Global Pharmacovigilance: Data for 2017–2025 with an Assessment of the Impact of the COVID-19 Pandemic

INTRODUCTION. Continuous assessment of the dynamics of quantitative indicators and the impact of extraordinary events on them, such as the COVID-19 pandemic, is critically important for the development of the international drug safety monitoring program and national pharmacovigilance systems.

AIM. This study aimed to provide a preliminary assessment of the dynamics of quantitative indicators in the World Health Organization (WHO) VigiBase database in the periods before, during and after the COVID-19 pandemic (2017–2025) to identify trends for the expected identification of trends potentially related to changes in the global pharmacovigilance system under extraordinary events.

MATERIALS AND METHODS. The dynamics of the integral indicator of global pharmacovigilance, the annual total number of Individual Case Safety Reports (ICSR, cases) included in the VigiBase database in 2017–2025, divided into 3 periods of 3 years each: before the COVID-19 pandemic, during the pandemic and after the pandemic, was assessed. The data were analyzed using the VigiMatch statistical tool built into VigiLyze.

RESULTS. The development of global pharmacovigilance system in the period before the COVID-19 pandemic was reflected in an annual increase of 300–400 thousand cases. In 2021, there was a sharp increase in the number of cases, and the proportion of reports for COVID-19 vaccines out of the total number of cases during the pandemic was 39.2%. In the post-COVID period, the number of cases in the global pharmacovigilance system was below the predicted values. Deviations of the actual number of cases included annually in the global pharmaco vigilance system from the expected in 2020–2025, as well as changes in the ranking of data, occurred mainly due to active safety monitoring of the COVID-19 vaccines.

CONCLUSIONS. The identified trends in the global pharmacovigilance system in 2020–2025 may be preliminarily associated not only to the impact of the COVID-19 pandemic, but also to other causes and require further study.

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