A5082227471- SARS-CoV-2 and COVID-19 Research
- Vaccine Coverage and Hesitancy
- Viral Infections and Immunology Research
- Animal Virus Infections Studies
- Cervical Cancer and HPV Research
- Bacterial Infections and Vaccines
- Cutaneous Melanoma Detection and Management
- Hepatitis B Virus Studies
- Global Cancer Incidence and Screening
- Heparin-Induced Thrombocytopenia and Thrombosis
- Genital Health and Disease
- Economic and Financial Impacts of Cancer
- Drug-Induced Adverse Reactions
- HER2/EGFR in Cancer Research
- Viral-associated cancers and disorders
- BRCA gene mutations in cancer
- Polyomavirus and related diseases
- COVID-19 Clinical Research Studies
- Muscle and Compartmental Disorders
- Poxvirus research and outbreaks
- Viral gastroenteritis research and epidemiology
- Influenza Virus Research Studies
- COVID-19 epidemiological studies
- Pharmaceutical industry and healthcare
- Bacillus and Francisella bacterial research
New England College of Optometry
2018-2024
Optum (United States)
2011-2024
Center for Biologics Evaluation and Research
2024
Consejería de Educación de la Junta de Castilla y León
2022
HealthInsight
2011
Icahn School of Medicine at Mount Sinai
2006-2010
Inserm
2010
Roche (France)
2010
Importance Active monitoring of health outcomes after COVID-19 vaccination provides early detection rare that may not be identified in prelicensure trials. Objective To conduct near-real-time the US pediatric population. Design, Setting, and Participants This cohort study evaluated 21 prespecified exposure before 2023 to BNT162b2, mRNA-1273, or NVX-CoV2373 ancestral monovalent vaccines children aged 6 months 17 years by applying a framework using care data from 3 commercial claims databases...
Breast cancer in African-American (AA) women occurs at an earlier age than European-American (EA) and is more likely to have aggressive features associated with poorer prognosis, such as high-grade negative estrogen receptor (ER) status. The mechanisms underlying these differences are unknown. To address this, we conducted a case-control study evaluate risk factors for ER- disease both AA EA women. With the onset of Health Insurance Portability Accountability Act 1996, creative measures were...
To estimate the incidence rate (IR) of progressive multifocal leukoencephalopathy (PML) in patients without HIV.Within a large US health insurer database between January 2000 and June 2008, we conducted retrospective observational study. We identified people with autoimmune diseases, chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma (NHL), or history bone marrow solid organ transplantation, general population cohort. developed PML case-finding algorithm validated diagnoses medical...
Importance Active monitoring of health outcomes after COVID-19 vaccination offers early detection rare that may not be identified in prelicensure trials. Objective To conduct near–real-time following BNT162b2 the US pediatric population aged 5 to 17 years. Design, Setting, and Participants This population-based study was conducted under a public surveillance mandate from Food Drug Administration. years were included if they received through mid 2022 had continuous enrollment medical...
Background: The incidence of hospitalized rhabdomyolysis is not well characterized among patients taking statin-fibrate combination therapies. Objective: To estimate and compare the rates during periods exposure to different statins fibrates. Methods: We retrospectively identified a cohort who initiated statin or fibrate between January 1, 1998, December 31, 2007, using database large US hearth insurer. Patients were followed for occurrence rhabdomyolysis, determined by clinical review...
Base excision repair (BER) and nucleotide (NER) pathways damaged DNA, polymorphisms in these genes might affect breast cancer susceptibility. We evaluated associations between seven single-nucleotide four DNA ( ERCC4 rs1799801, XPC rs2227998, rs2228001, rs2228000, OGG1 rs1052133 XRCC1 rs25487 rs25486) risk, examining modification by smoking alcohol consumption, using data from the Western New York Exposures Breast Cancer Study. Women aged 35–79 years with incident n = 1170) age- race-matched...
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®...
Monovalent booster/additional doses of COVID-19 vaccines were first authorized in August 2021 the United States. We evaluated real-world effectiveness receipt a monovalent dose vaccine compared with receiving primary series without dose. Cohorts individuals after complete identified 2 administrative insurance claims databases (Optum, CVS Health) supplemented state immunization information system data between and March 2022. Individuals but one-to-one matched to boosted on calendar date,...
Abstract Overexpression of the epidermal growth factor (EGF) pathway has been implicated in melanoma pathogenesis, and a recent case-control study identified single nucleotide polymorphism (G to A) EGF gene where G allele was associated with increased expression an risk melanoma. To further evaluate this association, we conducted analysis from Genes, Environment, Melanoma at University Michigan site using two different designs. Incident cases histopathologically confirmed first primary that...
COVID-19 vaccines are authorized for use in children the United States; real-world assessment of vaccine effectiveness is needed. This study's objective was to estimate receiving a complete primary series monovalent BNT162b2 (Pfizer-BioNTech) US children.
Abstract Active monitoring of health outcomes after COVID-19 vaccination provides early detection rare post-licensure. Objective To evaluate following bivalent Pfizer-BioNTech (BNT162b2) and Moderna (mRNA-1273.222) among individuals 6 months older in the United States. Design Monthly from August 2022 to July 2023 four administrative claims databases. Descriptive analyses monitored vaccine uptake, outcome counts coadministration influenza vaccines. Sequential tested for elevated risk each a...
Importance Safety and effectiveness studies of COVID-19 vaccines are being conducted using clinical data, including administrative claims. However, claims data only partially capture administered vaccine doses for numerous reasons, such as vaccination at sites that do not generate reimbursement. Objective To evaluate the extent to which Immunization Information Systems (IIS) linked enhances claims-based a commercially insured population estimate magnitude misclassification vaccinated...
ABSTRACT Objective To evaluate febrile seizure risk following monovalent COVID-19 mRNA vaccination among children aged 2-5 years. Methods The primary analysis evaluated who had a outcome in the 0-1 days vaccination. A self-controlled case series was performed three commercial insurance databases to compare of interval (0-1 days) control (8-63 days). exposure interest receipt dose 1 and/or 2 vaccinations. day interval). conditional Poisson regression model used rates and intervals estimate...
Abstract Purpose Large numbers of multiple myeloma patients can be studied in real‐world clinical settings using administrative databases. The validity these studies is contingent upon accurate case identification. Our objective was to develop and evaluate algorithms use with data identify cases. Methods Patients aged ≥18 years ≥1 International Classification Diseases, 9th Revision, Clinical Modification (ICD‐9‐CM) code for (203.0 x ) were identified at two study sites. At site 1, several...
Abstract Importance Active monitoring of health outcomes after COVID-19 vaccination provides early detection rare that may not be identified in prelicensure trials. Objective To conduct near real-time following the United States (US) pediatric population aged 6 months to 17 years. Design We evaluated 21 pre-specified outcomes; 15 were sequentially tested through surveillance, and monitored descriptively within a cohort vaccinated children. for increased rate each outcome compared historical...
The 4-valent human papillomavirus (HPV) vaccine (4vHPV vaccine), Gardasil®, is indicated for the prevention of several HPV-related diseases. objective was to assess safety 4vHPV administered males as part routine care. study used a US health insurance claims database, and included males, age 9 26 years, who initiated between October 2009 December 2016. General outcomes were identified using ICD diagnosis codes associated with emergency room visits hospitalizations in database risk periods...
Abstract Purpose To evaluate the Risk Evaluation and Mitigation Strategies (REMS) for varenicline by assessing patients' understanding of medication guide (MG) at pre‐specified time points: 18 months, 3 years, 7 years after REMS approval. Methods Self‐administered surveys were mailed to people who received based on a pharmacy dispensing. Survey questions assessed potential risks outlined in MG: neuropsychiatric symptoms, skin reactions, allergic cardiovascular risks. Crude weighted analyses...
Abstract Background The U.S. FDA authorized the monovalent third primary series or booster doses of COVID-19 mRNA vaccines in August 2021 for persons 18 years and older. Monitoring outcomes following updated authorizations is critical to evaluate vaccine safety can provide early detection rare adverse events (AEs) not identified pre-licensure trials. Methods We evaluated risk 17 AEs from through 2022 among adults aged 18-64 three commercial databases (Optum, Carelon Research, CVS Health)...
With data from 2 US claims databases (Optum, CVS Health) supplemented with Immunization Information System COVID 19 vaccine records, we evaluated overall and time-specific effectiveness (VE) of an initial primary series for 3 monovalent vaccines—BNT162b2, mRNA-1273, JNJ-7836735—in adults (18-64 years). Vaccinated individuals were matched to unvaccinated comparators, estimated VE against any medically diagnosed hospital/emergency department (ED)-diagnosed 19. Additionally, by era predominant...
Two vaccines (JYNNEOS; ACAM2000) were available in the United States to prevent mpox during 2022 clade II outbreak with majority of people receiving JYNNEOS. As part Biologics Effectiveness and Safety (BEST) Initiative, FDA monitored safety JYNNEOS using three commercial health plan claims databases supplemented local state Immunization Information System data. We assessed vaccine uptake, described vaccinated population, rates 11 potential adverse events (AEs) following vaccination, compared...