CDC ACIP — Vaccine Advisory Committee
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Breakthroughs that change patients’ lives 1 ConfidentialAlejandra Gurtman, MD, FIDSA Presentation to ACIPJune 21, 2023RSVpreF Older Adults Clinical Development Program Updates 2 Confidential WRDM Worldwide Medical & SafetyABRYSVOTM(Respiratory Syncytial Virus Vaccine) FDA Approval on 5/31/2023RSVpreF Older Adult –Clinical Development Program Updates Indication Active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in…
CDC ACIP — Vaccine Advisory Committee
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CO-1 GSK’s RSVPreF3 OA Vaccine (AREXVY) AREXVY was approved by FDA on May 3, 2023, and is indicated for the prevention of LRTD caused by RSV in adults 60 and older, as a single dose. ACIP June 21, 2023 Leonard Friedland, MD Vice President, Scientific Affairs and Public Health Presentation by GSK at ACIP June 21, 2023 CO-2 Presentation Overview Efficacy and safety results over 2 full RSV seasons from pivotal Phase 3 Study ▪1 dose of AREXVY provides durable efficacy against RSV -associated…
CDC ACIP — Vaccine Advisory Committee
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Economic Analysis of RSV Vaccination in Older Adults David W. Hutton, PhD, MS Associate Professor, Health Management and Policy, School of Public Health Associate Professor of Global Public Health, School of Public Health Associate Professor, Industrial and Operations Engineering, College of Engineering University of Michigan Research Team University of Michigan •David Hutton, PhD •Lisa Prosser, PhD •Angela Rose, MPH •Kerra Mercon , MSCDC •Michael Melgar , MD •Mila Prill, MSPH •Jamison…
CDC ACIP — Vaccine Advisory Committee
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Economics of Vaccinating U.S. Adults ≥60 years -old against Respiratory Syncytial Virus UPDATED SUMMARY COMPARING MODELS FROM: GSK,Pfizer AND University of Michigan -CDC Ismael R. Ortega -Sanchez, PhD NCIRD/CDC ACIP Meeting, June 21, 2023 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. National Center for Immunization & Respiratory Diseases Conflict of interest…
CDC ACIP — Vaccine Advisory Committee
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Centers for Disease Control and Prevention Evidence to Recommendations Framework Respiratory Syncytial Virus (RSV) in Adults Pfizer bivalent RSVpreF vaccine in older adults GSK adjuvanted RSVPreF3 vaccine in older adults Michael Melgar, MD Amadea Britton, MD Advisory Committee on Immunization Practices June 21, 2023 2Evidence to Recommendations ( EtR) Framework Policy Questions ▪Should a single dose of Pfizer bivalent RSVpreF vaccine (120µg antigen, 1 dose IM), rather than no vaccine, be…
CDC ACIP — Vaccine Advisory Committee
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Centers for Disease Control and Prevention Summary of Proposed Clinical Considerations for RSV Vaccines June 21, 2023 ACIP Older Adult RSV Vaccine Session Amadea Britton, MD Michael Melgar, MD Overview of clinical considerations ▪Shared clinical decision -making based on risk assessment among adults aged 60 –64 years ▪Timing of RSV vaccination for the 2023 –2024 RSV season ▪Coadministration of RSV vaccines with other vaccines ▪Persons with immunocompromising conditions 2 Clinical…
CDC ACIP — Vaccine Advisory Committee
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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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Seasonal Influenza Vaccines H. Keipp Talbot, MD, MPH Chair, Influenza Work Group Advisory Committee on Immunization Practices June 21, 2023 Influenza Work Group ACIP Members Keipp Talbot (Chair) Camille Kotton Jamie Loehr Ex Officio Timothy Brennan (FDA) Uzo Chukwuma (IHS) Michael Cooper (NIH) Jeffrey Kelman (CMS) Valerie Marshall (OASH) Cynthia Nolletti (FDA) Chris Roberts (NIH)Liaison Representatives and Consultants Robert Atmar Kevin Ault Ed Belongia Hank Bernstein Thomas Boyce Kris…
CDC ACIP — Vaccine Advisory Committee
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National Center for Immunization & Respiratory Diseases Influenza Vaccination of Persons with Egg Allergy: Evidence to Recommendations Discussion and Work Group Considerations Lenee H. Blanton Lisa A. Grohskopf Influenza Division, CDC/NCIRD Advisory Committee on Immunization Practices June 21, 2023 •Donna Hummell •Karen Broder •Pedro Moro •Geta Aynalem •Shashi Sharma •Elaine Miller •Andrew Leidner •Rebecca Morgan •Doug Campos -OutcaltAcknowledgements 2 Background •Affects approximately 1 -3%…
CDC ACIP — Vaccine Advisory Committee
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National Center for Immunization & Respiratory Diseases Influenza Vaccine Safety Update and Proposed Recommendations for the 2023 -24 Influenza Season Lisa A. Grohskopf Influenza Division, CDC/NCIRD Advisory Committee on Immunization Practices June 21, 2023 Influenza Division •Lenee Blanton •Jill Ferdinands •Lindsay Trujillo •Lynette Brammer •Alicia Budd •Jessie Chung •Brendan Flannery •Sinead Morris •Samantha Olson •Sascha Ellington •Carrie Reed •Mark Tenforde •Tim UyekiImmunization Safety…
CDC ACIP — Vaccine Advisory Committee
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Pneumococcal Vaccines Katherine A. Poehling, MD, MPH Pneumococcal Vaccines Work Group Chair Advisory Committee on Immunization Practices June 22, 2023 Pneumococcal Vaccines Work Group ACIP Members •Katherine Poehling (Chair) •Sarah Long Ex Officio Members •Jeffrey Kelman (CMS) •Lucia Lee (FDA) •Tina Mongeau (FDA) •Uzo Chukwuma (IHS) •Mamodikoe Makhene (NIH) CDC Lead •Miwako Kobayashi (NCIRD)Liaison Representatives and Consultants •Lynn Fisher (AAFP) •Mark…
CDC ACIP — Vaccine Advisory Committee
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1E conomic A ssessment of R outine PC V 20 for C hildren C harles Stoecker Tulane University School of Public Health and Tropical Medicine ACIP June 22, 2023 2Conflicts of Interest Dr. Stoecker has no conflicts of interest to declare. 3Acronyms PC V : pneumococcal conjugate vaccine PCV 13: 13 valent PCV PCV 15: 15 valent PCV PCV 20: 20 valent PCV PPSV 23: 23 valent pneumococcal polysaccharide vaccine V E : vaccine effectiveness V T: vaccine type ST: s e r o t yp e …
CDC ACIP — Vaccine Advisory Committee
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Summary of three economic analyses of the use of 20-valent pneumococcal conjugate vaccine (PCV20) in children in the United States Diepreye V. Ayabina Division of Bacterial Diseases CDC/NCIRDAdvisory Committee on Immunization Practices June 22, 2023 Acknowledgements •This presentation summarizes work conducted by three modeling teams •Tulane -CDC team •Charles Stoecker (Tulane University), Miwako Kobayashi (CDC), Andrew Leidner (CDC), Diepreye Ayabina •Pfizer team •Mark Rozenbaum , Liping…
CDC ACIP — Vaccine Advisory Committee
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Evidence to Recommendations Framework and Policy Options: Use of 20 -valent Pneumococcal Conjugate Vaccine in U.S. Children Miwako Kobayashi, MD, MPH Pneumococcal Vaccines Work Group Advisory Committee on Immunization Practices June 22, 2023National Center for Immunization & Respiratory Diseases PICO QuestionShould PCV20 be recommended as an option for pneumococcal vaccination for U.S. children? Population All U.S. children aged <2 yearsU.S. children aged 2 –18 years with underlying…
CDC ACIP — Vaccine Advisory Committee
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Centers for Disease Control and Prevention National Center for Emerging and Zoonotic Infectious Diseases ACIP Dengue Vaccines Work Group Wilbur Chen, MD, MSc ACIP Member and Workgroup Chair Advisory Committee on Immunization Practices ACIP Meeting June 22, 2023 ▪DENV -1, 2, 3, 4 •Lifelong DENV type -specific immunity •Short -term cross -immunity (~1 –2 years) •A second dengue infection is the most important risk factor for severe dengue ▪Dengue is the most common mosquito -borne virus…
CDC ACIP — Vaccine Advisory Committee
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Centers for Disease Control and Prevention National Center for Emerging and Zoonotic Infectious Diseases Introduction of Policy Questions for TAK -003 Alfonso Hernandez -Romieu, MD, MPH ACIP June 22, 2023 Dengue Branch, CDC We formulated PICO questions based on the directness of data and risk -benefit differences. *Persons aged 17 years were considered in this category but were not included in original immunobridging (18 –60 years) or phase 3 trials (4 –16 years)•4–16 years: 57-month…
CDC ACIP — Vaccine Advisory Committee
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Economic analysis and health impacts of routine vaccination with TAK- 003 dengue vaccine inSan Juan, Puerto Rico Guido España, Manar Alkuzweny ,Alex Perkins University ofNotre Dame June 22nd,2023 Conflicts ofinterest & Disclosures •GEand APhave previously received research funding from GlaxoSmithKline tosupport unrelated research ondengue vaccine development. •APcurrently receives research funding and consulting fees from Emergent Biosciences tosupport unrelated research on chikungunya…
CDC ACIP — Vaccine Advisory Committee
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CHIKUNGUNYA VACCINES ACIP Meeting June 26, 2024 Wilbur Chen, MD, MS Chair, ACIP Chikungunya Vaccines Work Group •Chikungunya Vaccines Work Group formed in May 2022 •Developing policy options for ACIP’s consideration for use of chikungunya vaccine among U.S. persons at risk of chikungunya -Travelers -Laboratory workers -Residents of U.S. territories and states with risk of transmissionBackground •October 2022 -Overview of chikungunya virus disease and vaccines -Overview of live attenuated…
CDC ACIP — Vaccine Advisory Committee
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Update on chikungunya vaccinesNational 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, Colorado ACIP Meeting, June 26, 2024 •Manufactured by Bavarian Nordic •Submission of BLA to FDA completed on June 17, 2024 •Licensure possible first half of 2025 •Intended age group is adolescents and adults aged ≥12 years •Single dose schedule Virus -like particle…