Safety Monitoring of COVID‐19 Vaccines: Perspective from the European Medicines Agency
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 …
Union in 2021, a high vaccine uptake leading to an unprecedented volume of safety data …
Lessons learned from COVID-19, H1N1, and routine vaccine pharmacovigilance in the United States: a path to a more robust vaccine safety program
Introduction Vaccine pharmacovigilance is an essential component of vaccine safety
programs. Vaccine pharmacovigilance refers to detecting uncommon adverse events …
programs. Vaccine pharmacovigilance refers to detecting uncommon adverse events …
[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 …
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 …
adverse events (AEs) can significantly impact drug safety signal detection. Coronavirus …
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 …
example, in the context of generating background incidence rates (IRs) for adverse events of …
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 …
events of special interest (AESI) that may occur following COVID-19 vaccination is important …
Cohort event monitoring of adverse reactions to COVID-19 vaccines in seven European Countries: pooled results on first dose
M Raethke, F van Hunsel, NH Thurin… - Drug Safety, 2023 - Springer
Introduction COVID-19 vaccines were rapidly authorised, thus requiring intense post-
marketing re-evaluation of their benefit-risk profile. A multi-national European collaboration …
marketing re-evaluation of their benefit-risk profile. A multi-national European collaboration …
Safety of BA. 4-5 or BA. 1 bivalent mRNA booster vaccines: nationwide cohort study
NW Andersson, EM Thiesson, JV Hansen, A Hviid - bmj, 2023 - bmj.com
Objective To examine the association between the omicron adapted bivalent mRNA covid-
19 booster vaccines received as a fourth dose and risk of adverse events. Design …
19 booster vaccines received as a fourth dose and risk of adverse events. Design …
Uptake, effectiveness and safety of COVID-19 vaccines in individuals at clinical risk due to immunosuppressive drug therapy or transplantation procedures: a …
Background Immunocompromised individuals are at increased risk of severe COVID-19
outcomes, underscoring the importance of COVID-19 vaccination in this population. The lack …
outcomes, underscoring the importance of COVID-19 vaccination in this population. The lack …
Adverse Events Following the BNT162b2 mRNA COVID-19 Vaccine (Pfizer-BioNTech) in Aotearoa New Zealand
M Walton, V Pletzer, T Teunissen, T Lumley, T Hanlon - Drug Safety, 2023 - Springer
Abstract Introduction In February 2021, New Zealand began its largest ever immunisation
programme with the BNT162b2 mRNA coronavirus disease 2019 (COVID-19) vaccine …
programme with the BNT162b2 mRNA coronavirus disease 2019 (COVID-19) vaccine …