US FDA erratic approach to placebo-controlled trials after issuing an emergency use authorization for a COVID-19 vaccine.

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Tytuł:: US FDA erratic approach to placebo-controlled trials after issuing an emergency use authorization for a COVID-19 vaccine.
Autorzy:: Dal-Ré R; Epidemiology Unit, Health Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid, Madrid, Spain. Electronic address: .
Źródło:: Vaccine [Vaccine] 2021 Feb 22; Vol. 39 (8), pp. 1180-1182. Date of Electronic Publication: 2021 Jan 20.
Typ publikacji:: Journal Article
Język:: English
Imprint Name(s):: Publication: Amsterdam, The Netherlands : Elsevier Science
Original Publication: [Guildford, Surrey, UK] : Butterworths, [c1983-
MeSH Terms:: COVID-19 Vaccines*
United States Food and Drug Administration*
COVID-19/*prevention & control
Drug Approval/*methods
Randomized Controlled Trials as Topic/*standards
Clinical Trials, Phase III as Topic ; Humans ; Randomized Controlled Trials as Topic/ethics ; United States
References:: Clin Pharmacol Ther. 2008 May;83(5):788-93. (PMID: 17882160)
JAMA. 2020 Aug 4;324(5):437-438. (PMID: 32628244)
Lancet Respir Med. 2021 Apr;9(4):e30-e31. (PMID: 33476582)
N Engl J Med. 2020 Oct 29;383(18):1701-1703. (PMID: 32846056)
Ann Intern Med. 2021 Feb;174(2):258-260. (PMID: 33216636)
N Engl J Med. 2020 Nov 5;383(19):e107. (PMID: 33064383)
Contributed Indexing:: Keywords: COVID-19; Candidate vaccines; Clinical trials; Emergency use authorization; Expanded access; FDA; Phase 3 trials; SARS-CoV-2
Substance Nomenclature:: 0 (COVID-19 Vaccines)
Entry Date(s):: Date Created: 20210131 Date Completed: 20210224 Latest Revision: 20221221
Update Code:: 20240104
PubMed Central ID:: PMC7817401
DOI:: 10.1016/j.vaccine.2021.01.050
PMID:: 33516602
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Competing Interests: Declaration of Competing Interest The author declare that he has no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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