Vaccine Monitoring Platform
The Vaccine Monitoring Platform (VMP) is a joint 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 and effectiveness 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 vaccines use, safety, and effectiveness. These studies are conducted in EU 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.
The Vaccine Monitoring Platform (VMP) has the following responsibilities:
- Maintaining a system for the prioritisation, launch, registration and supervision of vaccine studies at the EU level
- Facilitating and coordinating the conduct of post-authorisation safety and effectiveness studies to monitor vaccine performance and impact over time
- Disseminating the study results to relevant decision-makers via public channels such as technical reports and scientific journals
The two structures that manage the VMP are its steering group and the joint EMA / ECDC secretariat.
The steering group is co-chaired by EMA and ECDC. It governs the VMP by bringing together senior representatives from both agencies. They are:
- Peter Arlett (co-chair)
- Karl Ekdahl (co-chair)
- Sabrina Bacci
- Marco Cavaleri
- Catherine Cohet
- Piotr Kramarz
The Joint EMA / ECDC secretariat - comprised of experts from both agencies, it runs VMP activities such as project management, scientific and technical work, and annual work plan implementation.
The VMP also benefits from the non-binding advice of the Immunisation and Vaccine Monitoring Advisory Board (IVMAB), a consultative body.
IVMAB focuses on the prioritisation, design, implementation and interpretation of post-authorisation 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).