Document text
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)
February 29, 2024
As a reminder, ACIP recommended that adults aged ≥60 years may
receive RSV vaccination, using shared clinical decision -making.
There are currently two licensed and recommended products for adults aged ≥60 years:
–GSK RSV vaccine (Arexvy ): a 1 -dose adjuvanted (AS01E) recombinant
prefusion F protein (preF ) vaccine.
–Pfizer RSV vaccine (Abysvo ): a 1 -dose recombinant preF vaccine. In June 2023, ACIP made the first -ever recommendation for
the use of RSV vaccine in older adults.
https://www.cdc.gov/mmwr/volumes/72/wr/mm7229a4.htm 2
The ACIP Adult RSV Work Group shared their early interpretations of
these data and the potential role of RSV vaccination in adults younger
than 60 years, including subpopulations that would benefit most from
vaccination and equity implications.
At that time ACIP members expressed the importance of reviewing safety surveillance data to inform future preferred policy
recommendations . In October 2023, GSK presented data to ACIP demonstrating that the humoral immune response to a single dose of GSK RSV vaccine in adults
50–59 years is non -inferior to that in adults ages 60 years and older.
3
The Work Group is committed to incorporating what we are learning from
post -licensure data in a transparent way that ensures safety for the public
and clarity for providers.
The preliminary data shared today are the first in what will be a series of rigorous analyses across multiple different platforms.
CDC and the Work Group will be engaged in ongoing re- assessment and
future policy will be responsive to what is learned over the coming
months. At today’s meeting CDC and FDA will be sharing preliminary
data from multiple safety surveillance platforms.
4
Risk of severe RSV disease in adults ages 50 -59 years, especially those
with chronic medical conditions
RSV vaccine uptake among different demographic groups
Potential policy options that would transition away from shared clinical
decision -making The Work Group has simultaneously been reviewing additional
data to prepare for upcoming potential policy decisions.
5
We will open today’s session with a presentation from Moderna, who will be sharing
safety and efficacy data with ACIP for the first time from their primary Phase 2 -3 trial
evaluating mRNA -1345.The Work Group has also begun reviewing data from Moderna on their
investigational RSV vaccine (mRNA- 1345) in adults aged ≥60 years.
6
Agenda: February 29, 2024
Manufacturer presentation: Overview of Moderna’s Investigational
RSV Vaccine (mRNA -1345) in Adults ≥60 Years of Age
Risk -stratified rates of RSV -associated hospitalization among
adults
Implementation update: older adult RSV vaccination
Post -marketing safety surveillance of older adult RSV vaccination
Preliminary Analysis of Guillain -Barré Syndrome (GBS) following
RSV Vaccination among adults 65 years and older
Older adult RSV vaccination: benefits and risks discussion
Work Group interpretations and discussionDr. Rituparna Das (Moderna)
Dr. Rebecca Woodruff (CDC)
Dr. Carla Black (CDC)
Dr. Tom Shimabukuro (CDC)Dr. Patricia Lloyd (FDA)
Dr. Michael Melgar (CDC)
Dr. Amadea Britton (CDC)
7
Adult RSV Work Group Membership
8ACIP Voting Members
Camille Kotton (Chair)
Keipp Talbot
Sarah Long
Ex Officio Members
Rachel Zhang (FDA)
Nicholas Geagan (FDA)
Nadine Peart Akindele (FDA)
Sonnie Kim (NIH/NIAID)
Jeffrey Kelman (CMS)Michelle Juaneza (HRSA/VICP )
Uzo Chukwuma (IHS)
Valerie Marshall (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 (NIH/NIAID)
Jonathan Temte (U Wisconsin)
Rebecca Morgan (Case Western)
Doug C ampos -Outcalt (U Arizona)
Liaisons
Kenneth Schmader (AGS)
Vidya Sundareshan (ACP)Gretchen LaSalle (AAFP)April Killikelly (NACI /PHAC)
Winnie Su (NACI/ PHAC)Katherine Williams (APTR)Ruth Lynfield (NFID)Bindy Crouch (AIM)Steven Pergam (IDSA)Elizabeth Skoy ( APhA)
CDC Contributors
Amadea Britton (co -lead)
Michael Melgar (co -lead)
Lauren Roper
Fiona Havers
Chris TaylorMonica Patton
Rebecca Woodruff
Meredith McMorrow
Dave Wentworth
Diya Surie
Jennifer DeCuir
Mila Prill
Monica GodfreyRuth Link -Gelles
Amanda Payne
Danielle Moulia
Megan Wallace
Natalie ThornburgMelissa Coughlin
Jefferson Jones
Katherine Fleming -Dutra
Ismael Ortega Sanchez
Noelle Molinari
Pragna Patel
Aron Hall
Hannah RosenblumDerrell Powers
Raigan Wheeler
Jarrett Gartin
Trang Nguyen Wisard
Elizabeth Greene
Manisha Patel
Lisa Grohskopf
Anne HauseDavid Shay
Christine Olson
Tom Shimabukuro
Karen Broder
John HsuPedro Moro
Patricia WodiAndrew Leidner
Jamison Pike
Sarah Meyer
Elisha Hall
Nicole DowlingTara Anderson
9
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.