Vaccine Monitoring Platform

The Vaccine Monitoring Platform (VMP) is a collaboration between the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) aiming to generate real-word evidence (RWE) on the safety, effectiveness and use of vaccines in the European Union (EU) and the European Economic Area (EEA).

The VMP enables EMA and ECDC to coordinate and oversee EU-funded, independent post-authorisation studies on vaccine use, safety, and effectiveness. These studies are conducted in EU and EEA countries.

EMA and ECDC established the VMP in May 2022, in accordance with the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123) and ECDC’s extended mandate Regulation (EU) 2022/2370.

The VMP is an important milestone for the European Commission’s European Health Union initiative.

EMA's participation is based on its formal role in preparing for and managing the response to health emergencies, and supporting regulators to make use of real-world data. 

For more information, see:

• Crisis preparedness and management
• Big data

Role

The Vaccine Monitoring Platform (VMP) has the following responsibilities:

• Maintaining a system for the prioritisation, launch, registration and supervision of vaccine studies at the European level
• Facilitating and coordinating the conduct of vaccine post-authorisation studies 
• Monitoring vaccine impact, safety, effectiveness and use over time
• Disseminating study results to relevant decision-makers via public channels, study reports and articles in scientific journals

Composition

The VMP is governed by a steering group and supported by a joint EMA-ECDC secretariat.

The steering group is co-chaired by EMA and ECDC. Members of the steering group are: 

• Peter Arlett (co-chair, EMA)
• Karl Ekdahl (co-chair, ECDC)
• Sabrina Bacci (ECDC)
• Marco Cavaleri (EMA)
• Catherine Cohet (EMA)
• Piotr Kramarz (ECDC)

​The joint EMA / ECDC secretariat is comprised of experts from both agencies. It oversees VMP activities such as project management, scientific and technical work, and annual workplan implementation.

The VMP also benefits from the non-binding advice of the Immunisation and Vaccine Monitoring Advisory Board (IVMAB), a consultative body.  

The IVMAB advises on the prioritisation, design, implementation and interpretation of post-authorisation vaccine studies coordinated by EMA and ECDC.

It consists of a multidisciplinary panel with representatives from the:

• European Commission
• ECDC’s National Focal Points for Vaccine Preventable Diseases
• EMA’s Emergency Task Force (ETF)
• EMA’s committees on human medicines (CHMP) and safety of medicines (PRAC)

Research agenda

A VMP research agenda is available outlining topics where expanding research is needed to gather additional knowledge for vaccines currently in use, and for future ones.

This document is mainly meant to support academia, public health bodies and the pharmaceutical industry to set priorities when planning real-world vaccine studies.

EMA and ECDC set up the research agenda based on categories of research topics which include:

• Data gaps for authorised vaccines
• Diseases for which post-authorisation monitoring is a priority due to change in vaccine composition (e.g. flu and COVID-19)
• Developing or re-purposing vaccines to support their use during a public health emergency
• Preparedness for the evaluation of future vaccines (e.g. burden of a disease)
• Post-authorisation monitoring of vaccines to inform their benefit / risk profile 

The VMP steering group endorsed the first version of the research agenda in July 2023.

Vaccine Monitoring Platform (VMP) research agenda

Reference Number: EMA/430310/2023

Studies

A list of EMA-funded studies is available providing an overview of real-world data studies that address the topics from the VMP research agenda.

Detailed information on each study is available on the HMA-EMA catalogue of real-world data studies:

• HMA-EMA catalogue of real-world data studies

Vaccine Monitoring Platform: List of EMA-funded studies

ECDC maintains its own list of VMP studies it has funded:

• ECDC: Vaccine Monitoring Platform