CDC ACIP — Vaccine Advisory Committee
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Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences. Chronic Conditions as Risk Factors for RSV -Associated Hospitalization Rebecca C. Woodruff, PhD, MPH Epidemiologist, Centers for Disease Control and Prevention February…
CDC ACIP — Vaccine Advisory Committee
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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 RSV Vaccination Implementation Update Carla Black, PhD Surveillance and Epidemiology Branch…
CDC ACIP — Vaccine Advisory Committee
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Centers for Disease Control and Prevention National Center for Emerging and Zoonotic Infectious Diseases Post -licensure safety monitoring of respiratory syncytial virus (RSV) vaccines in adults aged ≥60 years Tom Shimabukuro, MD, MPH, MBA On behalf of the Immunization Safety Office, CDC Advisory Committee on Immunization Practices (ACIP) February 29, 2024 Topics ▪Background ▪CDC vaccine safety monitoring for RSV vaccines in adults aged ≥60 years •V-safe •Vaccine Adverse Event Reporting…
CDC ACIP — Vaccine Advisory Committee
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1 Preliminary Analysis of Guillain-Barré Syndrome (GBS) following RSV Vaccination among adults 65 years and older Dr. Patricia Lloyd, ScM PhD Health Statistician Office of Biostatistics and Pharmacovigilance Center for Biologics Evaluation and Research U. S. Food & Drug Administration MEETING OF THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) Respiratory Syncytial Virus (RSV) Vaccines, Adults February 29, 2024 2 Outline •Study Methods •Statistical Analysis •Study Results…
CDC ACIP — Vaccine Advisory Committee
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Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences. RSV Vaccination in Older Adults: Benefit -Risk Discussion Michael Melgar , MD Lauren Roper, MPH Advisory Committee on Immunization Practices February 29, 2024 There are…
CDC ACIP — Vaccine Advisory Committee
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Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences. RSV Vaccination in Older Adults: Work Group Interpretations Amadea Britton, MD Advisory Committee on Immunization PracticesFebruary 29, 2024 2This includes follow- up of…
CDC ACIP — Vaccine Advisory Committee
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Introduction to Meningococcal Vaccines Session Jamie Loehr, MD ACIP Meningococcal Work Group Chair February 29, 2024National Center for Immunization & Respiratory Diseases The findings and conclusions in this presentation are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. ▪Revisiting the adolescent meningococcal vaccine schedule –Does ACIP concur with the 4 options for further assessment? –What additional…
CDC ACIP — Vaccine Advisory Committee
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Revising the Adolescent Meningococcal Vaccine Schedule: Term of Reference and Considerations Sarah Schillie, MD, MPH, MBA February 29, 2024National Center for Immunization & Respiratory Diseases The findings and conclusions in this presentation are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. ▪Vaccine recommendations and coverage ▪Epidemiology ▪Duration of vaccine -induced protection ▪Options for changing the…
CDC ACIP — Vaccine Advisory Committee
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GSK Pentavalent MenABCWY Vaccine: Term of Reference Sarah Schillie, MD, MPH, MBA February 29, 2024National Center for Immunization & Respiratory Diseases The findings and conclusions in this presentation are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. ▪Two new MenABCWY vaccines: –Pfizer (“ Penbraya ,” ACIP voted October 2023) –GSK (clinical trials) ▪Each vaccine is a combination of an existing: –MenACWY …
CDC ACIP — Vaccine Advisory Committee
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Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences. Pneumococcal Vaccines February 2024, ACIP Meeting February 29, 2024 Pneumococcal Vaccine Work Group ChairJames Loehr, MD, FAAFP ACIP Members Jamie Loehr (Chair, acting)…
CDC ACIP — Vaccine Advisory Committee
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Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences. Current Epidemiology of Pneumococcal Disease among Adults, United States February 2024, ACIP Meeting February 29, 2024 Ryan Gierke, MPH Outline Background on…
CDC ACIP — Vaccine Advisory Committee
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Public Interim Results from the PNEUMO Study . Pneumococcal pNeumonia Epidemiology, Urine serotyping, and Mental Outcomes study February 29, 2024 Study Leadership Wesley H. Self, MD Vanderbilt UniversityJ. Jackson Resser , MS Vanderbilt UniversityKelly D. Johnson, PhDMerck & Co., Inc. 1 Funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USANadine Rouphael , MD Emory University Public PNEUMO study overview •Adults 18+ years hospitalized with community acquired…
CDC ACIP — Vaccine Advisory Committee
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V116: An Investigational Adult Specific Pneumococcal Conjugate Vaccine Key Results from the Phase 3 Clinical Development Program ACIP Meeting, 29 -Feb -2024 Heather Platt, M.D., on behalf of the V116 team Distinguished Scientist, Global Clinical Development Merck Research Laboratories Merck & Company, Inc. Presentation Rationale for Development of V116 Overview of V116 Adult Clinical Development Program Immunogenicity Results •Vaccine naïve adults ≥18 years of age •Vaccine experienced…
CDC ACIP — Vaccine Advisory Committee
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National Center for Emerging and Zoonotic Infectious Diseases Post -licensure safety surveillance of 20 -valent pneumococcal conjugate vaccine (PCV20) among U.S. adults in the Vaccine Adverse Event Reporting System (VAERS) Pedro L. Moro, MD, MPH Immunization Safety Office Division of Healthcare Quality Promotion Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) February 29, 2024 Disclaimer The findings and conclusions in this presentation…
CDC ACIP — Vaccine Advisory Committee
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FDA CBER: Safety Assessment of 20- valent Pneumococcal Conjugate Vaccine (PCV20) ACIP February 2024 Richard Forshee, PhD Office of Biostatistics and Pharmacovigilance Center for Biologics Evaluation and Research US Food and Drug Administration 2 Disclaimer •The BEST Initiative and its studies are funded by the U.S. Food and Drug Administration (FDA) •There are no potentially conflicting relationships to disclose •The findings and conclusions in this presentation are those of the authors and…
CDC ACIP — Vaccine Advisory Committee
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Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences. Preliminary Work Group Interpretations of EtR and Next Steps February 2024, ACIP Meeting February 29, 2024 Miwako Kobayashi, MD, MPH, FACP , FIDSA 1.Should PCV21 be…
CDC ACIP — Vaccine Advisory Committee
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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…
CDC ACIP — Vaccine Advisory Committee
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Background on invasive Hib disease and vaccination among American Indian and Alaska Native populations Jennifer Collins MD, MSc Co-Lead, ACIP Hib/Meningococcal Vaccines Work Group February 29, 2024National Center for Immunization & Respiratory Diseases Background 3▪Gram -negative bacilli ▪Originally thought to be the cause of influenza ▪Abbreviated “ H. flu ” or Hi ▪Infections range from mild to severe invasive disease Haemophilus influenzae NTUnencapsulated (Non -typeable) b a c d e…
CDC ACIP — Vaccine Advisory Committee
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The HibVax Study Immunogenicity of H. influenzae type b PRP -OMP vaccines in American Indian and Alaska Native infants Laura Hammitt, MD Associate Professor, JHSPH Infectious Disease Program Lead, Center for Indigenous Health Johns Hopkins Bloomberg School of Public Health On behalf of the study team in Navajo Nation and Anchorage, Alaska Disclosures/Disclaimers ▪This study was supported in part by a research grant from the Investigator - Initiated Studies Program of Merck Sharp & Dohme LLC,…
CDC ACIP — Vaccine Advisory Committee
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Work Group Considerations Jennifer Collins MD, MSc Co-Lead, ACIP Hib/Meningococcal Vaccines Work Group February 29, 2024National Center for Immunization & Respiratory Diseases Policy question ▪Should Vaxelis (DTaP -IPV-Hib-HepB ) be included with PedvaxHIB in the preferential recommendation for American Indian and Alaska Native infants? 2 3▪574 federally recognized tribes in the United States –Listening to tribal communities is very important –CDC’s Office of Tribal Affairs and Strategic…