SPEAC held a webinar on April 24th, 2023, on the use of background rates for observed/expected analysis. The event gathered 250 attendees from various organizations in over 60 countries worldwide.
The webinar was divided into three informative presentations on the topic. Miriam Sturkenboom from SPEAC opened the webinar with her presentation on the background rates of AESI for COVID-19 and their application. Next, Brendan Day from the US FDA-CBER discussed the use of background rates and observed/expected analyses in COVID-19 vaccine safety surveillance. Finally, Maria Gordillo Maranon and Catherine Cohet from EMA gave a presentation on observed-to-expected analyses of COVID-19 vaccines.
After the presentations, the audience participated in a Q&A session where they had the opportunity to ask the speakers questions on their presentations and their perspectives on the use of background rates for observed/expected analysis in COVID-19 vaccine safety surveillance.