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Maternal/Pediatric Respiratory Syncytial Virus (RSV)
Work Group
Jefferson Jones MD MPH FAAP
Co-Lead, Maternal/Pediatric RSV Work Group
Presenting on behalf of
Helen Chu, MD, MPH
Chair, Maternal/Pediatric RSV Work Group
ACIP Meeting
April 16, 2025
1U.S. Centers for Disease Control and Prevention
CDC and ACIP recommend all infants should be protected against
severe RSV disease with either maternal RSV vaccine or nirsevimab
Maternal vaccine
Abrysvo , Pfizer
*Either maternal RSV vaccine or nirsevimab is given to protect infants against severe RSV disease – only one
is needed in most instances
Pregnant women 32 through 36
weeks’ gestation
Administer September through
January in most of
thecontinental United States†All infants <8 months*
Second season dose for children
ages 8 –19 months at increased risk
of severe RSV disease
Administer October through March
in most of the continental United
States†(as early as possible¥)
† Timing of administration for RSV immunization may differ in jurisdictions with RSV seasonality that differs from most of th e continental United States; ¥ The optimal timing for nirsevimab administration is
shortly before the RSV season begins (e.g., October –November), or within a baby's first week of life if born October through Mar ch (ideally during the birth hospitalization.)Nirsevimab
Beyfortus , Sanofi & AstraZeneca
Today we will be reviewing data on a second, long -acting monoclonal
antibody for protection of infants from severe RSV disease
Maternal vaccine
Abrysvo , Pfizer
*Either maternal RSV vaccine or an infant antibody is given to protect infants against severe RSV disease –
only one is needed in most instances
Pregnant women 32
through 36 weeks’
gestation
Administer
September through
January in most of
thecontinental
United States†All infants <8 months*
Second season dose for
children ages 8 –19 months
at increased risk of severe
RSV disease
Administer October through
March in most of the
continental United States †
(as early as possible¥)Nirsevimab
Beyfortus , Sanofi &
AstraZeneca Clesrovimab
Merck
Currently not FDA approved
Target action date: 6/10/25
All infants <8 months*
Administer October
through March in most of
the continental United
States † (as early as
possible¥)
† Timing of administration for RSV immunization may differ in jurisdictions with RSV seasonality that differs from most of th e continental United States; ¥ The optimal timing for nirsevimab administration is
shortly before the RSV season begins (e.g., October –November), or within a baby's first week of life if born October through Mar ch (ideally during the birth hospitalization.)
•September 2024
-Maternal/Pediatric RSV work group reviewed and discussed data from Merck on
safety and efficacy of clesrovimab
•October 2024
-ACIP reviewed and discussed data from Merck on safety and efficacy of
clesrovimab and work group interpretation of these data
•November 2024 – April 2025
-Maternal/Pediatric RSV work group reviewed and discussed
•GRADE (Grading of Recommendations, Assessment, Development, and
Evaluations) for clesrovimab
•Evidence to Recommendations Framework for clesrovimabTimeline of Maternal/Pediatric RSV work group and
ACIP review of clesrovimab
•Evidence to Recommendation Framework: Clesrovimab — Ms. Danielle
Moulia (CDC/NCIRD)
•Clinical Considerations — Dr. Jefferson Jones (CDC/NCIRD)Today’s agenda: April 16, 2025
5
•FDA has set a Prescription Drug User Fee Act (PDUFA) date, or target date for
regulation action, of June 10, 2025 , for clesrovimab .
•June 2025 ACIP meeting
-Presentation of any updates to the Evidence to Recommendation Framework and
Clinical Consideration for clesrovimab
-Vote on recommendation of clesrovimab (pending FDA regulatory action)Clesrovimab : Looking forward
6Source: Merck Press Release, 12/17/2024: https://www.merck.com/news/merck -announces -fda-acceptance -of-biologics -license -application -for-clesrovimab -an-investigational -
long -acting -monoclonal -antibody -designed -to-protect -infants -from -rsv-disease -during -their -first-rsv/
Work group members (external)
ACIP Members
Helen Chu (chair)
Oliver Brooks
Denise JamiesonConsultants
Cody Meissner (Dartmouth Geisel School of Medicine)
Kevin Ault (Western Michigan University)
Pablo Sanchez (Nationwide Children’s Hospital)
Liaisons
James McAuley (IDSA)
Nicole Chaisson (AAFP)
Sean O’Leary (AAP)
Jennifer Schuster (PIDS)
Molly Howell (AIM)
Stacy Buchanan (NAPNAP)
Caitlin Newhouse (CSTE)Ex Officio Members
Lucia Lee (FDA -CBER)
Yodit Belew (FDA -CDER)
Prabha Viswanathan (FDA -CDER)
Yugenia Hong -Nguyen (FDA -CDER)
Sonnie Kim (NIH -NIAID)
April Killikelly (Public Health Agency of Canada)
Elissa Abrams (Public Health Agency of Canada)
Jessica Lee (CMS/CMCS)
Terry Dalle -Tezze (HRSA)
Matthew Clark (IHS)
7
Work group members (CDC)
Amanda Payne
Noelle Molinari
Fiona Havers
Pragna Patel
Ruth Link -Gelles
Monica Godfrey
Heidi Moline
Hannah Rosenblum
Manisha Patel
Heather Scobie
Michele Hlavsa CDC ACIP Staff
Melinda Wharton
Stephanie Thomas
Jessica MacNeilMonica Patton
Jarrett Gartin
Dennis Wang
Jordan Singleton
Fatimah Dawood
Agustin Lopez
Lakshmi Panagiotakopoulos
Suzanne Heitfeld
Molly Gaines -McCollom
Amber Rose Kautz
Allison CieslaCDC
Jefferson Jones (co -lead)
Danielle Moulia (co -lead)
Meredith McMorrow
Mila Prill
Natalie Thornburg
Ismael Ortega -Sanchez
Melissa Coughlin
Jamison Pike
Lauren Roper
Tami Skoff
Angie Campbell
Michael Melgar
Amadea BrittonChristine Olson
Anne Hause
Andrew Leidner
David Shay
Pedro Moro
Tarayn Fairlie
John Su
Micheal McNeal
Julianne Gee
Naomi Tepper
Ellen Boundy
Alaya Koneru
Melissa Taylor
Ebony Thomas
8
For more information, contact CDC
1-800-CDC-INFO (232 -4636)
TTY: 1 -888-232-6348 cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position
of the U.S. Centers for Disease Control and Prevention.
Thank you