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The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of nucleic acid (RNA and DNA) vaccines.

Identifieur interne : 000243 ( Main/Exploration ); précédent : 000242; suivant : 000244

The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of nucleic acid (RNA and DNA) vaccines.

Auteurs : Denny Kim [États-Unis] ; James S. Robertson [Royaume-Uni] ; Jean-Louis Excler [Corée du Sud] ; Richard C. Condit [États-Unis] ; Patricia E. Fast [États-Unis] ; Marc Gurwith [États-Unis] ; George Pavlakis [États-Unis] ; Thomas P. Monath [États-Unis] ; Jonathan Smith [États-Unis] ; David Wood [Royaume-Uni] ; Emily R. Smith [États-Unis] ; Robert T. Chen [États-Unis] ; Sonali Kochhar [États-Unis]

Source :

RBID : pubmed:32571717

Descripteurs français

English descriptors

Abstract

Nucleic acid (DNA and RNA) vaccines are among the most advanced 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 nucleic acid vaccines. This will facilitate the assessment by key stakeholders of potential safety issues and understanding of overall benefit-risk. The structured assessment provided by the template can also help improve communication and public acceptance of licensed nucleic acid vaccines.

DOI: 10.1016/j.vaccine.2020.06.017
PubMed: 32571717
PubMed Central: PMC7304391


Affiliations:


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<div type="abstract" xml:lang="en">Nucleic acid (DNA and RNA) vaccines are among the most advanced 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 nucleic acid vaccines. This will facilitate the assessment by key stakeholders of potential safety issues and understanding of overall benefit-risk. The structured assessment provided by the template can also help improve communication and public acceptance of licensed nucleic acid vaccines.</div>
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<AbstractText>Nucleic acid (DNA and RNA) vaccines are among the most advanced 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 nucleic acid vaccines. This will facilitate the assessment by key stakeholders of potential safety issues and understanding of overall benefit-risk. The structured assessment provided by the template can also help improve communication and public acceptance of licensed nucleic acid vaccines.</AbstractText>
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<Initials>G</Initials>
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<ForeName>Thomas P</ForeName>
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<ForeName>Jonathan</ForeName>
<Initials>J</Initials>
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<Initials>D</Initials>
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<LastName>Smith</LastName>
<ForeName>Emily R</ForeName>
<Initials>ER</Initials>
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<ForeName>Sonali</ForeName>
<Initials>S</Initials>
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<Affiliation>Global Healthcare Consulting, New Delhi, India; University of Washington, Seattle, WA 98195, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<CollectiveName>Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG)</CollectiveName>
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<Year>2020</Year>
<Month>06</Month>
<Day>19</Day>
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<Country>Netherlands</Country>
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<NlmUniqueID>8406899</NlmUniqueID>
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<DescriptorName UI="D018352" MajorTopicYN="N">Coronavirus Infections</DescriptorName>
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</MeshHeading>
<MeshHeading>
<DescriptorName UI="D019444" MajorTopicYN="N">Vaccines, DNA</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName>
<QualifierName UI="Q000235" MajorTopicYN="N">genetics</QualifierName>
<QualifierName UI="Q000592" MajorTopicYN="Y">standards</QualifierName>
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<MeshHeading>
<DescriptorName UI="D014765" MajorTopicYN="N">Viral Vaccines</DescriptorName>
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<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">DNA</Keyword>
<Keyword MajorTopicYN="Y">Nucleic acid</Keyword>
<Keyword MajorTopicYN="Y">RNA</Keyword>
<Keyword MajorTopicYN="Y">Safety</Keyword>
<Keyword MajorTopicYN="Y">Template</Keyword>
<Keyword MajorTopicYN="Y">Vaccine</Keyword>
</KeywordList>
<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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<Month>05</Month>
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<Year>2020</Year>
<Month>06</Month>
<Day>02</Day>
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<Year>2020</Year>
<Month>06</Month>
<Day>05</Day>
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<Reference>
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<ArticleIdList>
<ArticleId IdType="pubmed">31022829</ArticleId>
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</Reference>
<Reference>
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<ArticleIdList>
<ArticleId IdType="pubmed">19056451</ArticleId>
</ArticleIdList>
</Reference>
</ReferenceList>
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<li>Californie</li>
<li>Floride</li>
<li>Géorgie (États-Unis)</li>
<li>Maryland</li>
<li>Massachusetts</li>
<li>New Jersey</li>
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<li>Washington (État)</li>
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<name sortKey="Pavlakis, George" sort="Pavlakis, George" uniqKey="Pavlakis G" first="George" last="Pavlakis">George Pavlakis</name>
<name sortKey="Smith, Emily R" sort="Smith, Emily R" uniqKey="Smith E" first="Emily R" last="Smith">Emily R. Smith</name>
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