Improved post-marketing safety surveillance of quadrivalent inactivated influenza vaccine in Mexico using a computerized, SMS-based follow-up system

Abstract

Quadrivalent influenza vaccines (QIVs) are designed to prevent influenza disease caused by two influenza A viruses (H1N1 and H3N2) and both influenza B lineages. Risk-monitoring of QIVs to identify adverse events (AEs) is necessary as influenza vaccines are reformulated each year. We developed a new active surveillance system (Sistema de Control de Vacunación; SICOVA) to improve pharmacovigilance in Mexico. Participants (N = 2013) aged 0 − 96 years from nine sites across three influenza seasons (n

Enhanced safety surveillance of GSK's quadrivalent seasonal influenza vaccine in Germany and Spain (2021/2022 season) using an electronic patient‐reported outcome system for vaccine safety remote monitoring

“…Although the electronic ADR completion rate was lower than traditional active studies, 20 or web‐based intensive monitoring, 21 the completion rate in this study falls within the range observed in other surveillance studies using an e‐PRO system. 22 , 23 , 24 Therefore, e‐PRO systems can still be used to collect safety information, for example, to limit the burden of work for sites or to monitor safety when a site visit is not possible, for example, during COVID‐19 lockdowns.…”