Pilot protocol for influenza vaccine effectiveness against laboratory-confirmed influenza infections using healthcare worker cohorts
In 2020, the European Commission stressed the importance of continuously monitoring the safety and effectiveness of vaccines in the EU/EEA during the post-authorisation phase, with particular emphasis on COVID-19 vaccines in the context of the ongoing pandemic.
Executive Summary
Previously, the 2018 Council Recommendation on Strengthened Cooperation against Vaccine-preventable Diseases asked ECDC and the European Medicines Agency (EMA) to cooperate in ensuring the continued monitoring of vaccines and vaccination used in EU/EEA vaccination programmes. Such a request was subsequently formalised as part of the extended EMA regulatory mandate and ECDC’s newly amended mandate, requiring the two Agencies to develop a structured and independent post-authorisation vaccine monitoring platform, initially prioritising COVID-19 vaccines. ECDC and EMA officially established and launched such a platform in May 2022, with the intention of bringing together public health and regulatory experts to discuss the studies needed to generate real-life evidence on the safety and effectiveness of vaccines used in EU/EEA immunisation programmes.
