Pharmacovigilance plays a critical role in ensuring the safety of vaccines by monitoring and analyzing adverse events (AEs) associated with immunization. Current pharmacovigilance frameworks rely heavily on the Medical Dictionary for Regulatory Activities (MedDRA) for AE classification, yet its structural and terminological limitations hinder systematic case retrieval and signal detection. These challenges are particularly evident in endocrine/metabolic and musculoskeletal/connective tissue (MSK/CT) AEs, where clinically oriented categorization is lacking.

The COVARE project aims to enhance vaccine safety monitoring by developing and validating clinically oriented (anatomo-physiological) classification models for vaccine-related AEs. These models will be applied to COVID-19 vaccines to facilitate a more structured, reproducible, and clinically relevant assessment of their safety profiles. Importantly, these models are not intended as alternatives to MedDRA but as complementary research tools that improve AE case retrieval and signal detection workflows for clinical and pharmacovigilance researchers. Moreover, their structured framework allows for adaptation to other vaccines, drugs, and health technologies, supporting broader pharmacovigilance efforts.

In parallel, COVARE investigates barriers and promoters of AE reporting among healthcare professionals (HCPs) in the Czech Republic by developing a validated behavioural assessment instrument grounded in the COM-B model and the Theory of Planned Behaviour (TPB). Through psychometric validation and a national cross-sectional survey, the project aims to identify determinants influencing HCPs’ AE reporting practices. The findings will provide evidence-based strategies to optimize pharmacovigilance effectiveness, improve vaccine safety monitoring, and enhance regulatory decision-making.