A5078200427- Influenza Virus Research Studies
- COVID-19 epidemiological studies
- Pharmacovigilance and Adverse Drug Reactions
- Viral Infections and Outbreaks Research
- SARS-CoV-2 and COVID-19 Research
- Health Systems, Economic Evaluations, Quality of Life
- Pharmaceutical Economics and Policy
- COVID-19 and healthcare impacts
- Heparin-Induced Thrombocytopenia and Thrombosis
- Vaccine Coverage and Hesitancy
- COVID-19 Clinical Research Studies
- Artificial Intelligence in Healthcare and Education
- Zoonotic diseases and public health
- Intramuscular injections and effects
- Statistical Methods in Clinical Trials
- Respiratory viral infections research
- Animal Disease Management and Epidemiology
- Machine Learning in Healthcare
- Bacillus and Francisella bacterial research
- Platelet Disorders and Treatments
- Emergency and Acute Care Studies
- COVID-19 and Mental Health
- Biosimilars and Bioanalytical Methods
- Risk Perception and Management
- SARS-CoV-2 detection and testing
United States Food and Drug Administration
2024
Center for Biologics Evaluation and Research
2024
University of Ottawa
2016-2022
Institute of Population and Public Health
2016
The U.S. Food and Drug Administration (FDA) Biologics Effectiveness Safety (BEST) Initiative conducts active surveillance of adverse events special interest (AESI) after COVID-19 vaccination. Historical incidence rates (IRs) AESI are comparators to evaluate safety.We estimated IRs 17 in six administrative claims databases from January 1, 2019, December 11, 2020: Medicare for adults ≥ 65 years commercial (Blue Health Intelligence®, CVS Health, HealthCore Integrated Research Database, IBM®...
A novel influenza virus has emerged to produce a global pandemic four times in the past one hundred years, resulting millions of infections, hospitalizations and deaths. There is substantial uncertainty about when, where how next will occur.We developed mathematical model chart evolution an pandemic. We estimate likely burden future pandemics through health economic endpoints. An important component this adequacy existing hospital-resource capacity. Using simulated population reflective...
Adverse events associated with vaccination have been evaluated by epidemiological studies and more recently gained additional attention the emergency use authorization of several COVID-19 vaccines. As part its responsibility to conduct postmarket surveillance, US Food Drug Administration continues monitor adverse special interest (AESIs) ensure vaccine safety, including for COVID-19.
Introduction: The Food and Drug Administration Center for Biologics Evaluation Research conducts post-market surveillance of biologic products to ensure their safety effectiveness. Studies have found that common vaccine exposures may be missing from structured data elements electronic health records (EHRs), instead being captured in clinical notes. This impacts monitoring adverse events following immunizations (AEFIs). For example, COVID-19 vaccines been regularly administered outside...
COVID-19 infections have contributed to substantial increases in hospitalizations. This study describes demographics, baseline clinical characteristics and treatments, outcomes among U.S. patients admitted hospitals with during the prevaccine phase of pandemic. A total 20,446 hospitalized a positive nucleic acid amplification test were identified from three large electronic health record databases 5 February-30 November 2020 (Academic Health System: n = 4504; Explorys; 7492; OneFlorida:...
Influenza pandemics emerge at irregular and unpredictable intervals to cause substantial health, economic social burdens. Optimizing health-system response is vital mitigating the consequences of future pandemics.
<sec> <title>BACKGROUND</title> Adverse events associated with vaccination have been evaluated by epidemiological studies and more recently gained additional attention the emergency use authorization of several COVID-19 vaccines. As part its responsibility to conduct postmarket surveillance, US Food Drug Administration continues monitor adverse special interest (AESIs) ensure vaccine safety, including for COVID-19. </sec> <title>OBJECTIVE</title> This study is Biologics Effectiveness Safety...
Thrombosis with thrombocytopenia syndrome (TTS) has been reported following receipt of adenoviral vector-based COVID-19 vaccines. However, no validation studies evaluating the accuracy International Classification Diseases-10-Clinical Modification (ICD-10-CM)-based algorithm for unusual site TTS are available in published literature.The purpose this study was to assess performance clinical coding 1) leverage literature review and input develop an ICD-10-CM-based identify as a composite...
Monitoring COVID-19 testing volumes and test positivity is an integral part of the response to pandemic. We described characteristics individuals who were tested positive for SARS-CoV-2 during pre-vaccine phase pandemic in United States (U.S.).This descriptive study analyzed three U.S. electronic health record (EHR) databases (Explorys, Academic Health System, OneFlorida) between February November 2020, identifying patients received interpretable nucleic acid amplification (NAAT) result....
Background: The U.S. Food and Drug Administration (FDA) Biologics Effectiveness Safety (BEST) Initiative conducts active surveillance of adverse events special interest (AESI) after COVID-19 vaccination. Historical incidence rates (IRs) AESI are comparators to evaluate safety.Methods: We estimated IRs 17 in six administrative claims databases from January 1, 2019, December 11, 2020: Medicare for adults ≥65 years commercial (Blue Health Intelligence®, CVS Health, HealthCore Integrated...