Understanding the role of observed vs. expected observational studies in vaccine safety

Helen Petousis-Harris, BSc, PGDipSci (Dist), PhD and Karin Batty, RN, PGDipPH (Dist)

Vaccines are a cornerstone of public health, providing protection against many infectious diseases. Vaccine safety monitoring is an important aspect of ensuring that vaccines are safe and effective. In this blog, we will discuss observed versus (vs.) expected observational studies, which are commonly used tools to actively monitor vaccine safety.

The next generation of pharmacovigilance

Robert T Chen, MD MA

Historically, much of the safety assessment of a new vaccine was deferred to post-introduction. Safety assessments within pre-approval clinical trials tended to be separate from post-approval Real-World evidence (RWE). There were barriers to implementing a vaccine lifecycle approach, including a disconnect between separate teams and staff for pre- versus post-approval. Applicability in low- and middle-income countries (LMICs) and high-income countries (HICs) was also limited. In fact, LMICs were often missing large administrative datasets.