CDC ACIP — Vaccine Advisory Committee
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Economic Analysis of COVID -19 Vaccination University of Michigan COVID -19 Vaccination Modeling Team Presentation to the Advisory Committee on Immunization Practices September 19, 2025 1 Study team •University of Michigan •Wake Forest University •Centers for Disease Control and Prevention 2Conflict of interest statement No known conflicts of interest. Economic Analysis of COVID -19 Vaccination: Objectives Using an economic model of COVID -19 vaccination: •Estimate the annual population…
CDC ACIP — Vaccine Advisory Committee
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ACIP Meeting, CDC September 19, 2025COVID -19 Vaccine Discussion Framing, 2025-2026 Professor Retsef Levi, PhD, MIT ACIP Meeting, CDC September 19, 2025WG Main Takeaways •Assessments of the protection level provided by COVID -19 vaccines and especially seasonal boosters against severe outcomes (hospitalization, ICU, death, long- covid) are based on very low -quality data and analyses •Vaccine injuries are demonstrably not recognized by current pharmacovigilance systems, leaving vaccine…
CDC ACIP — Vaccine Advisory Committee
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Additional Workgroup Considerations in COVID-19 Vaccination Policy and Practice Evolution of a vaccine program. Chen RT, Orenstein WA. Epidemiologic methods in immunization programs. Epidemiol Rev. 1996;18(2):102. Copyright © 1996 by the Oxford University Press. Edwards K, Hackell J, Committee on Infectious Diseases, Committee on Practice and Ambulatory Medicine Pediatrics Sep 2016, 138 (3) e20162146; DOI: 10.1542/peds.2016- 2146Simple, stable recommendations can increase vaccine…
CDC ACIP — Vaccine Advisory Committee
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Advisory Committee on Immunization Practices COVID -19 Session Coronavirus and Other Respiratory Viruses Division June 25, 2025National Center for Immunization and Respiratory Diseases 1 Introduction Dr. Adam MacNeil (CDC/NCIRD) COVID -19 epidemiology Dr. Adam MacNeil (CDC/NCIRD) COVID -19 vaccine effectiveness update Dr. Adam MacNeil (CDC/NCIRD) COVID -19 vaccine safety update Dr. Sarah Meyer (CDC/NCEZID) COVID -19 vaccine coverage and implementation Dr. Georgina Peacock (CDC/NCIRD)…
CDC ACIP — Vaccine Advisory Committee
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Current Epidemiology of COVID -19 Coronavirus and Other Respiratory Viruses Division Advisory Committee on Immunization Practices (ACIP) June 25, 2025National Center for Immunization and Respiratory Diseases 1 COVID- 19 continues to impact Americans’ health. * Based on data from September 29, 2024 through June 7, 2025. Source: https://www.cdc.gov/covid/php/surveillance/burden- estimates.html 2 Among adults aged ≥18 years, 3.6% reported Long COVID symptoms, and 8.4% reported ever having…
CDC ACIP — Vaccine Advisory Committee
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Updates to COVID -19 Vaccine Effectiveness COVID -19 Session Coronavirus and Other Respiratory Viruses Division June 25, 2025National Center for Immunization and Respiratory Diseases 2•Vaccine effectiveness methods & context •Estimates of COVID -19 Vaccine Effectiveness in Children •Estimates of COVID -19 Vaccine Effectiveness in Adults •ConclusionsAgenda –COVID -19 vaccine effectiveness (VE) Methods & Context 3 4 Case ControlPerson with acute respiratory illness SARS -CoV-2 test COVID -19 …
CDC ACIP — Vaccine Advisory Committee
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Update on CDC’s COVID-19 Vaccine Safety Monitoring Sarah Meyer, MD MPH Director, CDC’s Immunization Safety Office June 25, 2025 1 Key Points • CDC and interagency partners launched an extensive vaccine safety monitoring program for COVID-19 vaccines • Many potential safety outcomes were rigorously assessed through complementary passive and active systems • Myocarditis is causally associated with mRNA COVID-19 vaccines …
CDC ACIP — Vaccine Advisory Committee
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COVID- 19 Vaccination ImplementationNational Center for Immunization and Respiratory Diseases June 25, 2025Immunization Services Division Centers for Disease Control and Prevention •National Immunization Survey (NIS): -Random -digit -dial cellular telephone survey of adults age ≥18 years in the U.S. (all 50 states, 5 local jurisdictions, and territories); all responses are self reported. -Sample size: ~15,000 adult respondents weekly, ~60,000 adult respondents monthly -Data are weighted to…
CDC ACIP — Vaccine Advisory Committee
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Evidence to Recommendations (partial) for 2025 –2026 COVID -19 Vaccination Coronavirus and Other Respiratory Viruses Division June 25, 2025National Center for Immunization and Respiratory Diseases 1 Evidence to Recommendations ( EtR) Framework EtR Domain Question(s) Public Health Problem •Is the problem of public health importance? Benefits and Harms•How substantial are the desirable anticipated effects? •How substantial are the undesirable anticipated effects? •Do the desirable effects…
CDC ACIP — Vaccine Advisory Committee
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Maternal/Pediatric Respiratory Syncytial Virus (RSV) Session Advisory Committee on Immunization Practices Meeting June 25, 2025 1U.S. Centers for Disease Control and Prevention Session Introduction •RSV can infect the small airways in the lungs, particularly in infants •Most (68%) infants are infected in the first year of life and nearly all (97%) by age 2 years2 •2-3% of young infants are hospitalized for RSV3,4,5 -~80% of children hospitalized with RSV age <2 years have no underlying…
CDC ACIP — Vaccine Advisory Committee
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Implementation and Uptake of Nirsevimab and Maternal Vaccine for Infant Protection from RSV Immunization Services Division Centers for Disease Control and Prevention June 25, 2025National Center for Immunization and Respiratory Diseases •National Immunization Survey (NIS): -Random -digit -dial cellular telephone survey of adults age ≥18 years in the U.S. (all 50 states, 5 local jurisdictions, and territories); all responses are self reported. -Sample size: ~15,000 adult respondents weekly,…
CDC ACIP — Vaccine Advisory Committee
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Effectiveness and impact of RSV prevention products in infants during the 2024 –2025 RSV season Coronavirus and Other Respiratory Viruses Division June 25, 2025National Center for Immunization and Respiratory Diseases Product Effectiveness (PE) •Summary of CDC systems used toevaluate PE •Effectiveness of nirsevimab and maternal RSV vaccine during the 2024 –2025 RSV season in the U.S. RSV Hospitalization Rates and Product Impact •Summary of CDC systems used for monitoring RSV…
CDC ACIP — Vaccine Advisory Committee
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Prenatal RSVpreF Vaccine Safety 2023 –2024 Respiratory Season The Vaccine Safety Datalink (VSD) Malini DeSilva, MD, MPH Presentation to ACIP June 25, 2025 © HealthPartners 2Vaccine Safety Datalink (VSD) •Collaborative project between CDC and 13 integrated healthcare organizations •Monitors safety of vaccines used in the U.S., primarily through observational multisite studies •Includes data on ~15.5 million individuals across all sites annually (~4.5% of U.S. population) •Annual birth…
CDC ACIP — Vaccine Advisory Committee
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Monitoring the Safety of Nirsevimab in Infants Birth through <8 Months June 25, 2025Matthew F. Daley, MDPreliminary Results from the Vaccine Safety Datalink for the 2024 -2025 Season KAISER PERMANENTE INSTITUTE FOR HEALTH RESEARCH •No conflicts of interest •Presenting on behalf of the Vaccine Safety Datalink (VSD) teamDisclosures and Acknowledgments Nirsevimab Safety Surveillance Slide 2 Background Slide 3 KAISER PERMANENTE INSTITUTE FOR HEALTH RESEARCH •Long -acting monoclonal antibody,…
CDC ACIP — Vaccine Advisory Committee
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U.S. Centers for Disease Control and Prevention Evidence to Recommendation Framework : Clesrovimab Maternal/Pediatric RSV Work Group Advisory Committee on Immunization Practices June 25, 2025 1 Policy Question • Should clesrovimab be recommended for all infants <8 months of age born during or entering their first RSV season? 2 Evidence to Recommendation (EtR ) Framework EtR Domain Question(s) Public Health Problem…
CDC ACIP — Vaccine Advisory Committee
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Work group considerations and clinical considerations for clesrovimab Maternal and Pediatric RSV Session Coronavirus and Other Respiratory Viruses Division June 25, 2025U.S. Centers for Disease Control and Prevention •Work group considerations and interpretations of uptake, safety, effectiveness, and impact studies •Review of clinical considerations -Clesrovimab recommendations compared with nirsevimab -Clesrovimab storage, handling, and administrationOutline 2 •Nirsevimab was effective…
CDC ACIP — Vaccine Advisory Committee
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U.S. 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. Influenza Session —Introduction Dr. Vivien Dugan Influenza Division, CDC/NCIRD June 26, 2025 Flublok (recombinant influenza vaccine) in older children and …
CDC ACIP — Vaccine Advisory Committee
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VAP00027 Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine (RIV4) in Children and Adolescents Aged 9 to 17 Years and Adults Aged 18 to 49 Years For the Advisory Committee of Immunization Practices (ACIP) Influenza Working Group MAT-US-2504669 P v3.0 EXP 28 APR 2026Pedro Folegatti – Global Clinical Development Director (Presenter) Thinus Marais – Medical Head: Influenza & COVID, Vaccines North America Presenter’s disclosures Pedro Folegatti , MD DTM&H MSc Dphil is a…
CDC ACIP — Vaccine Advisory Committee
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Severity, Disease Burden, and Prevented Burden for the 2024 -2025 Influenza Season Influenza Division, CDC 2024 -2025 Influenza Season News Influenza Severity Assessment by Season and by Age Group Severity Classification by Age Group Influenza Season* 0-17 years 18-64 years ≥65 years All Ages 2009- 2010 Very High Moderate Low Moderate 2010- 2011 Moderate Moderate Moderate Moderate 2011- 2012 Low Low Low Low 2012- 2013 Moderate Moderate High Moderate 2013- 2014 Moderate Moderate Moderate…
CDC ACIP — Vaccine Advisory Committee
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U.S. 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. 2024 -25 Influenza Season Update and Seasonal Influenza Vaccine Recommendations for the 2025 -26 U.S. Influenza Season Dr. Vivien Dugan Influenza Division,…