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1000 Titel
  • WHO informal consultation on regulatory considerations for evaluation of the quality, safety and efficacy of RNA-based prophylactic vaccines for infectious diseases, 20-22 April 2021
1000 Autor/in
  1. Liu, Margaret A. |
  2. Zhou, Tiequn |
  3. Sheets, Rebecca L. |
  4. Meyer, Heidi |
  5. Knezevic, Ivana |
1000 Erscheinungsjahr 2022
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2022-01-31
1000 Erschienen in
1000 Quellenangabe
  • 11(1):384-391
1000 FRL-Sammlung
1000 Copyrightjahr
  • 2022
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1080/22221751.2022.2026742 |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8812800 |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • This paper presents the key outcomes of the above WHO informal consultation with global stakeholders including regulatory authorities, vaccine developers and manufacturers, academia and other international health organizations and institutions involved in the development, evaluation and use of messenger RNA (mRNA) vaccines. The aim of the consultation was to further clarify the main principles to be presented in an upcoming WHO guidance document on the regulatory considerations in evaluating the quality, safety and efficacy of mRNA prophylactic vaccines for infectious diseases. This WHO guidance document is intended to facilitate global mRNA vaccine development and regulatory convergence in the assessment of such vaccines. The urgent need to develop such a document as a new WHO written standard is outlined in this report along with the key scientific and regulatory challenges. A number of key conclusions are provided at the end of this report along with an update on the steps taken following this meeting.
1000 Sacherschließung
gnd 1206347392 COVID-19
lokal infectious diseases
lokal WHO
lokal regulatory considerations
lokal mRNA vaccines
lokal prophylactic vaccines
1000 Fächerklassifikation (DDC)
1000 Liste der Beteiligten
  1. https://frl.publisso.de/adhoc/uri/TGl1LCBNYXJnYXJldCBBLg==|https://frl.publisso.de/adhoc/uri/WmhvdSwgVGllcXVu|https://frl.publisso.de/adhoc/uri/U2hlZXRzLCBSZWJlY2NhIEwu|https://d-nb.info/gnd/1252253737|https://frl.publisso.de/adhoc/uri/S25lemV2aWMsIEl2YW5h
1000 Label
1000 Förderer
  1. U.S. Food and Drug Administration |
1000 Fördernummer
  1. U01 FD005959
1000 Förderprogramm
  1. -
1000 Dateien
1000 Förderung
  1. 1000 joinedFunding-child
    1000 Förderer U.S. Food and Drug Administration |
    1000 Förderprogramm -
    1000 Fördernummer U01 FD005959
1000 Objektart article
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1000 @id frl:6431707.rdf
1000 Erstellt am 2022-02-21T10:11:12.956+0100
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1000 Zuletzt bearbeitet Fri Mar 04 11:39:13 CET 2022
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