Vaccine-associated enhanced disease: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data
Усиленное заболевание, ассоциированное с вакцинацией: определение случая и рекомендации по сбору, анализу и представлению данных о безопасности иммунизации
2021-02-23
SCID: 54.1/mnt7nr4s
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Brighton Collaboration case definitionSARS-CoV-2 vaccinesadverse events following immunizationimmunization safety datavaccine-associated enhanced disease
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Abstract (AI)
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.
Key Findings
1
Experts convened by CEPI created a consensus definition and graded levels of diagnostic certainty through literature review and expert consultation.
2
The definition was developed to support evaluation of vaccine safety, particularly during SARS-CoV-2 and other emerging-pathogen vaccine development.
3
The paper establishes a Brighton Collaboration case definition for vaccine-associated enhanced disease as an adverse event following immunization.
4
The proposed case definition underwent peer review by the Brighton Collaboration Network and selected expert reviewers before submission.
Research Object
vaccine-associated enhanced disease as an adverse event following immunization
Research Subject
case definition, levels of diagnostic certainty, and guidelines for collecting, analyzing, and presenting immunization safety data
Publication Details
Publication Date
2021-02-23
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