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Coronavirus (COVID-19) Update: May 21, 2021

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The U.S. Meals and Drug Administration (FDA) continued to take motion within the ongoing response to the COVID-19 pandemic:

  • The FDA issued a reminder to well being care suppliers to provide clear, step-by-step directions to sufferers who, in a well being care setting, self-collect anterior nasal samples for SARS-CoV-2 testing. With out correct directions, sufferers might not gather an sufficient pattern for testing, which can lower the sensitivity of the take a look at.
  • The FDA issued a security communication to remind well being care suppliers and the general public that outcomes from presently licensed SARS-CoV-2 antibody exams shouldn’t be used to guage an individual’s stage of immunity or safety from COVID-19 at any time, and particularly after the particular person acquired a COVID-19 vaccination. The FDA additionally up to date the Serology/Antibody Assessments: FAQs on Testing for SARS-CoV-2 and the Antibody (Serology) Testing for COVID-19: Info for Sufferers and Customers net pages to offer up to date data on using SARS-CoV-2 antibody take a look at outcomes.
  • The FDA up to date the definition of excessive danger for COVID-19 to incorporate further medical situations and elements related to elevated danger for development to extreme illness. This replace applies to the emergency use authorizations (EUAs) for REGEN-COV (Casirivimab and Imdevimab) and Bamlanivimab and Etesevimab. Extra data is accessible within the truth sheets for every EUA:
  • The FDA’s Scientific Methodologies Group inside CDER’s Workplace of Medical Coverage acquired a $9.2 million grant by way of the HHS Workplace of the Assistant Secretary for Planning and Analysis’s (ASPE) Affected person Centered Outcomes Analysis Belief Fund. The ASPE grant will fund enlargement of the CURE ID platform to facilitate automated assortment of de-identified knowledge from digital well being data and medical illness registries worldwide for COVID-19 and different difficult-to-treat infectious ailments.
  • As a part of the FDA’s effort to guard customers, on Might 19, 2021, the company issued a warning letter collectively with the Federal Commerce Fee to BGP, LLC for promoting an unapproved product with unproven COVID-19 claims. Customers involved about COVID-19 ought to seek the advice of with their well being care supplier.
  • Testing updates:
    • As of right now, 376 exams and pattern assortment units are licensed by the FDA below emergency use authorizations (EUAs). These embrace 272 molecular exams and pattern assortment units, 79 antibody and different immune response exams, and 25 antigen exams. There are 50 molecular authorizations and one antibody authorization that can be utilized with home-collected samples. There may be one molecular prescription at-home take a look at, two antigen prescription at-home exams, 4 antigen over-the-counter (OTC) at-home exams, and two molecular OTC at-home exams.
    • The FDA has licensed 9 antigen exams and 4 molecular exams for serial screening packages. The FDA has additionally licensed 508 revisions to EUA authorizations.

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The FDA, an company throughout the U.S. Division of Well being and Human Companies, protects the general public well being by assuring the protection, effectiveness, and safety of human and veterinary medication, vaccines and different organic merchandise for human use, and medical units. The company is also liable for the protection and safety of our nation’s meals provide, cosmetics, dietary dietary supplements, merchandise that give off digital radiation, and for regulating tobacco merchandise.


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