Review

.2021 May 21;39(22):3053-3066.

doi: 10.1016/j.vaccine.2021.01.055. Epub 2021 Feb 23.

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

Flor M Munoz¹, Jakob P Cramer², Cornelia L Dekker³, Matthew Z Dudley⁴, Barney S Graham⁵, Marc Gurwith⁶, Barbara Law⁷, Stanley Perlman⁸, Fernando P Polack⁹, Jonathan M Spergel¹⁰, Eva Van Braeckel¹¹, Brian J Ward¹², Arnaud M Didierlaurent¹³, Paul Henri Lambert¹³; Brighton Collaboration Vaccine-associated Enhanced Disease Working Group

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.

PMID:33637387
PMCID: PMC7901381
DOI: 10.1016/j.vaccine.2021.01.055

Review

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

Flor M Munoz et al. Vaccine.2021.

.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.

PMID:33637387
PMCID: PMC7901381
DOI: 10.1016/j.vaccine.2021.01.055

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.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: F. M. Munoz is a consultant for the Coalition for Epidemic Preparedness Innovations (CEPI) for the development of Brighton Collaboration Case Definitions for the Safety Platform for Emergency vACcines (SPEAC) Project. J. Cramer is a member of the Coalition for Epidemic Preparedness Innovations (CEPI). C. Dekker is a consultant for the Coalition for Epidemic Preparedness Innovations (CEPI) via Brighton Collaboration for the Safety Platform for Emergency vACcines (SPEAC) Project and a consultant for Medicago Inc. M. Dudley is a consultant for the Coalition for Epidemic Preparedness Innovations (CEPI) via Brighton Collaboration, for the Safety Platform for Emergency vACcines (SPEAC) Project. B. Graham is inventor on pending patent applications related to coronavirus vaccines and monoclonal antibodies. M. Gurwith is a consultant for the Coalition for Epidemic Preparedness Innovations (CEPI) via Brighton Collaboration for the Safety Platform for Emergency vACcines (SPEAC) Project; and is Chief Medical Officer for Verndari, Inc., which is developing vaccines for influenza and Covid-19. S. Perlman is a member of the ACIP COVID-19 Vaccine Work Group. F. Polack is an investigator in the Pfizer's COVID-19 vaccine trial. B. Ward is Chief Medical Officer for Medicago Inc., which is developing vaccines for influenza and Covid-19. PH Lambert is a consultant for the Coalition for Epidemic Preparedness Innovations (CEPI) for the development of Case Definitions in the Brighton Collaboration format and for DSMB members training. He is also member of several vaccine DSMBs. The following authors have no conflict of interests to disclose: J. Spergel, B. Law, E. Van Braeckel, A. Didierlaurent.

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

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