Prior to deployment of coronavirus disease 2019 (COVID‐19) vaccines in the European
Union in 2021, a high vaccine uptake leading to an unprecedented volume of safety data …

Pharmacovigilance (PV) came suddenly into the spotlight when several new vaccines,
developed as a response to the COVID-19 pandemic, received emergency authorisation …

Vaccines against COVID-19 are being developed at speeds not previously achieved. With
this unprecedented effort comes challenges for post-marketing safety monitoring and …

Abstract Background In May 2020, the ACCESS (The vACCine covid-19 monitoring
readinESS) project was launched to prepare real-world monitoring of COVID-19 vaccines …

Introduction COVID-19 vaccines were rapidly authorised, thus requiring intense post-
marketing re-evaluation of their benefit-risk profile. A multi-national European collaboration …

Background The coronavirus disease 2019 (COVID-19) vaccines have been rapidly
implemented in national vaccination programs world-wide after accelerated approval …

In this special issue, we present the main highlights of the first weeks of pharmacovigilance
monitoring of coronavirus disease 2019 (COVID-19) vaccines in this unprecedented …

Background The rapid process of research and development and lack of follow-up time post-
vaccination aroused great public concern about the safety profile of COVID-19 vaccine …

Background Real‐world experience with adenoviral vector vaccines against COVID‐19
raised some safety concerns. Cases of cerebral vein thrombosis (CVT) associated with …

Multiple preventive COVID-19 vaccines have been developed during the ongoing SARS
coronavirus (CoV) 2 pandemic, utilizing a variety of technology platforms, which have …