Emergency Use Authorizations for COVID-19 Therapeutics: The Good, the Bad, and the Data-Deficient

Trials that have followed have had mixed results and while the WHO's SOLIDARITY study did not show a mortality benefit for remdesivir, the results that led to the EUA have not been invalidated. Bamlanivimab was approved after a phase 2 outpatient study looking primarily at reductions in viral l...

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Bibliographic Details
Published inContagion Vol. 5; no. 6
Format Journal Article
LanguageEnglish
Published Cranbury MultiMedia Healthcare Inc 19.12.2020
Subjects
Coronaviruses
COVID-19 vaccines
Emergency medical care
Pandemics
Severe acute respiratory syndrome coronavirus 2
United States > US
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Summary:Trials that have followed have had mixed results and while the WHO's SOLIDARITY study did not show a mortality benefit for remdesivir, the results that led to the EUA have not been invalidated. Bamlanivimab was approved after a phase 2 outpatient study looking primarily at reductions in viral load also found lower rates of combined hospitalization and emergency room visits (1.6% vs 6.3%). With ill-defined guidance, they can also be subject to political interference, as was alleged in the jockeying between the FDA and White House in October over criteria for EUAs for COVID-19 vaccines, and which may have played a part in the hydroxychloroquine EUA.
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ISSN:1553-538X