Vaccine-associated enhanced disease: Case definition and guidelines for data collection,analysis, and presentation of immunization safety data |
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| Institution: | 1. Departments of Pediatrics, Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA;2. Coalition for Epidemic Preparedness Innovations, CEPI, London, UK;3. Department of Pediatrics, Stanford University School of Medicine, CA, USA;4. Institute for Vaccine Safety, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA;5. Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, USA;6. Safety Platform for Emergency Vaccines, Los Altos Hills, CA, USA;7. Safety Platform for Emergency Vaccines, Manta, Ecuador;8. Department of Microbiology and Immunology, Department of Pediatrics, University of Iowa, USA;9. Fundacion Infant, Argentina;10. Division of Allergy and Immunology, Children’s Hospital of Philadelphia, Department of Pediatrics, Perelman School of Medicine at University of Pennsylvania, PA, USA;11. Department of Respiratory Medicine, Ghent University Hospital, and Department of Internal Medicine and Paediatrics, Ghent University, Ghent, Belgium;12. Research Institute of the McGill University Health Center, Montreal, Quebec, Canada;13. Center of Vaccinology, University of Geneva, Switzerland |
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| Abstract: | This is a Brighton Collaboration Case Definition of the term “Vaccine Associated Enhanced Disease” to be utilized in the evaluation of adverse events following immunization. The Case Definition was developed by a group of experts convened by the Coalition for Epidemic Preparedness Innovations (CEPI) in the context of active development of vaccines for SARS-CoV-2 vaccines and other emerging pathogens. The case definition format of the Brighton Collaboration was followed to develop a consensus definition and defined levels of certainty, after an exhaustive review of the literature and expert consultation. The document underwent peer review by the Brighton Collaboration Network and by selected Expert Reviewers prior to submission. |
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| Keywords: | Adverse event Immunization Guidelines Case definition Vaccine Enhanced disease Respiratory Systemic disease |
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