Challenges in implementing yearly enhanced safety surveillance of influenza vaccination in Europe: lessons learned and future perspectives

Abstract

Seasonal influenza vaccines are frequently reformulated, leading to specific challenges for continuous benefit/risk monitoring. In 2014, the European Medicines Agency started requiring annual enhanced safety surveillance (ESS). This article provides a perspective on ESS studies conducted ever since and aims to map existing initiatives used to monitor adverse events following influenza immunization. Of 11 ESS studies, reporting surveillance data of at least five different vaccine brands during four seasons, all were able to rapidly capture vaccine-specific adverse events of interest reports. However, challenges have been identified during study implementation, including recruitment of sufficient participants, enrolling younger age groups, collecting data of vaccine batch numbers, comparing observed with expected rates and achieving adequate return of reported events. Harmonizing safety monitoring standards across countries, and bridging between routine pharmacovigilance and ESS, is likely to allow more comprehensive assessments of influenza vaccine safety, requiring close collaboration between regulators, public health, and manufacturers.

Keywords: European Medicines Agency; Pharmacovigilance; adverse events following immunization; enhanced safety surveillance; influenza vaccine; safety signal.

Figure 1.

Challenges in implementing ESS in the EU. AEFI: adverse event following immunization; AERC: adverse event reporting card; ESS: enhanced safety surveillance; EU: European Union