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

The Global COVID Vaccine Safety (GCoVS) project was established in 2021 under the multinational Global Vaccine Data Network (GVDN) consortium to facilitate the rapid assessment of the safety of newly introduced vaccines. This study analyzed data from GVDN member sites on the background incidence rat...

Full description

Saved in:
Bibliographic Details
Published in:Vaccine 2023-10, Vol.41 (42), p.6227-6238
Main Authors: Phillips, A., Jiang, Y., Walsh, D., Andrews, N., Artama, M., Clothier, H., Cullen, L., Deng, L., Escolano, S., Gentile, A., Gidding, G., Giglio, N., Junker, T., Huang, W., Janjua, N., Kwong, J., Li, J., Nasreen, S., Naus, M., Naveed, Z., Pillsbury, A., Stowe, J., Vo, T., Buttery, J., Petousis-Harris, H., Black, S., Hviid, A.
Format: Article
Language:English
Subjects:
Adverse event following immunization
Adverse events
Age groups
Assessments
Background rates
Confidence intervals
Coronaviruses
COVID-19
COVID-19 vaccines
Data analysis
Embolism
Emergency medical care
Encephalomyelitis
Guillain-Barre syndrome
Health care
Heart diseases
Immunization
Life Sciences
Myocarditis
Pandemics
Pharmacovigilance
Population
Safety
Seizures
Sex
Thrombocytopenia
Thrombosis
Uranium
Vaccine safety surveillance
Vaccines
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:The Global COVID Vaccine Safety (GCoVS) project was established in 2021 under the multinational Global Vaccine Data Network (GVDN) consortium to facilitate the rapid assessment of the safety of newly introduced vaccines. This study analyzed data from GVDN member sites on the background incidence rates of conditions designated as adverse events of special interest (AESI) for COVID-19 vaccine safety monitoring. Eleven GVDN global sites obtained data from national or regional healthcare databases using standardized methods. Incident events of 13 pre-defined AESI were included for a pre-pandemic period (2015–19) and the first pandemic year (2020). Background incidence rates (IR) and 95% confidence intervals (CI) were calculated for inpatient and emergency department encounters, stratified by age and sex, and compared between pre-pandemic and pandemic periods using incidence rate ratios. An estimated 197 million people contributed 1,189,652,926 person-years of follow-up time. Among inpatients in the pre-pandemic period (2015–19), generalized seizures were the most common neurological AESI (IR ranged from 22.15 [95% CI 19.01–25.65] to 278.82 [278.20–279.44] per 100,000 person-years); acute disseminated encephalomyelitis was the least common (
ISSN:0264-410X
1873-2518
0264-410X
DOI:10.1016/j.vaccine.2023.08.079