The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) convened on December 6 and 7 in Amsterdam the first meeting of the Immunization 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-authorization 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 prioritize 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 skepticism 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 prioritization, design, implementation and interpretation of VMP studies to help inform regulatory and public health decisions on key vaccines used in EU immunization programs.
The first EU-funded study is already underway. It is a pre-exposure prophylaxis study to assess the effectiveness of Imvanex (monkeypox vaccine) in 15,000 individuals, which was launched by the VMP in October 2022.
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 programs in the post-authorization phase. It represents an important milestone of the European Commission initiative to support the European Health Union.