EMA, ECDC Team Up to Strengthen Post-Marketing Surveillance of COVID-19 Vaccines

April 29, 2021
Pharmaceutical Technology Editors

The European Medicines Agency and the European Centre for Disease Prevention have joined forces in a new initiative aimed at strengthening the post-marketing surveillance of COVID-19 vaccines in Europe.

According to an April 26, 2021 press release, the European Medicines Agency (EMA) and the European Centre for Disease Prevention (ECDC) have joined forces in a new initiative aimed at strengthening the post-marketing surveillance of COVID-19 vaccines in Europe.

The safety, effectiveness, and impact of COVID-19 vaccines being used in the European Union (EU) and European Economic Area will be evaluated in large-scale studies to monitor how the vaccines are performing in real-world settings. These EU-wide observational studies will be key in the creation of evidence to support the continuous assessment of the benefits and risks of the vaccines, and to inform any decision-making on the use of the vaccines in national or regional strategies.

EMA and ECDC will work together on the coordination and oversight of several observational studies that will be funded from the EU budget and performed in several EU countries. EMA will be the lead on monitoring safety of the vaccines and ECDC will take the lead on the effectiveness of the vaccines. A Joint Advisory Board, which is co-chaired by EMA and ECDC, will support the work via consultation on prioritization, design, conduct, and interpretation of the studies.

“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, in the press release. “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.”

“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,” added Andrea Ammon, ECDC director, in the press release. “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.”

Source: EMA