Abstract Objectives Despite concerted efforts, Mycobacterium tuberculosis (M. tb), the
pathogen that causes tuberculosis (TB), continues to be a burden on global health …

Introduction During the COVID-19 pandemic, EMA set-up a large-scale cohort event
monitoring (CEM) system to estimate incidence rates of patient-reported adverse drug …

The pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
led to urgent actions by innovators, vaccine developers, regulators, and other stakeholders …

The successful deployment of safe and effective vaccines against coronavirus disease 2019
(COVID-19) has been crucial in reducing the global disease burden. Owing to the need for …

Introduction During the signal detection process, statistical methods are used to identify drug–
event combinations (DECs) which are disproportionately reported when compared with …

Concerns remain regarding the rare cardiovascular adverse events, myocarditis and
pericarditis (myo/pericarditis), particularly in younger individuals following mRNA COVID-19 …

The rapid and large-scale roll-out of new COVID-19 vaccines has led to unprecedented
challenges in assessing vaccine safety. In 2021, the European Medicines Agency (EMA) …

Italian occupational physicians (OPs) are instrumental in promoting vaccination practice in
occupational settings, and this study aims to characterize their attitudes, knowledge, and …

The evolution of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the
waning of immunity over time has necessitated the use of booster doses of original …

A s of January 5, 2023, there have been 657,430,133 confirmed cases of COVID-19,
including 6,676,645 deaths, reported to World Health Organization [1]. To control COVID-19 …