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 : 000244The 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 :
- Vaccine [ 1873-2518 ] ; 2020.
Descripteurs français
- KwdFr :
- Appréciation des risques (méthodes), Appréciation des risques (normes), Humains (MeSH), Infections à coronavirus (génétique), Infections à coronavirus (prévention et contrôle), Opinion publique (MeSH), Vaccins antiviraux (effets indésirables), Vaccins antiviraux (génétique), Vaccins antiviraux (normes), Vaccins à ADN (effets indésirables), Vaccins à ADN (génétique), Vaccins à ADN (normes).
- MESH :
- effets indésirables : Vaccins antiviraux, Vaccins à ADN.
- génétique : Infections à coronavirus, Vaccins antiviraux, Vaccins à ADN.
- méthodes : Appréciation des risques.
- normes : Appréciation des risques, Vaccins antiviraux, Vaccins à ADN.
- prévention et contrôle : Infections à coronavirus.
- Humains, Opinion publique.
English descriptors
- KwdEn :
- COVID-19 Vaccines (MeSH), Coronavirus Infections (genetics), Coronavirus Infections (prevention & control), Humans (MeSH), Public Opinion (MeSH), Risk Assessment (methods), Risk Assessment (standards), Vaccines, DNA (adverse effects), Vaccines, DNA (genetics), Vaccines, DNA (standards), Viral Vaccines (adverse effects), Viral Vaccines (genetics), Viral Vaccines (standards).
- MESH :
- chemical , adverse effects : Vaccines, DNA, Viral Vaccines.
- chemical , genetics : Vaccines, DNA, Viral Vaccines.
- chemical , standards : Vaccines, DNA, Viral Vaccines.
- chemical : COVID-19 Vaccines.
- genetics : Coronavirus Infections.
- methods : Risk Assessment.
- prevention & control : Coronavirus Infections.
- standards : Risk Assessment.
- Humans, Public Opinion.
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:
- Corée du Sud, Royaume-Uni, États-Unis
- Californie, Floride, Géorgie (États-Unis), Maryland, Massachusetts, New Jersey, Région capitale de Séoul, Washington (État)
- Seattle, Séoul
- Université de Washington
Links toward previous steps (curation, corpus...)
Le document en format XML
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<front><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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<Month>07</Month>
<Day>20</Day>
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<DateRevised><Year>2021</Year>
<Month>01</Month>
<Day>10</Day>
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<Month>07</Month>
<Day>22</Day>
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<Title>Vaccine</Title>
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<Abstract><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>
<CopyrightInformation>Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Kim</LastName>
<ForeName>Denny</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Janssen Pharmaceuticals, Titusville, NJ, USA.</Affiliation>
</AffiliationInfo>
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<Initials>JS</Initials>
<AffiliationInfo><Affiliation>Independent Adviser, United Kingdom.</Affiliation>
</AffiliationInfo>
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<ForeName>Jean-Louis</ForeName>
<Initials>JL</Initials>
<AffiliationInfo><Affiliation>International Vaccine Institute, Seoul, Republic of Korea.</Affiliation>
</AffiliationInfo>
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<ForeName>Richard C</ForeName>
<Initials>RC</Initials>
<AffiliationInfo><Affiliation>Department of Molecular Genetics and Microbiology, University of Florida, Gainesville, FL 32610, USA.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Fast</LastName>
<ForeName>Patricia E</ForeName>
<Initials>PE</Initials>
<AffiliationInfo><Affiliation>International AIDS Vaccine Initiative, New York, NY 10004, USA; Stanford School of Medicine, Palo Alto, CA 94305, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Gurwith</LastName>
<ForeName>Marc</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Brighton Collaboration, A Program of the Task Force for Global Health, Decatur, GA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Pavlakis</LastName>
<ForeName>George</ForeName>
<Initials>G</Initials>
<AffiliationInfo><Affiliation>National Cancer Institute, National Institutes of Health, Frederick, MD 21702, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Monath</LastName>
<ForeName>Thomas P</ForeName>
<Initials>TP</Initials>
<AffiliationInfo><Affiliation>Crozet BioPharma LLC, Devens, MA 01434, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Smith</LastName>
<ForeName>Jonathan</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>VLP Therapeutics, Gaithersburg, MD 20878, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Wood</LastName>
<ForeName>David</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Independent Adviser, United Kingdom.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Smith</LastName>
<ForeName>Emily R</ForeName>
<Initials>ER</Initials>
<AffiliationInfo><Affiliation>Brighton Collaboration, A Program of the Task Force for Global Health, Decatur, GA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Chen</LastName>
<ForeName>Robert T</ForeName>
<Initials>RT</Initials>
<AffiliationInfo><Affiliation>Brighton Collaboration, A Program of the Task Force for Global Health, Decatur, GA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Kochhar</LastName>
<ForeName>Sonali</ForeName>
<Initials>S</Initials>
<AffiliationInfo><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>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016454">Review</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2020</Year>
<Month>06</Month>
<Day>19</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>Netherlands</Country>
<MedlineTA>Vaccine</MedlineTA>
<NlmUniqueID>8406899</NlmUniqueID>
<ISSNLinking>0264-410X</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList><Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D000086663">COVID-19 Vaccines</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D019444">Vaccines, DNA</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D014765">Viral Vaccines</NameOfSubstance>
</Chemical>
</ChemicalList>
<CitationSubset>IM</CitationSubset>
<MeshHeadingList><MeshHeading><DescriptorName UI="D000086663" MajorTopicYN="N">COVID-19 Vaccines</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D018352" MajorTopicYN="N">Coronavirus Infections</DescriptorName>
<QualifierName UI="Q000235" MajorTopicYN="N">genetics</QualifierName>
<QualifierName UI="Q000517" MajorTopicYN="N">prevention & control</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D011639" MajorTopicYN="N">Public Opinion</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D018570" MajorTopicYN="N">Risk Assessment</DescriptorName>
<QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName>
<QualifierName UI="Q000592" MajorTopicYN="N">standards</QualifierName>
</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>
</MeshHeading>
<MeshHeading><DescriptorName UI="D014765" MajorTopicYN="N">Viral Vaccines</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName UI="Q000235" MajorTopicYN="Y">genetics</QualifierName>
<QualifierName UI="Q000592" MajorTopicYN="Y">standards</QualifierName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM"><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>
</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year>
<Month>05</Month>
<Day>04</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="revised"><Year>2020</Year>
<Month>06</Month>
<Day>02</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted"><Year>2020</Year>
<Month>06</Month>
<Day>05</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="pubmed"><Year>2020</Year>
<Month>6</Month>
<Day>24</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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<PubMedPubDate PubStatus="medline"><Year>2020</Year>
<Month>7</Month>
<Day>21</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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<PubMedPubDate PubStatus="entrez"><Year>2020</Year>
<Month>6</Month>
<Day>24</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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</History>
<PublicationStatus>ppublish</PublicationStatus>
<ArticleIdList><ArticleId IdType="pubmed">32571717</ArticleId>
<ArticleId IdType="pii">S0264-410X(20)30789-1</ArticleId>
<ArticleId IdType="doi">10.1016/j.vaccine.2020.06.017</ArticleId>
<ArticleId IdType="pmc">PMC7304391</ArticleId>
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<ReferenceList><Reference><Citation>Vaccines (Basel). 2019 Apr 24;7(2):</Citation>
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</ReferenceList>
</PubmedData>
</pubmed>
<affiliations><list><country><li>Corée du Sud</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
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<li>Floride</li>
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<li>Massachusetts</li>
<li>New Jersey</li>
<li>Région capitale de Séoul</li>
<li>Washington (État)</li>
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<orgName><li>Université de Washington</li>
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<tree><country name="États-Unis"><region name="New Jersey"><name sortKey="Kim, Denny" sort="Kim, Denny" uniqKey="Kim D" first="Denny" last="Kim">Denny Kim</name>
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<name sortKey="Condit, Richard C" sort="Condit, Richard C" uniqKey="Condit R" first="Richard C" last="Condit">Richard C. Condit</name>
<name sortKey="Fast, Patricia E" sort="Fast, Patricia E" uniqKey="Fast P" first="Patricia E" last="Fast">Patricia E. Fast</name>
<name sortKey="Gurwith, Marc" sort="Gurwith, Marc" uniqKey="Gurwith M" first="Marc" last="Gurwith">Marc Gurwith</name>
<name sortKey="Kochhar, Sonali" sort="Kochhar, Sonali" uniqKey="Kochhar S" first="Sonali" last="Kochhar">Sonali Kochhar</name>
<name sortKey="Monath, Thomas P" sort="Monath, Thomas P" uniqKey="Monath T" first="Thomas P" last="Monath">Thomas P. Monath</name>
<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>
<name sortKey="Smith, Jonathan" sort="Smith, Jonathan" uniqKey="Smith J" first="Jonathan" last="Smith">Jonathan Smith</name>
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<country name="Royaume-Uni"><noRegion><name sortKey="Robertson, James S" sort="Robertson, James S" uniqKey="Robertson J" first="James S" last="Robertson">James S. Robertson</name>
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<name sortKey="Wood, David" sort="Wood, David" uniqKey="Wood D" first="David" last="Wood">David Wood</name>
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<country name="Corée du Sud"><region name="Région capitale de Séoul"><name sortKey="Excler, Jean Louis" sort="Excler, Jean Louis" uniqKey="Excler J" first="Jean-Louis" last="Excler">Jean-Louis Excler</name>
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