The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) today kicked off a new initiative aimed at strengthening post-marketing monitoring of the safety, effectiveness and impact of COVID-19 vaccines in the European Union (EU) and the European economic Area (EEA).

With the ongoing authorisation and rollout of several COVID-19 vaccines in the EU, jointly coordinated, large-scale, EU-wide effectiveness and safety studies are an essential tool to closely monitor how these novel vaccines perform in real life. These studies are key to generate adequate evidence to support continuous assessment of the benefits and risks of the vaccines and inform decision-making on their use in national or regional vaccination strategies for different populations.

EMA and ECDC will jointly coordinate and oversee a number of observational studies which will be funded from the EU budget and conducted in several European countries. In line with their respective mandates and in collaboration with EU/EEA countries, EMA leads on monitoring the safety, and ECDC the effectiveness, of these vaccines. This work will be supported by a Joint Advisory Board (JAB) to the two Agencies that held its first meeting today.

“Observational research is an important pillar in the post-marketing surveillance of COVID-19 vaccines and increased EU level collaboration is needed so that Member States can join forces and organise large studies that meet the needs of both medicines regulators and national institutes for public health and vaccination,” said Emer Cooke, EMA’s Executive Director. “EMA and ECDC are ideally placed to coordinate such studies and will work closely together, alongside the European Commission, to involve national competent authorities of the Member States in the set-up, execution and assessment of the data.”

“Today, at the start of the European Immunisation Week, I am very happy to launch this new scientific forum and joint work that will provide important insights and evidence to shape public health strategies and vaccination policies in the Member States. This new model of collaboration brings medicine regulators and public health authorities closer together and establishes processes towards a more permanent, sustainable collaboration platform for monitoring vaccine safety and effectiveness. This work has its underpinnings in the Council Recommendation of 2018 and will continue to deliver results for the benefit of all Europeans for years to come,” said Andrea Ammon, ECDC Director.

The JAB is co-chaired by EMA and ECDC. It is composed of representatives of the European Commission, the EU / EEA National Immunisation Technical Advisory Groups (NITAG) collaboration organised by ECDC, members of the EMA COVID-19 pandemic Task Force (ETF) and EMA’s committees on human medicines (CHMP) and medicine safety (PRAC). The JAB is established as a consultative body to advise on the prioritisation, design, conduct and interpretation of the independent post-authorisation observational studies. It may provide guidance on operational aspects related to the implementation of these studies, as needed.

The JAB will meet at regular intervals, as the need for studies will continue to emerge to inform vaccination strategies and relevant regulatory actions on COVID-19 vaccines.

Posted on the EMA website on 26 April 2021