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RSV Vaccination in Adults:
Introduction
Albert Shaw, MD, PhD
Chair, Adult RSV Work Group
Advisory Committee on Immunization Practices
April 16, 2025National Center for Immunization and Respiratory Diseases
2Adult RSV Work Group Membership
ACIP Voting Members
Albert Shaw (Chair)
Helen Chu
Mini Kamboj
Keipp Talbot
Ex Officio Members
Nicholas Geagan (FDA)
Rachel Zhang (FDA)
Michelle Juaneza (HRSA)
Uzo Chukwuma (IHS)
Sonnie Kim (NIH/NIAID)CDC Co -Leads
Amadea Britton
Michael Melgar
Diya SurieConsultants
Robert Atmar (Baylor College of Medicine)
Peter Donofrio (Vanderbilt University)
Marie Griffin (Vanderbilt University)
Camille Kotton (Massachusetts General Hospital)
Cynthia Lucero (Veterans Health Administration)
Tracy Ruckwardt (NIH/NIAID)
Jonathan Temte (University of Wisconsin)Liaisons
Bindy Crouch (AIM)
April Killikelly (NACI, PHAC)
Gretchen LaSalle (AAFP)
Ruth Lynfield (NFID)
Steven Pergam (IDSA)
Kenneth Schmader (AGS)
Winnie Siu (NACI, PHAC)
Elizabeth Skoy ( APhA )
Vidya Sundareshan (ACP)
Katherine Williams (APTR)
3CDC Contributors
Melissa Coughlin
Fatima Dawood
Jarrett Gartin
Monica Godfrey
Fiona Havers
Suzanne Heitfield
Michele Hlavsa
Jefferson Jones
Ruth Link -Gelles
Amber Kautz
Agustin Lopez
Josephine Mak
Meredith McMorrow
Noelle -Angelique MolinariDanielle Moulia
Ismael Ortega -Sanchez
Lakshmi Panagiotakopoulos
Pragna Patel
Monica Patton
Amanda Payne
Mila Prill
Lauren Roper
Melisa Shah
Natalie Thornburg
Dennis Wang
Trang WisardImmunization Safety Office
Tarayn Fairlie
Julianne Gee
Anne Hause
Sarah Meyer
Michael McNeil
Pedro Moro
Christine Olson
David Shay
John Su
Evelyn Twentyman
Eric WeintraubImmunization Services Division
Carla Black
Kayla Calhoun
Nicole Dowling
Jennifer Kriss
Andrew Leidner
Jamison Pike
Influenza Division
Jill Ferdinands
Lisa GrohskopfNCIRD Office of the Director
Jessica MacNeil
Hannah Rosenblum
Melinda WhartonCoronavirus and Other Respiratory Viruses Division
4June 2024 ACIP Recommendations for RSV Vaccination
in Older Adults:
ACIP recommends all adults aged ≥75 years and adults aged 60 –74 years
who are at increased risk of severe RSV disease receive a single dose of RSV
vaccine.1,2
1. Recommendation is for any Food and Drug Administration –approved RSV vaccine ( Arexvy [GSK];
Abrysvo [Pfizer]; or mResvia [Moderna]). There is no product preference.
2. Eligible adults are currently recommended to receive a single dose of RSV vaccine; adults who have
already received RSV vaccination should not receive another dose.
5Chronic medical conditions and other risk factors associated
with increased risk of severe RSV disease
Neurological or neuromuscular conditions
causing impaired airway clearance or
respiratory muscle weaknessChronic cardiovascular
disease
Moderate or severe
immunocompromise Diabetes mellitus
complicated by chronic kidney disease,
neuropathy, retinopathy or other end -
organ damage or requiring treatment
with insulin or sodium -glucose
cotransporter -2 (SGLT2) inhibitorSevere obesity
(body mass index
≥40 kg/m2)Chronic lung
or respiratory
disease
End stage renal
disease/dialysis
dependenceChronic liver
diseaseChronic hematologic
conditions
Residence in a
nursing homeOther chronic medical conditions or risk factors that a
provider determines would increase risk of severe disease
due to viral respiratory infection (e.g., frailty)
Britton A, Roper LE, Kotton CN, et al. Use of Respiratory Syncytial Virus Vaccines in Adults Aged ≥60 Years: Updated Recommen dations of the Advisory Committee on Immunization Practices — United States, 2024. MMWR Morb Mortal Wkly Rep 2024;73:696 -702.
DOI: http://dx.doi.org/10.15585/mmwr.mm7332e1 .
6•Protein subunit (based on RSV F protein in prefusion conformation)
-GSK Arexvy1: monovalent RSV -A, AS01E adjuvant
-Pfizer Abrysvo2: bivalent RSV -A/RSV -B, no adjuvant
•Messenger RNA (mRNA, encoding RSV F protein in prefusion conformation)
-Moderna mResvia3: monovalent RSV -A, no adjuvantCurrent FDA -approved RSV vaccines
1. https://www.fda.gov/media/167805/download
2. https://www.fda.gov/media/168889/download
3. https://www.fda.gov/media/179005/download
7•Protein subunit
-GSK Arexvy1: monovalent RSV -A, AS01E adjuvant
-Pfizer Abrysvo2: bivalent RSV -A/RSV -B, no adjuvant
•mRNA
-Moderna mResvia3: monovalent RSV -A, no adjuvantCurrent FDA -approved RSV vaccines
Approved for prevention of
lower respiratory tract
disease (LRTD) caused by RSV
in adults aged ≥60 years
1. https://www.fda.gov/media/167805/download
2. https://www.fda.gov/media/168889/download
3. https://www.fda.gov/media/179005/download
8•Protein subunit
-GSK Arexvy1: monovalent RSV -A, AS01E adjuvant
-Pfizer Abrysvo2: bivalent RSV -A/RSV -B, no adjuvant
•mRNA
-Moderna mResvia3: monovalent RSV -A, no adjuvantCurrent FDA -approved RSV vaccines
Approved for prevention of
LRTD caused by RSV in adults
aged 50 –59 years who are at
increased risk for LRTD
caused by RSV*
1. https://www.fda.gov/media/167805/download
2. https://www.fda.gov/media/168889/download
3. https://www.fda.gov/media/179005/download*There is no current ACIP recommendation for RSV
vaccination in adults aged <60 years, except for the maternal
vaccination recommendation:
https://www.cdc.gov/mmwr/volumes/72/wr/mm7241e1.htm
9•Protein subunit
-GSK Arexvy1: monovalent RSV -A, AS01E adjuvant
-Pfizer Abrysvo2: bivalent RSV -A/RSV -B, no adjuvant
•mRNA
-Moderna mResvia3: monovalent RSV -A, no adjuvantCurrent FDA -approved RSV vaccines
Approved for prevention of
LRTD caused by RSV in adults
aged 18 –59 years who are at
increased risk of LRTD
caused by RSV*
1. https://www.fda.gov/media/167805/download
2. https://www.fda.gov/media/168889/download
3. https://www.fda.gov/media/179005/download*There is no current ACIP recommendation for RSV
vaccination in adults aged <60 years, except for the maternal
vaccination recommendation:
https://www.cdc.gov/mmwr/volumes/72/wr/mm7241e1.htm
10•Protein subunit
-GSK Arexvy1: monovalent RSV -A, AS01E adjuvant
-Pfizer Abrysvo2: bivalent RSV -A/RSV -B, no adjuvant
•mRNA
-Moderna mResvia3: monovalent RSV -A, no adjuvantCurrent FDA -approved RSV vaccines
Also approved and
recommended for active
immunization in pregnancy*
at 32 –36 weeks gestational
age for the prevention of
LRTD and severe LRTD caused
by RSV in infants from birth
through 6 months of age.
*There is no current ACIP recommendation for RSV
vaccination in adults aged <60 years, except for the maternal
vaccination recommendation:
https://www.cdc.gov/mmwr/volumes/72/wr/mm7241e1.htm 1. https://www.fda.gov/media/167805/download
2. https://www.fda.gov/media/168889/download
3. https://www.fda.gov/media/179005/download
11•Protein subunit
-GSK Arexvy1: monovalent RSV -A, AS01E adjuvant
-Pfizer Abrysvo2: bivalent RSV -A/RSV -B, no adjuvant
•mRNA
-Moderna mResvia3: monovalent RSV -A, no adjuvantCurrent FDA -approved RSV vaccines
PDUFA: Prescription Drug User Fee Act
1. https://www.fda.gov/media/167805/download
2. https://www.fda.gov/media/168889/download
3. https://www.fda.gov/media/179005/download
4. https://investors.modernatx.com/news/news -details/2025/Moderna -Reports -Fourth -Quarter -and-Fiscal -Year -2024 -Financial -Results -and-Provides -Business -
Updates/default.aspx Moderna has submitted
an application for
licensure for adults aged
18–59 years who are at
increased risk of LRTD
caused by RSV. PDUFA
date June 12th, 2025.4
12•Adult RSV Work Group will propose a policy recommendation for age expansion of
the use of RSV vaccines to include adults aged 50 -59 years at increased risk of severe
RSV disease.
•Immunobridging and safety data in adults aged 50 -59 years at increased risk of
severe RSV disease were previously presented to ACIP by GSK and Pfizer; today
Moderna will present immunobridging and safety data in adults aged 18 -59 years at
increased risk.
•ACIP will also see presentations from manufacturers on immunogenicity and safety
of re -vaccination and economic analyses of RSV vaccination in adults aged 50 -59
years at increased risk.
•Then we will share the complete Evidence to Recommendation framework and
propose a policy recommendation for an ACIP vote.Today’s meeting
13
Acknowledging there is also one FDA -approved vaccine for RSV
prevention in adults aged <50 years, the Work Group continues to
evaluate recommendations for RSV vaccination in this age group
14•The Work Group recognizes that certain adults aged <50 years may
benefit from RSV vaccination
•However, the Work Group has indicated there are likely important
differences in considering a recommendation for adults aged <50 years
compared to adults aged ≥50 years, including:
-Absolute risk of RSV -associated disease and which medical conditions increase risk the most
-Risk-benefit balance
-Cost -effectiveness
-Importance of ability to restore protection with revaccination
•As of today’s meeting, information on the absolute risk of RSV -
associated disease among adults with risk conditions is still being
analyzed and estimates of risk -benefit balance and cost -effectiveness of
vaccination in younger adults are not yet available. Policy for the use of RSV vaccines in adults aged <50
years will be revisited at the June 2025 meeting.
15•The Work Group is also reviewing or anticipates reviewing the following data
deemed critical for a recommendation in adults aged <50 years:
-The projected balance of public health benefits and risks considering uncertainty in vaccine -
associated Guillain -Barré syndrome risk in a younger population
-Evidence of RSV vaccine immunogenicity or effectiveness in adults with the most severely
immunocompromising conditions
-The duration of protection over time in adults aged ≥60 years who were vaccinated in 2023
-Available data on immunogenicity of revaccination with different vaccine platforms and
revaccination intervals
•The Work Group has indicated it needs to review these data and needs additional
time to consider the best policy option in adults aged <50 years.
•The Work Group welcomes ACIP’s thoughts about adults aged <50 years during
discussion at the end of today’s session. Policy for the use of RSV vaccines in adults aged <50
years will be revisited at the June 2025 meeting.
16Agenda: Wednesday April 16, 2025
•Manufacturer Presentation: mRNA -1345 (Moderna)
Immunogenicity in Adults Aged 18 -59 Years at Increased Risk; 24 -
Month Re -Vaccination
•Manufacturer Presentation: Arexvy (GSK) 36 -Month Re -
Vaccination
•Economic Analysis of Adult RSV Vaccination, including benefits
and risk discussion
•Comparison of Economic Analyses of Adult RSV Vaccination
•Evidence to Recommendations
•Clinical Considerations
•ACIP discussion and vote •Dr. Frances Priddy (Moderna)
•Dr. Susan Gerber (GSK)
•Dr. Ismael Ortega -Sanchez (CDC) on behalf of Dr.
David Hutton (University of Michigan)
•Dr. Ismael Ortega -Sanchez (CDC)
•Dr. Michael Melgar, Dr. Diya Surie (CDC)
•Dr. Diya Surie (CDC)
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.