Contribution of real-life studies in France during the COVID-19 pandemic and for the national pharmaco-epidemiological surveillance of COVID-19 vaccines - 03/02/23

Doi : 10.1016/j.therap.2022.12.013

Mahmoud Zureik ^a,^b,⁎ , François Cuenot ^a, Alain Weill ^a, Rosemary Dray-Spira ^a
^a EPI-PHARE, Epidemiology of Health Products (French National Agency for Medicines and Health Products Safety, and French National Health Insurance), Saint-Denis cedex, France
^b University of Paris-Saclay, UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmaco-epidemiology, CESP (Center for Research in Epidemiology and Population Health), 78180 Montigny le Bretonneux, France

^⁎Corresponding author. EPI-PHARE, Epidemiology of Health Products (French National Agency for Medicines and Health Products Safety, and French National Health Insurance), 143/147, boulevard Anatole-France, Saint-Denis cedex, FranceEPI-PHARE, Epidemiology of Health Products (French National Agency for Medicines and Health Products Safety, and French National Health Insurance)143/147, boulevard Anatole-FranceSaint-Denis cedexFrance

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Summary

During the COVID-19 pandemic, EPI-PHARE, a scientific group in pharmaco-epidemiology created by the French National Agency for the Safety of Medicines and Health Products (ANSM) and the French National Health Insurance (Cnam), has reoriented its work program to enlighten health authorities in this health crisis. By exploiting massive and complex data of the French Health Data System (SNDS) from the beginning of the first lockdown in France in March 2020, we were able to publish numerous results on the use, benefits and risks of medicines, on the risk factors of COVID-19 before and after vaccination, and on the benefits and risks of COVID-19 vaccines. Our results were widely taken into account by the French health authorities and allowed them to take informed decision in this pandemic situation in order to ensure the health of the population.

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Keywords : Pharmacoepidemiology, National Health Data System (SNDS), COVID-19, Public-decision, Anti-COVID19 vaccine