CDC ACIP — Vaccine Advisory Committee
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Evidence to Recommendations Framework: Additional Doses of 2024– 2025 COVID -19 Vaccine in Older Adults and People with Moderate or Severe Immunocompromise Ms. Lauren Roper, MPH COVID -19 ACIP Work Group co -lead Advisory Committee on Immunization Practices Meeting October 23, 2024National Center for Immunization and Respiratory Diseases •On June 27, 2024, ACIP voted to recommend 2024 –2025 COVID -19 vaccines for everyone ages 6 months and older •On August 22, 2024, FDA approved and…
CDC ACIP — Vaccine Advisory Committee
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Clinical Considerations for the use of 2024 -2025 COVID -19 Vaccines in the United States Lakshmi Panagiotakopoulos, MD, MPH COVID -19 ACIP Work Group co -lead Advisory Committee on Immunization Practices Meeting October 23, 2024National Center for Immunizations and Respiratory Diseases •On June 27, 2024, ACIP recommended 2024 -2025 COVID -19 vaccination for everyone ages 6 months and older •On August 22, 2024, FDA approved and authorized Moderna and Pfizer - BioNTech 2024 -2025 COVID -19…
CDC ACIP — Vaccine Advisory Committee
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Maternal/Pediatric Respiratory Syncytial Virus (RSV) Work Group Helen Chu, MD, MPH Chair, Maternal/Pediatric RSV Work Group ACIP Meeting October 23, 2024 1U.S. Centers for Disease Control and Prevention All infants should be protected against severe RSV disease with either maternal RSV vaccine or nirsevimab Maternal vaccine Abrysvo , Pfizer *Either maternal RSV vaccine or nirsevimab is given to protect infants against severe RSV disease – only one is needed in most instances …
CDC ACIP — Vaccine Advisory Committee
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Clesrovimab (MK-1654): Pediatric Clinical Program Presentation to the Advisory Committee on Immunization Practices Anushua Sinha, MD, MPH Clinical Director -Vaccines Clinical Research Merck & Co., Inc. Rahway, NJ, USA October 23, 2024 Confidential Clesrovimab is a human monoclonal antibody with four unique molecular characteristics that enable robust and durable protection from RSV 2Notes: a. Clesrovimab is ~50-fold more potent in vitro than palivizumab; …
CDC ACIP — Vaccine Advisory Committee
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RSVpreF Vaccine, Preterm Birth, and Small for Gestational Age at Birth Preliminary Results from The Vaccine Safety Datalink Malini DeSilva, MD, MPH ACIP October 23, 20241 Vaccine Safety Datalink, 2024 •Collaborative project between CDC and 13 integrated healthcare organizations •Monitors safety of vaccines used in the U.S., primarily through observational multisite studies of rare and serious events following vaccination •Includes data on ~15.5 million individuals across all sites …
CDC ACIP — Vaccine Advisory Committee
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Maternal & Pediatric RSV Work Group Interpretations and Next Steps Danielle Moulia, MPH Co-Lead, Maternal/Pediatric RSV Work Group ACIP Meeting October 23, 2024 1U.S. Centers for Disease Control and Prevention Safety and efficacy of clesrovimab 2 Policy question being considered by the work group •Should clesrovimab be recommended for all infants <8 months of age entering their first RSV season or born during the RSV season? 3 Evidence reviewed by the work group •Safety and efficacy…
CDC ACIP — Vaccine Advisory Committee
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Introduction to Meningococcal Session Jamie Loehr, MD Advisory Committee on Immunization Practices October 24, 2024National Center for Immunization & Respiratory Diseases 1 23 Terms of Reference GSK pentavalent ( MenABCWY ) vaccine –Prescription Drug User Fee Act date for regulatory decision: •February 14, 2025 MenB- 4C (Bexsero) FDA interval and dosing change Revisiting the adolescent meningococcal vaccine schedule 33 Terms of Reference GSK pentavalent ( MenABCWY ) vaccine Vote Feb…
CDC ACIP — Vaccine Advisory Committee
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Economic Analyses of GSK MenABCWY Vaccinations among Adolescents in the United States Xiaoyu Donga, PhD, Andrew J Leidnera, PhD, Sarah F Schilliea, MD, Lucy Alexandra McNamaraa, PhD a National Center for Immunization & Respiratory Diseases, CDC Disclaimers: 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 ACIP Meeting…
CDC ACIP — Vaccine Advisory Committee
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GRADE/Evidence to Recommendations Framework (EtR) for GSK Pentavalent (MenABCWY) Vaccine Sarah F. Schillie, MD, MPH, MBA Advisory Committee on Immunization Practices October 24, 2024National Center for Immunization & Respiratory Diseases 1 Meningococcal Vaccine Recommendations Routine schedule –One MenACWY* dose at age 11 –12 years and a booster at age 16 years –Two MenB** doses at age 16 –23 years (shared clinical decision -making [SCDM]) •Preferred age range: 16 –18 years Increased…
CDC ACIP — Vaccine Advisory Committee
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Introduction to MenB -4C (Bexsero) Interval and Dosing Label Change Sarah F. Schillie, MD, MPH, MBA Advisory Committee on Immunization Practices October 24, 2024National Center for Immunization & Respiratory Diseases 1 2MenB -4C (Bexsero) Interval Changes Initially licensed by FDA under an accelerated approval process New immunogenicity data support changes to dosing schedule –No safety concerns Full FDA approval: August 19, 2024 New dosing schedule aligned with MenB- FHbp …
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 October 24, 2024National 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) Nadine Peart Akindele (FDA) Rachel Zhang (FDA) Michelle Juaneza (HRSA) Uzo Chukwuma (IHS) Sonnie Kim (NIH/NIAID)CDC Co -Leads Amadea…
CDC ACIP — Vaccine Advisory Committee
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© 2024 Moderna, inc. All rights reserved.RSV Vaccine ( mRESVIA , mRNA -1345) Concomitant Administration Overview Advisory Committee on Immunization Practices Rituparna Das, MD PhD Oct 24, 2024 1 © 2024 Moderna, inc. All rights reserved. Cumulative Burden of Seasonal Respiratory Viruses in US Older Adults RSV Influenza2 Cumulative US Hospitalization Rate (≥65 yr, rate/100,000, 9/28/2024)1 227 106 US Vaccine Coverage 2023 -242-4 (COVID -19 & Flu ≥65 yrs, RSV ≥60 yrs)70% 23% 1.CDC RESP -NET,…
CDC ACIP — Vaccine Advisory Committee
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ACIP Presentation October 24, 2024 Iona Munjal, MD, FAAP Clinical Research and Development, Pfizer Vaccines Bivalent Stabilized Prefusion F RSV A and RSV B strains Adult Active immunization for the prevention of LRTD caused by RSV in individuals 60 years of age and older.Maternal Active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in…
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 October 24, 2024 Susan Gerber, MD Medical Director GSK Presentation by GSK at ACIP October 24, 2024 CO-2 ~ 9 million AREXVY doses administered in US to dateAREXVY Indications 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…
CDC ACIP — Vaccine Advisory Committee
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1 Evaluation of Guillain -Barré Syndrome (GBS) following Respiratory Syncytial Virus (RSV) Vaccination Among Adults 65 Years and Older Dr. Patricia Lloyd, ScM PhD Health Statistician Office of Biostatistics and Pharmacovigilance Center for Biologics Evaluation and Research U. S. Food & Drug Administration MEETING OF THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) Respiratory Syncytial Virus (RSV) Vaccine, Adults October 23 -24, 2024 2 Outline •Introduction •Presentation of End…
CDC ACIP — Vaccine Advisory Committee
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Introduction to MenQuadfi Label Change for 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. MenACWY Vaccines Available for Use in the United States* Manufacturer Trade Name AbbreviationLicensed Age…
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…