01 RSV Adult Kotton 508

CDC ACIP — Vaccine Advisory Committee

Acip

Slides

10

Document text

1
Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation 
use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences.
Adult Respiratory Syncytial Virus (RSV) Session
Camille Kotton, MD 
Chair, Adult RSV Work Group
Advisory Committee on Immunization Practices (ACIP) 
June 26, 2024
2Adult RSV Work Group Membership 
ACIP Voting Members
Camille Kotton (Chair)
Keipp  Talbot 
Sarah Long
Albert Shaw
Ex Officio Members
Rachel Zhang (FDA) 
Nicholas Geagan (FDA)
Nadine Peart Akindele (FDA) 
Sonnie Kim (NIH/NIAID)
Michelle Juaneza (HRSA)
Uzo Chukwuma (IHS)CDC Co -Leads
Michael Melgar 
Amadea BrittonConsultants
Robert Atmar (Baylor College of 
Medicine)
Doug Campos -Outcalt (University of 
Arizona)
Helen Chu (University of Washington)
Peter Donofrio (Vanderbilt University)
Marie Griffin (Vanderbilt University)
Rebecca Morgan (Case Western Reserve 
University)
Cynthia Lucero -Obusan  (Veterans Health 
Administration)
Tracy Ruckwardt (NIH/NIAID)
Jonathan Temte  (University of Wisconsin)Liaisons
Kenneth Schmader (AGS)
Vidya Sundareshan (ACP)
Gretchen LaSalle (AAFP)
April Killikelly (NACI, PHAC)
Winnie Siu (NACI, PHAC)
Katherine Williams (APTR) 
Ruth Lynfield (NFID) 
Bindy Crouch (AIM) 
Steven Pergam (IDSA)
Elizabeth Skoy ( APhA )
3▪Dr. Albert Shaw will be the incoming work group chair for the adult RSV work group 
starting in July 2024. Transition in Work Group Chair
4Melissa Coughlin
Fatima Dawood
Katherine Fleming -Dutra
Kristen Folsom
Jarrett Gartin
Monica Godfrey
Aron Hall
Fiona Havers
Michele Hlavsa
Jefferson Jones
Ruth Link -Gelles
Agustin Lopez
Josephine Mak
Meredith McMorrow
Noelle -Angelique MolinariDanielle Moulia
Ismael Ortega -Sanchez
Lakshmi Panagiotakopoulos
Pragna Patel
Monica Patton
Amanda Payne
Derrell Powers
Mila Prill
Lauren Roper
Diya Surie
Natalie Thornburg
Raigan Wheeler
Megan Wallace
Trang WisardCDC Contributors
Immunization Safety Office
Anne Hause
Pedro Moro
Christine Olson
David Shay
Karen Broder
John Su
Eric Weintraub
Michael McNeil
Julianne GeeImmunization Services Division
Carla Black
Kayla Calhoun 
Jennifer Kriss 
James Singleton
Nicole Dowling
Andrew Leidner
Jamison Pike
James Singleton
Patricia Wodi
Influenza Division
Jill Ferdinands
Lisa GrohskopfNCIRD Office of the Director
Hannah Rosenblum
Melinda Wharton
Jessica MacNeilCoronavirus and Other Respiratory Viruses Division 
5▪ACIP voted on this recommendation at the June 2023 meeting
▪Recommendation is not product -specific; administer whichever vaccine is availableCDC and ACIP currently recommend that adults aged 60 
years and older may receive a single dose of RSV 
vaccination, using shared clinical decision -making.
https://www.cdc.gov/mmwr/volumes/72/wr/mm7229a4.htm  
6▪Moderna presented safety and efficacy data from the first 9 months of follow up in their phase 3 
trial in adults aged ≥60 years
▪CDC presented risk -stratified rates of RSV -associated hospitalization in U.S. adults aged 50 
years and older
▪CDC gave an update on uptake and implementation of RSV vaccine in U.S. adults aged 60 years 
and older during the first season following the recommendation
▪CDC and FDA presented on post -marketing safety of the protein subunit RSV vaccines (GSK’s 
AREXVY and Pfizer’s ABRYSVO) in adults aged 60 years and older
▪CDC presented an analysis comparing the estimated magnitude of public health benefit and 
potential risk of Guillain -Barre syndrome (GBS) associated with protein subunit RSV vaccination 
in adults aged 60 years and older
▪For adults aged 60 years and older who remain unvaccinated, ACIP agreed with encouraging 
timing of RSV vaccination in the late summer and early fall to optimize public health benefitsRecap of Adult RSV session, February 2023
7▪Moderna mRESVIA  for use in adults aged 60 years and older (received FDA approval 
May 31, 2024)
▪GSK AREXVY for use in adults aged 50 -59 years at increased risk of severe RSV disease 
(received FDA approval June 7, 2024)
▪Continued discussion of safety, including risk of GBS, following RSV vaccination
▪Shift from a shared clinical decision -making recommendation to:
–Potential universal recommendation in adults 75 and older
–Potential risk -based recommendation in adults 60 –74
–Potential risk -based recommendation in adults 50 –59Recent work group discussion
8▪In June 2023, ACIP recommended RSV vaccination in adults 60 and older using shared 
clinical decision -making
–In addition to benefits of vaccination, the shared clinical decision -making discussion, as intended by ACIP , is also 
meant to include discussion of the potential risk of vaccine -associated adverse events associated with RSV 
vaccine, specifically Guillain Barre Syndrome.
▪In the first year following this recommendation, we have learned:
–Feedback from healthcare providers that having SCDM conversations is not simple in practice.
–Unlike a universal recommendation where there’s a clear call to action to vaccinate, with SCDM the call to action 
is to discuss with a healthcare provider, a less clear message.
▪A risk -based recommendation for adults 60 –74 and a universal recommendation for 
adults ≥75 years would potentially highlight more clearly for providers and other public 
health officials which adults are likely to benefit from an RSV vaccine and provide a 
clearer recommendation for patients. Re-evaluating Shared Clinical Decision -Making (SCDM) 
recommendation
9▪Dr. Iona Munjal (Pfizer) 
▪Dr. Susan Gerber (GSK) 
▪Dr. Rituparna Das (Moderna) 
▪Dr. James Donahue (Marshfield Clinic Research Institute)
▪Dr. Patricia Lloyd (FDA)
▪Dr. Diya Surie (CDC, NCIRD)
▪Dr. David Hutton (University of Michigan)
▪Dr. David Hutton (University of Michigan)
▪Dr. Ismael Ortega -Sanchez (CDC/NCIRD)
▪Dr. Michael Melgar (CDC/NCIRD), Lauren 
Roper (CDC/NCIRD), Dr. Amadea Britton (CDC/NCIRD)
▪Dr. Michael Melgar (CDC/NCIRD)Agenda: Wednesday June 26, 2024
▪Manufacturer presentation: ABRYSVO (Pfizer) safety and 
immunogenicity in non -pregnant adults aged 18 -59 years 
▪Manufacturer presentation: AREXVY (GSK) immunogenicity 
with a 24 -month revaccination interval 
▪Manufacturer presentation: mRESVIA  (Moderna) season 2 
safety and efficacy update
▪Postmarketing  safety updates: Vaccine Safety Datalink 
▪Evaluation of Guillain -Barre Syndrome (GBS) following RSV 
vaccination among adults 65 years and older
▪Observational RSV vaccine effectiveness
▪Economic analysis of adult RSV vaccination
▪Update to benefits and risks discussion
▪Comparison of economic analyses of adult RSV vaccination
▪Evidence to Recommendations
▪Clinical Considerations
10
For more information, contact CDC
1-800 -CDC -INFO (232 -4636)
TTY:  1 -888 -232-6348    www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official 
position of the Centers for Disease Control and Prevention.
Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation 
use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences.