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CBER BEST Initiative Seminar Series - Methods for Monitoring the Safety and Effectiveness of COVID-19 vaccines
Methods for Monitoring the Safety and Effectiveness of COVID-19 vaccines

We review statistical methods used in observational studies of the safety and effectiveness of COVID-19 vaccines. Topics include:

- How to compare recent vaccinees 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

Presented by: Bruce Fireman, MA - Kaiser Permanente

Jun 16, 2021 11:00 AM in Eastern Time (US and Canada)

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