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The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of inactivated viral vaccines.

Identifieur interne : 000244 ( Main/Exploration ); précédent : 000243; suivant : 000245

The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of inactivated viral vaccines.

Auteurs : Sonali Kochhar [États-Unis] ; Jean-Louis Excler [Corée du Sud] ; Denny Kim [États-Unis] ; James S. Robertson [Royaume-Uni] ; Patricia E. Fast [États-Unis] ; Richard C. Condit [États-Unis] ; Stephen Drew [États-Unis] ; David Wood [Royaume-Uni] ; Marc Gurwith [États-Unis] ; Bettina Klug [Allemagne] ; Mike Whelan [Royaume-Uni] ; Najwa Khuri-Bulos [Jordanie] ; Tamala Mallett Moore [États-Unis] ; Emily R. Smith [États-Unis] ; Robert T. Chen [États-Unis]

Source :

RBID : pubmed:32747214

Descripteurs français

English descriptors

Abstract

Inactivated viral vaccines have long been used in humans for diseases of global health threat and are now among the vaccines for COVID-19 under development. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) has prepared a standardized template to describe the key considerations for the benefit-risk assessment of inactivated viral vaccines. This will help key stakeholders to assess potential safety issues and understand the benefit-risk of the vaccine platform. The standardized and structured assessment provided by the template would also help to contribute to improved communication and support public acceptance of licensed inactivated viral vaccines.

DOI: 10.1016/j.vaccine.2020.07.028
PubMed: 32747214
PubMed Central: PMC7834840


Affiliations:


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<term>Pneumopathie virale</term>
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<term>Humans</term>
<term>Immunogenicity, Vaccine</term>
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<term>Appréciation des risques</term>
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<term>Humains</term>
<term>Immunogénicité des vaccins</term>
<term>Protection civile</term>
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<div type="abstract" xml:lang="en">Inactivated viral vaccines have long been used in humans for diseases of global health threat and are now among the vaccines for COVID-19 under development. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) has prepared a standardized template to describe the key considerations for the benefit-risk assessment of inactivated viral vaccines. This will help key stakeholders to assess potential safety issues and understand the benefit-risk of the vaccine platform. The standardized and structured assessment provided by the template would also help to contribute to improved communication and support public acceptance of licensed inactivated viral vaccines.</div>
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<Year>2020</Year>
<Month>09</Month>
<Day>02</Day>
</DateCompleted>
<DateRevised>
<Year>2021</Year>
<Month>01</Month>
<Day>29</Day>
</DateRevised>
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<Journal>
<ISSN IssnType="Electronic">1873-2518</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>38</Volume>
<Issue>39</Issue>
<PubDate>
<Year>2020</Year>
<Month>09</Month>
<Day>03</Day>
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</JournalIssue>
<Title>Vaccine</Title>
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<ArticleTitle>The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of inactivated viral vaccines.</ArticleTitle>
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<AbstractText>Inactivated viral vaccines have long been used in humans for diseases of global health threat and are now among the vaccines for COVID-19 under development. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) has prepared a standardized template to describe the key considerations for the benefit-risk assessment of inactivated viral vaccines. This will help key stakeholders to assess potential safety issues and understand the benefit-risk of the vaccine platform. The standardized and structured assessment provided by the template would also help to contribute to improved communication and support public acceptance of licensed inactivated viral vaccines.</AbstractText>
<CopyrightInformation>Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.</CopyrightInformation>
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<LastName>Kochhar</LastName>
<ForeName>Sonali</ForeName>
<Initials>S</Initials>
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<Affiliation>Global Healthcare Consulting, New Delhi, India; University of Washington, Seattle, WA, USA.</Affiliation>
</AffiliationInfo>
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<ForeName>Jean-Louis</ForeName>
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<Affiliation>International Vaccine Institute, Seoul, Republic of Korea.</Affiliation>
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<LastName>Kim</LastName>
<ForeName>Denny</ForeName>
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<ForeName>Patricia E</ForeName>
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<Affiliation>International AIDS Vaccine Initiative, New York, NY, USA; Stanford School of Medicine, Palo Alto, CA, USA.</Affiliation>
</AffiliationInfo>
</Author>
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<Affiliation>Department of Molecular Genetics and Microbiology, University of Florida, Gainesville, FL, USA.</Affiliation>
</AffiliationInfo>
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</AffiliationInfo>
</Author>
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</Author>
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<ForeName>Bettina</ForeName>
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<Affiliation>Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Whelan</LastName>
<ForeName>Mike</ForeName>
<Initials>M</Initials>
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</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Khuri-Bulos</LastName>
<ForeName>Najwa</ForeName>
<Initials>N</Initials>
<AffiliationInfo>
<Affiliation>University of Jordan, Amman, Jordan.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Mallett Moore</LastName>
<ForeName>Tamala</ForeName>
<Initials>T</Initials>
<AffiliationInfo>
<Affiliation>Sanofi Pasteur, Swiftwater, PA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Smith</LastName>
<ForeName>Emily R</ForeName>
<Initials>ER</Initials>
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<Affiliation>Brighton Collaboration, A Program of the Task Force for Global Health, Decatur, GA, USA.</Affiliation>
</AffiliationInfo>
</Author>
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<ForeName>Robert T</ForeName>
<Initials>RT</Initials>
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<CollectiveName>Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG). Electronic address: brightoncollaborationv3swg@gmail.com</CollectiveName>
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<Language>eng</Language>
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<Year>2020</Year>
<Month>07</Month>
<Day>31</Day>
</ArticleDate>
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<Country>Netherlands</Country>
<MedlineTA>Vaccine</MedlineTA>
<NlmUniqueID>8406899</NlmUniqueID>
<ISSNLinking>0264-410X</ISSNLinking>
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<ChemicalList>
<Chemical>
<RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D000086663">COVID-19 Vaccines</NameOfSubstance>
</Chemical>
<Chemical>
<RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D015164">Vaccines, Inactivated</NameOfSubstance>
</Chemical>
<Chemical>
<RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D014765">Viral Vaccines</NameOfSubstance>
</Chemical>
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<MeshHeading>
<DescriptorName UI="D000073640" MajorTopicYN="N">Betacoronavirus</DescriptorName>
<QualifierName UI="Q000187" MajorTopicYN="N">drug effects</QualifierName>
<QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName>
<QualifierName UI="Q000472" MajorTopicYN="N">pathogenicity</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D000086382" MajorTopicYN="N">COVID-19</DescriptorName>
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<MeshHeading>
<DescriptorName UI="D000086663" MajorTopicYN="N">COVID-19 Vaccines</DescriptorName>
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<MeshHeading>
<DescriptorName UI="D002959" MajorTopicYN="N">Civil Defense</DescriptorName>
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<DescriptorName UI="D018352" MajorTopicYN="N">Coronavirus Infections</DescriptorName>
<QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName>
<QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName>
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<MeshHeading>
<DescriptorName UI="D061214" MajorTopicYN="N">Patient Safety</DescriptorName>
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<DescriptorName UI="D011024" MajorTopicYN="N">Pneumonia, Viral</DescriptorName>
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<MeshHeading>
<DescriptorName UI="D018570" MajorTopicYN="Y">Risk Assessment</DescriptorName>
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<DescriptorName UI="D000086402" MajorTopicYN="N">SARS-CoV-2</DescriptorName>
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<MeshHeading>
<DescriptorName UI="D015164" MajorTopicYN="N">Vaccines, Inactivated</DescriptorName>
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<MeshHeading>
<DescriptorName UI="D014765" MajorTopicYN="N">Viral Vaccines</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
<QualifierName UI="Q000096" MajorTopicYN="N">biosynthesis</QualifierName>
<QualifierName UI="Q000592" MajorTopicYN="Y">standards</QualifierName>
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<Keyword MajorTopicYN="Y">Benefit-risk</Keyword>
<Keyword MajorTopicYN="Y">Brighton Collaboration</Keyword>
<Keyword MajorTopicYN="Y">CEPI</Keyword>
<Keyword MajorTopicYN="Y">COVID-19</Keyword>
<Keyword MajorTopicYN="Y">Inactivated</Keyword>
<Keyword MajorTopicYN="Y">Safety</Keyword>
<Keyword MajorTopicYN="Y">Template</Keyword>
<Keyword MajorTopicYN="Y">Vaccine</Keyword>
<Keyword MajorTopicYN="Y">Virus</Keyword>
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<CoiStatement>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.</CoiStatement>
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