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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 Munoz  1 , Jakob P Cramer  2 , Cornelia L Dekker  3 , Matthew Z Dudley  4 , Barney S Graham  5 , Marc Gurwith  6 , Barbara Law  7 , Stanley Perlman  8 , Fernando P Polack  9 , Jonathan M Spergel  10 , Eva Van Braeckel  11 , Brian J Ward  12 , Arnaud M Didierlaurent  13 , Paul Henri Lambert  13 ; Brighton Collaboration Vaccine-associated Enhanced Disease Working Group
Affiliations
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. .

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.

References

    1. Graham B.S. Rapid COVID-19 vaccine development. Science (New York, NY) 2020;368(6494):945–946. - PubMed
    1. Acosta P.L., Caballero M.T., Polack F.P. Brief History and Characterization of Enhanced Respiratory Syncytial Virus Disease. Clin Vaccine Immunol: CVI. 2015;23(3):189–195. - PMC - PubMed
    1. Jorquera P.A., Anderson L., Tripp R.A. Understanding respiratory syncytial virus (RSV) vaccine development and aspects of disease pathogenesis. Expert Rev Vaccines. 2016;15(2):173–187. - PubMed
    1. Vittucci A.C., Zangari P., Ciarlitto C., Di Camillo C., Grandin A., Cotugno N., et al. Active prophylaxis for respiratory syncytial virus: current knowledge and future perspectives. Minerva Pediatr. 2018;70(6):566–578. - PubMed
    1. Moss W.J., Polack F.P. Immune responses to measles and measles vaccine: challenges for measles control. Viral Immunol. 2001;14(4):297–309. - PubMed

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