CDC ACIP — Vaccine Advisory Committee
· Acip
/ Slides
· 10 pages
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
· Acip
/ Slides
· 44 pages
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
· Acip
/ Slides
· 67 pages
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
· Acip
/ Slides
· 63 pages
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
· Acip
/ Slides
· 12 pages
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
· Acip
/ Slides
· 19 pages
© 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
· Acip
/ Slides
· 38 pages
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
· Acip
/ Slides
· 33 pages
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
· Acip
/ Slides
· 21 pages
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…
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2020
Yi Zeng · UNIVERSITY OF ARIZONA · 2020 · $84,066 — Project Summary / Abstract: Flow Cytometry Shared Resource (FCSR) The goal of the Flow Cytometry Shared Resource (FCSR), which has served investigators of the University of Arizona Cancer Center (UACC) for more than 25 years, is to offer UACC Members efficient and reliable flow cytometric service…
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2020
DAVID Branch MOODY · BRIGHAM AND WOMEN'S HOSPITAL · 2020 · $223,437 — The Metabolomics Core (B) is comprised of a Biosafety Level 3 suite for handling infectious samples, massively parallel detection of mycobacterial metabolites using Time of Flight mass spectrometry (Agilent Accurate Mass ToF 6230), specialized resources for identifying known mycobacterial compound…
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2020
Ron L Morales · BOSTON UNIVERSITY MEDICAL CAMPUS · 2020 · $1,650,526 — Environmental Health and Biosafety Regulations and Requirements (EH&S): Summary The Environmental Health and Biosafety Regulations and Requirements Core (EH&S) includes three components, Environmental Health and Safety, Emergency Management, and Occupational Medicine. The EH&S Core is integrated wit…
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2020
Ricardo Rajsbaum · UNIVERSITY OF TEXAS MED BR GALVESTON · 2020 · $395,000 — The most recent outbreak of Ebola virus (EBOV) in West Africa reached alarming numbers of infections and deaths, prompting extensive efforts to develop antiviral strategies; however, none have thus far been approved for use in humans. The development of antiviral drugs is mostly based on designing c…
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2020
Jay Kenneth Fisher · REDBUD LABS, INC. · 2020 · $299,268 — ABSTRACT We propose to develop a point-of-need system for differential molecular identification of filoviruses from syndromically similar infections. Our goal is to enable rapid, sensitive, and specific identification of quarantinable infections to reduce nosocomial risk and improve outbreak respons…
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2020
Juergen A Richt · KANSAS STATE UNIVERSITY · 2020 · $2,261,498 — Overall Project Summary: This COBRE application will form a unique research center on Emerging and Zoonotic Infectious Diseases (EZID). Four primary research projects bridge areas of excellence in the Infectious Diseases programs at Kansas State University (KSU) within the Colleges of Arts and Scien…
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2020
SUZETTE Alise PRIOLA · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · 2020 · $1,145,487 — Transmissible spongiform encephalopathies (TSEs or prion diseases) are a group of rare neurodegenerative diseases which include sporadic Creutzfeldt-Jakob disease (sCJD) in humans, scrapie in sheep, bovine spongiform encephalopathy (BSE), and chronic wasting disease (CWD) in mule deer and elk. Prion…
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2020
Thomas William Geisbert · HENRY M. JACKSON FDN FOR THE ADV MIL/MED · 2020 · $852,988 — Abstract Among viruses that cause disease in humans the henipaviruses, Hendra virus (HeV) and Nipah virus (NiV), stand out for their impressive lethality. These viruses are among the most deadly human pathogens known to man with case fatality rates averaging about 75% for NiV. Significantly, there i…
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2020
STEPHEN C JAMESON · UNIVERSITY OF MINNESOTA · 2020 · $192,500 — Summary Core B NME Mouse Core Our published studies suggest that mice with more physiological exposure to natural mouse microbes have immune systems that are a better match for the immune system in humans: In contrast to typical “clean” laboratory mice (which are maintained in barrier facilities to …
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2020
Thomas William Geisbert · UNIVERSITY OF TEXAS MED BR GALVESTON · 2020 · $2,655,768 — PROJECT SUMMARY/ABSTRACT – BSL-4 Evaluation Core (Core B) Among viruses that cause disease in humans the filoviruses, Ebolavirus and Marburgvirus, stand out for their impressive lethality. These viruses are the most deadly human pathogens known to man with reported case fatality rates of up to 90%. …
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2019
Harris R Perlman · NORTHWESTERN UNIVERSITY AT CHICAGO · 2019 · $904,075 — Project Summary/ Abstract The aim of the Robert H. Lurie Comprehensive Cancer Center Flow Cytometry Core Facility is to provide analysis and cell sorting to enhance scientific interaction and productivity within Northwestern University's research community. This is accomplished by allowing access to…