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CBER BEST Initiative Seminar Series - Exploring Vaccine Safety Datalink COVID vaccine rapid cycle analysis (RCA) methods
Background: The CBER BEST Initiative Seminar Series is designed to share and discuss recent research of relevance to ongoing and future surveillance activities of CBER regulated products, namely biologics. The series focuses on safety and effectiveness of biologics including vaccines, blood components, blood-derived products, tissues and advanced therapies. The seminars will provide information on characteristics of biologics, required infrastructure, study designs, and analytic methods utilized for pharmacovigilance and pharmacoepidemiologic studies of biologics. They will also cover information regarding potential data sources, informatics challenges and requirements, utilization of real-world data and evidence, and risk-benefit analysis for biologic products. The length of each session may vary, and the presenters will be invited from outside FDA. Please see the details below for our upcoming seminar. Anyone can register and join for free. Stay tuned for more details and additional webinars during the year.

Topic: Exploring Vaccine Safety Datalink COVID vaccine rapid cycle analysis (RCA) methods

Description: We will review statistical methods used in observational studies of the safety and effectiveness of COVID-19
vaccines. Topics will include:
• How to compare recent vaccines with concurrent comparators (unvaccinated or less recently vaccinated) and
• with comparators who are not concurrent (historical rates or self-controls) to make inferences about outcome rates
• that would be expected among vaccinees had they not been vaccinated
• Methods for estimating risk ratios
• How to examine change in vaccine effectiveness (waning) or vaccine safety over time-since-vaccination
• Sequential tests

Presenter: Nicola P. Klein, MD, PhD

Oct 20, 2021 11:00 AM in Eastern Time (US and Canada)

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