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.