Vaccine Trials? Oh My

Speaker: Dr. Dean Follmann

National Institute of Allergy and Infectious Diseases

Dean Follmann earned degrees in Mathematics from Elgin Community College and Northern Illinois University. He received a PhD in Statistics from Carnegie Mellon University in 1985. His career began at the Center for Naval Analyses, a think tank for the Navy, followed by stints within the National Institutes of Health, where he founded the Biostatistics Research Branch at the National Institute of Allergy and Infectious Diseases in 2002. He has authored over 250 peer-reviewed manuscripts and is a Fellow of the American Statistical Association and the Society for Clinical Trials. He serves on committees and advisory boards for the FDA, NIH, philanthropic organizations, and academic departments. Current research interests include vaccinology, emerging infectious diseases, and causality.

Abstract:

Entering the world of randomized vaccine trials can feel like Alice stepping through the looking glass; familiar features and principles of trials become shifted. Vaccine trials often don’t follow the intention to treat principle, have non—zero null hypothesis, give an irrelevant vaccine instead of a placebo, randomize healthy people, celebrate surrogate endpoints, and involve communicable diseases which can lead to indirect vaccine effects on the placebo group. In short, a treasure trove of problems for an eager statistician. This talk will tour the curious world of vaccine trials and discuss multiple issues that arose during the Operation Warp Speed Covid-19 vaccine trials.