Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Presentation. CBER Plans for Monitoring COVID-19 Vaccine Safety and Effectiveness

by Steve Anderson, PhD, MPP Director, Office of Biostatistics & Epidemiology, CBER | Dec 20, 2022 | C19 (COVID-19), VC19 (VACCINES COVID-19), VS (VACCINE SAFETY)

Motivation

FDA. Presentation to VRBPAC by CBER on 22 October 2020 (prior to EUA), wrt Plans for Monitoring COVID-19 Vaccine Safety and Effectiveness. NB Slide on page 17 – DRAFT Working list of possible adverse event outcomes. Remarkably close correlation with subsequent VAERS reports.

Author

Steve Anderson, PhD, MPP Director, Office of Biostatistics & Epidemiology, CBER

Submitted By

Dr Herman Edeling

Supported By

Dr Stephen Schmidt

Type of Article

FDA Slide Presentation