Safety Monitoring of COVID‐19 Vaccines: Perspective from the European Medicines Agency

J Durand, JM Dogné, C Cohet… - Clinical …, 2023 - Wiley Online Library
Prior to deployment of coronavirus disease 2019 (COVID‐19) vaccines in the European
Union in 2021, a high vaccine uptake leading to an unprecedented volume of safety data …

Current Approaches in Postapproval Vaccine Safety Studies Using Real-World Data: A Systematic Review of Published Literature

JJ Wu, M Hauben, M Younus - Clinical Therapeutics, 2024 - Elsevier
Purpose: Well-designed observational postmarketing studies using real-world data (RWD)
are critical in supporting an evidence base and bolstering public confidence in vaccine …

[HTML][HTML] Background rates of adverse events of special interest for COVID-19 vaccines: A multinational Global Vaccine Data Network (GVDN) analysis

A Phillips, Y Jiang, D Walsh, N Andrews, M Artama… - Vaccine, 2023 - Elsevier
Abstract Background The Global COVID Vaccine Safety (GCoVS) project was established in
2021 under the multinational Global Vaccine Data Network (GVDN) consortium to facilitate …

Impact of the COVID-19 pandemic on the spontaneous reporting and signal detection of adverse drug events

D Montes-Grajales, R Garcia-Serna, J Mestres - Scientific Reports, 2023 - nature.com
External factors severely affecting in a short period of time the spontaneous reporting of
adverse events (AEs) can significantly impact drug safety signal detection. Coronavirus …

Applying two approaches to detect unmeasured confounding due to time-varying variables in a self-controlled risk interval design evaluating COVID-19 vaccine safety …

SH Bots, S Belitser, RHH Groenwold… - American journal of …, 2025 - academic.oup.com
We test the robustness of the self-controlled risk interval (SCRI) design in a setting where
time between doses may introduce time-varying confounding, using both negative control …

Lessons learned from COVID-19, H1N1, and routine vaccine pharmacovigilance in the United States: a path to a more robust vaccine safety program

DA Salmon, RT Chen, S Black… - Expert Opinion on Drug …, 2024 - Taylor & Francis
Introduction Vaccine pharmacovigilance is an essential component of vaccine safety
programs. Vaccine pharmacovigilance refers to detecting uncommon adverse events …

Assessing heterogeneity of electronic health‐care databases: A case study of background incidence rates of venous thromboembolism

M Russek, C Quinten, VMT de Jong… - … and Drug Safety, 2023 - Wiley Online Library
Purpose Heterogeneous results from multi‐database studies have been observed, for
example, in the context of generating background incidence rates (IRs) for adverse events of …

Standardised and reproducible phenotyping using distributed analytics and tools in the data analysis and real world interrogation network (DARWIN EU)

F Dernie, G Corby, A Robinson, J Bezer… - … and Drug Safety, 2024 - Wiley Online Library
Purpose The generation of representative disease phenotypes is important for ensuring the
reliability of the findings of observational studies. The aim of this manuscript is to outline a …

Background incidence rates of selected adverse events of special interest (AESI) to monitor the safety of COVID-19 vaccines

A Pillsbury, A Phillips, L Deng, H Quinn, K Macartney… - Vaccine, 2023 - Elsevier
Background Determining background rates of medical conditions identified as adverse
events of special interest (AESI) that may occur following COVID-19 vaccination is important …

Optogenetic control of kinesin-1,-2,-3 and dynein reveals their specific roles in vesicular transport

S Nagpal, K Swaminathan, D Beaudet, M Verdier… - Cell reports, 2024 - cell.com
Each cargo in a cell employs a unique set of motor proteins for its transport. To dissect the
roles of each type of motor, we developed optogenetic inhibitors of endogenous kinesin-1 …