10000 documents

Facility Management, Maintenance and Operation Core

NIH Pandemic-Era Grants · Pandemic Era Grants / 2023

Raymond Paul Goodrich · COLORADO STATE UNIVERSITY · 2023 · $1,338,439 — Project Summary: The BSL3 suites in the Rocky Mountain Regional Biocontainment Laboratory (RMRBL) at Colorado State University (CSU) have been operational and at capacity since being commissioned. These facilities support research in response to new threats from established pathogens, such as Mycoba…

Core D: Clinical Research

NIH Pandemic-Era Grants · Pandemic Era Grants / 2023

Ighovwerha Ofotokun · EMORY UNIVERSITY · 2023 · $525,581 — PROJECT SUMMARY/ABSTRACT The Clinical Research Core (CRC) (Core D) provides services to support researchers conducting human subjects research studies investigating the pathogenesis of HIV disease, treatment and prevention of HIV, strategies to eliminate HIV from those who are infected, and the re…

Pilot Grant Program

NIH Pandemic-Era Grants · Pandemic Era Grants / 2023

Daniel E Voth · UNIV OF ARKANSAS FOR MED SCIS · 2023 · $228,000 — PROJECT SUMMARY/ABSTRACT A primary means of research support for investigators in the Center for Microbial Pathogenesis and Host Inflammatory Responses (CMPHIR) in Phase III will be the NIGMS-funded Pilot Grant Program (PGP), supplemented with institutional funds ($100,000 per year for each year) t…

Animal Core

NIH Pandemic-Era Grants · Pandemic Era Grants / 2023

Stephen Mark Tompkins · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · 2023 · $390,290 — Summary/Abstract Robust animal models of coronavirus infection are required for pre-clinical assessment of candidate vaccines and therapeutic antibodies to prevent coronavirus infection and disease. The goal of the Animal Model Core is to provide a central resource of animal models and virological t…

Data Management and Analysis Core

NIH Pandemic-Era Grants · Pandemic Era Grants / 2023

Olivier Elemento · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · 2023 · $135,600 — Data Management Core Principal Investigator: Olivier Elemento, PhD. Co-I: Zhengming Chen, PhD Abstract This Core will provide bioinformatics expertise and support with data integration and analyses. The Core will serve three main goals. First, it will provide central data storage and data management…

Clinical Phenotyping and Human Core

NIH Pandemic-Era Grants · Pandemic Era Grants / 2023

RICHARD G WUNDERINK · NORTHWESTERN UNIVERSITY AT CHICAGO · 2023 · $234,154 — PROJECT SUMMARY CORE B Lower respiratory tract infections cause nearly 80% of deaths from infectious diseases in the US, and respiratory viruses, such as influenza and SARS-CoV-2, are increasingly recognized as common causes of severe community-acquired pneumonia (CAP). As mortality from severe CAP …

COVID-19: NIAID Regulatory Support Center

NIH Pandemic-Era Grants · Pandemic Era Grants / 2023

ASIMAH RAFI · TECHNICAL RESOURCES INTERNATIONAL, INC. · 2023 · $5,439,404 — The purpose of this contract is to provide regulatory expertise and support to operate and manage the NIAID Regulatory Support Center (RSC) to provide a wide range of clinical research activities and programs for NIAID. The RSC provides comprehensive regulatory support to: 1) perform NIAID-funded an…

MICROBIOLOGY AND INFECTIOUS DISEASES BIOLOGICAL RESEARCH REPOSITORY (MID BRR) - SARS-CoV-2 RESEARCH

NIH Pandemic-Era Grants · Pandemic Era Grants / 2023

TIMOTHY STEDMAN · AMERICAN TYPE CULTURE COLLECTION · 2023 · $1,864,880 — This contract provides unique and quality-assured infectious reagents and resources to the scientific community for use in basic research and product development. The scope of this contract includes the acquisition, authentication, production, preservation, storage, and distribution of research and …

MICROBIOLOGY AND INFECTIOUS DISEASES BIOLOGICAL RESEARCH REPOSITORY (MID BRR) - SARS-CoV-2 RESEARCH

NIH Pandemic-Era Grants · Pandemic Era Grants / 2023

TIMOTHY STEDMAN · AMERICAN TYPE CULTURE COLLECTION · 2023 · $1,647,582 — This contract provides unique and quality-assured infectious reagents and resources to the scientific community for use in basic research and product development. The scope of this contract includes the acquisition, authentication, production, preservation, storage, and distribution of research and …

The Military HIV Research Program ( MHRP ) Clinical Trial Unit

NIH Pandemic-Era Grants · Pandemic Era Grants / 2022

Julie A. Ake · HENRY M. JACKSON FDN FOR THE ADV MIL/MED · 2022 · $42,798 — Abstract COVID-19 Vaccine Clinical Development Team The USG enterprise to develop and optimize vaccine prevention modalities for SARS CoV-2 incorporates the DAIDS HVTN as a key partner in strategic development, research prioritization and execution, landscape analysis for future directions and analy…

03 MacNeil COVID 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 41 pages

Updates to COVID -19 Vaccine Effectiveness COVID -19 Session Coronavirus and Other Respiratory Viruses Division June 25, 2025National Center for Immunization and Respiratory Diseases 2•Vaccine effectiveness methods & context •Estimates of COVID -19 Vaccine Effectiveness in Children •Estimates of COVID -19 Vaccine Effectiveness in Adults •ConclusionsAgenda –COVID -19 vaccine effectiveness (VE) Methods & Context 3 4 Case ControlPerson with acute respiratory illness SARS -CoV-2 test COVID -19 …

04 Meyer COVID 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 41 pages

Update on CDC’s COVID-19 Vaccine Safety Monitoring Sarah Meyer, MD MPH Director, CDC’s Immunization Safety Office June 25, 2025 1 Key Points • CDC and interagency partners launched an extensive vaccine safety monitoring program for COVID-19 vaccines • Many potential safety outcomes were rigorously assessed through complementary passive and active systems • Myocarditis is causally associated with mRNA COVID-19 vaccines …

05 Peacock COVID 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 9 pages

COVID- 19 Vaccination ImplementationNational Center for Immunization and Respiratory Diseases June 25, 2025Immunization Services Division Centers for Disease Control and Prevention •National Immunization Survey (NIS): -Random -digit -dial cellular telephone survey of adults 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 weighted to…

06 MacNeil COVID 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 6 pages

Evidence to Recommendations (partial) for 2025 –2026 COVID -19 Vaccination Coronavirus and Other Respiratory Viruses Division June 25, 2025National Center for Immunization and Respiratory Diseases 1 Evidence to Recommendations ( EtR) Framework EtR Domain Question(s) Public Health Problem •Is the problem of public health importance? Benefits and Harms•How substantial are the desirable anticipated effects? •How substantial are the undesirable anticipated effects? •Do the desirable effects…

01 MacNeil Mat Peds RSV 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 8 pages

Maternal/Pediatric Respiratory Syncytial Virus (RSV) Session Advisory Committee on Immunization Practices Meeting June 25, 2025 1U.S. Centers for Disease Control and Prevention Session Introduction •RSV can infect the small airways in the lungs, particularly in infants •Most (68%) infants are infected in the first year of life and nearly all (97%) by age 2 years2 •2-3% of young infants are hospitalized for RSV3,4,5 -~80% of children hospitalized with RSV age <2 years have no underlying…

02 Peacock Mat Peds RSV 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 15 pages

Implementation and Uptake of Nirsevimab and Maternal Vaccine for Infant Protection from RSV Immunization Services Division Centers for Disease Control and Prevention June 25, 2025National Center for Immunization and Respiratory Diseases •National Immunization Survey (NIS): -Random -digit -dial cellular telephone survey of adults 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,…

03 MacNeil Mat Peds RSV 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 54 pages

Effectiveness and impact of RSV prevention products in infants during the 2024 –2025 RSV season Coronavirus and Other Respiratory Viruses Division June 25, 2025National Center for Immunization and Respiratory Diseases Product Effectiveness (PE) •Summary of CDC systems used toevaluate PE •Effectiveness of nirsevimab and maternal RSV vaccine during the 2024 –2025 RSV season in the U.S. RSV Hospitalization Rates and Product Impact •Summary of CDC systems used for monitoring RSV…

04a DeSilva Mat Peds RSV 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 27 pages

Prenatal RSVpreF Vaccine Safety 2023 –2024 Respiratory Season The Vaccine Safety Datalink (VSD) Malini DeSilva, MD, MPH Presentation to ACIP June 25, 2025 © HealthPartners 2Vaccine Safety Datalink (VSD) •Collaborative project between CDC and 13 integrated healthcare organizations •Monitors safety of vaccines used in the U.S., primarily through observational multisite studies •Includes data on ~15.5 million individuals across all sites annually (~4.5% of U.S. population) •Annual birth…

04b Daley Mat Peds RSV 508

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

Monitoring the Safety of Nirsevimab in Infants Birth through <8 Months June 25, 2025Matthew F. Daley, MDPreliminary Results from the Vaccine Safety Datalink for the 2024 -2025 Season KAISER PERMANENTE INSTITUTE FOR HEALTH RESEARCH •No conflicts of interest •Presenting on behalf of the Vaccine Safety Datalink (VSD) teamDisclosures and Acknowledgments Nirsevimab Safety Surveillance Slide 2 Background Slide 3 KAISER PERMANENTE INSTITUTE FOR HEALTH RESEARCH •Long -acting monoclonal antibody,…

05 MacNeil Mat Peds RSV 508

CDC ACIP — Vaccine Advisory Committee · Acip / Slides · 51 pages

U.S. Centers for Disease Control and Prevention Evidence to Recommendation Framework : Clesrovimab Maternal/Pediatric RSV Work Group Advisory Committee on Immunization Practices June 25, 2025 1 Policy Question • Should clesrovimab be recommended for all infants <8 months of age born during or entering their first RSV season? 2 Evidence to Recommendation (EtR ) Framework EtR Domain Question(s) Public Health Problem…