Hector S. Izurieta, MD, MPH, PhD, is an Associate Director for Novel Clinical Investigations at the Office of Vaccine Research and Review (OVRR), in CBER, FDA. He has extensive U.S. and international vaccine research and public health experience, having also worked at CDC (including in the EIS program), PAHO, WHO, Médecins Sans Frontières and other organizations. His publications include over 90 manuscripts on COVID-19, Influenza, Herpes Zoster, Measles, Tetanus, Diphtheria, Pertussis, and on vaccine and real-world evidence study methods.