RSV burden
among persons from racial and ethnic minority groups and  persons with lower income
levels.
An RSV vaccination recommendation that excludes adults aged 60 -64 years might
decrease equity by excluding persons from racial and ethnic minority groups that would
benefit from the vaccine at earlier ages due to risk conditions. Anticipated impact on equity of an age -based recommendation
for RSV vaccination in adults ≥65
68Shared clinical decision -making
▪One policy option that the Work Group discussed to address the varied
risk of severe RSV disease (e.g., hospitalization) among 60 –64 year -olds
is shared clinical decision -making (SCDM) for adults aged 60 –64 years.
▪Ideally, this would allow adults aged 60 –64 years at high risk of RSV
hospitalization to be vaccinated and decrease age -based racial and
ethnic health disparities.
▪Prior experience with SCDM might inform the expected impact on
equity.
69ACIP recommendations for vaccination based on shared clinical decision -
making (SCDM) that appear (or appeared) on the tables and/or notes of the
immunization schedules
▪Historical: Pneumococcal conjugate vaccination (PCV13) for adults aged 65 years
and older who do not have an immunocompromising condition, cerebrospinal fluid
leak, or cochlear implant (recommendation revised in 2021 with introduction of
PCV15 and PCV20)
▪Historical: Hepatitis B ( HepB ) vaccination for adults aged 60 years and older with
diabetes mellitus (recommendation revised in 2022)
▪Meningococcal B ( MenB ) vaccination for adolescents and young adults aged 16 –23
years
▪Human papillomavirus (HPV) vaccination for adults aged 27 –45 years
70History of Hepatitis B and SCDM
▪In2011, ACIP recommended Hepatitis B vaccination for all unvaccinated adults with
diabetes mellitus aged <60 years butfor unvaccinated adults with diabetes mellitus
aged ≥60 years, ACIP recommended Hepatitis B vaccination at the discretion of
their healthcare provider.
▪(This recommendation was revised in 2022. Now HepB vaccination is universally
recommended for adults aged 19 –59 years and adults aged ≥60 years with risk
factors for hepatitis B; adults aged ≥60 years without known risk factors for
hepatitis B may also receive HepB vaccines).
Source: Weng MK, Doshani M, Khan MA, et al. Universal Hepatitis B Vaccination in Adults Aged 19 –59 Years: Updated Recommendations of the
Advisory Committee on Immunization Practices —United States, 2022. MMWR Morb Mortal Wkly Rep 2022;71:477 –483.
DOI: http://dx.doi.org/10.15585/mmwr.mm7113a1 external icon .
71Hep B vaccine coverage remained suboptimal when recommended to be
given at provider discretion
▪ Lu et al. analyzed 2014 –2018 NHIS
data to determine hepatitis B
vaccination coverage (≥3 doses)
among adults ≥60 years by
diabetes mellitus status
▪ Hepatitis B vaccination coverage
remained low among older adults
with diabetes mellitus even 7 years
after the recommendation was
made
Source: Lu PJ, Hung MC, Srivastav A, Williams WW, Harris AM. Hepatitis B Vaccination Among Adults With Diabetes Mellitus, U.S., 2018. AmJ Prev Med. 2021 Nov;61(5):652 -664. doi:
10.1016/j.amepre.2021.04.029. Epub 2021 Jul 20. PMID: 34294463; PMCID: PMC9077536.Race and
ethnicity Vaccination
coverage with ≥3 Hep B
doses
among adults ≥60 with
diabetes mellitusVaccination coverage
with ≥3 Hep B doses
among
adults ≥60 without
diabetes mellitus
All 15.3 (13.3 –17.4) 15.9 (14.8 -17.0)
White, non -
Hispanic15.5 (13.1 -18.1) 15.9 (14.7 -17.2)
Black, non -
Hispanic17.3 (12.2 -23.9) 13.4 (10.5 -17.2)
Hispanic 9.2 (4.9 -16.7) 16.0 (12.0 -21.0)
Asian, non -
Hispanic 15.7 (8.1 -28.2) 18.4 (13.4 -24.8)
72Hep B vaccine coverage remained suboptimal when recommended to be
given at provider discretion
▪ Lu et al. analyzed 2014 –2018 NHIS
data to determine hepatitis B
vaccination coverage (≥3 doses)
among adults ≥60 years by
diabetes mellitus status
▪ Hepatitis B vaccination coverage
remained low among older adults
with diabetes mellitus even 7 years
after the recommendation was
made
▪ However, coverage may have been
higher among Black, non -Hispanic
older adults with diabetes mellitus
Source: Lu PJ, Hung MC, Srivastav A, Williams WW, Harris AM. Hepatitis B Vaccination Among Adults With Diabetes Mellitus, U.S., 2018. AmJ Prev Med. 2021 Nov;61(5):652 -664. doi:
10.1016/j.amepre.2021.04.029. Epub 2021 Jul 20. PMID: 34294463; PMCID: PMC9077536.Race and
ethnicity Vaccination
coverage with ≥3 Hep B
doses
among adults ≥60 with
diabetes mellitusVaccination coverage
with ≥3 Hep B doses
among
adults ≥60 without
diabetes mellitus
All 15.3 (13.3 –17.4) 15.9 (14.8 -17.0)
White, non -
Hispanic15.5 (13.1 -18.1) 15.9 (14.7 -17.2)
Black, non -
Hispanic17.3 (12.2 -23.9) 13.4 (10.5 -17.2)
Hispanic 9.2 (4.9 -16.7) 16.0 (12.0 -21.0)
Asian, non -
Hispanic 15.7 (8.1 -28.2) 18.4 (13.4 -24.8)
73In studies assessing knowledge, attitude, and practices around SCDM for
other vaccines, providers have reported mixed views and understanding
of recommendations
1. Kempe A, Lindley MC, O'Leary ST, et al. Shared Clinical Decision -Making Recommendations for Adult Immunization: What Do Physicia ns Think?. J Gen Intern Med . 2021;36(8):2283 -2291.
doi:10.1007/s11606 -020-06456 -z
2. Hurley LP, O'Leary ST, Kobayashi M, et al. Physician survey regarding updated PCV13 vaccine recommendations for adults ≥65 ye ars.J Am Geriatr Soc. 2021;69(9):2612 -2618. doi:10.1111/jgs.17274•Some think that SCDM requires more time
than routine recommendations, that SCDM
creates confusion, and many do not know
vaccines recommended for SCDM would be
covered by most health insurance1,2
•Providers unsure of what points to emphasize
in discussions with patients2•Some in favor of SCDM recommendations
because they give more flexibility in decisions
about use of a vaccine1
74Brief summary of SCDM equity considerations
▪Ideally SCDM would increase access for adults aged 60 –64 years with
medical risk factors for severe RSV disease (disproportionately in racial
and ethnic groups impacted by RSV at earlier ages)
▪Limited evidence regarding the impact of conditional
recommendations, like SCDM, in older adults suggests they may not
substantially increase uptake in the target population
▪However, without a recommendation for adults aged 60 –64 years,
adults with medical risk factors for severe RSV disease would likely face
additional barriers to RSV vaccination, increasing health disparities
Anticipated impact on equity
RSV vaccination in adults aged ≥65 years might increase equity by decreasing RSV burden
among persons from racial and ethnic minority groups and  persons with lower income
levels.
RSV vaccination that excludes adults aged 60 -64 years might decrease equity by
excluding persons from racial and ethnic minority groups that would benefit from the
vaccine at earlier ages due to risk conditions.
RSV vaccination that includes both adults aged 65 and older and adults aged 60 -64 years
under shared clinical decision -making (SCDM) would increase access for adults 60 –64
with medical risk factors for severe RSV disease (disproportionately in racial and ethnic
groups impacted by RSV at earlier ages). However, SCDM may not substantially increase
uptake in the target population .
76Equity
▪What would be the impact on health equity of recommending RSV
vaccines in adults aged ≥65 years ?
Reduced
Probably reduced
Probably no impact
Probably increased
Increased
Varies
Don’t know
77Equity
▪What would be the impact on health equity of recommending RSV
vaccines in adults aged 60–64 years ?
Reduced
Probably reduced
Probably no impact
Probably increased
Increased
Varies
Don’t know
Minority opinion
Summary
79Domain Question Work Group Judgements
Adults aged ≥65 years Pfizer GSK
Public Health
ProblemIs RSV of public health importance? Yes
Benefits and
HarmsHow substantial are the desirable anticipated effects? Moderate Moderate
How substantial are the undesirable anticipated effects? Small Small
Do the desirable effects outweigh the undesirable effects? Favors intervention Favors intervention
What is the overall certainty of the evidence profile? Moderate Moderate
ValuesDoes the target population feel the desirable effects are large
relative to the undesirable effects?Yes/Probably yes
Is there important variability in how patients value the
outcomes?Important variability/Probably important variability
Acceptability Is the intervention acceptable to key stakeholders? Yes/Probably yes
Feasibility Is the intervention feasible to implement? Yes/Probably yes Yes/Probably yes
Resource UseIs the intervention a reasonable and efficient allocation of
resources?Probably yes Probably yes
Equity What would be the impact on health equity? Probably increased/Probably no impact
80Domain Question Work Group Judgements
Adults aged 60–64 years Pfizer GSK
Public Health
ProblemIs RSV of public health importance? Yes
Benefits and
HarmsHow substantial are the desirable anticipated effects? Small –Moderate Small –Moderate
How substantial are the undesirable anticipated effects? Small Small
Do the desirable effects outweigh the undesirable effects? Unclear Unclear
What is the overall certainty of the evidence profile? Moderate Moderate
ValuesDoes the target population feel the desirable effects are large
relative to the undesirable effects?Yes/Probably yes
Is there important variability in how patients value the
outcomes?Important variability/Probably important variability
Acceptability Is the intervention acceptable to key stakeholders? Yes/Probably yes
Feasibility Is the intervention feasible to implement? Yes/Probably yes Yes/Probably yes
Resource UseIs the intervention a reasonable and efficient allocation of
resources?Probably no Probably no
Equity What would be the impact on health equity? Unclear
81Work Group interpretation (part 1)
▪Pfizer’s bivalent RSVpreF and GSK’s adjuvanted RSVPreF3 vaccines both
have demonstrated significant efficacy against lower respiratory tract
illness caused by RSV among older adults over at least two seasons
–Trials were underpowered to show efficacy in the oldest adults and in adults
who are frail
–Trials were underpowered to show efficacy against RSV hospitalization
•Efficacy against symptomatic illness may indicate efficacy against more
severe disease
▪RSV vaccination has the potential to prevent considerable morbidity from
RSV disease among older adults, particularly in those with chronic medical
conditions and those who are frail (e.g., long -term care facility residents)
82Work Group interpretation (part 2)
▪Cases of inflammatory neurologic events have been reported within 42
days after vaccination with each RSV vaccine
▪Clinical trials were not sufficiently powered to determine whether the
small number of cases occurred due to random chance
▪Whether there is an increased risk of GBS or other inflammatory
neurologic events from RSV vaccination is not known at this time
▪Post -licensure surveillance for both safety and vaccine effectiveness will be
critical
83Choice of age threshold at which to recommend RSV vaccines
Pros Cons
Age ≥65 years
only•Greater risk of RSV disease and therefore
more favorable population -wide balance
of risks and benefits of vaccination (in
light of cases of inflammatory neurologic
events observed)
•Aligns with recommendations for high -
dose and adjuvanted influenza vaccines,
and universal pneumococcal vaccination•Lost opportunity to prevent additional disease
in the 60 –64 age group, who are
disproportionately from racial and ethnic
groups impacted by RSV at earlier ages
Also in ages
60–64 years•Potential to prevent a greater total
burden of disease (e.g., number of
hospitalizations)
•Increases access to adults 60 –64 with
medical risk factors for severe RSV
disease (disproportionately in racial and
ethnic groups impacted by RSV at earlier
ages)•Risk/benefit balance depends on the patient
population that seeks and receives vaccination
among those 60 –64
•Uninsured adults would face financial barriers
obtaining vaccination (disproportionately aged
60–64 in racial, ethnic and socioeconomic
groups at greater risk of severe RSV)
•May experience more difficulty achieving
clinician adoption of the recommendation
among patients 60 –64
•Less efficient allocation of societal resources
84Evidence to Recommendations Framework
Summary: Work Group Interpretations
▪Work Group interpretations were similar for:
–Pfizer bivalent RSVpreF
–GSK adjuvanted RSVPreF3
85Evidence to Recommendations Framework
Summary: Work Group Interpretations (Pfizer RSVpreF , GSK RSVPreF3)
Balance of
consequencesUndesirable
consequences
clearly outweigh
desirable
consequences in
most settingsUndesirable
consequences
probably
outweigh
desirable
consequences in
most settingsThe balance
between
desirable and
undesirable
consequences is
closely balanced
or uncertainDesirable
consequences
probably
outweigh
undesirable
consequences in
most settingsDesirable
consequences
clearly outweigh
undesirable
consequences in
most settingsThere is
insufficient
evidence to
determine the
balance of
consequencesAmong adults aged ≥65 years :
Balance of
consequencesUndesirable
consequences
clearly outweigh
desirable
consequences in
most settingsUndesirable
consequences
probably
outweigh
desirable
consequences in
most settingsThe balance
between
desirable and
undesirable
consequences is
closely balanced
or uncertainDesirable
consequences
probably
outweigh
undesirable
consequences in
most settingsDesirable
consequences
clearly outweigh
undesirable
consequences in
most settingsThere is
insufficient
evidence to
determine the
balance of
consequencesAmong adults aged 60–64 years :Minority opinion
86Evidence to Recommendations Framework
Summary: Work Group Interpretations (Pfizer RSVpreF , GSK RSVPreF3)
Type of recommendation, adults aged ≥65 years
We do not recommend the intervention
We recommend the intervention for individuals based on shared clinical decision -making
We recommend the intervention
Minority opinion
87Evidence to Recommendations Framework
Summary: Work Group Interpretations (Pfizer RSVpreF , GSK RSVPreF3)
Type of recommendation, adults aged ≥65 years
We do not recommend the intervention
We recommend the intervention for individuals based on shared clinical decision -making
We recommend the intervention
Type of recommendation, adults aged 60–64years
We do not recommend the intervention
We recommend the intervention for individuals based on shared clinical decision -making
We recommend the intervention
Minority opinion
88Proposed ACIP Voting Language
•Adults 65 years of age and older are recommended to receive
a single dose of RSV vaccine.
•Individual adults aged 60 –64 years may receive a single dose
of RSV vaccine, using shared clinical decision -making based on
risk assessment.
89Acknowledgements
▪ Karen Broder
▪ Doug Campos -Outcalt
▪ Katherine Fleming -Dutra
▪ Monica Godfrey
▪ Fiona Havers
▪ Anne Hause
▪ Jefferson Jones
▪ Andrew Leidner
▪ Meredith McMorrow
▪ Rebecca Morgan
▪ Dani Moulia
▪ Neil Murthy▪ Sara Oliver
▪ Christine Olson
▪ Ismael Ortega Sanchez
▪ David Shay
▪ Amanda Payne
▪ Huong Pham
▪ Jamison Pike
▪ Mila Prill
▪ Lauren Roper
▪ Hannah Rosenblum
▪ Jim Sejvar
▪ Tom Shimabukuro▪ Evelyn Twentyman
▪ Megan Wallace
▪ Michael Whitaker
▪ Patricia Wodi

Summary: Centers for Disease Control and Prevention Evidence to Recommendations Framework Respiratory Syncytial Virus (RSV) in Adults Pfizer bivalent RSVpreF vaccine in older adults  GSK adjuvanted RSVPreF3 vaccine in older adults Michael Melgar, MD Amadea Britton, MD Advisory Committee on Immunization Practices June 21, 2023 2Evidence to Recommendations ( EtR) Framework Policy Questions ▪Should a single dose of Pfizer bivalent RSVpreF vaccine (120µg antigen, 1 dose IM),  rather than no vaccine, be…


07 RSV Adults Britton 508

Centers for Disease Control and Prevention
Summary of Proposed Clinical Considerations for RSV
Vaccines
June 21, 2023
ACIP Older Adult RSV Vaccine Session
Amadea Britton, MD
Michael Melgar, MD
Overview of clinical considerations
▪Shared clinical decision -making based on risk assessment among
adults aged 60 –64 years
▪Timing of RSV vaccination for the 2023 –2024 RSV season
▪Coadministration of RSV vaccines with other vaccines
▪Persons with immunocompromising conditions
2
Clinical consideration: Shared clinical decision -making
based on risk assessment among adults aged 60 –64 years
The decision about whether or not to vaccinate
an individual may be informed by:
•Best available evidence of who may
benefit
•An individual’s characteristics, values, and
preferences
•Health care provider’s clinical discretion
•Characteristics of the vaccine being
considered
3Source: CDC. ACIP Shared Clinical Decision -Making Recommendations. Website:  https://www.cdc.gov/vaccines/acip/acip -scdm -faqs.html .
Last updated February 10, 2020. Accessed June 13, 2023. For shared clinical
decision -making
recommendations
there is no default.
If shared clinical decision -making is recommended adults who may
be at higher risk of RSV disease include persons with:
4
Immune
compromise
Endocrine disorders
such as diabetes
Hematologic
disorders
Chronic cardiovascular
diseases such as congestive
heart failure and coronary
artery disease
Residents of nursing
homes and other long -
term care facilities
Neurologic disorders
Chronic lung diseases
such as COPD and
asthma
Kidney and liver
disorders
Other underlying conditions or
factors that the provider
determines might increase the
risk of severe respiratory illness
If shared clinical decision -making is recommended adults who may
be at higher risk of RSV disease include persons with:
5
Immune
compromise
Endocrine disorders
such as diabetes
Hematologic
disorders
Chronic cardiovascular
diseases such as congestive
heart failure and coronary
artery disease
Residents of nursing
homes and other long-
term care facilities
Neurologic disorders
Chronic lung diseases
such as COPD and
asthma
Kidney and liver
disorders
Other underlying conditions
or factors that the provider
determines might increase the
risk of severe respiratory illness
Clinical consideration: Timing of RSV vaccination for
the 2023 –2024 RSV season
6RSV vaccination is currently approved and recommended as a
single dose.
Optimally, vaccination of eligible adults should occur before
the onset of increased RSV activity in the community.
The timing of the onset, peak, and decline of RSV activity
varies each year, and RSV seasonality during the COVID -19
pandemic deviated from prior seasons.
7RSV Hospitalizations in adults aged ≥65 years by season:
RSV-NET 2017 –2023
COVID -19 pandemic affected RSV
seasonality in 2020 -21, 2021 -22,
and 2022 -23
RSV-NET: unpublished data. Surveillance for 2017 -18 through 2019 -20 seasons were conducted from October –April; for 2020 -21 and 2021 -22 surveillance was conducted continuously from
October –September. Data shown for 2022 -23 season is from October –December 2022. 050100150200250300
40424446485052 2468101214161820222426283032343638Weekly RSV hospitalizations
MMWR Week
2017-18 2018-19 2019-20 2020-21 2021-22 2022-23January
Clinical consideration: Timing of RSV vaccination for
the 2023 –2024 RSV season
8Given this
variability the
ideal time to start
vaccinating
cannot be
predicted in
advance of the
2023-2024 RSV
season.Providers should
therefore offer
RSV vaccination
as soon as
vaccine supply
becomes
available.Providers should
continue to offer
RSV vaccination
throughout the
RSV season to
eligible adults
who remain
unvaccinated .There are
insufficient data
at this time to
determine the
need for
revaccination.
Clinical consideration: Coadministration of RSV
vaccines with other vaccines
9In accordance with General Best Practice Guidelines for
Immunization, coadministration of RSV vaccines with other
adult vaccines is acceptable.*
*ACIP Timing and Spacing Guidelines for Immunization | CDCThis includes giving RSV vaccines simultaneously with
seasonal influenza vaccines, COVID -19 vaccines,
pneumococcal vaccines, Td/Tdap, and recombinant zoster
vaccine (Shingrix) .
Data on immunogenicity of coadministration of RSV
vaccines with other vaccines
•There are currently limited data available on immunogenicity of
coadministration of RSV vaccines and other vaccines.
•In general, coadministration of RSV and seasonal influenza
vaccines met non -inferiority criteria for immunogenicity.*
•However, RSV and influenza antibody titers were generally
somewhat lower with coadministration.
•Additional studies on immunogenicity of coadministration of RSV
with other adult vaccines are in process.
10* Pre -specified non -inferiority criteria for immune responses were met across trials, with the exception of the FluA /Darwin H3N2 strain
after simultaneous administration of RSVPreF3 vaccine ( Arexvy by GSK) and adjuvanted quadrivalent inactivated influenza vaccine.
Reactogenicity and safety of coadministration of RSV
vaccines with other vaccines
•Coadministration of multiple vaccines at the same visit may increase reactogenicity.
•Only coadministration of RSV and influenza vaccines have clinical trial data available.
Evidence is mixed on whether there may be increased reactogenicity with
coadministration of RSV and influenza vaccines.
•Data are lacking on coadministration of other vaccines that might be recommended
for people in this age group, such as COVID -19 vaccines, pneumococcal vaccines,
Td/Tdap, and the recombinant zoster vaccine (Shingrix by GSK) which contains the
same adjuvant as RSVPreF3 vaccine ( Arexvy by GSK).
•Post -licensure safety monitoring of coadministration of RSV vaccines with other
vaccines will further inform coadministration guidance.
11
Clinical consideration: RSV vaccines and persons with
immunocompromising conditions
12Persons with
immunocompromising conditions
are recommended to receive the
RSV vaccine under shared clinical
decision -making given the
potential for significant benefit.Adults with immunocompromising
conditions are at risk of severe RSV -
associated disease and death.
They may benefit from RSV vaccination
but were not included in the clinical
trials so efficacy in this population is
unknown.
These individuals, including those
receiving immunosuppressive therapy,
may have a diminished immune
response to RSV vaccination.
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.
Acknowledgements:
Michael Melgar
Lauren Roper
Hannah Rosenblum
Melinda Wharton
Tara Anderson
Lisa Grohskopf
David ShayTom Shimabukuro
Karen Broder
Mila Prill
Anne Hause
Fiona Havers
Meredith McMorrow
Jefferson Jones
Katherine Fleming -DutraAndrew Kroger
Manisha Patel
Sarah Meyer
Neil Murthy
Patricia Wodi
Sara Oliver

Summary: Centers for Disease Control and Prevention Summary of Proposed Clinical Considerations for RSV  Vaccines June 21, 2023 ACIP Older Adult RSV Vaccine Session Amadea Britton, MD Michael Melgar, MD Overview of clinical considerations ▪Shared clinical decision -making based on risk assessment among  adults aged 60 –64 years ▪Timing of RSV vaccination for the 2023 –2024 RSV season ▪Coadministration of RSV vaccines with other vaccines ▪Persons with immunocompromising conditions 2 Clinical…


01 POLIO Brooks 508

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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.ACIP Polio Vaccination Work Group
Oliver Brooks, MD, FAAP
ACIP Meeting
June 21, 2023

1)Whether more specific guidance on adult vaccination , including use of adult
booster doses, can be provided in the context of circulating poliovirus.
2)Whether adults who are immunocompromised should be recommended an
additional adult booster of a polio -containing vaccine.
3)Whether fractional doses of IPV ( fIPV ), as prequalified by WHO, should m eet polio
vaccination requirements, including for people immigrating to the United States .
4)Consider criteria under which novel Oral Polio Vaccine type 2 (nOPV2) might be
used in areas with outbreaks or persistent circulation of poliovirus.Polio Vaccination Work Group Terms of Reference
Policy topics under consideration:

Summary: CenCenCen Centt tterer erers fs f s fs for Disease Coor Disease Coor Disease Coor Disease Co nn nntrtrtr trol ol ol ol andandandand    PrPr PrPree eevv vvenen enentiti tition ononon NaNaNaNational Cen tional Centional Centional Cent ttter f er fer fer for or or or ImIm ImImmunizmuniz munizmuniz aa aation antion an tion antion an d Rd Rd Rd Respiespi espiespir rrra aaattttoror orory y y y DiseDiseDiseDise ases asesasesases Photographs and images included in this presentation are licensed solely…