Sean O'Leary, MD¹, Jason Glanz, PhD², David McClure, PhD², Aysha Akhtar, MD, MPH³, Matthew F. Daley, MD⁴, Cynthia Nakasato, MD⁵, Roger Baxter, MD⁶, Robert Davis, MD, MPH⁷, Hector Izurieta, MD, MPH⁸, Tracy Lieu, MD, MPH⁹ and Robert Ball, MD, MPH³, 1Department of Pediatrics, University of Colorado Denver, Aurora, CO, 2Institute for Health Research, Kaiser Permanente Colorado, Denver, CO, 3Center for Biologics Evaluation and Research, Food and Drug Administration, 4Kaiser Permanente Colorado, Institute for Health Research, Denver, CO, 5Center for Health Research Hawaii, Kaiser Permanente Hawaii, 6Kaiser Permanente Vaccine Study Center, Oakland, CA, 7Center for Health Research Southeast, Kaiser Permanente of Georgia, 8Center for Biologics Evaluation and Research, FDA, Washington D.C, DC, 9Ambulatory Care and Prevention, Harvard Pilgrim Health Care