EMA published the information on this page for use during the COVID-19 public health emergency. EMA is no longer updating this page.

COVID-19 vaccines: pharmacovigilance plan

The pharmacovigilance plan for COVID-19 vaccines sets out how EMA and the national competent authorities in the EU Member States identify and evaluate any new information that arises promptly, including any safety signals that are relevant for the benefit-risk balance of these vaccines:

Pharmacovigilance plan of the EU Regulatory Network for COVID-19 vaccines

Observational research

EMA is taking steps to use real-world data from clinical practice to monitor the safety and effectiveness of COVID-19 treatments and vaccines and other medicines used in patients with COVID-19.

Real-world monitoring complements EMA's regular safety-monitoring activities, including spontaneous reporting of suspected side effects by patients and healthcare professionals.

Information on ongoing COVID-19-related observational studies in the EU is available in the European Union electronic register of post-authorisation studies (EU PAS Register). Users can find these studies by entering 'COVID-19' in the 'Title of Study' search filter.

EMA and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) are encouraging all researchers to register their pharmacoepidemiological studies related to COVID-19 in the EU PAS Register.

They should also upload and make their study protocols public, with a description of the data collected, and include ‘COVID-19’ in the study title.

EMA has contracted institutions specialising in observational research to conduct several research projects detailed below.

Click on the research areas to read more about each project.

Project titleSafety monitoring of COVID-19 vaccines in the EU (Covid-Vaccine-Monitor)
Objectives
  • Cohort-event monitoring to generate prospective data on the incidence of suspected adverse reactions following vaccination in the general population and in special populations (e.g. pregnant women, immunocompromised) in a large number of EU Member States
  • Readiness and rapid signal assessment of emerging safety concerns in at least 10 electronic healthcare data sources from VAC4EU and the EU Pharmacoepidemiology and Pharmacovigilance (PE & PV) research network at Utrecht University, using common protocols, common data models and distributed analytics. Contributing EU Member States include The Netherlands, Denmark, Norway, Spain, Italy, France and Germany; and in addition, the United Kingdom.
Timelines
  • Start of project:  April 2021
  • Start of study: mid-2021
  • Final study report: April 2023
ContractorEU PE&PV Research Network, coordinated by Utrecht University: Pharmacoepidemiology and Clinical Pharmacology - Universiteit Utrecht (uu.nl)
Related information

Project titleNatural history of coagulopathy and use of anti-thrombotic agents in COVID-19 patients and people vaccinated against SARS-CoV-2
Objectives
  • Determine the incidence of arterial and venous thromboembolic events and their consequences among groups of patients diagnosed with COVID-19 infection, and groups of persons vaccinated against SARS-CoV-2 with a first dose and a second dose
  • In these patients, evaluate how arterial and venous thromboembolic events are associated with patient characteristics that promote stasis of circulation, vascular endothelial injury and hypercoagulability, taking into account factors such as treatments
Deliverables
Timelines
  • Start of project: November 2020
  • First deliverables: January 2021
  • Final delivery: September 2021 
ContractorErasmus MC Rotterdam

Project titleEarly safety monitoring of COVID-19 vaccines in EU Member States (Early-Covid-Vaccine-Monitor) 
Objectives

The study complements routine pharmacovigilance and other EU-level safety monitoring activities by:

  • Generating prospective data on the incidence of suspected adverse reactions following vaccination of different population groups in 2021, in seven EU Member States (the Netherlands, Belgium, Luxembourg, Italy, France, Germany, Croatia) and the United Kingdom. The study uses a web-based application to collect self-reported information from vaccinated individuals.
  • Conducting cohort monitoring of exposure, adverse events of special interest (including coagulation disorders) in vaccinated cohorts (by brand) and COVID-19 diagnoses using 4 electronic healthcare databases (the Netherlands, Italy, Spain and the United Kingdom) prior to and after COVID-19 vaccination
  • Test systems and tools to enable larger studies aimed at further monitoring the safety of COVID-19 vaccines, as vaccination campaigns continue to be rolled out
Deliverables
Timelines
  • Start of project: December 2020
  • Start of study: February 2021
  • Final study report: December 2021
Contractor

EU PE&PV Research Network, coordinated by Utrecht University: Pharmacoepidemiology and Clinical Pharmacology - Universiteit Utrecht (uu.nl)

Related information

Project titleCONSIGN (COVID-19 infectiOn aNd medicineS In preGNancy)
Objectives
  • Establish a multinational research network using existing data sources and cohorts of pregnant women
  • Estimate the prevalence of medicines used in pregnant women with COVID-19
  • Describe the severity and clinical outcomes of COVID-19 according to treatments received during pregnancy
  • Assess and compare the rate of pregnancy and neonatal outcomes of different treatments for COVID-19 in pregnant women
Timelines
  • Start of project: July 2020
  • First deliverables: October 2020
  • Final delivery: July 2021 
ContractorUtrecht University
Related information

Project titleMulticentre collaboration for COVID-19 observational studies
Objectives
  • Identify large national cohorts of COVID-19 patients and appropriate comparator groups
  • Develop a study protocol template for multinational studies
  • Establish a collaborative framework for researchers together with the European Health Data & Evidence Network (EHDEN) consortium established under the EU's Innovative Medicines Initiative
  • Conduct a multinational pilot study on a research question to be agreed with EMA
Timelines
  • Start of project: June 2020
  • First deliverables: September 2020
  • Final delivery: June 2021 
Contractor

IQVIA Ltd.

Results
Related information

Project titleACCESS (vACcine Covid-19 monitoring readinESS)
Objectives
  • Generate background incidence rates of adverse events of special interest
  • Identify a Europe-wide network of healthcare databases for monitoring the coverage, safety and effectiveness of COVID-19 vaccines, to enable pharmacoepidemiological studies
  • Develop template protocols for COVID-19 vaccine coverage, effectiveness and safety studies
Deliverables

Background incidence rates of adverse events of special interest (AESIs)

Vaccine safety studies

  • Study protocols (EU PAS register). These cover:
    • Prospective cohort-event monitoring
    • Rapid assessment of safety concerns using electronic health records
    • Signal evaluation in electronic healthcare databases
    • Hospital case-based signal evaluation 

Vaccine effectiveness studies

Coverage of COVID-19 vaccines in electronic healthcare databases

Feasibility analysis of an EU infrastructure for COVID-19 vaccine monitoring

These deliverables are also available on the website of the Vaccine monitoring Collaboration for Europe, VAC4EU.

Timelines
  • Start of project: May 2020
  • First deliverables: August 2020
  • Final delivery: first quarter of 2021
Contractor

Utrecht University

Related information

For more information, see:

Report on pharmacovigilance tasks from EU Member States and the European Medicines Agency (EMA) 2019-2022

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