SW-1G - What can pharmacoepidemiologists do to enhance vaccine confidence?

Background: Misinformation about vaccines, particularly since the COVID-19 pandemic, has increased, and vaccine confidence has declined. It is critically important for pharmacoepidemiologists to generate real world evidence on vaccine effects. This symposium assembles experts with a range of perspectives to consider challenges and opportunities to improve the design, interpretation, and communication of vaccine real-world data (RWD) studies. We will discuss how specific methodology and international guidance coupled with a focus on equity, and combined with purposeful dissemination, can improve vaccine confidence. We will address RWD-based vaccine safety and effectiveness research broadly, beyond regulatory requirements.

Objectives: 1) Identify data, methods, and approaches that support causal inference and generate robust findings, including those not routinely used in vaccine studies; 2) Discuss specific population groups that have been underserved by vaccine research to date, and what data are needed to include those populations in clinical trials and RWD studies; 3) Engage the audience to consider our responsibility as researchers to disseminate and effectively communicate study findings to support vaccine confidence. Those interested in non-interventional vaccine studies are the target audience.

Description: This symposium will begin with an orientation to the topic by Dr. Robert Chen. Three 15-min presentations will follow: Drs. Noelle Cocoros and Vincent Lo Re, using RSV vaccines as a use case, will highlight data and analytic issues that must be considered given the current climate. Prof. Dani Prieto-Alhambra will discuss approaches to confounding resolution not often used in vaccine studies, illustrated in studies focused on underrepresented populations (e.g., nursing home residents, pregnant persons). Dr. Catherine Cohet will present a case study in vaccine communication from the European Medicines Agency and will discuss how data quality and methods considered adequate by regulatory agencies can ultimately support vaccine confidence.
A 40-min panel discussion will include audience engagement. The panelists (Drs. Robert Chen, Daniel Salmon) will respond to the speakers, comment on additional subjects, and address audience questions. Panelist topics will include:
● The need to study endpoints of interest to the public and all target populations
● How to optimize vaccine benefit-risk communications
● Changing recommendations regarding vaccine safety in the US. The symposium will conclude with a summary of key recommendations.