The global rapid spread of COVID-19 has lead to the development of vaccines to control the spread of the pandemic. The benefit and safety of these new vaccins is something that needs to be monitored. In this study, which is a continuation of a previous study where we looked at the frequency of new occurrences of about 40 different of adverse events of interest prior to the introduction of any covid-vaccines on the market ("background rates"), we will assess the frequency of these events over time since the introduction of covid-vaccins and compare between vaccinated and nonvaccinated people.
The global rapid spread of COVID-19 caused by the SARS-CoV2 triggered the need for developing vaccines to control for this pandemic. This study will generate incidence rates of adverse events of special interest (AESI) prior to and after COVID-19 vaccination, to facilitate monitoring of the benefit-risk profile of licensed COVID-19 vaccines.
The objectives of this study are to monitor and estimate the incidence rates of adverse events of special interest (AESI), diagnosed COVID-19 in vaccinated and non-vaccinated persons by data source over the period January 1st 2020-October 31st 2021 by brand and dose of vaccine and age of the population. We will further stratify by the at-risk population for developing severe COVID-19 by data source, brand and dose of vaccine as well as age.
Study design:
A retrospective, multi-database, dynamic cohort study in 4 data sources in 4 European countries (Italy, Netherlands, Spain, United Kingdom).
Variables:
Variables of interest will be:
• Person-time: birth and death dates as well as periods of observation.
• Events: dates of medical and/or procedure and/or prescription/dispensing codes to identify AESI, COVID-19 and at-risk medical conditions.
• Vaccines: vaccine brands and batch numbers (where possible)
Data analysis:
Incidence rates of listed AESI will be calculated in non-exposed time periods (prior to vaccination or in non-vaccinated) and during each one-week risk window since vaccination by each dose, stratified per brand of vaccine. Data on vaccine exposures (doses), incidence rate of diagnosed COVID-19 and each AESI of interest by time since vaccination dose will be displayed on a dashboard. Incidence rates (and 95%CI) of COVID-19 and AESI among at-risk populations (in terms of comorbidity and by age) will also be computed.
COVID disease; Multisystem inflammatory syndrome; Acute respiratory distress syndrome;Acute cardiovascular injury (including microangiopathy, heart failure, stress cardiomyopathy, coronary artery disease, arrhythmia, myocarditis); Coagulation disorders ( including deep vein thrombosis, pulmonary embolus, cerebrovascular stroke, haemorrhagic disease, cerebral vein sinus
thrombosis, disseminated intravascular coagulation); Generalised convulsion ; Guillain Barré Syndrome; Diabetes (type 1); Acute kidney injury; Acute liver injury; Anosmia, ageusia ; Chilblain-like lesions; Single organ cutaneous vasculitis ;Erythema multiforme
Anaphylaxis; Death (any cause) ;Sudden death (by codes) ;Acute aseptic arthritis ;Meningoencephalitis ;Acute disseminated encephalomyelitis (ADEM);Narcolepsy ;Thrombocytopenia;Transverse myelitis;Bells’ palsy
Olaf Klungel - Chief Investigator - Utrecht University
Patrick Souverein - Corresponding Applicant - Utrecht University
HES Admitted Patient Care