Benefit Risk contextualisation of COVID-19 vaccines in the EU

Study type

• Study topic:
  Human medicinal product

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

  Disease epidemiology

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  200000030564

  Covid-19 vaccines
• Medical condition to be studied:
  COVID-19 immunisation
• Additional medical condition(s):
  Adverse events likely to associated to COVID-19 vaccines as reported to EudraVigialance (e.g. myocarditis, TTS)

Population studied

• Short description of the study population:
  Individuals who have received COVID-19 vaccines.
• Age groups:
  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:
  44800000

Study design details

• Main study objective:
  1) to propose a valid method to quantify both the benefits and the risks related to COVID-19 vaccines given potential data limitations and reflecting uncertainty with regard to the various ingredients of the proposed risk-benefit measure. 2) to explore the possibility of developing composite measures. 3) to provide a toolkit to support the calculations and interpretation of the various outcomes.
• Data analysis plan:
  For the benefit of COVID-19 vaccines assessment: Dynamic disease transmission models will be used to study multiple benefits and take into account uncertainty about parameter estimates. Both the societal perspective, via compartmental models, and the individual perspective, via individual-based models, belong to this family of dynamic transmission models. For the risk assessment: The ratio of the observed events and patients exposed to vaccine results in an estimate for the probability of the risk after vaccination. The probability of risk in the unvaccinated population or background risk can be retrieved through background rates provided (or estimated) by EMA. Additional benefits and risks can be added to the model, as well as additional covariates such as comorbidities and additional compartments for vaccines or mixed vaccines.Uncertainty of input variables can be incorporated into priors into the Bayesian analysis. Alternatively, sensitivity analysis can be performed.

Documents

Study results

EMA_COVID19_vaccines_final_report_20042022