A Narrative Review of Vaccine Pharmacovigilance During Mass Vaccination Campaigns: Focus on Myocarditis and Pericarditis after COVID-19 mRNA Vaccination.

Vaccines have had a tremendous impact on reducing the burden of infectious diseases, however, they have the potential to cause adverse events following immunisation (AEFIs). Prelicensure clinical trials are limited in their ability to detect rare AEFI that may occur in less than one per thousand individuals. While post-marketing surveillance systems have shown COVID-19 mRNA vaccines to be safe, they led to the identification of rare cases of myocarditis and pericarditis after COVID-19 vaccination that were not initially detected in clinical trials. In this narrative review, we highlight concepts of vaccine pharmacovigilance during mass vaccination campaigns and compare the approaches used in the context of myocarditis and pericarditis following COVID-19 vaccination to historical examples. We describe mechanisms of passive and active surveillance, their strengths and limitations, and how they interacted to identify and characterize the safety signal of myocarditis and pericarditis after COVID-19 mRNA vaccination. Articles were synthesized from a PubMed search using relevant keywords for articles published on vaccine surveillance systems and myocarditis and pericarditis after COVID-19 vaccination, in addition to the authors' collections of relevant publications and grey literature reports. The global experience around the identification and monitoring of myocarditis and pericarditis after COVID-19 mRNA vaccination has provided important lessons for vaccine safety surveillance and highlighted its importance in maintaining public trust in mass vaccination programs in a pandemic context.