Video-on-Demand Library

10 December 2020

Dr. Scott Patterson

Traditional vaccine clinical development is an undertaking involving meticulous, multiple studies in multiple populations at risk of infection and disease over multiple years. SARS-CoV-2 and COVID-19 vaccine development is following this traditional development pathway, but accelerated Phase I-II-III clinical programs are being applied (c.f., USA FDA guidances 2020). This is not the first time vaccines have been manufactured and tested quickly to meet a public health crisis (1976, 2009). Selected statistical concepts pertaining to vaccine efficacy and safety, relevant during the design and implementation of such crisis programs, are discussed.

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