Benefit Risk contextualisation of COVID-19 vaccines in the EU

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47485
• EU PAS number:
  EUPAS44229
• Study ID:
  47485
• Official title and acronym:
  Benefit Risk contextualisation of COVID-19 vaccines in the EU
• DARWIN EU® study:
  No
• Study countries:
  Belgium
• Study description:
  The Belgian CenStat/I-BioStat team is delighted to contribute to EMA’s important task to monitor important benefits and safety signals of COVID-19 vaccines by addressing three specific objectives. The first objective is 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. The second objective is to explore the possibility of developing composite measure The third objective is to provide a toolkit to support the calculations and interpretation of the various outcomes.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Planned: 27/07/2021

Actual: 27/07/2021

Study start date

Planned: 04/08/2021

Actual: 04/08/2021

Date of final study report

Planned: 25/04/2022

Actual: 25/05/2022

Sources of funding

EMA

Study protocol

Initial protocol

COVID 19 risk benefit analysis for EMA- study protocol

Updated protocol

Study protocol EUPAS44229

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable