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449 documents

04 Pneumococcal Platt 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 37 pages

V116: An Investigational Adult Specific Pneumococcal Conjugate Vaccine Key Results from the Phase 3 Clinical Development Program ACIP Meeting, 29 -Feb -2024 Heather Platt, M.D., on behalf of the V116 team Distinguished Scientist, Global Clinical Development Merck Research Laboratories Merck & Company, Inc. Presentation Rationale for Development of V116  Overview of V116 Adult Clinical Development Program  Immunogenicity Results •Vaccine naïve adults ≥18 years of age •Vaccine experienced…

05 Pneumococcal Moro 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 19 pages

National Center for Emerging and Zoonotic Infectious Diseases Post -licensure safety surveillance of 20 -valent pneumococcal conjugate vaccine (PCV20) among U.S. adults in the Vaccine Adverse Event Reporting System (VAERS) Pedro L. Moro, MD, MPH Immunization Safety Office Division of Healthcare Quality Promotion Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) February 29, 2024 Disclaimer The findings and conclusions in this presentation…

05 Pneumococcal Forshee 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 16 pages

FDA CBER: Safety Assessment of 20- valent Pneumococcal Conjugate Vaccine (PCV20) ACIP February 2024 Richard Forshee, PhD Office of Biostatistics and Pharmacovigilance Center for Biologics Evaluation and Research US Food and Drug Administration 2 Disclaimer •The BEST Initiative and its studies are funded by the U.S. Food and Drug Administration (FDA) •There are no potentially conflicting relationships to disclose •The findings and conclusions in this presentation are those of the authors and…

06 Pneumococcal Kobayashi 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 57 pages

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. Preliminary Work Group Interpretations of EtR and Next Steps February 2024, ACIP Meeting February 29, 2024 Miwako Kobayashi, MD, MPH, FACP , FIDSA 1.Should PCV21 be…

01 Vaxelis Loehr 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 7 pages

Introduction and Terms of Reference: Combined Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus influenzae Type B Conjugate, and Hepatitis B vaccine (Vaxelis) Jamie Loehr Interim Chair, ACIP Meningococcal/Hib Vaccines Work Group February 29, 2024National Center for Immunization & Respiratory Diseases ACIP Meningococcal/Hib Vaccines Work Group ▪ ACIP Members on the WG •Jamie Loehr (Interim Chair) •Wilbur Chen ▪ Ex Officio WG Members •Margaret Bash…

02 Vaxelis Collins 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 38 pages

Background on invasive Hib disease and vaccination among American Indian and Alaska Native populations Jennifer Collins MD, MSc Co-Lead, ACIP Hib/Meningococcal Vaccines Work Group February 29, 2024National Center for Immunization & Respiratory Diseases Background 3▪Gram -negative bacilli ▪Originally thought to be the cause of influenza ▪Abbreviated “ H. flu ” or Hi ▪Infections range from mild to severe invasive disease Haemophilus influenzae NTUnencapsulated (Non -typeable) b a c d e…

03 Vaxelis Hammitt 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 29 pages

The HibVax Study Immunogenicity of H. influenzae type b PRP -OMP vaccines in American Indian and Alaska Native infants Laura Hammitt, MD Associate Professor, JHSPH Infectious Disease Program Lead, Center for Indigenous Health Johns Hopkins Bloomberg School of Public Health On behalf of the study team in Navajo Nation and Anchorage, Alaska Disclosures/Disclaimers ▪This study was supported in part by a research grant from the Investigator - Initiated Studies Program of Merck Sharp & Dohme LLC,…

04 Vaxelis Collins 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 13 pages

Work Group Considerations Jennifer Collins MD, MSc Co-Lead, ACIP Hib/Meningococcal Vaccines Work Group February 29, 2024National Center for Immunization & Respiratory Diseases Policy question ▪Should Vaxelis (DTaP -IPV-Hib-HepB ) be included with PedvaxHIB in the preferential recommendation for American Indian and Alaska Native infants? 2 3▪574 federally recognized tribes in the United States –Listening to tribal communities is very important –CDC’s Office of Tribal Affairs and Strategic…

01 Meningococcal Poehling 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 7 pages

ACIP Meningococcal Vaccines Work Group Introduction Katherine Poehling, MD, MPH Chair, ACIP Meningococcal Vaccines Work Group October 25, 2023National Center for Immunization & Respiratory Diseases Meningococcal Vaccines Work Group ▪ ACIP Members on the WG •Katherine Poehling (Chair) •Lynn Bahta •Jamie Loehr ▪ Ex Officio WG Members •Margaret Bash (FDA) •Mark Connelly (FDA) •Francisco Leyva (NIH) ▪ WG Liaisons and Consultants •Amra Resic (AAFP) •Samir Shah (AAP) •Sharon McMullen (ACHA) •Cacky…

02 Meningococcal McNamara 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 7 pages

Plan for revisiting the adolescent schedule for meningococcal vaccines Lucy McNamara, PhD, MS Interim Co -Lead, ACIP Meningococcal Vaccines Work Group October 25, 2023National Center for Immunization & Respiratory Diseases Considerations for routine schedule discussed during June 2023 ACIP meeting ▪Strong interest in revisiting the meningococcal vaccine schedule, including –Whether 11 –12-year old dose is still needed given recent epidemiology –Revisiting SCDM for B vaccines •Pentavalent…

final posted 2025 12 04 7pm 508

CDC ACIP — Vaccine Advisory Committee · Acip / Agendas · 3 pages

MEETING OF THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP)    AGENDA   Thursday, December 4, 2025   8:00 AM   Welcome , Roll Call , and Opening Statement Dr. Robert Malone (ACIP Vice Chair)   Dr. Mina Zadeh (ACIP Executive Secretary, CDC)        8:30 AM   Hepatitis B – Recap Dr. Robert Malone (ACIP Vice Chair)   Policy Context and Schedule Comparison Dr. Vicky Pebsworth (ACIP Childhood and Adolescent Immunization Schedule Workgroup …

final posted 2025 12 04 508

CDC ACIP — Vaccine Advisory Committee · Acip / Agendas · 3 pages

MEETING OF THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP)    AGENDA   Thursday, December 4, 2025   8:00 AM   Welcome , Roll Call , and Opening Statement Dr. Robert Malone (ACIP Vice Chair)   Dr. Mina Zadeh (ACIP Executive Secretary, CDC)        8:30 AM   Hepatitis B – Recap Dr. Robert Malone (ACIP Vice Chair)   Policy Context and Schedule Comparison Dr. Vicky Pebsworth (ACIP Childhood and Adolescent Immunization Schedule Workgroup …

draft posted 2025 12 01 508

CDC ACIP — Vaccine Advisory Committee · Acip / Agendas · 2 pages

MEETING OF THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) AGENDA - DRAFT Ce nters for Disease Control and Prevention Atlanta, Georgia 30329 Thursd ay, December 4, 2025 8:00 AM Welcome and Roll Call Agency Updates Hepatitis B Vaccine Presentation Discussion Break Hepatitis B Vaccine (continued) Presentation Discussion Lunch Hepatitis B Vaccine (continued) VFC presentation CMS presentation …

draft posted 2025 11 14 508

CDC ACIP — Vaccine Advisory Committee · Acip / Agendas · 2 pages

MEETING OF THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) AGENDA - DRAFT Ce nters for Disease Control and Prevention Atlanta, Georgia 30329 Thursday, December 4, 2025 9:00 AM Welcome and Roll Call Updates on ACIP Workgroups CDC Vaccine Risk Monitoring Evaluation Discussion Vaccine Schedule History Childhood /Adolescent Immunization Schedule Discussion Lunch Vaccine Schedule Considerations Discussion …

final posted 2025 09 19 508

CDC ACIP — Vaccine Advisory Committee · Acip / Agendas · 3 pages

MEETING OF THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) Agenda Centers for Disease Control and Prevention Atlanta, GA Thursday, September 18, 2025 10:00 AM Welcome and Roll Call Dr. Martin Kulldorff (ACIP Chair) Dr. Mina Zadeh (ACIP Executive Secretary, CDC) 10:30 AM Update on Work Groups Dr. Martin Kulldorff (ACIP Chair) 10:40 AM Measles, Mumps, Rubella, and Varicella (MMRV) Vaccines Introduction Dr. Martin Kulldorff (ACIP Chair) …

final posted 2025 09 18 508

CDC ACIP — Vaccine Advisory Committee · Acip / Agendas · 3 pages

MEETING OF THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) Agenda Cent ers for Disease Control and Prevention Atlanta, GA Thursday, September 18, 2025 10:00 AM Welcome and Roll Call Dr. Martin Kulldorff (ACIP Chair) Dr. Mina Zadeh (ACIP Executive Secretary, CDC) 10:30 AM Update on Work Groups Dr. Martin Kulldorff (ACIP Chair) 10:40 AM Measles, Mumps, Rubella, and Varicella (MMRV) Vaccines Introduction Dr. Martin Kulldorff (ACIP Chair) …

final posted 2025 09 17 508

CDC ACIP — Vaccine Advisory Committee · Acip / Agendas · 3 pages

MEETING OF THE ADVISORY COMMITTEE ON IMMUNIZA TION PRACTICES (ACIP) Agenda (Final) Centers for Disease Cont rol and Prevention Atlanta, GA Thursday, September 18, 2025 10:00 AM Welcome and Roll Call Dr. Martin Kulldorff (ACIP Chair) Dr. Mina Zadeh (ACIP Executive Secretary, CDC) 10:30 AM Update on Work Groups Dr. Martin Kulldorff (ACIP Chair) 10:40 AM Measles, Mumps, Rubella, and Varicella (MMRV) Vaccines Introduction Dr. Martin Kulldorff (ACIP Chair) Background on…

draft posted 2025 09 12 508

CDC ACIP — Vaccine Advisory Committee · Acip / Agendas · 2 pages

MEETING OF THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) Agenda (Draft) Centers for D isease Con trol and Prevention Atlanta, GA Thursday, September 18, 2025 10:00 AM Welcome and Roll Call Dr. Martin Kulldorff (ACIP Chair) Dr. Mina Zadeh (ACIP Executive Secretary, CDC) 10:30 AM Update on Work Groups Dr. Martin Kulldorff (ACIP Chair) 11:00 AM Measles, Mumps, Rubella, and Varicella (MMRV) Vaccines Introduction Dr. Martin Kulldorff (ACIP Chair) …

summary 2025 9 18 19 508

CDC ACIP — Vaccine Advisory Committee · Acip / Minutes · 104 pages

MEETING OF THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) SEPTEMBER 18-19, 2025 MEETING SUMMARY Trade names are used for identification purposes only and do not indicate endorsement. 2 Note: Text enclosed in [brackets] was added following the meeting, per the presenter’s request. THURSDAY : SEPTEMBER 18, 202 5 WELCOME AND ROLL CALL Call to Order/Roll Call Dr. Mina Zadeh, ACIP…

Final posted 2025 06 24 508

CDC ACIP — Vaccine Advisory Committee · Acip / Agendas · 2 pages

Final Agenda 10:00 Opening Remarks Dr. Martin Kulldorff (ACIP Chair) 10:15 Welcome and Roll Call Dr. Mina Zadeh (ACIP Executive Secretary, CDC) 10:35 Update on Work Groups Dr. Martin Kulldorff (ACIP Chair) 11:00 COVID-19 Vaccines 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 safety update Dr. Sarah Meyer (CDC/NCEZID) COVID-19 vaccine coverage and implementation Dr.…