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1 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 June 22, 2023 2Work group members (External) ACIP Members Sarah Long (chair) Pablo Sanchez Oliver 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) Lucia Lee (FDA -CBER)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) GRADE/ EtRconsultants Doug Campos -Outcalt Rebecca Morgan 3Work group members (CDC) Lauren Roper Amber Winn Chris Taylor Tami Skoff Angie Campbell Michael Melgar Amanda Payne Nicole Dowling Noelle MolinariClaire Midgley Fiona Havers Pragna Patel Andrea Sharma Amadea Britton Ruth Link -Gelles Danielle Moulia Megan Wallace Monica GodfreyCDC ACIP Staff Melinda Wharton Stephanie Thomas Jessica MacNeilKaren Broder Naomi Tepper Hannah Rosenblum Heidi Moline Derrell Powers Raigan Wheeler Sally Ezra Elizabeth GreeneCDC Katherine Fleming -Dutra (co -lead) Jefferson Jones (co -lead) Meredith McMorrow Mila Prill Natalie Thornburg Aron Hall Ismael Ortega -Sanchez Melissa Coughlin Jamison PikeA. Patricia Wodi Neil Murthy Christine Olson Anne Hause Andrew Leidner David Shay 4▪Epidemiology and burden of RSV in infants ▪Virology and immunology of RSV ▪Safety and efficacy of nirsevimab ▪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 VaccinePrevious maternal/pediatric RSV ACIP presentations 5Agenda: Thursday June 22, 2023 ▪Economic Analy sis of RSVpreFin Pediatric Popul ations ▪Evidence to Recommen dations Frame work f or Pfizer Maternal RSVpreF Vaccine ▪Economics of combi ned use of Pfizer maternal RSVpreFvaccine and nirsevimab ▪Clinical considerations for RSVpreFmaternal vaccine and nirsevimabDr. David Hutton (University of Michigan) Dr. Kather ine Fleming-Dutra (CDC) Dr. David Hutton (University of Michigan) Dr. Jefferson Jones (CDC) 6