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

Dal-Ré, Rafael

Dal-Ré, Rafael.

Dal-Ré R; Epidemiology Unit, Health Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid, Madrid, Spain. Electronic address: rafael.dalre@quironsalud.es.

Vaccine ; 39(8): 1180-1182, 2021 02 22.

Article in English | MEDLINE | ID: covidwho-1039582

Subject(s)

COVID-19 Vaccines; COVID-19/prevention & control; Drug Approval/methods; Randomized Controlled Trials as Topic/standards; United States Food and Drug Administration; Clinical Trials, Phase III as Topic; Humans; Randomized Controlled Trials as Topic/ethics; United States

Keywords

COVID-19; Candidate vaccines; Clinical trials; Emergency use authorization; Expanded access; FDA; Phase 3 trials; SARS-CoV-2

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Full text: Available Collection: International databases Database: MEDLINE Main subject: United States Food and Drug Administration / Randomized Controlled Trials as Topic / Drug Approval / COVID-19 Vaccines / COVID-19 Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Country/Region as subject: North America Language: English Journal: Vaccine Year: 2021 Document Type: Article

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