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 data processing pipelines. The tool will be used for study teams in VAC4EU and similar organisations to enhance their workflow efficiency and capacity in following programming guidelines.

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.

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 introduces an innovative approach by estimating the sensitivity of ‘narrow’ algorithms through the positive predictive value assessment of ‘possible’ algorithms.

FLOW

This study aims to review available phenotype libraries, and design tools for implementation of a VAC4EU phenotype library.

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 for these populations using electronic healthcare records databases.

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.

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 purpose of conducting vaccine safety studies.

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 overexposure potentially related to hepatic or renal impairment.

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 pregnancy.

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 their offspring.