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Introduction to Session: Combined Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus influenzae Type b Conjugate, and Hepatitis B vaccine (Vaxelis) Jamie Loehr, MD Chair, ACIP Hib/Meningococcal Vaccines Work Group June 26, 2024National Center for Immunization & Respiratory Diseases 1 ACIP Meningococcal/Hib Vaccines Work Group ▪ ACIP Members on the WG •Jamie Loehr (Chair) •Wilbur Chen ▪ Ex Officio WG Members •Margaret Bash (FDA) •Matthew Clark (IHS) •Xin-Xing Gu (NIH) ▪ WG Liaisons and Consultants •Amra Resic (AAFP) •Mary Healy (AAP) •Barb Fluty (ACHA) •Karyn Lyons (AIM) •Paul Cieslak (CSTE) •Kathy Hsu (IDSA) •Pamela Doyon -Plourde (NACI) •Jeff Goad (NFID) •Jessica Cataldi (PIDS) •Amy Middleman (SAHM) •Kathy Poehling (Wake Forest) •Lynn Bahta (Minnesota Department of Health) •David Stephens (Emory) ▪ GRADE/ EtR Support •Doug Campos -Outcalt (Arizona) •Rebecca Morgan (Case Western Reserve)▪ CDC Contributors •Jennifer Collins (DBD/NCIRD) •Sarah Schillie (DBD/NCIRD) •Lucy McNamara (DBD/NCIRD) •LeAnne Fox (DBD/NCIRD) •Susan Hariri (DBD/NCIRD) •Amy Rubis (DBD/NCIRD) •Gabrielle Cooper (DBD/NCIRD) •Noele Nelson (DBD/NCIRD) •Alison Albert (DBD/NCIRD) •Shelby Miller (DBD/NCIRD) •Marc Fischer (DIDRI/NCEZID) •Xiaoyu Dong (ISD/NCIRD) •Andrew Leidner (ISD/NCIRD) •Ismael Ortega -Sanchez (CORVD/NCIRD) •Jonathan Duffy (DHQP/NCEZID) •Pedro Moro (DHQP/NCEZID) •Tanya Myers (DHQP/NCEZID) •Liz Velazquez (ISD/NCIRD) •Jessica MacNeil (ACIP Secretariat) •Hannah Rosenblum (ACIP Secretariat) •Melinda Wharton (ACIP Secretariat) 2 Background ▪PRP-OMP ( PedvaxHIB ) is preferentially recommended for American Indian and Alaska Native (AI/AN) infants •It provides a protective antibody response after the first dose •Historically, Hib meningitis peaked at an earlier age among AI/AN infants ▪Vaxelis (DTaP -IPV-Hib-HepB ) does not currently have a preferential recommendation for AI/AN infants because •It contains PRP -OMP in a lower amount than PedvaxHIB •Post -dose 1 immunogenicity data were not previously available 3 The use of trade names is for identification purposes only and does not imply endorsement by CDC. Policy question Should DTaP-IPV-Hib-HepB (Vaxelis) be included with PRP-OMP (PedvaxHIB) in the preferential recommendation for American Indian and Alaska Native (AI/AN) infants based on the Hib component? 4 The use of trade names is for identification purposes only and does not imply endorsement by CDC. February 2024 ACIP Meeting Presentations ▪Epidemiology of invasive Hib disease in AI/AN populations and evidence supporting the existing preferential recommendation for PedvaxHIB ▪Clinical trial data on post -dose 1 immunogenicity of Vaxelis vs. PedvaxHIB ▪Preliminary Work Group considerations 5 The use of trade names is for identification purposes only and does not imply endorsement by CDC. 6Today’s agenda All topics will be presented for information, discussion, and voteTopic Presenter Evidence to Recommendations and Proposed Recommendations: Use of Vaxelis among American Indian and Alaska Native Infants Dr. Jennifer Collins (CDC/NCIRD) Updated Vaccines for Children (VFC) ResolutionDr. Jeanne Santoli (CDC/NCIRD) The use of trade names is for identification purposes only and does not imply endorsement by CDC.