NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2020
ROBERT A DAVEY · PURDUE UNIVERSITY · 2020 · $704,383 — A research team from Purdue University and Texas Biomedical Research Institute is in pursuit of important new approaches to validate the host V-ATPase. The project goal to define antiviral drug leads for diseases caused by Ebola and Marburg filoviruses. Many viral pathogens bind to specific factors …
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2020
Jae U Jung · CLEVELAND CLINIC LERNER COM-CWRU · 2020 · $619,413 — Project Summary/Abstract Severe fever with thrombocytopenia syndrome virus (SFTSV) listed in the World Health Organization 9 most dangerous pathogens is an emerging Phlebovirus in the Phenuiviridae family. Due to the lack of therapy and vaccine against SFTSV infection, there is a pressing need to u…
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2020
Corrie Ntiforo · UNIVERSITY OF TEXAS MED BR GALVESTON · 2020 · $467,803 — The overall goal of this project is to maintain the high containment research resources (infrastructure and facilities) required to conduct research that will facilitate the next generation therapeutics, diagnostics and vaccines for infectious diseases. The Galveston National Laboratory (GNL) at the…
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2020
JOANN M TUFARIELLO · GEORGIA STATE UNIVERSITY · 2020 · $209,214 — Summary This developmental project seeks to develop methods to dramatically boost immunogenicity of virus-like particle (VLP) vaccines. Ebola virus (EBOV) and Marburg virus (MARV) are members of the filovirus family of enveloped, negative-sense RNA viruses that causes outbreaks of severe human disea…
CDC ACIP — Vaccine Advisory Committee
· Acip
/ Slides
· 22 pages
Highly Pathogenic Avian Influenza A (H5N1) Tom Shimabukuro, MD, MPH, MBA Influenza Division National Center for Immunization and Respiratory Diseases (NCIRD) Centers for Disease Control and Prevention (CDC) October 23, 2024 HPAI A(H5N1)/ HPAI A(H5) Human Cases Since 1997 Past Reported Global Human Cases with Highly Pathogenic Avian Influenza A(H5N1) (HPAI H5N1) by Country, 1997 -2024 | Bird Flu | C DC (Thru Aug 7, 2024; may include A(H5)+, presumed H5N1 cases) 2 •Historically, human…
CDC ACIP — Vaccine Advisory Committee
· Acip
/ Slides
· 6 pages
CHIKUNGUNYA VACCINES ACIP Meeting October 23, 2024 Edwin Asturias, MD Chair, ACIP Chikungunya Vaccines Work Group •Chikungunya Vaccines Work Group formed in May 2022 •Chikungunya vaccines -Live attenuated vaccine licensed in November 2023 (manufactured by Valneva) -Virus -like particle vaccine submitted to FDA for licensure (manufactured by Bavarian Nordic) •Some recommendations developed, and others under development, for use of chikungunya vaccines among U.S. persons at risk of…
CDC ACIP — Vaccine Advisory Committee
· Acip
/ Slides
· 16 pages
Update on chikungunya and chikungunya vaccinesNational Center for Emerging and Zoonotic Infectious Diseases Susan Hills MBBS MTH CDC Lead , Chikungunya Vaccines Work Group Arboviral Diseases Branch Division of Vector -Borne Diseases Fort Collins, Colorado ACIP Meeting, October 23, 2024 •Mosquito -borne disease •Key vectors are Aedes aegypti and Aedes albopictus mosquitoesChikungunya 2 Distribution and virus transmission Typically tropical and subtropical regions Periodically causes…
CDC ACIP — Vaccine Advisory Committee
· Acip
/ Slides
· 20 pages
CHIKV VLP vaccine Bavarian Nordic’s chikungunya vaccine candidate October 2024 Victoria Jenkins, PhD, MBA VP Regulatory Affairs & CHIKV Program LeadBavarian Nordic vije@bavarian -nordic.com 2E protein Membrane Capsid shell RNA CHIKV VLP vaccine Chikungunya virus3CHIKV virus -like particle vaccine (CHIKV VLP)1 CHIKV, chikungunya virus; VLP, virus -like particle ; BLA, Biologics License Application; PDUFA, Prescription Drug User Free Act 1. Bennett SR, et al. Lancet Infect Dis.…
CDC ACIP — Vaccine Advisory Committee
· Acip
/ Slides
· 9 pages
Work Group interpretation of data for virus -like particle chikungunya vaccineNational Center for Emerging and Zoonotic Infectious Diseases Susan Hills MBBS MTH CDC Lead , Chikungunya Vaccines Work Group Arboviral Diseases Branch Division of Vector -Borne Diseases Fort Collins , Colorado ACIP Meeting, October 23, 2024 •No vaccine effectiveness data •Short -term* immunogenicity data available from ~2,750 vaccinated subjects in two Phase 3 studies -Majority adults aged 18 –64 years (~2350…
CDC ACIP — Vaccine Advisory Committee
· Acip
/ Slides
· 10 pages
ACIP COVID -19 Vaccines Work Group Robert Schechter, MD COVID -19 ACIP Work Group Chair Advisory Committee on Immunization Practices Meeting October 23, 2024National Center for Immunization and Respiratory Diseases •To protect against COVID -19 disease, caused by SARS -CoV-2, ACIP recommended at its June 2024 meeting the 2024 –2025 COVID -19 vaccines, as authorized or approved by FDA: -Moderna COVID -19 vaccine in persons ≥6 months -Pfizer -BioNTech COVID -19 vaccine in persons ≥6 months…
CDC ACIP — Vaccine Advisory Committee
· Acip
/ Slides
· 27 pages
Implementation Considerations for Additional COVID -19 Vaccine Doses Georgina Peacock, MD, MPH Immunization Services Division Centers for Disease Control and Prevention October 23, 2024National Center for Immunization and Respiratory Diseases COVID -19 Vaccination Coverage and Intent for 2 Doses, National Immunization Survey -Adult COVID Module 2023 -2024 Data 2-Dose Coverage and Intent Among Adults 65 Years and Older COVID -19Vaccination Coverage (≥1 Dose and ≥2 Doses) A mong Adults…
CDC ACIP — Vaccine Advisory Committee
· Acip
/ Slides
· 19 pages
COVID -19–Associated Hospitalizations Update — COVID -NET, July 2023– September 2024 Adults Ages ≥65 Years and Persons with Immunocompromising Conditions Christopher A. Taylor, PhD RESP -NET Hospitalization Surveillance Team Coronavirus and Other Respiratory Viruses Division Meeting of the Advisory Committee on Immunization Practices (ACIP) October 23, 2024National Center for Immunization and Respiratory Diseases 1 COVID -NET is a population -based hospitalization surveillance platform.…
CDC ACIP — Vaccine Advisory Committee
· Acip
/ Slides
· 30 pages
Effectiveness of COVID -19 vaccines Ruth Link -Gelles, PhD, MPH CDR, US Public Health Service Vaccine Effectiveness Program LeadCoronavirus and Other Respiratory Viruses DivisionCenters for Disease Control and Prevention October 23, 2024National Center for Immunization and Respiratory Diseases •VE data to inform need for: -Additional doses in immunocompromised •What’s known about VE in immunocompromised vs. non- immunocompromised adults, including waning by time since dose -Additional dose…
CDC ACIP — Vaccine Advisory Committee
· Acip
/ Slides
· 28 pages
Economic analysis of an additional dose of the 2024 -2025 COVID -19 vaccine University of Michigan COVID -19 Vaccination Modeling Team Presentation to the Advisory Committee on Immunization Practices October 23, 2024 1 Study team University of Michigan •Lisa A. Prosser, PhD, Principal Investigator •David W. Hutton, PhD, Co -Investigator •Acham Gebremariam, MS, Programmer/Analyst •Angela Rose, MS, MPH, Project Manager •Kerra Mercon, MS, Research Assistant Wake Forest University •Cara Janusz,…
CDC ACIP — Vaccine Advisory Committee
· Acip
/ Slides
· 118 pages
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
· Acip
/ Slides
· 23 pages
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
· Acip
/ Slides
· 7 pages
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
· Acip
/ Slides
· 22 pages
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
· Acip
/ Slides
· 14 pages
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
· Acip
/ Slides
· 14 pages
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…