Evidence map›Paper›PMID 34453703›Full record

ReviewPharmaceutical medicine2021

The Emergency Use Authorization of Pharmaceuticals: History and Utility During the COVID-19 Pandemic.

Allan Tran, Theodore J Witek

Abstract readHistorical ArticleReview
In one paragraph

Review in Pharmaceutical medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed.

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  14. A validated UHPLC-MS/MS method for simultaneous quantification of some repurposed COVID-19 drugs in rat plasma: Application to a pharmacokinetic study.Microchemical journal : devoted to the application of microtechniques in all branches of science · 2022
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Allan TranInstitute of Health Policy, Management, and Evaluation, University of Toronto, 155 College Street, Suite 425, Toronto, M5T 3M6, Canada.
Theodore J WitekInstitute of Health Policy, Management, and Evaluation, University of Toronto, 155 College Street, Suite 425, Toronto, M5T 3M6, Canada. Ted.Witek@utoronto.ca.ORCID 0000-0002-1399-2702

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The Emergency Use Authorization (EUA) originated in 2004 because of the need for emergency medical countermeasures (MCMs) against potential bioterrorist attacks. The EUA also proved useful in dealing with subsequent pandemics and has emerged as a critical regulatory pathway for therapeutics and vaccines throughout the Coronavirus Disease 2019 (COVID-19) pandemic. With the EUA process in the USA, we witnessed emergency authorizations, their expansions, as well as withdrawal of previously authorized products, which exemplifies the dynamic nature of scientific review of EUA products. EUAs proved vital for the first group of COVID-19 vaccines, including the temporary pause of one vaccine while emergency safety issues were evaluated. Although this review on the EUA is primarily focused on the USA, distinctions were made with other jurisdictions such as Europe and Canada with respect to the emergency authorizations of the vaccines. Finally, we discuss some important differences following EUA and formal new drug/vaccine application (NDA/BLA) approvals.

Indexed as

Antiviral AgentsBioterrorismCanadaCivil DefenseCOVID-19COVID-19 Drug TreatmentCOVID-19 VaccinesDrug ApprovalEmergenciesEuropeHistory, 21st CenturyHumansPandemicsUnited StatesAntiviral AgentsCOVID-19 Vaccines

Identifiers

PMID34453703
PMCPMC8401346

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.