COVID-19 Vaccine Monitor (CVM)
This two-year project was requested by the EMA to extend and build on work from the Early Covid Vaccine Monitor Study. CVM supported COVID-19 vaccine...
Early COVID-19 Vaccine Monitor (ECVM)
This project was a complement to an EU passive surveillance system for the four COVID-19 vaccines available on the market at the time. The project...
COVID-19 Vaccines Effectiveness (CoVE)
The aim of this project was to study waning immunity after primary COVID-19 vaccine regimens as well as booster vaccinations. The study complemented common test-negative...
vACcine COVID-19 monitoring ReadinESS (ACCESS)
The goal of this project was to prepare a European infrastructure for monitoring COVID-19 vaccines, initiated prior to their rollout in early 2021. The main...
A framework for the post-authorisation SAFETY Evaluation of VACcines in the EU (SAFETY-VAC)
The primary aim of this project was to assess the capacity to conduct safety studies in a netowrk of electronic health record data sources from...
Global Vaccine Safety Project (GCoVS)
The GCoVS project, led by Global Vaccine Data Network (GVDN) and supported by funding from the U.S. Centers for Disease Control and Prevention (CDC), aims...
Pfizer/BioNTech Comirnaty® bivalent Post-Authorisation Safety Study
The aim of this study is to assess whether there is an increased risk of AESI after receiving the bivalent Pfizer/BioNTech COVID-19 vaccine.
Pfizer/BioNTech Comirnaty® myocarditis and pericarditis study
The aim of this study is to characterise the clinical course of myocarditis and/or pericarditis diagnosed after receiving the Pfizer-BioNTech COVID-19 vaccine
Pfizer/BioNTech Comirnaty® Post-Authorisation Safety Study
The primary aim of this study was to determine whether there is an increased risk of AESI after receiving the Pfizezr/BioNTech COVID-19 vaccine.
Pfizer ABRYSVO® Post-Authorisation Safety Study – Hepatically and renally impaired
The purpose of this study is to assess the safety profile of the Pfizer RSV vaccine in renally and hepatically impaired older adults.
Pfizer ABRYSVO® Post-Authorisation Safety Study – Pregnancy
The purpose of this study is to assess the safety profile of the Pfizer RSV vaccine in women who receive the vaccine during pregnancy and...
Pfizer PAXLOVID™ – Safety in pregnancy
The study aims to assess the risk of adverse pregnancy, offspring, and maternal outcomes in women exposed to Paxlovid or to other COVID-19 treatments during...
Pfizer PAXLOVID™ – Safety in patients with hepatic or renal impairment
The study aims to assess the safety of Paxlovid in persons with moderate or severe hepatic or renal impairment and adverse events resulting from drug...
SAFETY-VAC – Immunocompromised populations
This study aims to provide a consolidated approach to identify and characterise immunocompromised populations in real-world data sources and to produce incidence and prevalence rates...
FLOW
This study aims to review available phenotype libraries, and design tools for implementation of a VAC4EU phenotype library.
SeValid
This study aims to assess the validity of algorithms used to identify cases of myocarditis and deep vein thrombosis from hospital discharge forms. Notably, SeValid...
Metasyn
This study aims to develop open-source software capable of generating high quality synthetic data from metadata information that preserves the privacy of patients.
CoMaSy
This study aims to develop open-source software that facilitates the creation and iterative revision of codebooks and can generate Directed Acyclic Graphs (DAGs) to showcase...
ACCESS – Background rates
This study aimed to generate background rates of 27 adverse events of special interest for monitoring of COVID-19 vaccines, creating a series of event definition...
ACCESS – Template protocols for COVID-19 vaccine safety monitoring
The goal of this study was to develop template protocols for four different safety monitoring designs: (1) cohort event monitoring to assess safety, (2) rapid...
ACCESS – Template protocols for COVID-19 vaccine effectiveness monitoring
The goal of this study was to develop template protocols for two study designs that monitor the effectiveness of COVID-19 vaccines: (1) a test negative...
ACCESS – Template protocol for COVID-19 vaccine coverage monitoring
The goal of this study was to develop a template protocol for vaccine coverage studies through the secondary use of electronic healthcare databases and/or immunisation...
COVID-19 Vaccines Effectiveness
The primary objective of this study was to estimate the effectiveness and waning of effectiveness in adults and adolescents (heterologous vs homologous primary vaccinations), children...
COVID-19 Vaccine Monitor – rapid safety assessment using electronic healthcare datasources
The primary objective for this study was to assess the potential association between the occurrence of specific AESIs and vaccination with COVID-19 vaccines within disease-specific...
COVID-19 Vaccine Monitor – cohort event monitoring in special populations
The primary aim of this study was to generate and compare incidence rates of patient-reported adverse reactions of different COVID-19 vaccines in pregnant and lactating...
(Early) COVID-19 Vaccine Monitor – cohort event monitoring via primary data collection
The objectives of this study were (1) to generate incidence rates of patient-reported ADRs of COVID-19 vaccine brand in near real-time, and (2) to describe...
(Early) COVID-19 Vaccine Monitor – cohort event monitoring via primary and secondary data collection
This study aimed to monitor AESI prior and following COVID-19 vaccination, in order to estimate incidence rates and pick up signals.
AstraZeneca AZD1222 Post-Authorisation Safety Study
This study aimed to evaluate the incidence and relative risk of AESI after receiving the AstraZeneca COVID-19 vaccine.
Janssen Jcovden® Post-Authorisation Safety Study
The first aim of the study was to conduct a feasibility assessment on a safety evaluation study on the Janssen COVID-19 vaccine, then to assess...
Moderna Spikevax® Post-Authorisation Safety Study – Pregnancy
The primary objective of this study is to assess whether there is a higher risk of pregnancy and/or neonatal complications or adverse outcomes after exposure...
Moderna Spikevax® Post-Authorisation Safety Study
The primary objective of this study is to assess whether vaccination with the Moderna COVID-19 vaccine is associated with increased rates of AESI in the...
Moderna Spikevax® myocarditis and pericarditis study
The primary objective of this study is to identify risk factors for myocarditis and pericarditis after vaccination with the Moderna COVID-19 vaccine, as well as...
SAFETY-VAC – Network of data sources for vaccine safety evaluation
This study aims to provide and describe a network of real-world data sources to evaluate vaccine safety signals and to assess its fitness for the...
SAFETY-VAC – Background rates of pre-existing chronic diseases
This study aims to assess the feasibility of participating European data sources in estimating the background and cumulative incidence of 10 selected autoimmune disease flares.
Request a Study
Vaccine manufacturers, regulators, public health institutes, patient groups, ministries, representatives from the European Commission and/or research organisations can request the conduct of a study. After alignment has been reached with the requester on the scope and organisation of the study, VAC4EU will send out an expression of interest request to member organisations, then assist in contract negotiation and assembling a study team.
If you have a need for the implementation of a specific pharmacovigilance study you may request it through the Studies Acquisition team, at study@vac4eu.org.
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