Online Program

Statistical Observations on Vaccine Clinical Development for Pandemic Diseases (302455)

Fabrice Bailleux, Sanofi Pasteur 
Josh Chen, Sanofi Pasteur 
*Bo Fu, Sanofi Pasteur 
Ya Meng, Sanofi Pasteur 
Scott Patterson, Sanofi Pasteur 

Keywords: SARS-CoV-2, COVID-19, vaccine, pandemic

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, and accelerated Phase I-II-III clinical programs are being applied. This is not the first time vaccines have been manufactured and tested quickly to meet a public health crisis. Selected statistical concepts pertaining to vaccine efficacy and safety, relevant during the design and implementation of such clinical development programs, will be discussed.