COVID-19 vaccine monitoring

VAC4EU is providing the infrastructure, governance and sustainability solution to prepare Europe for monitoring of the COVID-19 vaccines through the ACCESS project.

What is ACCESS?

The ACCESS project has been requested to prepare a European infrastructure for the monitoring of the COVID-19 vaccines and for conducting specific studies in a collaborative manner across EU countries.

ACCESS is funded with public money through the European Medicines Agency. By December 2020 a system should be in place (protocols, governance, data sites, and people readiness) for the conduct of studies that may be requested from public or private organizations (e.g. vaccine manufacturers).

How can persons and organizations contribute to preparation of EU readiness?

VAC4EU organizes open scientific webinars around certain topics:

Anyone can register to join the webinars

What will ACCESS deliver?

  1. Definitions, codes (ICD9-CM, ICD10-CM, READ, ICPC and Meddra) and algorithms to identify 37 pre-specific adverse events of special interest

  2. Background rates of these events from 7 countries covering 130 million source population. Incidence rates will be made available in a dashboard on the VAC4EU website when available. Rates are generated using the VAC4EU infrastructure and tools

  3. Seven template protocols for monitoring vaccines using different types of data sources and data collection, so that each EU country may be able to participate.

    • Hospital-based studies (primary data collection)
      • Prospective monitoring of COVID-19 vaccine effectiveness using a test negative design
      • Case-based studies (Self-controlled) to assess safety
    • Patient-based safety monitoring
      • Prospective monitoring of COVID-19 safety using apps administered directly to vaccinated persons
    • Secondary use of electronic health record data
      • Retrospective assessment of the safety of COVID-19 vaccines using available EHR data
      • Retrospective monitoring of COVID-19 vaccine effectiveness using available EHR data
    • Immunization registries
      • Retrospective monitoring of coverage of COVID-19 vaccines based on immunization registries/data sources
  4. Inventory of country capacity and feasibility to participate in any such study to create readiness.

For more details, please find enclosed the briefing book. All protocols will be delivered to the EMA. Any organisation interested to explore how to participate can contact: