Problem being addressed: The rapid development and introduction of numerous COVID-19 vaccines spurred by an ongoing pandemic has required rapid safety and effectiveness evaluations using real-world data. Worldwide deployment of vaccines through different regulatory pathways in countries with variable systems for active and passive surveillance has raised numerous challenges for vaccine manufacturers, regulators, health care delivery systems, and public health authorities, especially as these evaluations will be required concurrently for multiple products utilizing different vaccine platforms, some never before used in human vaccines. The rapid timetable required development and implementation of real-world data systems while considerable unknowns remains regarding vaccine approval, recommendations, distribution, and use. Creative solutions have been required to gather accurate data on vaccine exposure and outcomes, develop methodologically sound approaches to analyze the data, and communicate results to an increasingly skeptical public. The valuable lessons learned through these experiences will be shared through this session to the world-wide community of pharmacoepidemiologists.
Why is this a topic of interest? The effectiveness and safety of COVID-19 vaccines are of universal interest. Researchers from all sectors are actively engaged in this topic.
Rationale for Hot Topic Suggestion: COVID-19 is affecting the entire globe, currently, and mass vaccination of billions of people with novel vaccines based on previously unused vaccine technologies is expected.
