01 RSV Long 508
Document text
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 August 3, 2023 2Work 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/ EtRConsultants 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) 3Work 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 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 with manufacturer model ▪Evidence to Recommendations framework for nirsevimab ▪Clinical considerations for nirsevimabPrevious maternal/pediatric RSV ACIP presentations on nirsevimab 5Agenda: Thursday August 3, 2023 ▪Evidence to Recommendations Framework for nirsevimab ▪Nirsevimab implementation considerations ▪Clinical considerations for nirsevimab ▪Workgroup considerations and proposed recommendations and voting language ▪Vaccines for Children ResolutionDr. Jefferson Jones (CDC) Dr. Georgina Peacock (CDC) Dr. Jefferson Jones (CDC) Dr. Jefferson Jones (CDC) Dr. Jeanne Santoli (CDC) 6 7▪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) Proposed ACIP Voting Language