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449 documents

09 Mat Peds Schillie 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 32 pages

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 Photographs and images included in this presentation are licensed solely for CDC/NCIRD online…

01 COVID Daley 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 9 pages

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. ACIP COVID -19 Vaccines Work Group Dr. Matthew F. Daley, Work Group Chair Sept 12, 2023 ▪September 11, 2023: –FDA updated COVID -19 vaccine emergency use authorizations…

02 COVID Thornburg 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 12 pages

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 landscape of SARS -CoV-2 lineages September 2023 Natalie J. Thornburg, PhD Chief, Laboratory Branch Coronaviruses and Other Respiratory Viruses Division Trends in…

03 COVID Havers 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 20 pages

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. COVID -19–Associated Hospitalizations among Infants, Children and Adults —COVID -NET, January – August 2023 ACIP , September 12, 2023 Fiona P . Havers, MD, MHS Team…

04 COVID Saydah 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 16 pages

National Center for Immunization & Respiratory Diseases Update: E pidemiologic Characteristics of Long COVID Sharon Saydah, PhD, MHS, CDR USPHS Coronaviruses and Other Respiratory Viruses Division, Epidemiology Branch Post COVID Conditions -Longer Term Sequelae Team Lead September 12, 2023 A general framework for Post -COVID Conditions Conditions frequently overlap Patients may experience any combination *ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome ** MIS -C: Multisystem…

05 COVID Link Gelles 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 33 pages

1 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. Updates to COVID -19 vaccine effectiveness (VE) in the U.S September 12, 2023 Ruth Link -Gelles, PhD, MPH CDR, US Public Health Service COVID -19 Vaccine Effectiveness…

06 COVID Prosser 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 45 pages

Economic Analysis of Vaccination with mRNA Booster Dose against COVID -19 Among Adults University of Michigan COVID -19 Vaccination Modeling Team Presentation to ACIP September 12, 2023 1 Study Team University of Michigan •Lisa A. Prosser, PhD, Principal Investigator •David W. Hutton, PhD, Co -Investigator •Acham Gebremariam, MS, Programmer/Analyst •Angela Rose, MS, MPH, Project Manager •Kerra Mercon, MS, Research Assistant Wake Forest University •Cara Janusz, PhD Additional contributors to…

07 COVID Klein 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 66 pages

COVID -19 Vaccine Safety Surveillance: Summary from VSD RCA Nicola Klein, MD, PhD Director, Kaiser Permanente Vaccine Study Center Kaiser Permanente Northern California Advisory Committee in Immunization Practices September 12, 2023 2Vaccine Safety Datalink •Active surveillance: newly licensed vaccines ̶Rapid Cycle Analysis (RCA) •Evaluate vaccine safety: ̶of new recommendations for existing vaccines ̶for vaccines in high -risk populations, particularly pregnant women (+ other groups)…

08 COVID Priddy 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 16 pages

1 Safety and Immunogenicity of Moderna COVID -19 Vaccine (2023 -2024 Formula) Monovalent XBB.1.5 Variant Vaccine ACIP September 12, 2023 Frances Priddy, MD MPH Moderna 2 Outline of Presentation ▪Overview of clinical trial of XBB.1.5 vaccine ▪Design ▪Safety data ▪Immunogenicity data ▪Analysis of cross neutralization data for recent variants ▪Summary 3 Phase 2/3 Randomized Safety and Immunogenicity Study of XBB.1.5 -Containing Booster in Adults ≥18 Years…

09 COVID Dubovsky 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 10 pages

Data in Support of Novavax XBB.1.5 Vaccine Dr. Filip Dubovsky , President, Research & Development September 12, 2023 1 Novavax Vaccine Platform: Recombinant Protein Particle Plus Matrix -M™ Adjuvant 2Recombinant protein particle Native 3-dimensional conformation Truncated S. frugiperda glycans Particulate structure facilitates antigen presentation and processing Novavax 2023- 2024 vaccine Matrix -M adjuvant Induces robust neutralizing antibodies Induces polyfunctional CD4+ Th1 …

10 COVID Modjarrad 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 14 pages

1 Breakthroughs that change patients’ lives Monovalent XBB.1.5 BNT162b2 COVID-19 Vaccine ACIP Presentation September 12, 2023 CC-2Presentation Outline Kayvon Modjarrad, M.D., Ph.D. Executive Director, Viral Vaccines Vaccine Research and Development, Pfizer Inc. Variant Epidemiology COVID-19 Updated Vaccine Approval Pathway Monovalent XBB.1.5 BNT162b2 Vaccine Activity Against Contemporary Omicron Sublineages Clinical Update CC-3XBB Sublineages Continue to Dominate the Epidemiolo…

11 COVID Wallace 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 150 pages

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. Evidence to Recommendations Framework: 2023 –2024 (Monovalent, XBB Containing) COVID -19 Vaccine Megan Wallace, DrPH, MPH ACIP Meeting September 12, 2023 Evidence to…

12 COVID Peacock 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 18 pages

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. COVID -19 Vaccine Implementation Georgina Peacock, MD, MPH Immunization Services Division Centers for Disease Control and PreventionEnsuring no -cost, timely access to…

13 COVID Twentyman 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 14 pages

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. Bridge Access Program Ensuring no -cost, timely access to the 2023 -2024 COVID -19 vaccines for adults Evelyn Twentyman, MD, MPH Immunization Services Division Centers…

ACIP approach to mAbs

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 3 pages

▪Passive immunization –Transfer of preformed antibody produced externally to provide protection to the recipient –Provides temporary protection that wanes with time –Transfer of maternal antibody across the placenta that provides protection in early infancy is an example of passive immunization ▪Active immunization –Administration of specific components of an infectious agent that elicit an immune response in the recipient –Immunology memory provides prolonged protection that may be…

01 RSV Long 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 7 pages

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,…

02 RSV jones 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 126 pages

Centers for Disease Control and Prevention Evidence to Recommendations Framework: Nirsevimab Updates Jefferson Jones MD MPH FAAP , CDR USPHS Co-Lead, Respiratory Syncytial Virus Vaccines -Pediatric/Maternal Work Group Coronavirus and Other Respiratory Viruses Division National Center for Immunization and Respiratory Diseases August 3, 2023 2Evidence to Recommendations ( EtR) Framework Policy Questions ▪Should one dose of nirsevimab be recommended for infants aged <8 months born during or…

03 RSV Peacock 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 16 pages

National Center for Immunization & Respiratory Diseases Centers for Disease Control and Prevention Nirsevimab : Implementation Considerations Georgina Peacock, MD, MPH, FAAP Director, Immunization Services Division National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention (CDC) Implementation Considerations •Definition of Vaccine •Cost •Storage and Handling •Hospital Dosing •Outpatient Dosing •Coding and Immunization Information Systems •Timing of…

04 RSV Jones 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 19 pages

Centers for Disease Control and Prevention Proposed Clinical Consideration Updates for Nirsevimab Jefferson Jones MD MPH FAAP , CDR USPHS Co-Lead, Respiratory Syncytial Virus Vaccines -Pediatric/Maternal Work Group Coronavirus and Other Respiratory Viruses Division National Center for Immunization and Respiratory Diseases August 3, 2023 2Timing of nirsevimab ▪Providers should target administration1: –In the first week of life for infants born shortly before and during the season –Shortly…

01 RSV Adults Kotton 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 8 pages

Centers for Disease Control and Prevention Adult Respiratory Syncytial Virus (RSV) Session Camille Kotton, MD Chair, Adult RSV Work Group Advisory Committee on Immunization Practices (ACIP) June 21, 2023 2Adult RSV Work Group Membership ACIP Voting Members Camille Kotton (Chair) Keipp Talbot Sarah Long Ex Officio Members Rachel Zhang (FDA) Judy Beeler (FDA) Nicholas Geagan (FDA) Nadine Peart Akindele (FDA) Sonnie Kim (NIH/NIAID) Jeffrey Kelman (CMS) Valerie Marshal (OIDP)CDC Co-Leads Michael…