The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) have started a new initiative to strengthen the post-marketing monitoring of the safety, effectiveness and impact of COVID-19 vaccines in the European Union (EU) and the European economic Area (EEA). 

The EMA stated that as the authorisation and rollout of COVID-19 vaccines continues, large-scale, EU-wide effectiveness and safety studies will be an essential tool to monitor how these novel vaccines perform. Additionally, they will be key to generating the necessary 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.

Under the new initiative, EMA and ECDC will jointly co-ordinate and oversee numerous observational studies, funded from the EU budget and conducted in several European countries. The EMA will lead on monitoring the vaccine’s safety and the ECDC will lead on their effectiveness.

The work will be supported by a Joint Advisory Board (JAB), co-chaired by the two agencies and composed of representatives from the European Commission (EC), 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 Committee for Medicinal Products for Human Use (CHMP) and Pharmacovigilance Risk Assessment Committee (PRAC).

“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 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 board 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.