The world has been hit by the COVID-19 pandemic since late 2019.
The BPE, with its network of European partners, has been involved in research on COVID-19 since then, in particular on the evaluation of COVID-19 vaccine safety.
As a member of VAC4EU, the BPE took part to ACCESS, a project funded by the European Medicines Agency (EMA) that aimed to prepare a European infrastructure to monitor COVID-19 vaccines. This project, conducted between May 2020 and February 2021 delivered a List of Adverse events of special interest for COVID-19 vaccine safety assessment with their corresponding background rates in several countries in Europe, a set of template protocols for vaccine safety and effectiveness evaluation, and a feasibility assessment of countries to participate in these studies.
The BPE actively worked to the implementation of the ACCESS protocol related to Cohort event monitoring of COVID-19 vaccines in France through the EVANESCO project ‘Cohort event monitoring of COVID-19 vaccine safety in France using patient-reported outcomes’, which received the “National Research Priority” label on COVID-19 research from the French Ministry of Health and Solidarity. EVANESCO aims to establish a cohort of more than 11 000 vaccinated French people who will be followed during 6 months after their 1st vaccine injection, to assess actual rate of potential adverse reactions in real life settings and to strengthen the evaluation of the COVID-19 vaccines benefice-risk balance.
The BPE also provides its expertise in the analysis of SNDS data in the frame of the CONSIGN project funded by the EMA to study the impact of COVID-19 on pregnant women.