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449 documents

02 Mening Rubis 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 51 pages

Epidemiology of Meningococcal Disease in the United States Amy Rubis, MPH Advisory Committee on Immunization Practices Meeting June 28, 2024National Center for Immunization and Respiratory Diseases 2▪Overall epidemiology of meningococcal disease in the United States ▪Recent notable epidemiology –Serogroup Y meningococcal disease cases –OutbreaksAgenda 3▪Cases reported through National Notifiable Diseases Surveillance System (NNDSS) ▪Additional serogroup, outcome , and clinical…

03 Mening GSK 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 23 pages

MenABCWY for the prevention of Invasive Meningococcal Disease caused by serogroups A, B, C, W and Y Wendy Sohn, MD Global Medical Lead Neisseria Vaccines 2 Presentation by GSK at ACIP, June 2024 Concerted Prevention of IMD in Adolescents and Young Adults Improve vaccination coverage rates5 to meet the greatest medical needReduce overall burden of pain and discomfort6 Improved convenience and compliance6Potentially better overall economic value6Need for pentavalent vaccines 1.Mbaeyi…

04 Mening Schillie 508

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

Work Group Considerations Regarding MenABCWY Vaccine and Discussion of Potential Risk Groups for MenB Vaccination Sarah F. Schillie , MD, MPH, MBA DBD/NCIRD Advisory Committee on Immunization Practices June 28, 2024 The findings and conclusions in this presentation are those of the authors and do not necessarily represent the official posi tion of the Centers for Disease Control and Prevention CONFIDENTIAL GSK’s MenABCWY Vaccine Clinical Development Program Phase 3 studies •V72_72: ages…

Dengue 02 Biswal 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 26 pages

TAK-003 (Tetravalent Dengue Vaccine Candidate) 23 February 2023 Shibadas Biswal, MD Senior Medical Director – Clinical Development Dengue Takeda Vaccines 9 Efficacy and safety of a tetravalent dengue vaccine (TAK-003) VV-MEDMAT-82307 Disclaimers • TAK-003 is an investigational compound that has not been approved for use by the US Food and Drug Administration • There is no guarantee TAK-003 will…

Dengue 03 Paz Bailey 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 22 pages

WW Woo orr rkk kGG Grr roo ouu upp pSS Suu umm mmm maa arr ryy yaa ann ndd d II Inn ntt tee err rpp prr ree ett taa att tii ioo onn noo off fTT TAA AKK K-- -00 000 033 3EE Eff fff fii icc caa acc cyy y,, , SS Saa aff fee ett tyy y,, ,aa ann ndd dII Imm mmm muu unn noo ogg gee enn nii icc cii itt tyy yDD Daa att taa aWork Group Summary and Interpretation of TAK-003 Efficacy, Safety, and Immunogenicity Data Gabriela Paz-Bailey, MD, PhD, MSc Dengue Branch Chief Division of Vector Borne…

Varicella 01 Marin 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 23 pages

National Center for Immunization & Respiratory Diseases Division of Viral Diseases 25 Years of Varicella Vaccination Program in the United States: Health and Economic Impact during 1995–2019 Mona Marin, MD Centers for Disease Control and Prevention, Atlanta, GA Advisory Committee on Immunization Practices Atlanta, GA February 23, 2023 Varicella: from rite of passage to vaccine- preventable disease.  Historically,…

COVID 01 Daley 508

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

cdc.gov/coronavirus ACIP COVID-19 Vaccines Work Group Dr. Matthew F. Daley, Work Group Chair February 24, 2023 December 8, 2022: FDA1granted emergency use authorization (EUA) for: – –Use of Moderna bivalent COVID- 19 vaccine booster in children ages 6 months -5 years Use of Pfizer- B ioNTech bivalent COVID- 19 vaccine as a third primary series dose for children 6 months- 4 years of age December 9, 2022: CDC2expanded the use of updated (bivalent) COVID- 19 vaccines for children 6 months…

COVID 02 Shimabukuro 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 43 pages

National Center for Emerging and Zoonotic Infectious Diseases COVID-19 mRNA bivalent booster vaccine safety Advisory Committee on Immunization Practices (ACIP) meeting February 24, 2023 Tom T. Shimabukuro, MD, MPH, MBA Director, Immunization Safety Office Division of Healthcare Quality Promotion Centers for Disease Control and Prevention (CDC) Topics Describe CDC’s Vaccine Safety Datalink (VSD) Rapid Cycle Analysis (RCA) m onitoring methods and assessment processes for statistical signals…

COVID 03 Forshee 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 17 pages

Update on Original COVID -19 Vaccine and COVID -19 Vaccine, Bivalent Safety Richard Forshee Deputy Director, FDA/CBER/OBPV Advisory Committee on Immunization Practices February 24, 2023 2 •CBER Active Surveillance Program (BEST Initiative) •Bivalent COVID - 19 mRNA Vaccines Safety Surveillance •ConclusionOutline 3 *Data lag varies based on data source, ranges from a few days to a few months. BEST Initiative Data Sources 4 Claims Data Source Age (years)Population Enrolled (million) CMS…

COVID 04 Talbot 508

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

COVID-19 Vaccine Safety Technical (VaST) Work Group VaST assessment H. Keipp Talbot, MD MPH (VaST Chair) Robert H. Hopkins, Jr., MD (NVAC Chair ) Advisory Committee on Immunization Practices February 24, 2023 COVID -19 Vaccine Safety Technical (VaST) Work Group Objectives Review, evaluate, and interpret post -a uthorization/approval COVID -19 vaccination safety data Serve as the central hub for technical subject matter expertise from fe deral agencies conducting…

COVID 05 Twentyman 508

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

cdc.gov/coronavirus Ischemic Stroke, COVID -19 and Influenza in Adults Ages ≥65 Years: Interpretation & Next Steps Evelyn Twentyman, MD, MPH ACIP MeetingFebruary 24, 2023 Statistical signal for ischemic stroke identified in Vaccine Safety Datalink (VSD) Rapid Cycle Analysis (RCA) monitoringIschemic stroke, COVID -19, and influenza in review New and published data regarding relationships of ischemic stroke, COVID -19, and influenza Work group interpretation and next steps Statistical signal…

COVID 06 Taylor 508

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

National Center for Immunization & Respiratory Diseases Trends in COVID -19-Associated Hospitalizations —COVID -19-Associated Hospitalization Surveillance Network (COVID -NET), March 2020–February 2023 Christopher A. Taylor, PhD Epidemiologist, COVID -NET Coronaviruses and Other Respiratory Viruses Division National Center for Immunizations and Respiratory DiseasesCenters for Disease Control and Prevention Advisory Committee on Immunization Practices February 24, 2023 Weekly Population-Based…

COVID 07 Britton 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 29 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…

COVID 08 Oliver 508

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

cdc.gov/coronavirus Considerations for Bivalent Primary Series Sara Oliver, MD, MSPH ACIP MeetingFebruary 24, 2023 Does ACIP support h armonizing the vaccine strain composition for mRNA COVID- 19 vaccines across both primary series and booster doses: Changing the primary series from monovalent (Original) to bivalent (Original plus Omicron BA.4/5) for all ages?Question for consideration 2Mono- valent Mono- valent BivalentPeople ages 6 months and older* Bivalent Bivalent BivalentPeople ages…

COVID 09 Wallace 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 21 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…

COVID 10 Oliver 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 37 pages

cdc.gov/coronavirus COVID -19 Vaccine : Considerations for Future Planning Sara Oliver, MD, MSPH ACIP MeetingFebruary 24, 202 3 Considerations for future planning COVID -19 vaccines COVID -19 vaccines: Where we are now How do we get there?COVID -19 vaccines: Where we are going Considerations for future planning COVID -19 vaccines COVID -19 vaccines: Where we are now How do we get there?COVID -19 vaccines: Where we are going Considerations for future planning COVID -19 vaccines COVID…

acip charter

CDC ACIP — Vaccine Advisory Committee · Acip / Other · 6 pages

CHARTER ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES Advisory Committee’s Official Designation. Advisory Committee on Immunization Practices (ACIP or Committee). Authority. The ACIP was established under Section 222 of the Public Health Service Act (42 U.S.C. §2l7a), as amended. The Committee is governed by the provisions of the Federal Advisory Committee Act (FACA), Public Law 92-463 (5 U.S.C. § 1001 et seq.), as amended. The ACIP has been given statutory roles…

economics studies guidance

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

ACIP Guidance for Health Economics Studies Guidance for Health Economics Studies P resented to the Advisory Committee on Immunization Practices (ACIP) Prepared by The ACIP Ad Hoc WG on Economic Analyses (Members listed alphabetically) Tracy Lieu, M.D., M.P.H. Professor and Director, Center for Child Health Care Studies Departme nt of Ambulatory Care and Prevention Harvard Pilgrim Health Care and Harvard Medical School ACIP Member July 2004-June 2008 Martin I. Meltzer, M.S., Ph.D. …

11 COVID Moulia 508

CDC ACIP — Vaccine Advisory Committee · Acip / Other · 35 pages

cdc.gov/coronavirus Myocarditis and COVID- 19 Vaccine Intervals: International Data and Policies Danielle Moulia, MPH ACIP MeetingFebruary 4, 2021 Discussion background and framework Goal: Examine international data and policies on preferential recommendations of an mRNA vaccine product or extended primary series intervals as they relate to myocarditis and/or pericarditis* Discussion framework International data on risk of myocarditis by mRNA vaccine product, focusing on the highest…

04 COVID Kracalic 508

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

cdc.gov/coronavirusMyocarditis Outcomes Following mRNA COVID -19 Vaccination Preliminary Data: data are subject to change Advisory Committee on Immunization Practices February 4, 2022 Ian Kracalik PhD MPH Vaccine Safety Team CDC COVID-19 Vaccine Task Force Disclaimer The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention (CDC) Mention of a product or company name is for…