RSV Pediatric 01 Long 508

CDC ACIP — Vaccine Advisory Committee

Acip

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Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Maternal/Pediatric Respiratory Syncytial Virus (RSV) 
Work Group
Sarah S. Long, MD
Chair, Maternal/Pediatric RSV Work Group 
ACIP General Meeting
February 23, 2023

2Work group members
ACIP Members
Sarah Long (chair)
Pablo SanchezOliver Brooks
Camille Kotton
Ex 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)Consultants
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)CDC
Katherine Fleming -Dutra (co -lead)
Jefferson Jones (co -lead)
Meredith McMorrow
Mila Prill
Natalie Thornburg
Aron Hall
Ismael Ortega -Sanchez
Tamara Pilishvili
Melissa Coughlin
Jamison Pike
Lauren Roper
Amber Winn
Chris Taylor
GRADE/ EtRconsultants
Doug Campos -Outcalt
Rebecca MorganClaire Midgley
Fiona Havers 
Tami SkoffAngie Campbell
Michael Melgar
Amanda PayneNicole Dowling
Noelle Molinari
Pragna Patel
Andrea Sharma
3Epidemiology and burden of RSV in infants
–RSV seasonality in United States
–Outpatient, emergency department (ED) visits, hospitalizations, and 
deaths
Virology and immunology of RSV
Safety and efficacy of nirsevimab
–Phase 3 study in infants born ≥35 weeks gestation (initial and updated results)
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–Phase 2b study in infants born 29 –34 weeks gestation
–Phase 2/3 safety and pharmacokinetic study in infants at high risk of RSV disease
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1Initial results from start of trial until pause for COVID- 19 pandemic and updated 
results that included entire sample. 2Eligible for palivizumab.Previous maternal/pediatric RSV ACIP presentations
4Agenda: Thursday February 23, 2023
Cost effectiveness analysis for nirsevimab –
CDC model
Cost effectiveness analysis for nirsevimab –
Comparison to manufacturer model
Evidence to Recommendations framework for 
nirsevimab
Clinical considerations for nirsevimab
Safety and Efficacy of RSV Bivalent PreF
Maternal Vaccine
Workgroup considerationsDr. David Hutton (University of Michigan)
Dr. Ismael Ortega Sanchez (CDC)
Dr. Jefferson Jones (CDC)
Dr. Jefferson Jones (CDC)
Dr. Iona Munjal (Pfizer)
Dr. Katherine Fleming -Dutra 
(CDC)
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