Europe – Pharmacovigilance Plan of the EU Regulatory Network for COVID-19 Vaccines

Since its emergence in 2019, the SARS-Cov2 virus has spread to almost every country making the COVID-19 pandemic a global health crisis.

COVID-19 vaccines once available are expected to play a major role in the control of the pandemic. While developed at unprecedented speed, they will only be authorised by European Union (EU) authorities if their benefits outweigh their risks based on data on efficacy, safety and quality.

During the development phase of any medicine, a limited number of selected participants are included in clinical trials and followed up for a relatively short duration under controlled conditions. As a result, certain side effects, particularly rare or very rare ones, only emerge during real life use in many different people. It is therefore essential to closely monitor the safety and effectiveness of any medicine after it is authorised…