Acute respiratory distress syndrome (ARDS) as an adverse event following immunization: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data.

ARDS Acute respiratory distress syndrome Adult Adverse event COVID-19 Case definition Guidelines Immunization Pediatric

Journal

Vaccine
ISSN: 1873-2518
Titre abrégé: Vaccine
Pays: Netherlands
ID NLM: 8406899

Informations de publication

Date de publication:
21 05 2021
Historique:
received: 08 01 2021
accepted: 20 01 2021
pubmed: 16 2 2021
medline: 28 5 2021
entrez: 15 2 2021
Statut: ppublish

Résumé

This is a Brighton Collaboration Case Definition of the term "Acute Respiratory Distress Syndrome - ARDS" 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. The comments of the reviewers were taken into consideration and edits incorporated in this final manuscript.

Identifiants

pubmed: 33583673
pii: S0264-410X(21)00092-X
doi: 10.1016/j.vaccine.2021.01.053
pmc: PMC7843093
pii:
doi:

Substances chimiques

COVID-19 Vaccines 0

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

3028-3036

Informations de copyright

Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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Auteurs

Nathan A Serazin (NA)

Department of Pediatrics, Section of Critical Care Medicine, Baylor College of Medicine and Texas Children's Hospital, Houston, TX, USA.

Bassey Edem (B)

Department of Vaccines and Immunity, Medical Research Council the Gambia Unit at the London School of Hygiene and Tropical Medicine, UK.

Sarah R Williams (SR)

Division of Pulmonary and Critical Care Medicine, University of Maryland School of Medicine, Baltimore, MD, USA.

Justin R Ortiz (JR)

Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.

Anand Kawade (A)

King Edward Memorial Hospital Research Centre, Vadu Rural Health Program Pune, India.

Manoj Kumar Das (MK)

The INCLEN Trust International, New Delhi, India.

Maja Šubelj (M)

National Institute of Public Health, University of Ljubljana, Slovenia.

Kathryn M Edwards (KM)

Division of Infectious Diseases, Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.

Shreemanta K Parida (SK)

CureVac AG, Frankfurt, Germany.

T Anh Wartel (TA)

International Vaccine Institute, Seoul, Republic of Korea.

Flor M Munoz (FM)

Departments of Pediatrics, Section of Infectious Diseases, and Molecular Virology and Microbiology, Baylor College of Medicine and Texas Children's Hospital, Houston, TX, USA.

Patricia Bastero (P)

Department of Pediatrics, Section of Critical Care Medicine, Baylor College of Medicine and Texas Children's Hospital, Houston, TX, USA. Electronic address: pxbaster@texaschildrens.org.

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