2. Clinical Trials, Red Tape & Regulators

The Vax Files

In this second episode, experts talk about what goes into designing a clinical trial, how they are set up to give answers and where they can be flawed. We'll look at a few key questions about the ongoing Covid-19 vaccine trials including the vaccines being set up to show protection against mild disease versus severe disease and how releasing results early may raise some concerns in how we can interpret the results. Experts also discuss the regulators that approve the vaccines and their tough position to release a new vaccine to the public on limited data and very tight review timelines amid the pressure of a pandemic. Expert Guests:

-- Dr Deborah Fuller is a Professor of Microbiology at The University of Washington School of Medicine. A veteran vaccinologist and researcher, she has been working on vaccine development for the last 30 years with specific research around DNA and RNA technologies.

-- Dr Michael Kurilla is the Director of the Division of Clinical Innovation at the National Center for Advancing Translational Sciences, US National Institute of Health. He has been a member of the advisory committee for vaccines and related biologics since 2018.

-- Dr Scott Evans is a Professor and Founding Chair of The Department of Biostatistics and Bioinformatics at George Washington University. He is a former member of an FDA advisory committee and a member of the steering committee of the clinical trials transformation initiative.

-- Dr Nikolai Petrovsky is a Professor of Medicine, Flinders University in Australia and vice-president and secretary general of the International Immunomics Society. He is the founder of vaccine biotech Vaccine, which has a protein based candidate in early development for Covid-19.

-- Dr Gregory Gray is a Professor at Duke University and infectious disease epidemiologist with three affiliations: Duke Global Health Institute, Division of Infectious Diseases, and Duke Nicholas School of Environment. He was on the FDA advisory committee for vaccines and related biologics between 2010-2013.