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The U.S. FDA CBER BEST Initiative is hosting a seminar with guest speaker Nicola P. Klein on October 20th, 2021 11-12 pm ET. The seminar will review statistical methods used in observational studies of the safety and effectiveness of COVID-19 vaccines.
Topics will 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
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. Â
Nicola P. Klein, MD, PhD, is a board-certified Pediatrician, Director of the Kaiser Permanente Vaccine Study Center, Research Scientist III at the Kaiser Permanente Northern California Division of Research, and a Professor in the Department of Health Systems Science at the Kaiser Permanente Bernard J. Tyson School of Medicine. Her research has focused on vaccine safety and effectiveness, genetics of vaccine responses, vaccine safety among special populations and the epidemiology of vaccine preventable diseases. She had led observational studies investigating the effectiveness of many vaccines, including pivotal studies describing waning effectiveness of acellular pertussis vaccines in children and adolescents. She is principal investigator (PI) for both industry and federally sponsored Phase 2 and 3 vaccine clinical trials, including mRNA COVID-19 vaccines, and is the PI for the CDC-sponsored Clinical Immunization Safety Assessment Network and Vaccine Safety Datalink (VSD) Project. She is currently leading the VSD COVID-19 vaccines Rapid Cycle Analysis (RCA), which monitors the safety of vaccines in near real-time and is the CDC’s primary active surveillance safety monitoring system for COVID-19 vaccines. She currently serves on the Western States Scientific Safety Review Workgroup for COVID-19 vaccines. Dr. Klein received her medical and doctorate degrees at New York University School of Medicine.
