Centers for Disease Control and Prevention

National Center for Immunization and Respiratory DiseasesPhotographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation 

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ACIP Adult RSV Work Group Considerations

Respiratory Syncytial Virus (RSV) in AdultsUse of RSV vaccines in adults aged 50–59 years

Amadea Britton, MD, MSAdvisory Committee on Immunization PracticesOctober 25, 2023
 Review current recommendation for use of RSV vaccines in adults age

older

 Summarize available safety and immunogenicity data on the use of R

in adults aged 50–59 years

 Share preliminary Adult RSV Work Group interpretations on the use o

adults aged 50–59 years and upcoming policy decisions 

Overview
Review of current ACIP recommendati

of RSV vaccines in adults aged 60 year
 RSVPreF3 (Arexvy, GSK) is a 1-dose adjuvanted (AS01E) r

prefusion F protein (preF) vaccine. 

 RSVpreF (Abrysvo, Pfizer) is a 1-dose recombinant preF v

In June 2023, ACIP and CDC recommended the first vaccines for older adults.*The same vaccine formulation is FDA-approved and CDC-recommended for vaccination of pregnant persons for RSV prevention in infants.https://www.cdc.gov/mmwr/volumes/72/wr/mm7229a4.htm
 GSK’s adjuvanted RSVPreF3 and Pfizer’s RSVpreF vaccines 

demonstrated significant efficacy against lower respiratory caused by RSV among older adults over at least two season– Trials were underpowered to show efficacy in the oldest adults and in frail – Trials were underpowered to show efficacy against RSV hospitalization, a

against symptomatic illness may indicate efficacy against more severe dis

 Acknowledging these limitations, the Work Group and ACIP 

vaccination had the potential to prevent considerable morbdisease among older adults.

Vaccine Efficacyhttps://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-06-21-23/06-RSV-Adults-Melgar-508.pdf
 Six cases of inflammatory neurologic events (including Guill

syndrome) were reported across trials in older adults within RSV vaccination, compared with no cases within 6 weeks af– 3 cases after vaccination with GSK’s RSVPreF3* – 3 cases after vaccination with Pfizer’s RSVpreF

 Imbalance in the small number of atrial fibrillation events; m

among vaccine recipients, compared with placebo recipient

 It is unknown at this time whether these events occurred by 

whether RSV vaccination increases the risk of these events.

Vaccine Safety

https://www.cdc.gov/mmwr/volumes/72/wr/mm7229a4.htm* Two of the 3 reported inflammatory neurologic events after vaccination with GSK’s RSVPreF3 were reported as acute disseminated encepparticipants that simultaneously received RSVPreF3 vaccine and standard dose seasonal influenza vaccine. The site investigator that initialsince revised the diagnosis in both cases (from ADEM to hypoglycemia and dementia, and from ADEM to stroke). FDA’s package insert for to list these as Serious Adverse Events.
 In June, the Adult RSV Work Group proposed: – A universal recommendation for RSV vaccination in adults 65 and older – RSV vaccination in adults aged 60–64 years, using shared clinical decisio

 During ACIP deliberations an amendment was proposed an

the following recommendation: – Adults ages 60 years and older (both those 60–64 and 65 and older) m

dose of RSV vaccine using shared clinical-decision making. 

 The shared clinical decision-making recommendation was 

allow flexibility for providers and patients to consider indivRSV disease and target RSV vaccination to those most like

ACIP deliberations leading to a recommendation of RSV vaccine in adults 60 and older ACIP Adult RSV Session. June 21, 2023. Webcast: https://www.youtube.com/watch?v=DunxtgBmRxI&list=PLvrp9iOILTQb6D9e1YZWpbUvzfptN
Chronic underlying medical conditions associated 

increased risk of severe RSV disease

Lung diseaseCardiovascular diseaseModerate or severe immune compromiseDiabetes Mellitus

Other conditions that might increase the risk for severe disease

Neurologic or neuconditionsKidney disordersHematologic diso

Liver disorders

https://www.cdc.gov/mmwr/volumes/72/wr/mm7229a4.htm
Other factors associated with increased risk 

severe RSV disease

Residence in a nursing home or other long-term care facility (LTCF)FrailtyAdvanced age

https://www.cdc.gov/mmwr/volumes/72/wr/mm7229a4.htm
Next steps: new data on the safety and 

immunogenicity of RSVPreF3 in adults 59 years
 Humoral immune response* at day 31 after a single dose of RSVPreF3 

older compared to: – Adults 50–59, healthy (without prespecified conditions associated with increa

RSV disease)OR – Adults 50–59, at-increased-risk (AIR, with conditions associated with increase

disease) 

• AIR conditions included: COPD resulting in activity restricting symptoms or us

medication, chronic cardiovascular disease, diabetes mellitus type 1 or 2, chroand chronic liver disease

 Cellular immune response appeared similar across groups, but was no

evaluated 

 Safety profile of RSVPreF3 in adults 50–59 years similar to profile in 6

Today, GSK shared data demonstrating that the humoral iresponse to a single dose of RSVPreF3 in adults 50–59 yearinferior to that in adults 60 and older.

*The primary immunogenicity analysis of non-inferiority of the healthy and at-increased risk (AIR) 50–59 year-old group versus the established was based on geometric mean titer ratios and seroresponse rates. Data provided by GSK. 
What do these new data mean for future policy? 

 The non-inferiority data suggest that RSVPreF3 vaccine efficacy in 

(immunocompetent) adults aged 50–59 years with and without chrconditions that increase risk of RSV disease will be similar to efficacdemonstrated among adults 60 years and older.

 The Work Group notes that if FDA licensure is granted for use of R

adults aged 50–59 years, then ACIP will likely need to make a policrecommendation on:

– Whether RSV vaccination should be recommended in this age group– And if so, should the recommendation be the same as in adults aged 

older, i.e. shared clinical decision-making, or is a different type of recpreferred?
Additional work group interpretations of immunogin adults aged 50–59 years Persons with immunocompromising conditions were excluded from 

prior trials). This is a group likely to benefit from RSV vaccination acspectrum. 

 Would have preferred efficacy data in this age group, noting that th

immunologic correlate of protection against RSV disease. 

 If risk conditions are being prioritized, then those under 50 are also 

immuno-bridging (and ideally efficacy) studies in at-risk adults undalso provide important information. 
Work Group considerations on the use 

vaccines in adults aged 50–59 years 
RSV disease is a public health problem in adults aged 50–59 yea

the rate of RSV-associated disease in the general population of years is less than the rate in adults 60 and older.

Adjusted RSV-associated hospitalization rates* per 100,000 adults ≥18 years by 5-year age group and year, RSV-NET, 2015–2016 to 2019–2020

0

100200300400500600

18–49 50-54 55-59 60-64 65-69 70-74 75-79 80-8

Annual RSV-associated hospitalizations 

per 100,000 population 

2015–16 2016–17 2017–18 2018–19 2019–20

RSV vaccination currently recommended, with SCDM

26–59

23–42

*Unpublished data from RSV-NET. Rates are adjusted for the frequency of RSV testing during recent prior seasons and the sensitivity of RSV diagnostic 
Persons with certain risk conditions are at increased 

severe RSV disease, even at younger ages.*Clinical data were collected for all patients with laboratory-confirmed RSV hospitalizations during the 2014–2015 to 2017–2018 seasons, and for an age- and site-stratified laboratory-confirmed RSV hospitalizations during the 2022–2023 season. Displayed percentages were weighted for the probability of selection.†National Center for Health Statistics. United States, 2022. National Health Interview Survey. Generated interactively: Oct 17, 2023 from https://wwwn.cdc.gov/NHISDataQ

Prevalence of certain medical conditions

* among non-pregnant adults with RSV-associated hospitalizatio

to 2017–2018 and 2022–2023) and among the general population (National Center for Health Statistics

†, 20

50–64 years ≥65 y

General

population RSV-NET RSV- NET/ 

Pop

General 

population 

Condition % (95% CI) % (95% CI) % (95% CI) 

Coronary artery disease 5.0 (4.4, 5.6) 18.9 (16.9, 21.0) 3.8 15.3 (14.4, 16.2) 3COPD 6.2 (5.5, 6.9) 35.4 (32.9, 37.9) 5.7 9.8 (9.1, 10.5) 3Diabetes mellitus 13.8 (12.9, 14.7) 37.7 (35.1, 40.4) 2.7 20.1 (19.1, 21.1) 3Asthma 9.1 (8.4, 9.9) 28.6 (26.3, 31.0) 3.1 8.0 (7.3, 8.6) 1Obesity 37.6 (36.2, 38.9) 46.4 (43.7, 49.0) 1.2 30.4 (29.2, 31.6) 2
 In adults aged 50–59 years,

hospitalization rates are higher among Black and American Indian/Alaska Native adults than among White adults.

There is an important equity component when con

use of RSV vaccine among adults aged 50–59 years

*Unpublished data from RSV-NET. Rates are adjusted for the frequency of RSV testing during recent prior seasons and the sensitivity of RSV diagnostiAmerican Indian/Alaska Native and Asian/Pacific Islander people were categorized as non-Hispanic

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

4.5

18–49 50–59 60–64 

Asian or Pacific Islander WhiteHispanic BlackAmerican Indian or Alaska Native

Burden-adjusted hospitalization rate ratios* amorace and ethnicity — RSV-NET, 2016–2017 to 20
 Work Group is considering multiple policy options.

 Upcoming data on the implementation of shared clinical 

making, safety, and effectiveness (if available) will be impdetermine future preferred policy options, both among aduand among those 60 and older.

 The Work Group continues to believe that a focus on those a

of severe RSV disease is warranted while awaiting post-marsurveillance data.

Work Group preliminary considerations on the polic(part 1) 
Work Group preliminary considerations on the polic(part 2) 

 Work Group members broadly agree that use of RSV vaccine amon

aged 50–59 years is likely to have public health benefit.

– Members particularly acknowledge the equity concern of a recomm

age group.

 In addition, they note that if FDA licenses this product for adults 50

there is NO recommendation made, insurance will not cover use in potentially furthering existing disparities.

 The current priority of the Work Group is to ensure access to vaccin

adults 50–59 (and those ≥60) who are at substantially increased ris

RSV disease and likely to benefit most.
Risk-based

Risk-based

Risk-based

Risk-based Shared clinical decision-making

Shared clinical 

decision-making

Shared clinical 

decision-making

Universal

50 55 60 65 70 75 80 

Example 5

Example 4

Example 3

Example 2Example 1

Current recommendation

Age (years)

Example potential policy options 
Next steps for the Work Group

 Over the next few months, the Work Group will review pos

marketing data on the use of RSV vaccines in adults 60 anthey become available, including: 

– Vaccine uptake, stratified by demographic characteristics and r– Vaccine safety surveillance

 The Work Group will consider the implementation and imp

shared clinical decision-making
Next steps for the Work Group

 The Work Group will then develop an updated policy quest

vaccination in adults through review of:

– Updated GRADE of evidence profile for use of GSK’s RSVPreF3 – Updated cost effectiveness analysis (CEA) of use of RSVPreF3 – Updated Evidence to Recommendations framework for adult 

vaccination

 The Work Group will also begin reviewing safety and effic

RSV vaccine (Moderna’s mRNA-1345) for use in adults 60 
1. What additional data are needed prior to ACIP voting on updated re

for RSV vaccination in adults aged ≥50 years?

2. Other questions from ACIP?Questions for ACIP
Adult RSV Work Group Membership

ACIP Voting MembersCamille Kotton (Chair)Keipp TalbotSarah LongEx Officio MembersRachel Zhang (FDA)Judy Beeler (FDA)Nicholas Geagan (FDA)Nadine Peart Akindele (FDA)Sonnie Kim (NIH/NIAID)Jeffrey Kelman (CMS)Michelle Juaneza (HRSA/VICP)Uzo Chukwuma (IHS)Valerie Marshal (OIDP)

Consultants

Robert Atmar (Baylor Coll. of Medicine)Helen Chu (U Washington)Peter Donofrio (Vanderbilt University)Marie Griffin (Vanderbilt University)Cynthia Lucero-Obusan (VHA)

Tracy Ruckwardt (NJonathan Temte (U Rebecca Morgan (CDoug Campos-Out

LiaisonsKenneth Schmader (AGS)Vidya Sundareshan (ACP)Gretchen LaSalle (AAFP)April Killikelly (NACI/PHAC)Winnie Su (NACI/PHAC)

Katherine Williams (ARuth Lynfield (NFID)Bindy Crouch (AIM)Steven Pergam (IDSA)Elizabeth Skoy (APhA)
CDC Contributors

Michael Melgar (co-lead)Lauren RoperFiona HaversElisha Hall Chris TaylorMonica PattonMeredith McMorrowDiya SurieJennifer DeCuirMila PrillMonica GodfreyRuth Link-Gelles

Amanda PayneDanielle MouliaMegan WallaceNatalie ThornburgMelissa CoughlinJefferson JonesKatherine Fleming-DutraIsmael Ortega SanchezNoelle MolinariPragna PatelAron HallHannah Rosenblum

Derrell PowersRaigan WheelerJarrett GartinElizabeth GreeneManisha PatelLisa GrohskopfAnne HauseDavid ShayChristine OlsonTom ShimabukuroKaren BroderNeil Murthy

Patricia WoAndrew LeJamison PiSarah MeyNicole Dow
For more information, contact CDC

1-800-CDC-INFO (232-4636)TTY: 1-888-232-6348 www.cdc.govThe 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.