Pharmacovigilance for COVID-19 vaccines: A 1-year experience in France.

ABSTRACT

As of February 2022, more than 130 million Covid vaccine doses had been distributed in France. During the first year of relevant vaccination, 128,766 adverse events (AE) were reported and analysed, as compared to an average of 40,000 per year for all drugs combined in the pre-pandemic years. A weekly monitoring committee was set up. Through enhanced pharmacovigilance, by February 2022, 49 safety signals had been identified nationwide and submitted to the EMA. For example, very few cases of myocarditis and pericarditis were reported. In children, 9 multisystem inflammatory syndromes were reported.