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Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
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Maternal/Pediatric Respiratory Syncytial Virus (RSV)
Work Group
Sarah S. Long, MD
Chair, Maternal/Pediatric RSV Work Group
ACIP General Meeting
September 22, 2023
2Each year in U.S. children aged less than 5 years,
RSV is associated with…
~1,500,0003
outpatient visits~520,0003
emergency department visits58,000 –80,0003,4
hospitalizations100–3001,2
deaths
1Thompson et al, JAMA, 2003 ; 2Hansen et al, JAMA Network Open, 2022 ; 3Hall et al, NEJM, 2009 ; 4McLaughlin et al, J Infect Dis, 2022 (*estimate 80,000 hospitalizations in infants
<1y)
3▪Most (68%) infants are infected in the first year of life and
nearly all (97%) by age 2 years2
▪2-3% of young infants will be hospitalized for RSV3,4,5
▪RSV is a common cause of lower respiratory tract infection
in infants
▪Highest RSV hospitalization rates occur in first months of
life and risk declines with increasing age in early
childhood3,5
▪79% of children hospitalized with RSV aged <2 years had no
underlying medical conditions3RSV is the leading cause of hospitalization in U.S.
infants1
1Suh et al. JID 2022 ; 2Glezen et al, Arch Dis Child, 1986 ; 3Hall et al, Pediatrics, 2013 ; 4Langley & Anderson, PIDJ, 2011 ; 5CDC NVSN data
Image: Goncalves et al. Critical Care
Research and Practice 2012
4▪Epidemiology and burden of RSV in infants
▪Virology and immunology of RSV
▪Safety and efficacy of RSVpreF
▪Cost effectiveness analysis for RSVpreF –CDC model
▪Cost effectiveness analysis for RSVpreF –Comparison with manufacturer model
▪Evidence to Recommendations framework for RSVpreF
▪Clinical considerations for RSVpreFPrevious maternal/pediatric RSV ACIP presentations on
RSVpreF vaccine
5▪On August 21, 2023, FDA approved Pfizer RSVpreF vaccine for use in pregnant people for the
prevention of RSV lower respiratory tract disease and severe lower respiratory tract disease in
infants from birth to 6 months of age
▪Approved as a single dose to be given at 32 –36 weeks gestation
–In phase 2b and 3 trials, vaccination was given during 24 –36 weeks gestation
–A numerical imbalance in preterm births was observed in RSVpreF vaccine compared to
placebo recipients in two clinical studies
–Available data are insufficient to establish or exclude a causal relationship between preterm
birth and RSVpreF
–Additionally, a numerical imbalance in hypertensive disorders of pregnancy was observed in
RSVpreF vaccine compared to placebo recipientsFDA approval for RSVpreF vaccine
FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants | FDA
Package Insert -ABRYSVO (STN 125768) (fda.gov)
August 21, 2023 Approval Letter -ABRYSVO (STN 125768) (fda.gov)
6▪Starting dosing at 32 weeks gestation can reduce the potential risk of and complications from
preterm birth until additional safety data are available
–Avoids the risk of extremely preterm births, where there is substantive morbidity and
mortality, and very preterm births
–Similar vaccine efficacy in 32 -36 weeks gestation compared to the overall study population
▪FDA has required the manufacturer to conduct post -marketing studies to assess preterm birth
and hypertensive disorders of pregnancy, including pre -eclampsiaFDA approval for RSVpreF vaccine (cont.)
FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants | FDA
Package Insert -ABRYSVO (STN 125768) (fda.gov)
August 21, 2023 Approval Letter -ABRYSVO (STN 125768) (fda.gov)
7▪On August 3, 2023, ACIP recommended nirsevimab for RSV prevention in infants
–Infants aged <8 months born during or entering their first RSV season are
recommended to receive one dose of nirsevimab (50 mg for infants <5 kg and 100
mg for infants ≥5 kg)
–Children aged 8 –19 months who are at increased risk of severe RSV disease and
entering their second RSV season are recommended to receive one dose of
nirsevimab (200 mg) RSVpreF vaccine is one of two available preventive
products for RSV in infants
8▪A person develops active immunity from infection or vaccination
–Triggers an immune response
–Immunologic memory provides prolonged protection that may be lifelong
▪Passive immunity is transfer of preformed antibody produced externally to provide
protection to the recipient
–From mother to baby through transplacental or breastmilk transfer
–Direct administration of antibodies, such as IVIG or monoclonal antibodies
–Provides temporary protection that wanes with timeBoth nirsevimab and maternal RSV vaccine provide passive
immunity
IVIG= Intravenous Immunoglobulin Therapy
https://www.cdc.gov/vaccines/vac -gen/immunity -types.htm
9Agenda: Friday September 22, 2023
RSVpreF Vaccine Safety Surveillance in Pregnancy from
The Vaccine Safety DatalinkDr. Malini DeSilva (HealthPartners
Institute)
Maternal RSV vaccine safety monitoring in the Vaccine
Adverse Event Reporting System (VAERS) and V -safeDr. Pedro Moro (CDC/NCEZID)
Economic analysis of RSVpreF maternal vaccination Dr. David Hutton (University of
Michigan)
Economics of Preventing Respiratory Syncytial Virus
Disease among US Infants by Maternal Vaccination Prior
to BirthDr. Ismael Ortega -Sanchez
(CDC/NCIRD)
Evidence to Recommendations Framework Updates:
Pfizer Maternal RSVpreF VaccineDr. Katherine Fleming -Dutra
(CDC/NCIRD)
10Agenda: Friday September 22, 2023 (cont.)
Updated clinical considerations for use of both
nirsevimab and Pfizer RSVpreF vaccineDr. Jefferson Jones (CDC/NCIRD)
Implementation considerations for maternal RSV
vaccineDr. Georgina Peacock (CDC/NCIRD)
Vaccines for Childrens Resolution Dr. Jeanne Santoli (CDC/NCIRD)
Break
Public Comment
Break
Vote on recommendation and Vaccines for Children
Adult and Pediatric Immunization Schedule Addendum Dr. Sarah Schillie (CDC/NCIRD)
11▪Should Pfizer RSVpreF vaccine be recommended for pregnant people to be given
during 32 through 36 weeks gestation to prevent RSV lower respiratory tract infection
in infants?Policy Question
12Work group members (External)
ACIP Members
Sarah Long (chair)
Pablo Sanchez
Oliver Brooks
Camille KottonConsultants
Cody Meissner (Dartmouth Geisel School of Medicine)
Helen Chu (University of Washington)
Natasha Halasa (Vanderbilt University)
Denise Jamieson (Emory University School of Medicine)
Daniel Feikin (World Health Organization)
Carol Baker (University of Texas Health Science Center)
Kevin Ault (Western Michigan University)Liaisons
James McAuley (IDSA)
Patsy Stinchfield (NFID)
Brenna L. Hughes (ACOG)
Nicole Chaisson (AAFP)
Sean O’Leary (AAP)
Jennifer Schuster (PIDS)
Molly Howell (AIM)GRADE/ EtR Consultants
Doug Campos -Outcalt
Rebecca MorganEx Officio Members
Rachel Zhang (FDA -CBER)
Nicholas Geagan (FDA -CBER)
Judy Beeler (FDA -CBER)
Yodit Belew (FDA -CDER)
Prabha Viswanathan (FDA -CDER)
Sonnie Kim (NIH -NIAID)
April Killikelly (Public Health Agency of Canada)
Winnie Siu (Public Health Agency of Canada)
Valerie Marshall (OIDP/OASH)
Jessica Lee (CMS/CMCS)
Terry Dalle -Tezze (HRSA)
Lucia Lee (FDA -CBER)
Robin Wisch (FDA -CBER)
13Work group members (CDC)
Amber Winn
Chris Taylor
Tami Skoff
Angie Campbell
Michael Melgar
Amanda Payne
Nicole Dowling
Noelle Molinari
Claire Midgley
Fiona HaversPragna Patel
Andrea Sharma
Amadea Britton
Ruth Link -Gelles
Danielle Moulia
Megan Wallace
Monica Godfrey
Karen Broder
Naomi Tepper
Heidi MolineCDC ACIP Staff
Melinda Wharton
Stephanie Thomas
Jessica MacNeilHannah Rosenblum
Derrell Powers
Raigan Wheeler
Sally Ezra
Elizabeth Greene
Manisha Patel
Tom Shimabukuro
Demorah Hayes
Latifah BoyceCDC
Katherine Fleming -Dutra (co -lead)
Jefferson Jones (co -lead)
Meredith McMorrow
Mila Prill
Natalie Thornburg
Aron Hall
Ismael Ortega -Sanchez
Melissa Coughlin
Jamison Pike
Lauren RoperA. Patricia Wodi
Neil Murthy
Christine Olson
Anne Hause
Andrew Leidner
David Shay
Sarah Meyer
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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.