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Introduction and Terms of Reference: Combined Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus influenzae Type B Conjugate, and Hepatitis B vaccine (Vaxelis) Jamie Loehr Interim Chair, ACIP Meningococcal/Hib Vaccines Work Group February 29, 2024National Center for Immunization & Respiratory Diseases ACIP Meningococcal/Hib Vaccines Work Group ▪ ACIP Members on the WG •Jamie Loehr (Interim Chair) •Wilbur Chen ▪ Ex Officio WG Members •Margaret Bash (FDA) •Matthew Clark (IHS) •Mark Connelly (FDA) •Francisco Leyva (NIH) ▪ WG Liaisons and Consultants •Amra Resic (AAFP) •Samir Shah (AAP) •Barb Fluty (ACHA) •Karyn Lyons (AIM) •Paul Cieslak (CSTE) •Kathy Hsu (IDSA) •Joseline Zafack (NACI) •Jeff Goad (NFID) •Jessica Cataldi (PIDS) •Amy Middleman (SAHM) •Kathy Poehling (Wake Forest) •Lynn Bahta (Minnesota Department of Health) •David Stephens (Emory)▪ 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) •Noele Nelson (DBD/NCIRD) •Alison Albert (DBD/NCIRD) •Angela Jiles (DBD/NCIRD) •Marc Fischer (DIDRI/NCEZID) •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) ▪ GRADE/ EtR Support •Doug Campos -Outcalt (Arizona) •Rebecca Morgan (Case Western Reserve) 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 Vaxelis (DTaP -IPV-Hib-HepB ) be included with PedvaxHIB in the preferential recommendation for American Indian and Alaska Native (AI/AN) infants? 4 The use of trade names is for identification purposes only and does not imply endorsement by CDC. Work Group activities ▪Review the epidemiology of invasive Hib disease in AI/AN populations and evidence supporting the existing preferential recommendation for PedvaxHIB ▪Review clinical trial data on post -dose 1 immunogenicity of Vaxelis vs. PedvaxHIB ▪Develop draft policy recommendation based on grading of recommendations, assessment, development, and evaluation (GRADE) and the evidence to recommendations ( EtR) framework 5The 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 and discussionTopic Presenter Background on Hib disease and vaccination among American Indian and Alaska Native populationsDr. Jennifer Collins (CDC/NCIRD) Immunogenicity of H. influenzae type b PRP-OMP vaccines in American Indian and Alaska Native infantsDr. Laura Hammitt (Johns Hopkins Bloomberg School of Public Health – Center for Indigenous Health) Work Group Considerations Dr. Jennifer Collins (CDC/NCIRD) Next steps 24▪Present evidence to recommendations ( EtR) framework and draft policy recommendations for a vote in June 7