Kathryn M. Edwards, MD, is Professor of Pediatrics Emerita at Vanderbilt University in Nashville, TN in the USA. She has led many of the pivotal clinical trials of vaccines licensed over the past several decades and has played a major role in their implementation and evaluation. Dr. Edwards has extensive experience leading NIH-funded multicenter initiatives and designing, conducting, and analyzing Phase I, II, and III clinical trials of vaccines and therapeutics. She has also conducted studies on maternal pertussis vaccines. She has facilitated collaboration among basic and clinical investigators with diverse expertise and has mentored many investigators who now lead vaccine research programs worldwide. She joined the Vanderbilt Vaccine Program in 1980 and directed it for many years, including serving as Director of the NIH-funded Vaccine Treatment and Evaluation Unit at Vanderbilt. She also led the CDC-funded Center for Immunization Safety Assessment site at Vanderbilt, where she and her colleagues evaluated adverse events associated with vaccines in individuals of all ages. In addition, she conducted comprehensive pneumonia surveillance studies in adults and children and established the New Vaccine Surveillance Network at Vanderbilt. Dr. Edwards has served on numerous committees for the CDC, NIH, FDA, WHO, and the Infectious Diseases Society of America (IDSA), including as Chair of the FDA’s Vaccines and Related Biological Products Advisory Committee. She continues to serve on several Data Safety and Monitoring Committees. In 2008, Dr. Edwards was elected to the Institute of Medicine of the National Academy of Sciences. Her honors include the IDSA Mentor Award (2006), the Maureen Andrews Mentoring Award from the Society for Pediatric Research (2014), the Maxwell Finland Award for Scientific Accomplishments (2018), the Frank Morriss Leadership Award in Pediatrics (2019), and the Howland Award from the American Pediatric Society (2020). She remains active in serving on Data Safety and Monitoring Boards assessing the safety and effectiveness of vaccines and monoclonal antibodies and in mentoring the next generation of vaccine scientists.