As part of the reinforced COVID-19 vaccine surveillance system, pharmaco-epidemiological surveillance is implemented by EPI-PHARE.

Pharmaco-epidemiological surveillance is based on the analysis of data from the National Health Data System (SNDS) which presents individual information on all healthcare consumption and hospitalizations of almost the entire population residing in France. Once the data are available, the comparative population-based approach implemented requires quantifying the risks of occurrence of serious adverse events following vaccination, that is to say essentially leading to hospitalization or death, at the scale of the entire population targeted by vaccination in France. Thus, the pharmaco-epidemiological information will be complementary to that obtained by the pharmacovigilance system based on the notification of individual cases by health professionals or vaccinated people.

A multidisciplinary expert committee has been set up to provide high-level expertise in the fields of clinical medicine, immunology, vaccination and pharmacovigilance at each stage of this pharmaco-epidemiological system.

Deaths and hospitalizations occur daily, regardless of COVID-19vaccination, particularly in certain categories of the population constituting priority targets for vaccination such as the elderly or those with pathologies exposing them to a high risk of severe form of COVID-19. It is thus important to estimate the frequency of these events within these populations outside the context of the COVID-19 vaccination campaign in order to have objective figures to compare with those that will be reported in the framework of the monitoring of vaccinated people, and thus to be able to correctly interpret these monitoring data.

In this context, EPI-PHARE carried out an initial work aimed at describing the frequency of deaths and hospitalizations among people residing in residential establishments for dependent elderly people (EHPAD) or long-term care units (USLD) in France in during the years 2018 and 2019.

This work confirms and quantifies the high frequency of deaths and hospitalizations among residents of EHPADs and USLDs outside the context of the Covid-19 epidemic, and it makes it possible to estimate the numbers expected over the coming months, as the vaccination campaign begins. These figures, which reach the order of 465 deaths and more than 1000 hospitalizations per day, present a first basis of comparison for monitoring vaccine safety in this population, pending the implementation of fine pharmaco-epidemiological studies.

In the continuation of this work, EPI-PHARE endeavors to quantify the frequency of deaths and hospitalizations among other categories of the population targeted by vaccination, in particular the non-institutionalized elderly and people with pathologies exposing to a high risk of severe form of COVID-19.