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1000 Titel
  • Regulatory concepts to guide and promote the accelerated but safe clinical development and licensure of COVID-19 vaccines in Europe
1000 Autor/in
  1. Wagner, Ralf |
  2. Meißner, Juliane |
  3. Grabski, Elena |
  4. Sun, Yuansheng |
  5. Vieths, Stefan |
  6. hildt, eberhard |
1000 Erscheinungsjahr 2021
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2021-04-22
1000 Erschienen in
1000 Quellenangabe
  • 77(1):72-82
1000 FRL-Sammlung
1000 Copyrightjahr
  • 2021
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1111/all.14868 |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8251031/ |
1000 Publikationsstatus
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1000 Abstract/Summary
  • The ongoing COVID-19 pandemic caused by the SARS-CoV-2 coronavirus has affected the health of tens of millions of people worldwide. In particular, in elderly and frail individuals the infection can lead to severe disease and even fatal outcomes. Although the pandemic is primarily a human health crisis its consequences are much broader with a tremendous impact on global economics and social systems. Vaccines are considered the most powerful measure to fight the pandemic and protect people from COVID-19. Based on the concerted activities of scientists, manufacturers and regulators, the urgent need for effective countermeasures has provoked the development and licensure of novel COVID-19 vaccines in an unprecedentedly fast and flexible manner within <1 year. To ensure the safety and efficacy of these novel vaccines during the clinical development and the routine use in post-licensure vaccination campaigns existing regulatory requirements and procedures had to be wisely and carefully adapted to allow for an expedited evaluation without compromising the thoroughness of the regulatory and scientific assessment. In this review, we describe the regulatory procedures, concepts and requirements applied to guide and promote the highly accelerated development and licensure of safe and efficacious COVID-19 vaccines in Europe.
1000 Sacherschließung
gnd 1206347392 COVID-19
lokal COVID-19 pandemic
lokal vaccine
lokal regulatory requirements
lokal clinical trial
lokal licensure
1000 Fächerklassifikation (DDC)
1000 Liste der Beteiligten
  1. https://orcid.org/0000-0003-4100-2830|https://orcid.org/0000-0002-1218-2337|https://d-nb.info/gnd/1032134410|https://frl.publisso.de/adhoc/uri/IFN1biwgWXVhbnNoZW5n|https://d-nb.info/gnd/143949705|https://orcid.org/0000-0002-3020-9564
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1000 Erstellt am 2022-03-16T11:39:25.110+0100
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1000 Zuletzt bearbeitet Wed May 04 09:13:37 CEST 2022
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