ECDC and EMA collaborate on vaccine safety and effectiveness monitoring studies
The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) convened on 6 and 7 December in Amsterdam the first meeting of the Immunisation and Vaccine Monitoring Advisory Board (IVMAB) of the Vaccine Monitoring Platform (VMP). The VMP is a joint initiative of the two Agencies for strengthening the continuous monitoring of the safety and effectiveness of vaccines in the European Union (EU).
Through the VMP, EMA and ECDC will coordinate and oversee EU-funded, independent post-authorisation studies on vaccines use, safety and effectiveness conducted in EU countries.
Emer Cooke, EMA’s Executive Director, said in her opening remarks:
“With the new vaccines monitoring platform we have an instrument in place through which we will prioritise research, fund independent studies and complement our knowledge of how vaccines work in real life. The additional evidence generated through these independent studies will enhance our ability to continuously monitor the safety and effectiveness of vaccines. This will improve the robustness of our decision making, which is essential to build and maintain people’s trust in these key products.”
Andrea Ammon, ECDC Director, said:
“The goal of this new collaboration is to build a network and a powerful infrastructure across Europe to generate real-world evidence on vaccines that is completely independent from industry interests and studies, using EU funds only. This is particularly important and crucial looking at the rising levels of vaccines scepticism that we have seen for COVID vaccines but also for other vaccines. At the same time, we also want to build a stronger bridge between the regulatory and public health dimension of vaccine assessment and the pandemic has shown how critical this is.”
The IVMAB is the Advisory Body supporting the operations of the VMP, co-chaired by EMA and ECDC. It is a unique multidisciplinary forum which brings together vaccine regulatory experts as well as representatives from EU national public health authorities. Its role is to provide advice on the prioritisation, design, implementation and interpretation of VMP studies to help inform regulatory and public health decisions on key vaccines used in EU immunisation programmes.
The first EU-funded study on the effectiveness and safety of Imvanex (mpox/monkeypox vaccine) is ongoing.*
The VMP has been created following the 2018 Council Recommendation on Strengthened Cooperation against vaccine preventable diseases and the subsequently extended mandates of EMA and ECDC regarding monitoring vaccines and vaccination programmes in the post-authorisation phase. It represents an important milestone of the European Commission initiative to support the European Health Union.
*This sentence was amended on 9 December 2022 to correct the information on the ongoing study of Imvanex.