Vaccine-associated enhanced disease: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data

Flor M Munoz; Jakob P Cramer; Cornelia L Dekker; Matthew Z Dudley; Barney S Graham; Marc Gurwith; Barbara Law; Stanley Perlman; Fernando P Polack; Jonathan M Spergel; Eva Van Braeckel; Brian J Ward; Arnaud M Didierlaurent; Paul Henri Lambert; Brighton Collaboration Vaccine-associated Enhanced Disease Working Group

doi:10.1016/j.vaccine.2021.01.055

Vaccine-associated enhanced disease: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data

Vaccine. 2021 May 21;39(22):3053-3066. doi: 10.1016/j.vaccine.2021.01.055. Epub 2021 Feb 23.

Authors

Affiliations

¹ Departments of Pediatrics, Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA. Electronic address: florm@bcm.edu.
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.

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.

Keywords: Adverse event; Case definition; Enhanced disease; Guidelines; Immunization; Respiratory; Systemic disease; Vaccine.

Publication types

Research Support, Non-U.S. Gov't
Review

MeSH terms

COVID-19 Vaccines
COVID-19*
Data Collection
Humans
Immunization / adverse effects
SARS-CoV-2
Vaccines* / adverse effects

Substances

COVID-19 Vaccines
Vaccines