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Approaches to Demonstrate Vaccine Effectiveness

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Approaches to Demonstrate Vaccine Effectiveness

June 18, 2020 at 12:30 PM - 1:45 PM

It is getting more difficult for some vaccines to be licensed on the basis of traditional randomized controlled trial demonstrations of efficacy against disease. This session will cover the latest thinking about clinical trial designs and approaches to demonstrate vaccine effectiveness to support licensure (including use of biomarkers predictive of protection, human challenge studies, and real world evidence).


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June 18, 2020
12:30 PM - 1:45 PM


Jeffrey N. Roberts, MD
Job Title:
Associate Director, Office of Vaccines Research and Review, CBER
US Food and Drug Administration
Natalie E. Dean, PhD
Job Title:
Assistant Professor
University of Florida
Alicia M. Fry, MD, MPH
Job Title:
Chief, Epidemiology and Prevention Branch, Influenza Division
Centers for Disease Control and Prevention