Programme d’évaluation de la vaccination COVID-19 : Risque d’effets indésirables d’intérêt des différents vaccins et comparaison du bénéfice-risque des vaccins (EVACOV-RISC)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07BX) Other viral vaccines

  Other viral vaccines
• Medical condition to be studied:
  COVID-19 immunisation

Population studied

• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  6700000

Study design details

• Main study objective:
  The first objective is to evaluate the incidence rate of each adverse event of special interest (AESI) following the introduction of various anti-COVID-19 vaccines in the French population compared to the baseline rates estimated just before their introduction. The second one is to compare the risk of each AESI between vaccinated and non-vaccinated persons, and between the different vaccines.
• Outcomes:
  The primary outcomes are the AESIs included in the list set up in collaboration with the EMA.
• Data analysis plan:
  For each year (2021, 2022, 2023) in the SNDS, 3 cohorts will be defined: one on a random sample of 10% of the French population, one on all patients with an AESI, and one on all pregnant women. For the first objective, the incidence rate of each AESI will be compared before (2017-2020) and after the introduction of vaccines. Interrupted time series and time-to-onset analyses related to the date of vaccination should complete these elements. For the second objective, a comparative approach relying on propensity score matching will be set up to assess AESI relative risks between vaccinated and non-vaccinated subjects. A self-controlled risk interval design will also be implemented for all suitable AESIs.