CDC ACIP — Vaccine Advisory Committee
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SENT VIA EMAIL Advisory Committee on Immunization Practices Centers for Disease Control and Prevention [email protected] Re: Supplement to December 5, 2025 Presentation Titled Development of the U.S. Childhood Vaccination Schedule: With a Focus on Suggested Improvements To ACIP: Please find herein additional sources for various slides for the above -referenced presentation. As disclosed in that presentation, I am the Manag ing Partner of Siri & Glimstad LLP which has…
CDC ACIP — Vaccine Advisory Committee
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Tracy Beth Høeg, M.D., Ph.D. FDA Ex Officio to ACIP Senior Advisor for Clinical Sciences Office of the Commissioner (OC) &Center for Biologics Evaluation and Research (CBER)US Food and Drug Administration Core Childhood Vaccination Schedules: An International Perspective with focus on the US & Denmark 3 Danish- US double citizen MD (WI, USA- MCW), Residency UC DavisPhD -Epidemiology & Public Health (U Copenhagen) 4 45 peer reviewed publications -last 5 years focus on infectious…
CDC ACIP — Vaccine Advisory Committee
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Considerations and Query for the Advisory Committee for Immunization Practices Presented by Dr. Evelyn Griffin, MD, FACOG, IFMCP Child/Adolescent Immunization Schedule Work Group Vaccinations during Pregnancy Work Group HPV Work GroupVaccines and Aluminum Adjuvants Background Child/Adolescent Immunization Schedule Work Group Discussion Objectives ACIP Charter: provide “advice and guidance to the Director of the CDC regarding the use of vaccines and related agents” •Consideration of an…
CDC ACIP — Vaccine Advisory Committee
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Rapid Systematic Review of the Safety of MMRV Vaccine A. Background The measles -mumps -rubella -varicella (MMRV) vaccine (ProQuad, Merck) was licensed in the United States in 2005 for use in children 12 months through 12 years of age. While not licensed for use in the United States, Priorix -Tetra, a MMRV vaccine manufactured by GlaxoSmithKline , first received licensing in some European countries in 2006, and in Canada in 2007. Both ProQuad and Priorix -Tetra are tetravalent…
CDC ACIP — Vaccine Advisory Committee
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1 Briefing Document : Policy Recommendations for Use of Measles , Mumps , Rubella, and Varicella (MMRV) Vaccine in the United States Overall Summary: • Current ACIP/CDC recommendations for MMRV vaccine use in the U .S. summary (MMWR, May 2010): o The routinely recommended ages for measles, mumps, rubella and varicella vaccination are 12 –15 months for the first dose and 4 –6 years for the second dose. Both the first and second dose can be administered at other…
CDC ACIP — Vaccine Advisory Committee
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Background on Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Arjun Srinivasan, MD, MS, MBA Acting Chief Medical Officer National Center for Immunization and Respiratory Di seases ACIP Meeting September 18, 2025 National Center for Immunization & Respiratory Dise ases During the last major rubella epidemic in the U.S. (1964-1965), in 1 year: –11,000 pregnant women lost their babies –2,100 newborns died –20,000 born with congenital rubella syndrome, causing deaf ness, heart…
CDC ACIP — Vaccine Advisory Committee
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Febrile Seizures following Measles, Mumps, Rubella, and Varicella (MMRV) vaccine John Su Acting Director Immunization Safety Office Centers for Disease Control and Prevention September 18, 2025 September 2025: Request to CDC from ACIP Chair Presentation on febrile seizures post administration of MMRV vs. simultaneous administration of separate MMR and Varicella vaccines, by two different age groups, 1 –2 and 4– 6-year -olds. Please use data both from randomized trials and from the Vaccine…
CDC ACIP — Vaccine Advisory Committee
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1 ACIP Meeting Materials for Public Posting: Hepatitis B Birth Dose Briefing Document Contents 1. Background 2. Epidemiology 3. Systematic Review s for studies on hepatitis B birth dose vaccine 4. Appendices Appendix 1 ACIP Recommendations Appendix 2 Global Recommendations 1. Background Introduction Hepatitis B virus (HBV) infection can be transmitted from mother -to-child during pregnancy and delivery. Without any interventions, up to 85% of infants born to…
CDC ACIP — Vaccine Advisory Committee
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Disclaimer: The findings and conclusions herein are draft and have not been formally disseminated by the Centers for Disease Control and Prevention and should not be construed to represent any agency determination or policy . Page 1 of 84 ACIP BRIEFING MATERIALS FOR PUBLIC POSTING The Safety of Hepatitis B Vaccines administered within 24 hrs of birth and within 30 days of birth: A Rapid Systematic Review Table of Contents Table of Tables ................................…
CDC ACIP — Vaccine Advisory Committee
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Disclaimer: The findings and conclusions herein are draft and have not been formally disseminated by the Centers for Disease Control and Prevention and should not be construed to represent any agency determination or policy . Page 1 of 24 ACIP BRIEFING MATERIALS FOR PUBLIC POSTING The Non -specific Effects of Hepatitis B Vaccines : A Rapid Systematic Revie w Table of Contents A. Background ................................ ................................…
CDC ACIP — Vaccine Advisory Committee
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Hepatitis B Birth Dose Vaccination CDC Advisory Committee for Immunization Practices Meeting September 18, 2025 1U.S. Centers for Disease Control and Prevention Perinatal HBV transmission, which accounts for most infections globally, results in severe health consequences. HBV = hepatitis B virus. Schillie S. MMWR Recomm Rep. 2018 *Image(s) generated by ChatGPT 5.0 (OpenAI), August 2025. Content originated as data from scientific publications and was tra nsformed into an image via text…
CDC ACIP — Vaccine Advisory Committee
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A Review of the Safety of Hepatitis B Birth Dose Vaccination John Su Acting Director Immunization Safety Office Centers for Disease Control and Prevention September 18, 2025National Center for Emerging and Zoonotic Infectious Diseases Request to CDC from ACIP Chair Safety data for HepB administration within 24 hours of birth from CDC’s Vaccine Safety Datalink and from FDA’s Biologics Effectiveness and Safety System. Include (i) mild and serious adverse events; (ii) all cause morbidity and…
CDC ACIP — Vaccine Advisory Committee
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Non -specific effects following hepatitis B vaccinationNational Center for Emerging and Zoonotic Infectious Diseases John Su Acting DirectorImmunization Safety OfficeCenters for Disease Control and Prevention September 18, 2025 1 Request to CDC from ACIP chair Present the results for the HepB vaccine from the study by Garly ML, Jensen H, Martins CL, Balé C, Baldé MA, Lisse IM, Aaby P . Hepatitis B vaccination associated with higher female than male mortality in Guinea - Bissau: an…
CDC ACIP — Vaccine Advisory Committee
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ACIP Meeting, Atlanta September 19, 2025ACIP COVID -19 IMMUNIZATION WG: INTRODUCTION Professor Retsef Levi, PhD, MIT ACIP Meeting, Atlanta September 19, 2025Immediate Goals 1)Formulate possible recommendations regarding the recent FDA authorized products with respect to sub- populations for discussion and vote during the ACIP meeting on Sep 18- 19 (with supporting data/analyses): -What are the appropriate subgroups (age, risk factors, prior infection, others)? -Options: Recommend, not…
CDC ACIP — Vaccine Advisory Committee
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Updates to COVID -19 epidemiology Advisory Committee on Immunization Practices September 19, 2025 1U.S. Centers for Disease Control and Prevention COVID -NET monitors COVID -19 hospitalizations across parts of the U.S. •RESP -NET includes COVID -NET, RSV -NET, FluSurv -NET •Collaboration between state and local health departments and CDC •Includes data from >300 hospitals in 185 counties across 13 states, covering about 10% of the U.S. population COVID -NET:…
CDC ACIP — Vaccine Advisory Committee
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COVID-19 Vaccination Implementation National Center for Immunization and Respiratory Di seases September 19, 2025 Immunization Services Division Centers for Disease Control and Prevention •National Immunization Survey (NIS): -Random-digit-dial cellular telephone survey of adul ts 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…
CDC ACIP — Vaccine Advisory Committee
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Updates to COVID -19 Vaccine Effectiveness Advisory Committee on Immunization Practices September 19, 2025National Center for Immunization and Respiratory Diseases 2•Vaccine effectiveness methods •Estimates of COVID -19 Vaccine Effectiveness in Children •Estimates of Maternal COVID -19 Vaccine Effectiveness •Estimates of COVID -19 Vaccine Effectiveness in Adults •ConclusionsAgenda –COVID -19 vaccine effectiveness (VE) Vaccine effectiveness methods 3 Randomized clinical trials vs. real -world…
CDC ACIP — Vaccine Advisory Committee
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Vaccine safety signal detection and evaluation John Su Immunization Safety Office Advisory Committee on Immunization Practices meeting September 19, 2025 Outline •Definitions •Approach to signal detection and evaluation •Example -Previous statistical signals for ischemic stroke in the Vaccine Safety Datalink (VSD) Definition: adverse event following immunization (AEFI) •Any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with…
CDC ACIP — Vaccine Advisory Committee
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Wafik El-Deiry , MD, PhD, FACP Director, Legorreta Cancer Center Associate Dean, Oncologic SciencesWarren Alpert Medical School, BrownUniversity September 19, 2025 Workgroup Safety Uncertainties of mRNA COVID Vaccines Charlotte Kuperwasser, PhD Director, Tufts Convergence Laboratory of Biomedical, Physical, and Engineering SciencesProfessor Developmental, Molecular & Chemical Biology, Tufts University School of Medicine TERMS OF REFERENCE # 6, 7 & 8 1.Immune Changes 2.Biodistribution…
CDC ACIP — Vaccine Advisory Committee
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Genomics of Vaccine -Induced Myocarditis Bruce Carleton Professor and Chair, Division of Translational Therapeutics, Department of Pediatrics, Professor of Pediatrics, Medical Genetics, Pharmaceutical Sciences, Population and Public Health University of British Columbia Clinical Pharmacology Lead, MedSafe Clinics, BC Children’s and St Paul’s Hospitals Senior Clinician Scientist, BC Children’s Hospital Research Institute Vancouver, Canada Dr.Carleton has received financial support…