CDC ACIP — Vaccine Advisory Committee
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FOR USE ONLY BY SANOFI MEDICAL AFFAIRS FOR SCIENTIFIC EXCHANGE PURPOSES. DO NOT COPY OR DISTRIBUTEMAT-US-2204183 -R -NONDISTRIB -EXP 7/3/26 Meningococcal (Groups A, C, Y, andW) Conjugate Vaccine ( MenQuadfi®) Extension of use to include infants from 6 weeks of age Agenda Public health burden of invasive meningococcal diseaseRationale for clinical developmentClinical data from infant studiesSummary 2 Public health burden of meningococcal disease •Meningococcal disease remains a major…
CDC ACIP — Vaccine Advisory Committee
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Work Group Considerations Regarding MenQuadfi in Infants Sarah Schillie, MD, MPH, MBA Advisory Committee on Immunization Practices April 16, 2025National Center for Immunization & Respiratory Diseases 1 The findings and conclusions in this report are those of the authors and do not necessarily represent the official position o f the U. S. Centers for Disease Control and Prevention. Studies Reviewed Three Phase III studies in U.S. infants aged 6 weeks – 19 months – 4,321 infants enrolled in…
CDC ACIP — Vaccine Advisory Committee
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RSV Vaccination in Adults: Introduction Albert Shaw, MD, PhD Chair, Adult RSV Work Group Advisory Committee on Immunization Practices April 16, 2025National Center for Immunization and Respiratory Diseases 2Adult RSV Work Group Membership ACIP Voting Members Albert Shaw (Chair) Helen Chu Mini Kamboj Keipp Talbot Ex Officio Members Nicholas Geagan (FDA) Rachel Zhang (FDA) Michelle Juaneza (HRSA) Uzo Chukwuma (IHS) Sonnie Kim (NIH/NIAID)CDC Co -Leads Amadea Britton Michael Melgar Diya…
CDC ACIP — Vaccine Advisory Committee
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1 © 2025 Moderna, inc. All rights reserved.RSV Vaccine (mRNA -1345) Update: -Safety & Immunogenicity in 18-59 Year Olds at increased Risk for RSV Disease * -Revaccination of Adults at 12 or 24 Months * ACIP Frances Priddy, MD MPH April 16, 2025 * mRESVIA has not been authorized for these indications 2 RSV Vaccine (mRNA -1345) Clinical Development NCT05127434, NCT05330975, NCT06060457, NCT06067230 Efficacy, Immunogenicity, Safety, and Correlate of Protection…
CDC ACIP — Vaccine Advisory Committee
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CO-1 Meeting of the Advisory Committee on Immunization Practices (ACIP) Centers for Disease Control and Prevention April 16, 2025 Susan Gerber, MD Medical Director GSK Presentation by GSK at ACIP April 16, 2025 CO-2 AREXVY Indications and Updates AREXVY is indicated for active immunization for prevention of lower respiratory tract disease (LRTD) caused by RSV in ▪Individuals ≥ 60 YOA ▪Individuals 50-59 YOA at increased risk for LRTD caused by RSV ~ 11 million AREXVY doses administered in US…
CDC ACIP — Vaccine Advisory Committee
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This slide deck was prepared by Dr. David Hutton of the University of Michigan and reflects his work. It is being presented by CDC staff on his behalf. Dr. Hutton will be available to answer questions at the end of this presentation. 1 Economic Analysis of Protein Subunit and mRNA RSV Vaccination in Adults aged 50 -59 Years David W. Hutton, PhD, MS Associate Professor, Health Management and Policy, School of Public Health Associate Professor of Global Public Health, School of Public…
CDC ACIP — Vaccine Advisory Committee
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Economics of Respiratory Syncytial Virus Vaccination in Adults aged 50 -59 years at Increased Risk of Severe RSV Disease SUMMARY COMPARING MODELS FROM: GSK,Moderna ,Pfizer AND University of Michigan -CDC Ismael R. Ortega -Sanchez, PhD NCIRD/CDC ACIP Meeting, April 16, 2025 1Disclaimer : The findings and conclusions in this report are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention. Conflicts of interest •GSK model : David…
CDC ACIP — Vaccine Advisory Committee
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Evidence to Recommendations Framework (EtR): RSV Vaccination in Adults Aged 50 –59 years Amadea Britton, MD, Co -Lead Adult RSV Vaccine Work Group Michael Melgar, MD, Co -Lead Adult RSV Vaccine Work Group Diya Surie, MD, Co -Lead Adult RSV Vaccine Work Group Coronavirus and Other Respiratory Viruses Division (CORVD) Advisory Committee on Immunization Practices (ACIP) April 16, 2025National Center for Immunization and Respiratory Diseases 2•Should adults aged 50 –59 years at increased risk of…
CDC ACIP — Vaccine Advisory Committee
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ACIP Adult RSV Work Group Clinical Considerations RSV vaccination in Adults 50 –59 at increased risk of severe RSV diseaseDiya Surie, MD Michael Melgar, MD Amadea Britton, MD Co-Leads, Adult RSV Vaccine Work Group Coronavirus and Other Respiratory Viruses Division (CORVD) Advisory Committee on Immunization Practices (ACIP) April 16, 2025National Center for Immunization and Respiratory Diseases •Licensed products for use in adults aged 50 –59 years at increased risk of severe RSV disease…
CDC ACIP — Vaccine Advisory Committee
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CHIKUNGUNYA VACCINES ACIP Meeting April 16, 2025 Edwin Asturias, MD Chair, ACIP Chikungunya Vaccines Work Group •Chikungunya Vaccines Work Group formed in May 2022 -Topics under discussion include use of chikungunya vaccines in U.S. persons at risk of chikungunya, including those who travel abroad, laboratory workers, and residents of U.S. territories and states at risk of transmission •Two chikungunya vaccines -Live attenuated vaccine licensed in November 2023 (manufactured by Valneva)…
CDC ACIP — Vaccine Advisory Committee
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Evidence to Recommendations and proposed recommendations for use of virus -like particle chikungunya vaccine among adolescent and adult travelers Dr Susan Hills CDC Lead, ACIP Chikungunya Vaccines Work GroupNational Center for Emerging and Zoonotic Infectious Diseases April 16 , 2025 Virus- like particle chikungunya vaccine (CHIK -VLP) and its licensure •Manufactured by Bavarian Nordic (trade name: VIMKUNYA ) •Licensed in United States on February 14, 2025 •Indicated for use in persons…
CDC ACIP — Vaccine Advisory Committee
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Evidence to Recommendations and proposed recommendations for use of virus -like particle chikungunya vaccine among laboratory workers Dr J. Erin Staples Arboviral Diseases Branch Centers for Disease Control and PreventionNational Center for Emerging and Zoonotic Infectious Diseases April 16 , 2025 Infections among laboratory workers •At least 44 chikungunya virus infections identified among laboratory workers worldwide over ~50 years1–3 -43 cases overt disease, 1 asymptomatic infection, no…
CDC ACIP — Vaccine Advisory Committee
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Surveillance for adverse events following use of live attenuated chikungunya vaccine and its use among travelersNational Center for Emerging and Zoonotic Infectious Diseases Dr. Susan Hills CDC Lead, Chikungunya Vaccines Work Group Arboviral Diseases Branch Division of Vector -Borne Diseases Fort Collins, Colorado Advisory Committee on Immunization Practices meeting April 16 , 2025 Background on live attenuated chikungunya vaccine Live attenuated chikungunya vaccine (CHIK -LA) …
CDC ACIP — Vaccine Advisory Committee
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Clinical guidance for use of virus -like particle chikungunya vaccine in pregnant and breastfeeding womenNational Center for Emerging and Zoonotic Infectious Diseases Susan Hills MBBS MTH CDC Lead, Chikungunya Vaccines Work Group Arboviral Diseases Branch Division of Vector- Borne Diseases Fort Collins, ColoradoDana Meaney- Delman, MD MPH FACOG Principal Deputy Director and Chief Medical Officer National Center on Birth Defects and Developmental Disabilities Chamblee, Georgia Advisory…
CDC ACIP — Vaccine Advisory Committee
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Maternal/Pediatric Respiratory Syncytial Virus (RSV) Work Group Jefferson Jones MD MPH FAAP Co-Lead, Maternal/Pediatric RSV Work Group Presenting on behalf of Helen Chu, MD, MPH Chair, Maternal/Pediatric RSV Work Group ACIP Meeting April 16, 2025 1U.S. Centers for Disease Control and Prevention CDC and ACIP recommend all infants should be protected against severe RSV disease with either maternal RSV vaccine or nirsevimab Maternal vaccine Abrysvo , Pfizer *Either maternal RSV…
CDC ACIP — Vaccine Advisory Committee
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Evidence to Recommendations Framework : Clesrovimab Danielle Moulia, MPH Co-Lead, Maternal/Pediatric RSV Work Group Advisory Committee on Immunization Practices April 16, 2025 1U.S. Centers for Disease Control and Prevention Policy Question •Should clesrovimab be recommended for all infants <8 months of age born during or entering their first RSV season? 2 Evidence to Recommendations ( EtR) Framework EtR Domain Question(s) Public Health Problem ▪Is the problem of public health…
CDC ACIP — Vaccine Advisory Committee
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Proposed clinical considerations for clesrovimab Advisory Committee on Immunization Practices April 16, 2025U.S. Centers for Disease Control and Prevention Jefferson Jones MD MPH FAAP Co-Lead, Maternal/Pediatric RSV Work Group •Similarities and differences in use of clesrovimab vs nirsevimab •Review of indications, timing, and dosing •Storage, handling, and administrationOutline 2 Active and Passive Immunity Chapter 1: Principles of Vaccination | Pink Book | CDC•Antibodies produced by own…
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 Photographs and images included in this presentation are licensed solely for CDC/NCIRD online…
CDC ACIP — Vaccine Advisory Committee
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Pneumococcal Vaccines October 2024, ACIP Meeting October 23, 2024 Pneumococcal Vaccines Work Group Chair James Loehr, MD, FAAFPNational Center for Immunization and Respiratory Diseases 1 Pneumococcal Vaccines Work Group ACIP Members Jamie Loehr Mini Kamboj George Kuchel Robert Schechter Ex Officio Members Lucia Lee Tina Mongeau Uzo Chukwuma Mamodikoe Makhene Meenu Upadhyay Risa Claytor Liaison…
CDC ACIP — Vaccine Advisory Committee
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1Economic Analysis and Public Health Impact of PCV use for Adults Aged ≥50 Years Charles Stoecker Tulane University Celia Scott Weatherhead School of Public Health and Tropical Medicine ACIP October 23, 2024 2Conflicts of Interest ❑Dr. Stoecker has no conflicts of interest to declare. 3Acronyms ❑ PCV: pneumococcal conjugate vaccine ❑ PCV20: 20 valent PCV ❑ PCV21: 21 valent PCV ❑ VE: vaccine effectiveness ❑ VT: vaccine type ❑ ST: serotype ❑ NBP: non -bacteremic pneumonia ❑ IPD: invasive…