EMA and ECDC join forces to monitor COVID-19 vaccines

Article written by Gary Finnegan.

The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) has unveiled 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, large-scale, EU-wide studies are an essential tool to closely monitor how these novel vaccines perform in real life, the agencies said.

These studies will generate 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.

‘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.

ECDC Director Andrea Ammon said the 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 will, she added, continue to deliver results for the benefit of all Europeans for years to come.

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.