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FDA COVID – 19 Update

February 12, 2021

The U.S. Food and Drug Administration, today, announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • This week, the FDA posted the webpage, COVID-19 Vaccine Safety Surveillance, which provides an overview of our active and passive systems used to monitor the safety of authorized COVID-19 vaccines. The FDA’s Center for Biologics Evaluation and Research is conducting these surveillance efforts in collaboration with the Centers for Disease Control and Prevention, the Center for Medicare and Medicaid Services, the Department of Veterans Affairs, and other academic and large non-government healthcare data systems.
  • This week, the FDA issued an emergency use authorization (EUA) for a a monoclonal antibody combination for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19.
  • This week, FDA revised its guidance, Investigational COVID-19 Convalescent Plasma and associated web page, to reflect the reissued Emergency Use Authorization for COVID-19 convalescent plasma.  Specifically, the guidance provides recommendations to blood establishments on the collection and labeling of high titer COVID-19 convalescent plasma under the EUA. In addition, the revisions address when individuals who have received an investigational COVID-19 monoclonal therapy as a participant in a clinical trial, or received an authorized or licensed COVID-19 monoclonal antibody therapy, qualify as convalescent plasma donors.
  • Testing updates:
    • As of today, 327 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 243 molecular tests and sample collection devices, 70 antibody tests, and 14 antigen tests. There are 35 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, one antigen prescription at-home test, and one over-the-counter (OTC) at-home antigen test.
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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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