CDC ACIP — Vaccine Advisory Committee
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1 Booster Doses of Moderna COVID -19 Vaccines in Adults, Adolescents & Children ACIP September 1, 2022 Jacqueline Miller, MD 2Indication for Use of Moderna COVID -19 Vaccine, Bivalent (Original And Omicron BA.4/BA.5) EUA of Aug 31, 2022 Moderna COVID -19 Vaccine, Bivalent (Original And Omicron BA.4/BA.5) is authorized for use in individuals 18 years of age and older as a single booster dose administered at least 2 months after either: ▪Completion of primary vaccination with any…
CDC ACIP — Vaccine Advisory Committee
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cdc.gov/coronavirusSafety update of 1stbooster mRNA COVID -19 vaccination Advisory Committee on Immunization Practices (ACIP) April 20, 2022 Nicola Klein, MD, PhD Kaiser Permanente Vaccine Study Center Kaiser Permanente Northern CaliforniaTom Shimabukuro, MD, MPH, MBA Vaccine Safety TeamCDC COVID- 19 Vaccine Task Force Safety Surveillance of 1stBooster Doses in the Vaccine Safety Datalink Nicola Klein, MD, PhD Kaiser Permanente Vaccine Study Center Kaiser Permanente Northern…
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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National Center for Emerging and Zoonotic Infectious Diseases Summary of Evidence to Recommendations Framework for Rabies Pre -Exposure Prophylaxis Vote Advisory Committee on Immunization Practices February 24, 2021Agam Rao, MD CAPT, US Public Health Service Poxvirus and Rabies Branch Centers for Disease Control and Prevention Rabies antibody response ▪Target response, i.e., ≥ minimum antibody titer, 0.5 IU/mL, regardless of series –Children –Pregnant women –Persons ≥ 65 years of age…
CDC ACIP — Vaccine Advisory Committee
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National Center for Immunization & Respiratory Diseases Influenza Work Group— Introduction Dr. Jamie Loehr (Work Group Chair) Advisory Committee on Immunization Practices April 15, 2025 Influenza Work Group ACIP Members •Jamie Loehr (Chair) •Robert Schechter •Albert Shaw •Keipp Talbot Ex Officio •Timothy Brennan (FDA) •Uzo Chukwuma (IHS) •Walter Greenhalgh (HRSA) •Michael Ison (NIH) •Cynthia Nolletti (FDA) •Jo Resnick (FDA) •Chris Roberts (NIH)Liaison Representatives and Consultants •Robert…
CDC ACIP — Vaccine Advisory Committee
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Interim Estimates of 2024 –25 Seasonal Influenza Vaccine Effectiveness Aaron M. Frutos, PhD, MPH On behalf of CDC Influenza Vaccine Effectiveness CollaboratorsNational Center for Immunization & Respiratory Diseases CDC Influenza Vaccine Effectiveness Networks Four networks to evaluate vaccine effectiveness (VE) against laboratory - confirmed influenza for children and adolescents and adults in the outpatient and inpatient settings •Investigating Respiratory Viruses in the Acutely Ill…
CDC ACIP — Vaccine Advisory Committee
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Confidential -Low Interim Influenza Vaccine Effectiveness Against Laboratory - Confirmed Influenza, California, October 2024 –January 2025 Sophie Zhu, PhD and Joshua Quint, PhD California Department of Public Health Advisory Committee on Immunization Practices Meeting April 15, 2025 Confidential -Low Influenza VEData Type : Electronic records Patient interviewsData Sources : Hospital networks Public health surveillance Population : Pediatric AdultSetting : Inpatient Outpatient…
CDC ACIP — Vaccine Advisory Committee
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4/11/2025 1 1 2 4/11/2025 2 3 4 4/11/2025 3 5 6 4/11/2025 4 7 8 4/11/2025 5 CO-9Instructions for Use Based on Human Factors Usability Studies that Aligned with FDA Guidance1 1. Application of Human Factors Engineering Principles for Combination Products: Questions and Answers, Guidance for Industry and FDA Staff, 2023ObjectiveConfirm intended users can administer FluMist to themselves or to an appropriate child without errors or difficulties that could result in administration failure…
CDC ACIP — Vaccine Advisory Committee
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ACIP COVID -19 Vaccines Work Group Robert Schechter, MD, MSc COVID -19 ACIP Work Group Chair Advisory Committee on Immunization Practices Meeting April 15, 2025National Center for Immunization and Respiratory Diseases •In August 2024, the Food and Drug Administration authorized and approved: -Moderna COVID -19 vaccine* in persons ≥6 months -Novavax COVID -19 vaccine** in persons ≥12 years -Pfizer -BioNTech COVID -19 vaccine* in persons ≥6 months 2024 –2025 COVID -19 vaccines *Omicron…
CDC ACIP — Vaccine Advisory Committee
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Overview of Moderna’s Investigational Next Generation COVID -19 Vaccine, mRNA -1283, in Individuals ≥12 Years of Age © 2025 Moderna, inc. All rights reserved.ACIP Bishoy Rizkalla, PhD April 15, 20251 2 COVID -19 Remains a Leading Cause of Hospitalization among Respiratory Viruses in the US Adults ≥65 years account for: •>60% of COVID -19 hospitalizations (since 2023 )2 •~76% of deaths (since 2020)3•95% of adults hospitalized with COVID -19 have ≥1…
CDC ACIP — Vaccine Advisory Committee
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COVID -19–Associated Hospitalizations — COVID -NET, April 2025 Update Fiona P. Havers, MD, MHS, FIDSA RESP -NET Hospitalization Surveillance Team Coronavirus and Other Respiratory Viruses Division Advisory Committee on Immunization Practices (ACIP) Meeting April 15, 2025National Center for Immunization and Respiratory Diseases 1 COVID -NET is a population -based hospitalization surveillance platform. •RESP -NET: COVID -NET, RSV -NET, FluSurv -NET •>300 acute -care hospitals •98 counties in 13…
CDC ACIP — Vaccine Advisory Committee
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Interim Estimates of 2024 -2025 COVID -19 Vaccine Effectiveness Ruth Link -Gelles, PhD, MPH CDR, US Public Health Service Coronavirus and Other Respiratory Viruses Division Centers for Disease Control and Prevention April 15, 2025National Center for Immunization and Respiratory Diseases 2•Context for interpretation of VE •2024 -2025 COVID -19 vaccine coverage •Vaccine effectiveness methods •Interim 2024 -2025 COVID -19 vaccine effectiveness Agenda –COVID -19 vaccine effectiveness (VE)…
CDC ACIP — Vaccine Advisory Committee
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Use of 2025 –2026 COVID -19 Vaccines: Work Group Considerations Lakshmi Panagiotakopoulos, MD, MPH Advisory Committee on Immunization Practices April 15, 2025National Center for Immunization and Respiratory Diseases •Current recommendations for 2024 –2025 COVID -19 vaccines •Policy options for 2025 –2026 COVID -19 vaccine recommendations •Supporting data and Work Group interpretations •Discussion questions for committee Overview 2 COVID -19 vaccine: ACIP Meeting Schedule October 2024April…
CDC ACIP — Vaccine Advisory Committee
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Pneumococcal Vaccines Work Group April 2025, ACIP meeting April 15, 2025 Miwako Kobayashi National Center for Immunization and Respiratory Diseases 1U.S. Centers for Disease Control and Prevention Pneumococcal Vaccines Work Group ACIP Members •Jamie Loehr (Chair) •Mini Kamboj •George Kuchel •Robert Schechter Ex Officio Members •Tina Mongeau (FDA) •Nick Geagan (FDA) •Uzo Chukwuma (IHS) •Mamodikoe Makhene (NIH, primary) •Meenu Upadhyay (NIH, alternate) •Risa Claytor …
CDC ACIP — Vaccine Advisory Committee
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Introduction to the HPV Vaccines Work Group Oliver Brooks, MD Chair, HPV Vaccines Work Group Advisory Committee on Immunization Practices April 15, 2025 National Center for Immunization & Respiratory Diseases •HPV can cause cancer of the cervix, vagina, vulva, penis, anus, and oropharynx •HPV vaccination provides lasting protection against the HPV types that most commonly cause cancer •In the 19 years since HPV vaccine licensure, we have seen: -High vaccine efficacy in clinical trials -High…
CDC ACIP — Vaccine Advisory Committee
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Reduced number of doses for HPV vaccination series: Work Group progress and literature update Carla L. DeSisto, PhD, MPH Co-Lead, HPV Vaccines Work GroupNational Center for Immunization and Respiratory Diseases Advisory Committee on Immunization Practices April 15, 2025 •PICO and outcomes •Introduction to systematic review •Updated data from studies of interest •Observational studies of HPV vaccine effectiveness •Outstanding questions for reduced number of HPV vaccine dosesOutline 2 PICOs…
CDC ACIP — Vaccine Advisory Committee
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A randomized trial of single -dose HPV vaccination efficacy among young women: Month 54 durability results Ruanne V. Barnabas, MBChB, DPhil Chief, Division of Infectious Diseases, Massachusetts General Hospital Department of Medicine, Harvard Medical School HPV vaccination for all and catch -up vaccination to young adulthood accelerate the timeline to cervical cancer elimination. Simms, K. T., Steinberg, J., …, & Canfell , K. (2019). Impact of scaled up human papillomavirus vaccination: A…
CDC ACIP — Vaccine Advisory Committee
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2023 National Immunization Survey -Teen (NIS -Teen) Data Summary Cassandra (Sandy) Pingali, MPH, MS Epidemiologist Surveillance and Epidemiology Branch (SEB) Immunization Services Division (ISD) NCIRD ACIP Meeting April 15th, 2025National Center for Immunization and Respiratory Diseases National Immunization Survey -Teen Methodology •Two phase survey -1stphase: random digit dialed cell phone survey of parents in households with teens age 13 -17 years -2ndphase: mailed survey of…
CDC ACIP — Vaccine Advisory Committee
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Population -Based Health Impact of Single -Dose HPV Vaccination in the United States Jane J. Kim, Ph.D. Advisory Committee on Immunization Practices April 15, 2025 Modeling Teams Harvard University •Jane Kim •Emily Burger •Nicole Campos •Mary Caroline Regan •Jennifer Spencer •Stephen Sy Universit é Laval •Marc Brisson •Jean -Francois Laprise •Mélanie Drolet •Éléonore Chamberland •Chantal Sauvageau •Élodie BénardFunding •PATH Single -Dose HPV Consortium •NIH/NCI CISNET Consortium (Grant …
CDC ACIP — Vaccine Advisory Committee
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Evidence to Recommendations Framework Wording of the age for routine HPV vaccination Ruth Stefanos, MD, MPH Advisory Committee on Immunization Practices April 15, 2025National Center for Immunization and Respiratory Diseases 1 Current recommendation https://www.cdc.gov/acip -recs/hcp/vaccine -specific/hpv.html•HPV vaccination is routinely recommended at age 11 or 12 years •Vaccination can be given starting at age 9 years •Since 2006 (first ACIP recommendation), the wording of age at HPV …