Current Approaches to Vaccine Safety Using Observational Data: A Rationale for the EUMAEUS (Evaluating Use of Methods for Adverse Events Under Surveillance-for Vaccines) Study Design

Lai, Lana Yin Hui, Faculty of Biology, Medicine and Health, Manchester, Greater Manchester, United Kingdom; Arshad, Faaizah, UCLA Fielding School of Public Health, Los Angeles, CA, United States; Areia, Carlos, University of Oxford Medical Sciences Division, Oxford, Oxfordshire, United Kingdom; Alshammari, Thamir M., King Saud University, Riyadh, Riyad, Saudi Arabia; Alghoul, Heba, Faculty of Medicine, Islamic University of Gaza, Gaza, Palestine; Casajust, Paula, Trial Form Support, Real-World Evidence, Barcelona, Spain; Li, Xintong, University of Oxford Medical Sciences Division, Oxford, Oxfordshire, United Kingdom; Dawoud, Dalia M., Faculty of Pharmacy, Cairo University, Cairo, Cairo, Egypt; Nyberg, Fredrik, School of Public Health and Community Medicine, Sahlgrenska Akademin, Gothenburg, Vastra Gotaland, Sweden; Pratt, Nicole L., Clinical and Health Sciences, University of South Australia, Adelaide, SA, Australia; Hripcsak, George M., Department of Biomedical Informatics, Columbia University, New York, NY, United States; Suchard, Marc A., UCLA Fielding School of Public Health, Los Angeles, CA, United States, David Geffen School of Medicine at UCLA, Los Angeles, CA, United States; Prieto-Alhambra, Daniel, University of Oxford Medical Sciences Division, Oxford, Oxfordshire, United Kingdom, Department of Medical Informatics, Erasmus MC, Rotterdam, Zuid-Holland, Netherlands; Ryan, Patrick Barry, Department of Biomedical Informatics, Columbia University, New York, NY, United States, Janssen Pharmaceuticals, Inc., Titusville, NJ, United States; Schuemie, Martijn J., UCLA Fielding School of Public Health, Los Angeles, CA, United States, Janssen Pharmaceuticals, Inc., Titusville, NJ, United States